Hi
I have an XSLT that transfroms some XML however I only need those records that have either the following Key attribute values, I would also like these grouped togther. Can someone help - thx. (XML /XSLT below)
Indexes/Index/ReportEvent/@Key = 'licensing agreement' ">
Indexes/Index/ReportEvent/@Key = 'licensing offer' ">
Indexes/Index/ReportEvent/@Key = 'pc launch' ">
-XML-----
<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<!DOCTYPE DrugNews PUBLIC "drugnews.dtd" "drugnews.dtd">
<DrugNews>
<Report Key="134871" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MAb, solid tumor, Daiichi Sankyo/Seattle Genetics, licensing agreement</Title>
<Text>Seattle Genetics announced on 8 July 2008 that it has signed an exclusive, worldwide collaboration agreement with Daiichi Sankyo relating to the development of antibody-drug conjugate (ADC) based therapies targeting a single antigen found on several types of solid tumors. In addition to a US$4 million upfront payment, Seattle Genetics will receive progress-dependent milestone payments and mid-single digit royalties on worldwide net sales of ADC products resulting from the alliance. Responsibility for research, product development, manufacturing and commercialization of all ADC products will reside with Daiichi Sankyo. In exchange for the assistance provided to Daiichi Sankyo in developing ADC products, Seattle Genetics will receive material supply, annual maintenance fees and research support payments. ....Seattle Genetics' proprietary ADC technology uses proprietary linkers and synthetic cytotoxic drugs. The linkers are stable in the bloodstream, releasing the drug payload once inside target tumor cells.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="1">
<Drug Key="2031008">MAb, solid tumor, Daiichi Sankyo/Seattle Genetics</Drug>
<Corporations>
<Corporation>
<Company>Daiichi Sankyo</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="2">
<Drug Key="2031008">MAb, solid tumor, Daiichi Sankyo/Seattle Genetics</Drug>
<Corporations>
<Corporation>
<Company>Seattle Genetics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134872" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MediGene places phase I trial on hold</Title>
<Text>On 8 July 2008 MediGene reported that it has put on hold an ongoing phase I trial evaluating the bioavailability of a new formulation of RhuDex, following the death of a volunteer. One subject experienced a heart problem in the days following treatment with RhuDex, for which hospital treatment was given and the patient was discharged. The volunteer died several days later at home; cause of death and any correlation with administration of RhuDex are being investigated. The 11 other volunteers in this phase I trial have reported only mild side effects such as headaches. ....On 15 July 2008, MediGene published autopsy findings for the deceased volunteer. The subject died of an acute myocardial re-infarction as a result of coronary thrombosis. The individual had experienced several small infarctions prior to the trial. A decision to continue with this trial will not be taken until final analyses of this incident are available. ....RhuDex is an orally active inhibitor of CD80 (B7-1), under development by MediGene for the potential treatment of rheumatoid arthritis and other inflammatory and autoimmune disorders. A recent phase IIa trial of a different formulation of RhuDex demonstrated positive safety data.</Text>
<Indexes>
<Index Counter="3">
<Drug Key="2016237">RhuDex</Drug>
<Corporations>
<Corporation>
<Company>MediGene</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134873" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>Giaconda suspends phase IIa trial</Title>
<Text>Giaconda announced on 8 July 2008 that it has suspended its phase IIa trial of HEPACONDA, a combination of bezafibrate and chenodeoxycholic acid for the treatment of patients with hepatitis C virus (HCV) genotype 1 infection. Results from this study showed that administration of the agent did not result in total normalization of liver function. Gamma-glutamyl transpeptidase (GGT) levels showed an immediate and lasting return to the normal range, and aspartate transaminase (AST) levels were close to the normal range. However, HEPACONDA had minimal effect on viral load and alanine aminotransferase (ALT) levels. No adverse events were reported at the dose used. ....A dose-ranging trial to identify an optimum dose of HEPACONDA is expected to begin once Giaconda secures further funding.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase II)</EventText>
<EventDate>7 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="4">
<Drug Key="2027960">bezafibrate + chenodeoxycholic acid</Drug>
<Corporations>
<Corporation>
<Company>Giaconda</Company>
<Nationality>Australia</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
</Index>
<Index Counter="5">
<Drug Key="2027960">bezafibrate + chenodeoxycholic acid</Drug>
<Corporations>
<Corporation>
<Company>Giaconda</Company>
<Nationality>Australia</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase II)">clinical data (phase II)</ReportEvent>
<ReportEventDate CCYYMMDD="20080707">7 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>hepatitis C</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134874" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>gadoxetic acid, registered</Title>
<Text>On 8 July 2008 Bayer Schering announced that the US FDA has approved gadoxetic acid (EOVIST) for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with suspected or known focal liver disease. ....In January 2008, Bayer Yakuhin launched gadoxetic acid (EOB PRIMOVIST) for the early diagnosis of liver tumors in Japan. The product is marketed across Europe.</Text>
<EventTable>
<EventRow>
<EventText>registered, USA</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="6">
<Drug Key="2007465">gadoxetic acid</Drug>
<Corporations>
<Corporation>
<Company>Bayer</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="6" Key="pc Reg">registered</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>diagnosis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134875" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>REXIN-G, Orphan Drug</Title>
<Text>On 8 July 2008 Epeius announced that the US FDA has granted REXIN-G Orphan Drug designation for the treatment of osteosarcoma. In addition, on 9 July Epeius reported that the product has been granted Orphan Drug status by the FDA for the treatment of all soft tissue sarcomas. ....REXIN-G (Retroviral Expression Vectors Bearing Inhibitory Genes) is a tumor-targeted injectable gene therapy for cancer which consists of Epeius' proprietary targeted vector system containing a proprietary mutant cell-cycle control gene. Epeius is conducting US phase I/II trials of REXIN-G in patients with breast and pancreatic cancers, and in sarcoma. A US phase II trial is ongoing in patients with osteosarcoma.</Text>
<EventTable>
<EventRow>
<EventText>Orphan Drug, USA</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
<EventRow>
<EventText>Orphan Drug, USA</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="7">
<Drug Key="2020206">REXIN-G</Drug>
<Corporations>
<Corporation>
<Company>Epeius</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="Orphan Drug">Orphan Drug</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>bone cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
<Index Counter="8">
<Drug Key="2020206">REXIN-G</Drug>
<Corporations>
<Corporation>
<Company>Epeius</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="Orphan Drug">Orphan Drug</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>soft tissue sarcoma</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134876" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>KYRBAX, preclinical data</Title>
<Text>On 7 July 2008 Hana Biosciences reported preclinical data on its topical menadione (KYRBAX) lotion. In vivo, topical menadione did not affect erlotinib's (TARCEVA) antitumor activity. In vitro studies showed that topical menadione therapy may restore normal cell turnover rates and prevent skin toxicities resulting from inhibition of protein kinases (such as tyrosine kinases MEK, CDK and RAF). ....KYRBAX is undergoing a US/Canadian phase I trial for the treatment and/or prevention of rash associated with epidermal growth factor receptor (EGFR) inhibitor therapy in cancer patients.</Text>
<EventTable>
<EventRow>
<EventText>preclinical data</EventText>
<EventDate>7 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="9">
<Drug Key="2029579">KYRBAX</Drug>
<Corporations>
<Corporation>
<Company>Hana Biosciences</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="preclinical data">preclinical data</ReportEvent>
<ReportEventDate CCYYMMDD="20080707">7 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134878" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>corifollitropin alfa, clinical data (phase III)</Title>
<Text>On 8 July 2008 Schering Plough announced results from a randomized, double-blind, North American and European, phase III fertility trial, designated ENGAGE, designed to determine the non-inferiority of corifollitropin alfa compared with recombinant follicle-stimulating hormone (FSH; follitropin beta) in 1509 patients attending in-vitro-fertilization (IVF) clinics. The co-primary endpoint of ongoing pregnancy rate at least ten weeks after embryo transfer was similar with 150 mcg corifollitropin alfa (38.9% per started cycle) compared with 200 IU recombinant FSH (38.1% per started cycle). The co-primary endpoint of number of oocytes retrieved was within the limits of clinical equivalence, and the estimated difference of +1.2 favored the corifollitropin alfa arm. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar for both treatments, 7.0% in the corifollitropin alfa arm (severe in 1.9%) and 6.3% in the follitropin beta arm (severe in 1.3%). ....Schering Plough is developing corifollitropin alfa, a long-acting FSH molecule, as a therapy for infertility.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase III)</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="10">
<Drug Key="2020802">corifollitropin alfa</Drug>
<Corporations>
<Corporation>
<Company>Schering Plough</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase III)">clinical data (phase III)</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>infertility</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134879" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>bortezomib, clinical data (phase III)</Title>
<Text>At the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA, Millennium (a wholly-owned subsidiary of Takeda) reported results on trials of bortezomib (VELCADE) in patients with newly diagnosed multiple myeloma. In a phase II trial with cyclophosphamide, bortezomib and dexamethasone, a complete remission of 46% was seen before stem cell transplant (SCT) and 72% post-transplant. An overall response rate (partial rate or better) of 95% was observed. ....In a second phase II trial, 86 evaluable patients were treated with bortezomib, pegylated-liposomal-doxorubicin and dexamethasone (VcDD). After autologous stem cell transplant (ASCT), lenalidomide on days 1 to 21 and prednisone every second day for four 28-day cycles were administered. Maintenance therapy was with lenalidomide on days 1-21 every 28 days. A partial response or more was observed in 94% patients. There was a complete remission rate of 21% following four cycles of VcDD which increased to 59% following ASCT. Median progression-free survival and overall survival were not reached at a median follow up of 13.6 months. ....In a randomized, phase III trial of bortezomib plus dexamethasone (VcD) versus vincristine, doxorubicin and dexamethasone (VAD), 95% of VcD versus 92% VAD patients were alive at one year. Corresponding results for complete remission were 19% and 8% as induction therapy. The complete remission rate was 35% in the VcD patients and 23% in VAD patients post-transplantation. A second transplantation was not required in 63% patients in the VcD arm and 44% patients in the VAD arm. ...Bortezomib is a small molecule proteasome inhibitor which is marketed worldwide for myeloma and in the USA for non-Hodgkin lymphoma.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase III)</EventText>
<EventDate>31 May 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="11">
<Drug Key="2011222">bortezomib</Drug>
<Corporations>
<Corporation>
<Company>Takeda</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase III)">clinical data (phase III)</ReportEvent>
<ReportEventDate CCYYMMDD="20080531">31 May 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>myeloma</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134880" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug delivery system, topical diclofenac, Nuvo, licensing agreement modified</Title>
<Text>Nuvo and Paladin announced modifications to their licensing arrangements for topical diclofenac (PENNSAID;PENNSAID PLUS) on 8 July 2008. Squire, a wholly owned subsidiary of Paladin, has paid Nuvo CAN$2.5 million in lieu of future payments relating to Canadian sales of PENNSAID prior to 1 January 2011. Squire will also pay Nuvo a royalty on Canadian sales of PENNSAID after 1 January 2011. Squire has invested CAN$2 million, by way of a convertible debenture, in Nuvo. The debenture bears interest at 8% per annum and is convertible into Nuvo common shares at CAN$0.1380. The Canadian licensing agreement between Nuvo and Squire for PENNSAID PLUS has been amended. Under the terms of the modified agreement, Squire has received the right to market, distribute and sell PENNSAID PLUS in South Africa and Israel, and if certain conditions are met, Central and South America. Squire will pay royalties on sales in these additional territories to Nuvo. ....PENNSAID is indicated for the treatment of pain, stiffness and impaired physical function associated with osteoarthritis and is marketed for the treatment of osteoarthritis in Canada and several European countries. Nuvo expects to resubmit a regulatory filing to the US FDA early 2009 and expects a response by third quarter 2009.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement modified</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="12">
<Drug Key="2023733">drug delivery system, topical diclofenac, Nuvo</Drug>
<Corporations>
<Corporation>
<Company>Nuvo</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement modified">licensing agreement modified</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="13">
<Drug Key="2023733">drug delivery system, topical diclofenac, Nuvo</Drug>
<Corporations>
<Corporation>
<Company>Paladin</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement modified">licensing agreement modified</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134881" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>armodafinil, phase change II</Title>
<Text>In May 2007 Cephalon initiated a US randomized, double-blind, placebo-controlled, parallel assignment phase II trial to assess armodafinil (NUVIGIL) as an adjunct to treatment for major depression associated with bipolar I disorder. The eight week study will evaluate the safety and efficacy of armodafinil in 240 patients. ....Cephalon has completed a US randomized, double-blind, placebo-controlled, parallel assignment phase II trial of armodafinil as an adjunct to treatment in schizophrenia patients with cognitive deficits. This trial, initiated in June 2007, evaluated the safety and efficacy of armodafinil in 60 adults with cognitive defects associated with schizophrenia. Armodafinil has US FDA marketing approval for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD).</Text>
<EventTable>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>June 2007</EventDate>
</EventRow>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>May 2007</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="14">
<Drug Key="2017546">armodafinil</Drug>
<Corporations>
<Corporation>
<Company>Cephalon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20070601" Qualifier="M">June 2007</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>cognitive defect</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
<Index Counter="15">
<Drug Key="2017546">armodafinil</Drug>
<Corporations>
<Corporation>
<Company>Cephalon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20070501" Qualifier="M">May 2007</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>depression</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134882" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>deltaFLU, phase change I</Title>
<Text>On 8 July 2008 AVIR Green Hills Biotechnology announced that it has initiated a randomized, double-blind, Austrian phase I trial of deltaFLU. The aim of the trial is to analyze the safety and efficacy of the vaccine in healthy volunteers. ....AVIR Green Hills Biotechnology is developing deltaFLU, a live-attenuated vaccine against pandemic influenza. The vaccine lacks the pathogenicity factor NS1, is produced in cell cultures, and is administered intranasally with a spray device. In preclinical studies, deltaFLU showed a good immune response even against distantly-related pandemic H5 influenza strains, and long-lasting immune responses were observed.</Text>
<EventTable>
<EventRow>
<EventText>phase change I, Austria</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="16">
<Drug Key="2031012">deltaFLU</Drug>
<Corporations>
<Corporation>
<Company>AVIR Green Hills Biotechnology</Company>
<Nationality>Austria</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="1" Key="pc I">phase change I</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Austria</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
<NewPhase>Yes</NewPhase>
</Index>
</Indexes>
</Report>
<Report Key="134883" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>pitavastatin, licensing agreement</Title>
<Text>Kowa has signed a license agreement with Solvay for pitavastatin (LIVALO) in the treatment of hypercholesterolemia. The terms of the agreement grant Solvay the exclusive right to commercialize the product in Canada. Solvay is to apply for marketing approval in 2009. Pitavastatin, an HMG CoA reductase inhibitor, is marketed in Japan for hypercholesterolemia and in South Korea for hyperlipidemia.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>5 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="17">
<Drug Key="2003139">pitavastatin</Drug>
<Corporations>
<Corporation>
<Company>Kowa</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080605">5 June 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
</Index>
<Index Counter="18">
<Drug Key="2003139">pitavastatin</Drug>
<Corporations>
<Corporation>
<Company>Solvay</Company>
<Nationality>Belgium</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080605">5 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>Canada</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134888" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>dexamethasone cipecilate, licensing agreement</Title>
<Text>Nippon Shinyaku has signed a license agreement with Yoo Young in South Korea, for dexamethasone cipecilate (NS 126) in the treatment of allergic rhinitis. Under the terms of the agreement, Yoo Young has exclusive rights to develop and commercialize dexamethasone cipecilate in South Korea. Nippon Shinyaku will receive development and sales milestone payments and royalties on sales, in addition to a license fee. Dexamethasone cipecilate is an inhaled synthetic steroid; an NDA was filed in Japan in December 2006.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>4 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="19">
<Drug Key="2008781">dexamethasone cipecilate</Drug>
<Corporations>
<Corporation>
<Company>Nippon Shinyaku</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="20">
<Drug Key="2008781">dexamethasone cipecilate</Drug>
<Corporations>
<Corporation>
<Company>Yoo Young</Company>
<Nationality>South Korea</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>South Korea</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134900" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MEDWAY, licensing agreement, marketed</Title>
<Text>R-Tech Ueno and Mitsubishi Tanabe Pharma have signed a licensing agreement for Mitsubishi Tanabe Pharma's recombinant human serum albumin (MEDWAY). Under the agreement, R-Tech Ueno has the rights to develop and commercialize ophthalmic solutions containing recombinant human serum albumin in Japan, for the treatment of dry eye. Milestone payments will be made to Mitsubishi Tanabe Pharma, in addition to a license fee. The recombinant human serum albumin was launched by Mitsubishi Tanabe Pharma in Japan under the brand name of MEDWAY Injection in May 2008, for the treatment of hypoalbuminemia.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>4 June 2008</EventDate>
</EventRow>
<EventRow>
<EventText>marketed, Japan</EventText>
<EventDate>May 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="21">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>Mitsubishi Tanabe Pharma</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="22">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>Mitsubishi Tanabe Pharma</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="7" Key="pc Launch">marketed</ReportEvent>
<ReportEventDate CCYYMMDD="20080501" Qualifier="M">May 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>hypoalbuminemia</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Japan</Region>
</AppliesToRegion>
<NewPhase>Yes</NewPhase>
</Index>
<Index Counter="23">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>R-Tech Ueno</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>Japan (ophthalmic solution)</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134902" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>cetuximab, phase change III</Title>
<Text>On 9 July 2008 Merck KGaA announced that it has initiated a phase III trial of cetuximab (ERBITUX), designated EXPAND (ERBITUX in combination with capecitabine (XELODA) and cisplatin in advanced esophago-gastric cancer). The multicenter, open-label, controlled trial, aims to enroll approximately 870 patients in 25 countries worldwide, and will assess the efficacy of the regimen as a first-line treatment for patients with advanced/metastatic gastric adenocarcinoma, with progression-free survival as the primary endpoint. ....Cetuximab, a chimeric (human/mouse) monoclonal antibody targeting the erbB-1 epidermal growth factor receptor (EGFR), has been approved for the treatment of colorectal cancer in several markets worldwide, and for the treatment of locally advanced squamous cell carcinoma of the head and neck in various markets, including the EU and USA.</Text>
<EventTable>
<EventRow>
<EventText>phase change III, Worldwide</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="24">
<Drug Key="2004877">cetuximab</Drug>
<Corporations>
<Corporation>
<Company>Merck KGaA</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="3" Key="pc III">phase change III</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="5">Sub-licensee</Relationship>
<IndicatedFor>
<Indication>gastric cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134903" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>VAL 201, licensing agreement</Title>
<Text>ValiRx announced on 9 July 2008 that it has signed a licensing agreement with Cancer Research Technology (UK) relating to VAL 201. Under the terms of the agreement, preclinical studies of VAL 201 (including toxicology) will need to be completed within 12 months in order for ValiRx to exercise its option to acquire worldwide rights to the agent. Further details of the agreement were not disclosed. ....VAL 201, an agent that inhibits the gene-based activity of a molecule causing prostate cancer progression, halted prostate cancer growth in in vivo models.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="25">
<Drug Key="2030982">VAL 201</Drug>
<Corporations>
<Corporation>
<Company>Cancer Research UK</Company>
<Nationality>UK</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="26">
<Drug Key="2030982">VAL 201</Drug>
<Corporations>
<Corporation>
<Company>ValiRx</Company>
<Nationality>UK</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134904" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>basiliximab, phase change II</Title>
<Text>Cerimon announced on 9 July 2008 that it has initiated a US phase II proof-of-concept trial of basiliximab (SIMULECT) for the treatment of noninfectious uveitis. This randomized, double-blind, placebo-controlled trial will enroll 56 patients in order to test the safety and efficacy of the agent as a maintenance therapy. The primary endpoint of the study (assessed at week 16) will be prevention of an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while patients undergo tapering of concomitant immunosuppressive agents. Secondary endpoints include changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Pharmacokinetic data and immunogenicity will also be evaluated. ....Basiliximab is a chimeric monoclonal antibody directed against the interleukin-2 receptor. It was developed by Novartis as an immunosuppressant for the prophylaxis of acute rejection episodes following renal transplantation and other autoimmune disorders, and it has been launched in several territories for the prevention of renal transplant rejection. Cerimon licensed rights to basiliximab as a therapy for inflammatory bowel disease in February 2006, and a phase IIb trial of basiliximab for the treatment of moderate-to-severe, steroid refractory ulcerative colitis is ongoing.</Text>
<EventTable>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="27">
<Drug Key="2007939">basiliximab</Drug>
<Corporations>
<Corporation>
<Company>Cerimon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>uveitis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134966" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>Ardea receives approval to initiate phase IIa trial (gout)</Title>
<Text>On 9 July 2008 Ardea announced that it has received regulatory approval to initiate a phase IIa proof-of-concept trial in Europe and Canada evaluating RDEA 806 for the potential treatment of gout patients with hyperuricemia. The randomized, double-blind, placebo-controlled efficacy and safety trial aims to evaluate the serum uric acid (sUA) levels, pharmacokinetics, safety and tolerability of two dosage regimens of RDEA 806, with the primary endpoint of the study an sUA level of less than 6.0 mg/dL after four weeks of treatment. Enrollment onto this study is yet to initiate. ....RDEA 806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is in phase II trials for the potential oral treatment of HIV infection. The uric acid lowering effects of RDEA 806 were observed in phase I and II trials in more than 100 subjects, and its major metabolite, RDEA 594, is believed to be responsible for this effect.</Text>
<Indexes>
<Index Counter="28">
<Drug Key="2029467">RDEA 806</Drug>
<Corporations>
<Corporation>
<Company>Ardea</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134967" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, hairless transgenic, Tokyo Metropolitan Organization for Medical Research, licensing offer</Title>
<Text>At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that researchers at Tokyo Metropolitan Organization for Medical Research (Japan) have developed a hairless transgenic animal model, using a transgene comprising a heparin-binding epidermal growth factor (EGF) gene driven by a type 2 keratin gene promoter. The model can be used in the discovery and development of therapies for dermatitis, including atopic dermatitis. Tokyo Metropolitan Organization for Medical Research granted Japanese rights to the model to an undisclosed Japanese company. The hairless transgenic animal model is available for licensing worldwide, excluding Japan.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="29">
<Drug Key="2030989">drug design technology, hairless transgenic, Tokyo Metropolitan Organization for Medical Research</Drug>
<Corporations>
<Corporation>
<Company>Tokyo Metropolitan Organization for Medical Research</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134968" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>TNIIIA2, licensing offer</Title>
<Text>Researchers at the Tokyo University of Science (Japan) are developing TNIIIA2, a pro-apoptotic 22-mer peptide derived from tenascin-C, as an adjuvant to cancer therapies. In preclinical studies, TNIIIA2 potentiated adhesion of mouse osteosarcoma LM8 cells to the fibronectin substrate by activation of beta1-integrins. The LM8 cells underwent apoptosis when kept adherent on the fibronectin substrate in the presence of TNIIIA2. TNIIIA2 increased the chemosensitivity of LM8 cells to doxorubicin; there was an increased accumulation of doxorubicin in the cells and an increased rate of apoptosis. TNIIIA2mut, an inactive control peptide, had no effect on accumulation of doxorubicin in LM8 cells. TNIIIA2 is available for worldwide licensing, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus, at BIO 2008, 17-20 June 2008, San Diego, USA.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192; Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="30">
<Drug Key="2031006">TNIIIA2</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134969" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>CGEN 25007, preclinical data</Title>
<Text>On 9 July 2008 Compugen reported results from preclinical studies of CGEN 25007. This agent, a peptide antagonist of the gp96 protein, is being developed as a potential treatment of various immune related diseases, including autoimmune diseases, inflammatory diseases, sepsis, cardiovascular diseases and acute transplant rejection. In a preclinical animal model of endotoxemia, CGEN 25007 had potent and dose-dependent anti-inflammatory activity: CGEN 25007 administration resulted in a reduction of about 50% in serum levels of inflammatory cytokines and chemokines (including TNF-alpha, IL-6, interferon gamma, MIP-1alpha and MIP-2). Ex vivo, the agent inhibited the secretion of inflammatory cytokines from human peripheral blood mononuclear cells (PBMCs) which had been challenged with compounds known to activate the immune system: CGEN 25007-treated PBMCs showed greater than 80% inhibition of cytokine secretion (including TNF-alpha, IL-1beta, IL-6, IL-8, IL-12 and MIP-1alpha). The agent had no effect on the secretion of IL-2 and only a 20% inhibitory effect on the secretion of GM-CSF. ....CGEN 25007 was predicted using Compugen's Blockers of Disease-Associated Conformation (DAC Blockers) platform; this discovery platform predicts and selects peptides capable of blocking proteins from adopting their disease-associated conformation.</Text>
<EventTable>
<EventRow>
<EventText>preclinical data</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="31">
<Drug Key="2030999">CGEN 25007</Drug>
<Corporations>
<Corporation>
<Company>Compugen</Company>
<Nationality>Israel</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="preclinical data">preclinical data</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134971" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>periodontal bone disease preventative, Kyushu University, licensing offer</Title>
<Text>Researchers at Kyushu University (Japan) are conducting a program to develop peptide derivatives and their salts, for the potential prevention of periodontal disease. The derivatives inhibit the proteolytic enzymes Lys-gingipain and Arg-gingipain, produced by Porphyromonas gingivalis. A lead series has been identified; discovery stage research is ongoing in Japan. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that this program is available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192; Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="32">
<Drug Key="2030986">periodontal bone disease preventative, Kyushu University</Drug>
<Corporations>
<Corporation>
<Company>Kyushu University</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134973" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>inflammatory disease therapy, Znomics/Oregon Health & Science University, licensing agreement</Title>
<Text>Znomics has established a collaborative drug discovery program with Oregon Health & Science University (USA) relating to the design and development of preclinical compounds for the treatment of rheumatoid arthritis, asthma, and inflammatory bowel syndrome. Under the terms of the agreement, announced on 9 July 2008, Znomics will have the option to exclusively license the rights to the compounds. The program will be funded by Znomics.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="33">
<Drug Key="2030987">inflammatory disease therapy, Znomics/Oregon Health & Science University</Drug>
<Corporations>
<Corporation>
<Company>Oregon Health & Science University</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="34">
<Drug Key="2030987">inflammatory disease therapy, Znomics/Oregon Health & Science University</Drug>
<Corporations>
<Corporation>
<Company>Znomics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134974" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>oligonucleotides, Bioniche Life Sciences, partnering opportunity</Title>
<Text>Bioniche Life Sciences is conducting a program to develop oligonucleotide therapeutics (OLIGOMODULATORS). BT 9925, a lead candidate from a series of non-antisense 6-mer oligonucleotides containing a GpT dinucleotide motif, is in preclinical studies in Canada as a potential therapy for adult acute myeloid leukemia (AML). BT 9925 has proapoptotic and immunostimulant effects. BT 9945 is in preclinical development for the treatment of an undisclosed indication. In an interview at BIO 2008, 17-20 June 2008, San Diego, USA, Graeme McRae, Chairman, President and CEO of Bioniche Life Sciences, and Jennifer Shea, Director of Corporate Communications, Investor and Government Relations at Bioniche Life Sciences, informed R&D Focus that Bioniche Life Sciences' oligonucleotide therapeutics program is available for partnering, worldwide.</Text>
<LicensingContact>Cameron Groome, Executive Vice-President, Corporate & Strategic Development, Bioniche Life Sciences, P.O. Box 1570, 231 Dundas St E, Belleville, Ontario K8N 5J2, Canada; Tel: +1 613 966 8058; Email: Cameron.Groome@Bioniche.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="35">
<Drug Key="2015546">oligonucleotides, Bioniche Life Sciences</Drug>
<Corporations>
<Corporation>
<Company>Bioniche Life Sciences</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134975" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>CR 002, partnering opportunity</Title>
<Text>CuraGen informed R&D Focus on 9 July 2008 that CR 002 is available for partnering, worldwide. CR 002 is a fully human monoclonal antibody, which neutralizes platelet-derived growth factor-D (PDGF-D), for the potential treatment of IgA nephropathy, lupus nephritis and diabetic nephropathy. A phase I trial, evaluating the safety and tolerability of the monoclonal, has completed.</Text>
<LicensingContact>Henri Lichenstein, VP Product Development, CuraGen Corporation, 322 East Main Street, Branford, CT 06405, USA; Tel: +1 203 481 1104; Email: business_development@curagen.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="36">
<Drug Key="2016041">CR 002</Drug>
<Corporations>
<Corporation>
<Company>CuraGen</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134978" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, anti-obesity compound screening, Kyushu University, licensing offer</Title>
<Text>Researchers at Kyushu University (Japan) have developed a platform for screening anti-obesity compounds. The platform comprises a transgenic animal model, which expresses ubiquitin ligase E4B in its central nerve system (excluding the cerebral nerve system) and an assay to assess adverse effects of anti-obesity agents. The obesity therapy screening platform is available for worldwide licensing, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus, at BIO 2008, 17-20 June 2008, San Diego, USA.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="37">
<Drug Key="2030983">drug design technology, anti-obesity compound screening, Kyushu University</Drug>
<Corporations>
<Corporation>
<Company>Kyushu University</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134980" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, allergy therapeutics screening, Tokyo University of Science, licensing offer</Title>
<Text>Researchers at Tokyo University of Science (Japan) have developed three cell lines, No N62.5 cells, R cells, and RCCM cells for use in the screening of therapeutics for chronic allergic diseases. The cell lines are similar to basophils or mast cells, they are FcepsilonRIalfa-positive, Fc gamma receptor II/III-positive and c-kit-positive. The cell lines require different growth conditions: No N62.5 cells require normal levels of growth factor, R cells require low levels of growth factor and RCCM cells do not require a growth factor. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that the cell lines are available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="38">
<Drug Key="2031011">drug design technology, allergy therapeutics screening, Tokyo University of Science</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134983" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>dihydronaphthalene-based proteasome inhibitors, Tokyo University of Science, licensing offer</Title>
<Text>Researchers at Tokyo University of Science (Japan) are developing dihydronaphthalene-based proteasome inhibitors, for the potential treatment of cancer, inflammation, immunological diseases, and neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. The dihydronaphthalene compounds can be synthesized with no isomers easily and efficiently. Discovery stage research is ongoing in Japan. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that this program is available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="39">
<Drug Key="2030992">dihydronaphthalene-based proteasome inhibitors, Tokyo University of Science</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134984" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>mycobacterial cell wall-DNA complex, partnering opportunity</Title>
<Text>At BIO 2008, 17-20 June 2008, San Diego, USA, Graeme McRae, Chairman, President and CEO of Bioniche Life Sciences, and Jennifer Shea, Director of Corporate Communications, Investor and Government Relations at Bioniche Life Sciences, informed R&D Focus that mycobacterial cell wall-DNA complex (MCC) for use in the treatment of bladder cancer is available for worldwide partnering. MCC, which is formulated from Mycobacterium phlei, is undergoing phase III development for the treatment of bladder cancer in Canada, under the trade name UROCIDIN. The bladder cancer indication is the primary focus of Bioniche Life Sciences' research efforts. MCC is also under development for the treatment of prostate cancer (as PROSTACIDIN) and other cancers.</Text>
<LicensingContact>Cameron Groome, Executive Vice-President, Corporate & Strategic Development, Bioniche Life Sciences, PO Box 1570, 231 Dundas St E, Belleville, Ontario K8N 5J2, Canada; Tel: +1 613 966 8058; Email: Cameron.Groome@Bioniche.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="40">
<Drug Key="2007102">mycobacterial cell wall-DNA complex</Drug>
<Corporations>
<Corporation>
<Company>Bioniche Life Sciences</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>bladder cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134985" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>PF 00299804, clinical data (phase I)</Title>
<Text>Phase I results for Pfizer's PF 00299804 for the treatment of nonsmall cell lung cancer (NSCLC) were reported at the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA. In this US and Dutch dose-escalation trial in 43 NSCLC patients, diarrhea (71%), and rash and other skin-related events (65%) were the most common treatment-related adverse events reported. Disease control was observed in half of the patients and durable partial responses were reported in four of 42 patients. ....PF 00299804 is an orally available selective and irreversible inhibitor of the HER family of kinases. In February 2008, a phase II trial of PF 00299804 was initiated in patients with NSCLC in South Korea and in April 2008, a second phase II trial in NSCLC patients was initiated in the USA. Further trials are planned in second- and third-line treatment of advanced NSCLC and in front-line advanced NSCLC (adenocarcinoma, non-smokers); combination trials with targeted agents are also planned.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase I)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="41">
<Drug Key="2027349">PF 00299804</Drug>
<Corporations>
<Corporation>
<Company>Pfizer</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>NSCLC</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134986" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>LORAMYC, marketed</Title>
<Text>On 10 July 2008 BioAlliance Pharma announced that it has launched LORAMYC, its once-daily, extended-release, mucoadhesive buccal tablet formulation of the antifungal miconazole, in Denmark and Germany for the treatment of oropharyngeal candidiasis in immunocompromised patients with cancer or HIV infection. LORAMYC is already marketed in France and the UK, and has been granted marketing approval for the same indication in several other European countries.</Text>
<EventTable>
<EventRow>
<EventText>marketed, Denmark, Germany</EventText>
<EventDate>10 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="42">
<Drug Key="2022771">LORAMYC</Drug>
<Corporations>
<Corporation>
<Company>BioAlliance Pharma</Company>
<Nationality>France</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="7" Key="pc Launch">marketed</ReportEvent>
<ReportEventDate CCYYMMDD="20080710">10 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>candidiasis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Denmark</Region>
<Region>Germany</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134987" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>ranolazine, registered</Title>
<Text>CV Therapeutics announced on 10 July 2008 that it has received marketing approval from the EMEA for ranolazine for the treatment of patients with chronic angina in all 27 EU countries. This authorization follows a recommendation from the EMEA's CHMP in April 2008. Ranolazine has been approved for use in the EU as add-on therapy for the symptomatic treatment of stable angina pectoris patients who are intolerant to or inadequately controlled by their current antianginal therapies. ....Ranolazine, a partial inhibitor of fatty acid oxidation, is marketed in the USA for the treatment of chronic angina under the trade name RANEXA.</Text>
<EventTable>
<EventRow>
<EventText>registered, EU</EventText>
<EventDate>10 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="43">
<Drug Key="2001961">ranolazine</Drug>
<Corporations>
<Corporation>
<Company>CV Therapeutics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="6" Key="pc Reg">registered</ReportEvent>
<ReportEventDate CCYYMMDD="20080710">10 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>angina</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>EU</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134988" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>denenicokin, clinical data (phase I), clinical data (phase II)</Title>
<Text>ZymoGenetics and Novo Nordisk presented results for denenicokin, a recombinant interleukin-21 (rIL-21), at the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA. In a two-stage Australian phase IIa trial in treatment-naive patients with advanced malignant melanoma, one patient, among the 14 patients enrolled in stage 1 of the study, achieved a confirmed complete response (CR). Ten additional patients were enrolled in stage 2. Best tumor response any time on study included one patient with confirmed CR and one with confirmed partial response (PR). Overall response rate was 8.3%; there were eight patients with stable disease (33.3%) and 14 patients had progressive disease (58.3%). Denenicokin 30 mcg/kg/day was well tolerated. ....Final results from the cohort expansion (second part) of a phase I trial conducted in 15 patients with relapsed/refractory indolent lymphoma showed that the combination therapy with denenicokin 100 mcg/kg and rituximab 375 mg/m2 was well tolerated. Among the 13 patients evaluable for efficacy, 38% had objective response rate (one complete response, one unconfirmed CR and one PR). Eight patients had stable disease. ....In an ongoing dose-escalation Danish and UK phase I trial of subcutaneous denenicokin conducted in 11 patients with renal cell cancer and 12 patients with malignant melanoma, two of seven patients had dose-limiting toxicities at 300 mcg/kg. Among the 14 patients evaluable for efficacy, one patient with malignant melanoma achieved a CR lasting eight months and two patients with renal cell cancer had PR.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase II)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
<EventRow>
<EventText>clinical data (phase I)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="44">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
<Indication>renal cancer</Indication>
</IndicatedFor>
</Index>
<Index Counter="45">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase II)">clinical data (phase II)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
</IndicatedFor>
</Index>
<Index Counter="46">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
<Indication>renal cancer</Indication>
<Indication>non-Hodgkin lymphoma</Indication>
</IndicatedFor>
</Index>
<Index Counter="47">
<Drug Key="2019223">denenicokin</Drug>
<Corporat
I have an XSLT that transfroms some XML however I only need those records that have either the following Key attribute values, I would also like these grouped togther. Can someone help - thx. (XML /XSLT below)
Indexes/Index/ReportEvent/@Key = 'licensing agreement' ">
Indexes/Index/ReportEvent/@Key = 'licensing offer' ">
Indexes/Index/ReportEvent/@Key = 'pc launch' ">
-XML-----
<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<!DOCTYPE DrugNews PUBLIC "drugnews.dtd" "drugnews.dtd">
<DrugNews>
<Report Key="134871" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MAb, solid tumor, Daiichi Sankyo/Seattle Genetics, licensing agreement</Title>
<Text>Seattle Genetics announced on 8 July 2008 that it has signed an exclusive, worldwide collaboration agreement with Daiichi Sankyo relating to the development of antibody-drug conjugate (ADC) based therapies targeting a single antigen found on several types of solid tumors. In addition to a US$4 million upfront payment, Seattle Genetics will receive progress-dependent milestone payments and mid-single digit royalties on worldwide net sales of ADC products resulting from the alliance. Responsibility for research, product development, manufacturing and commercialization of all ADC products will reside with Daiichi Sankyo. In exchange for the assistance provided to Daiichi Sankyo in developing ADC products, Seattle Genetics will receive material supply, annual maintenance fees and research support payments. ....Seattle Genetics' proprietary ADC technology uses proprietary linkers and synthetic cytotoxic drugs. The linkers are stable in the bloodstream, releasing the drug payload once inside target tumor cells.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="1">
<Drug Key="2031008">MAb, solid tumor, Daiichi Sankyo/Seattle Genetics</Drug>
<Corporations>
<Corporation>
<Company>Daiichi Sankyo</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="2">
<Drug Key="2031008">MAb, solid tumor, Daiichi Sankyo/Seattle Genetics</Drug>
<Corporations>
<Corporation>
<Company>Seattle Genetics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134872" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MediGene places phase I trial on hold</Title>
<Text>On 8 July 2008 MediGene reported that it has put on hold an ongoing phase I trial evaluating the bioavailability of a new formulation of RhuDex, following the death of a volunteer. One subject experienced a heart problem in the days following treatment with RhuDex, for which hospital treatment was given and the patient was discharged. The volunteer died several days later at home; cause of death and any correlation with administration of RhuDex are being investigated. The 11 other volunteers in this phase I trial have reported only mild side effects such as headaches. ....On 15 July 2008, MediGene published autopsy findings for the deceased volunteer. The subject died of an acute myocardial re-infarction as a result of coronary thrombosis. The individual had experienced several small infarctions prior to the trial. A decision to continue with this trial will not be taken until final analyses of this incident are available. ....RhuDex is an orally active inhibitor of CD80 (B7-1), under development by MediGene for the potential treatment of rheumatoid arthritis and other inflammatory and autoimmune disorders. A recent phase IIa trial of a different formulation of RhuDex demonstrated positive safety data.</Text>
<Indexes>
<Index Counter="3">
<Drug Key="2016237">RhuDex</Drug>
<Corporations>
<Corporation>
<Company>MediGene</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134873" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>Giaconda suspends phase IIa trial</Title>
<Text>Giaconda announced on 8 July 2008 that it has suspended its phase IIa trial of HEPACONDA, a combination of bezafibrate and chenodeoxycholic acid for the treatment of patients with hepatitis C virus (HCV) genotype 1 infection. Results from this study showed that administration of the agent did not result in total normalization of liver function. Gamma-glutamyl transpeptidase (GGT) levels showed an immediate and lasting return to the normal range, and aspartate transaminase (AST) levels were close to the normal range. However, HEPACONDA had minimal effect on viral load and alanine aminotransferase (ALT) levels. No adverse events were reported at the dose used. ....A dose-ranging trial to identify an optimum dose of HEPACONDA is expected to begin once Giaconda secures further funding.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase II)</EventText>
<EventDate>7 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="4">
<Drug Key="2027960">bezafibrate + chenodeoxycholic acid</Drug>
<Corporations>
<Corporation>
<Company>Giaconda</Company>
<Nationality>Australia</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
</Index>
<Index Counter="5">
<Drug Key="2027960">bezafibrate + chenodeoxycholic acid</Drug>
<Corporations>
<Corporation>
<Company>Giaconda</Company>
<Nationality>Australia</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase II)">clinical data (phase II)</ReportEvent>
<ReportEventDate CCYYMMDD="20080707">7 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>hepatitis C</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134874" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>gadoxetic acid, registered</Title>
<Text>On 8 July 2008 Bayer Schering announced that the US FDA has approved gadoxetic acid (EOVIST) for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with suspected or known focal liver disease. ....In January 2008, Bayer Yakuhin launched gadoxetic acid (EOB PRIMOVIST) for the early diagnosis of liver tumors in Japan. The product is marketed across Europe.</Text>
<EventTable>
<EventRow>
<EventText>registered, USA</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="6">
<Drug Key="2007465">gadoxetic acid</Drug>
<Corporations>
<Corporation>
<Company>Bayer</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="6" Key="pc Reg">registered</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>diagnosis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134875" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>REXIN-G, Orphan Drug</Title>
<Text>On 8 July 2008 Epeius announced that the US FDA has granted REXIN-G Orphan Drug designation for the treatment of osteosarcoma. In addition, on 9 July Epeius reported that the product has been granted Orphan Drug status by the FDA for the treatment of all soft tissue sarcomas. ....REXIN-G (Retroviral Expression Vectors Bearing Inhibitory Genes) is a tumor-targeted injectable gene therapy for cancer which consists of Epeius' proprietary targeted vector system containing a proprietary mutant cell-cycle control gene. Epeius is conducting US phase I/II trials of REXIN-G in patients with breast and pancreatic cancers, and in sarcoma. A US phase II trial is ongoing in patients with osteosarcoma.</Text>
<EventTable>
<EventRow>
<EventText>Orphan Drug, USA</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
<EventRow>
<EventText>Orphan Drug, USA</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="7">
<Drug Key="2020206">REXIN-G</Drug>
<Corporations>
<Corporation>
<Company>Epeius</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="Orphan Drug">Orphan Drug</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>bone cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
<Index Counter="8">
<Drug Key="2020206">REXIN-G</Drug>
<Corporations>
<Corporation>
<Company>Epeius</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="Orphan Drug">Orphan Drug</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>soft tissue sarcoma</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134876" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>KYRBAX, preclinical data</Title>
<Text>On 7 July 2008 Hana Biosciences reported preclinical data on its topical menadione (KYRBAX) lotion. In vivo, topical menadione did not affect erlotinib's (TARCEVA) antitumor activity. In vitro studies showed that topical menadione therapy may restore normal cell turnover rates and prevent skin toxicities resulting from inhibition of protein kinases (such as tyrosine kinases MEK, CDK and RAF). ....KYRBAX is undergoing a US/Canadian phase I trial for the treatment and/or prevention of rash associated with epidermal growth factor receptor (EGFR) inhibitor therapy in cancer patients.</Text>
<EventTable>
<EventRow>
<EventText>preclinical data</EventText>
<EventDate>7 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="9">
<Drug Key="2029579">KYRBAX</Drug>
<Corporations>
<Corporation>
<Company>Hana Biosciences</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="preclinical data">preclinical data</ReportEvent>
<ReportEventDate CCYYMMDD="20080707">7 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134878" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>corifollitropin alfa, clinical data (phase III)</Title>
<Text>On 8 July 2008 Schering Plough announced results from a randomized, double-blind, North American and European, phase III fertility trial, designated ENGAGE, designed to determine the non-inferiority of corifollitropin alfa compared with recombinant follicle-stimulating hormone (FSH; follitropin beta) in 1509 patients attending in-vitro-fertilization (IVF) clinics. The co-primary endpoint of ongoing pregnancy rate at least ten weeks after embryo transfer was similar with 150 mcg corifollitropin alfa (38.9% per started cycle) compared with 200 IU recombinant FSH (38.1% per started cycle). The co-primary endpoint of number of oocytes retrieved was within the limits of clinical equivalence, and the estimated difference of +1.2 favored the corifollitropin alfa arm. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar for both treatments, 7.0% in the corifollitropin alfa arm (severe in 1.9%) and 6.3% in the follitropin beta arm (severe in 1.3%). ....Schering Plough is developing corifollitropin alfa, a long-acting FSH molecule, as a therapy for infertility.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase III)</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="10">
<Drug Key="2020802">corifollitropin alfa</Drug>
<Corporations>
<Corporation>
<Company>Schering Plough</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase III)">clinical data (phase III)</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>infertility</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134879" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>bortezomib, clinical data (phase III)</Title>
<Text>At the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA, Millennium (a wholly-owned subsidiary of Takeda) reported results on trials of bortezomib (VELCADE) in patients with newly diagnosed multiple myeloma. In a phase II trial with cyclophosphamide, bortezomib and dexamethasone, a complete remission of 46% was seen before stem cell transplant (SCT) and 72% post-transplant. An overall response rate (partial rate or better) of 95% was observed. ....In a second phase II trial, 86 evaluable patients were treated with bortezomib, pegylated-liposomal-doxorubicin and dexamethasone (VcDD). After autologous stem cell transplant (ASCT), lenalidomide on days 1 to 21 and prednisone every second day for four 28-day cycles were administered. Maintenance therapy was with lenalidomide on days 1-21 every 28 days. A partial response or more was observed in 94% patients. There was a complete remission rate of 21% following four cycles of VcDD which increased to 59% following ASCT. Median progression-free survival and overall survival were not reached at a median follow up of 13.6 months. ....In a randomized, phase III trial of bortezomib plus dexamethasone (VcD) versus vincristine, doxorubicin and dexamethasone (VAD), 95% of VcD versus 92% VAD patients were alive at one year. Corresponding results for complete remission were 19% and 8% as induction therapy. The complete remission rate was 35% in the VcD patients and 23% in VAD patients post-transplantation. A second transplantation was not required in 63% patients in the VcD arm and 44% patients in the VAD arm. ...Bortezomib is a small molecule proteasome inhibitor which is marketed worldwide for myeloma and in the USA for non-Hodgkin lymphoma.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase III)</EventText>
<EventDate>31 May 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="11">
<Drug Key="2011222">bortezomib</Drug>
<Corporations>
<Corporation>
<Company>Takeda</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase III)">clinical data (phase III)</ReportEvent>
<ReportEventDate CCYYMMDD="20080531">31 May 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>myeloma</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134880" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug delivery system, topical diclofenac, Nuvo, licensing agreement modified</Title>
<Text>Nuvo and Paladin announced modifications to their licensing arrangements for topical diclofenac (PENNSAID;PENNSAID PLUS) on 8 July 2008. Squire, a wholly owned subsidiary of Paladin, has paid Nuvo CAN$2.5 million in lieu of future payments relating to Canadian sales of PENNSAID prior to 1 January 2011. Squire will also pay Nuvo a royalty on Canadian sales of PENNSAID after 1 January 2011. Squire has invested CAN$2 million, by way of a convertible debenture, in Nuvo. The debenture bears interest at 8% per annum and is convertible into Nuvo common shares at CAN$0.1380. The Canadian licensing agreement between Nuvo and Squire for PENNSAID PLUS has been amended. Under the terms of the modified agreement, Squire has received the right to market, distribute and sell PENNSAID PLUS in South Africa and Israel, and if certain conditions are met, Central and South America. Squire will pay royalties on sales in these additional territories to Nuvo. ....PENNSAID is indicated for the treatment of pain, stiffness and impaired physical function associated with osteoarthritis and is marketed for the treatment of osteoarthritis in Canada and several European countries. Nuvo expects to resubmit a regulatory filing to the US FDA early 2009 and expects a response by third quarter 2009.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement modified</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="12">
<Drug Key="2023733">drug delivery system, topical diclofenac, Nuvo</Drug>
<Corporations>
<Corporation>
<Company>Nuvo</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement modified">licensing agreement modified</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="13">
<Drug Key="2023733">drug delivery system, topical diclofenac, Nuvo</Drug>
<Corporations>
<Corporation>
<Company>Paladin</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement modified">licensing agreement modified</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134881" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>armodafinil, phase change II</Title>
<Text>In May 2007 Cephalon initiated a US randomized, double-blind, placebo-controlled, parallel assignment phase II trial to assess armodafinil (NUVIGIL) as an adjunct to treatment for major depression associated with bipolar I disorder. The eight week study will evaluate the safety and efficacy of armodafinil in 240 patients. ....Cephalon has completed a US randomized, double-blind, placebo-controlled, parallel assignment phase II trial of armodafinil as an adjunct to treatment in schizophrenia patients with cognitive deficits. This trial, initiated in June 2007, evaluated the safety and efficacy of armodafinil in 60 adults with cognitive defects associated with schizophrenia. Armodafinil has US FDA marketing approval for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD).</Text>
<EventTable>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>June 2007</EventDate>
</EventRow>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>May 2007</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="14">
<Drug Key="2017546">armodafinil</Drug>
<Corporations>
<Corporation>
<Company>Cephalon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20070601" Qualifier="M">June 2007</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>cognitive defect</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
<Index Counter="15">
<Drug Key="2017546">armodafinil</Drug>
<Corporations>
<Corporation>
<Company>Cephalon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20070501" Qualifier="M">May 2007</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>depression</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134882" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>deltaFLU, phase change I</Title>
<Text>On 8 July 2008 AVIR Green Hills Biotechnology announced that it has initiated a randomized, double-blind, Austrian phase I trial of deltaFLU. The aim of the trial is to analyze the safety and efficacy of the vaccine in healthy volunteers. ....AVIR Green Hills Biotechnology is developing deltaFLU, a live-attenuated vaccine against pandemic influenza. The vaccine lacks the pathogenicity factor NS1, is produced in cell cultures, and is administered intranasally with a spray device. In preclinical studies, deltaFLU showed a good immune response even against distantly-related pandemic H5 influenza strains, and long-lasting immune responses were observed.</Text>
<EventTable>
<EventRow>
<EventText>phase change I, Austria</EventText>
<EventDate>8 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="16">
<Drug Key="2031012">deltaFLU</Drug>
<Corporations>
<Corporation>
<Company>AVIR Green Hills Biotechnology</Company>
<Nationality>Austria</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="1" Key="pc I">phase change I</ReportEvent>
<ReportEventDate CCYYMMDD="20080708">8 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Austria</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
<NewPhase>Yes</NewPhase>
</Index>
</Indexes>
</Report>
<Report Key="134883" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>pitavastatin, licensing agreement</Title>
<Text>Kowa has signed a license agreement with Solvay for pitavastatin (LIVALO) in the treatment of hypercholesterolemia. The terms of the agreement grant Solvay the exclusive right to commercialize the product in Canada. Solvay is to apply for marketing approval in 2009. Pitavastatin, an HMG CoA reductase inhibitor, is marketed in Japan for hypercholesterolemia and in South Korea for hyperlipidemia.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>5 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="17">
<Drug Key="2003139">pitavastatin</Drug>
<Corporations>
<Corporation>
<Company>Kowa</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080605">5 June 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
</Index>
<Index Counter="18">
<Drug Key="2003139">pitavastatin</Drug>
<Corporations>
<Corporation>
<Company>Solvay</Company>
<Nationality>Belgium</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080605">5 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>Canada</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134888" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>dexamethasone cipecilate, licensing agreement</Title>
<Text>Nippon Shinyaku has signed a license agreement with Yoo Young in South Korea, for dexamethasone cipecilate (NS 126) in the treatment of allergic rhinitis. Under the terms of the agreement, Yoo Young has exclusive rights to develop and commercialize dexamethasone cipecilate in South Korea. Nippon Shinyaku will receive development and sales milestone payments and royalties on sales, in addition to a license fee. Dexamethasone cipecilate is an inhaled synthetic steroid; an NDA was filed in Japan in December 2006.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>4 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="19">
<Drug Key="2008781">dexamethasone cipecilate</Drug>
<Corporations>
<Corporation>
<Company>Nippon Shinyaku</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="20">
<Drug Key="2008781">dexamethasone cipecilate</Drug>
<Corporations>
<Corporation>
<Company>Yoo Young</Company>
<Nationality>South Korea</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>South Korea</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134900" Status="Minor" ReportType="GN">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>MEDWAY, licensing agreement, marketed</Title>
<Text>R-Tech Ueno and Mitsubishi Tanabe Pharma have signed a licensing agreement for Mitsubishi Tanabe Pharma's recombinant human serum albumin (MEDWAY). Under the agreement, R-Tech Ueno has the rights to develop and commercialize ophthalmic solutions containing recombinant human serum albumin in Japan, for the treatment of dry eye. Milestone payments will be made to Mitsubishi Tanabe Pharma, in addition to a license fee. The recombinant human serum albumin was launched by Mitsubishi Tanabe Pharma in Japan under the brand name of MEDWAY Injection in May 2008, for the treatment of hypoalbuminemia.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>4 June 2008</EventDate>
</EventRow>
<EventRow>
<EventText>marketed, Japan</EventText>
<EventDate>May 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="21">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>Mitsubishi Tanabe Pharma</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
</Index>
<Index Counter="22">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>Mitsubishi Tanabe Pharma</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="7" Key="pc Launch">marketed</ReportEvent>
<ReportEventDate CCYYMMDD="20080501" Qualifier="M">May 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>hypoalbuminemia</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Japan</Region>
</AppliesToRegion>
<NewPhase>Yes</NewPhase>
</Index>
<Index Counter="23">
<Drug Key="2022183">MEDWAY</Drug>
<Corporations>
<Corporation>
<Company>R-Tech Ueno</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080604">4 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<AppliesToRegion>
<Region>Japan (ophthalmic solution)</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134902" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>cetuximab, phase change III</Title>
<Text>On 9 July 2008 Merck KGaA announced that it has initiated a phase III trial of cetuximab (ERBITUX), designated EXPAND (ERBITUX in combination with capecitabine (XELODA) and cisplatin in advanced esophago-gastric cancer). The multicenter, open-label, controlled trial, aims to enroll approximately 870 patients in 25 countries worldwide, and will assess the efficacy of the regimen as a first-line treatment for patients with advanced/metastatic gastric adenocarcinoma, with progression-free survival as the primary endpoint. ....Cetuximab, a chimeric (human/mouse) monoclonal antibody targeting the erbB-1 epidermal growth factor receptor (EGFR), has been approved for the treatment of colorectal cancer in several markets worldwide, and for the treatment of locally advanced squamous cell carcinoma of the head and neck in various markets, including the EU and USA.</Text>
<EventTable>
<EventRow>
<EventText>phase change III, Worldwide</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="24">
<Drug Key="2004877">cetuximab</Drug>
<Corporations>
<Corporation>
<Company>Merck KGaA</Company>
<Nationality>Germany</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="3" Key="pc III">phase change III</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="5">Sub-licensee</Relationship>
<IndicatedFor>
<Indication>gastric cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134903" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>VAL 201, licensing agreement</Title>
<Text>ValiRx announced on 9 July 2008 that it has signed a licensing agreement with Cancer Research Technology (UK) relating to VAL 201. Under the terms of the agreement, preclinical studies of VAL 201 (including toxicology) will need to be completed within 12 months in order for ValiRx to exercise its option to acquire worldwide rights to the agent. Further details of the agreement were not disclosed. ....VAL 201, an agent that inhibits the gene-based activity of a molecule causing prostate cancer progression, halted prostate cancer growth in in vivo models.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="25">
<Drug Key="2030982">VAL 201</Drug>
<Corporations>
<Corporation>
<Company>Cancer Research UK</Company>
<Nationality>UK</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="26">
<Drug Key="2030982">VAL 201</Drug>
<Corporations>
<Corporation>
<Company>ValiRx</Company>
<Nationality>UK</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134904" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>basiliximab, phase change II</Title>
<Text>Cerimon announced on 9 July 2008 that it has initiated a US phase II proof-of-concept trial of basiliximab (SIMULECT) for the treatment of noninfectious uveitis. This randomized, double-blind, placebo-controlled trial will enroll 56 patients in order to test the safety and efficacy of the agent as a maintenance therapy. The primary endpoint of the study (assessed at week 16) will be prevention of an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while patients undergo tapering of concomitant immunosuppressive agents. Secondary endpoints include changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Pharmacokinetic data and immunogenicity will also be evaluated. ....Basiliximab is a chimeric monoclonal antibody directed against the interleukin-2 receptor. It was developed by Novartis as an immunosuppressant for the prophylaxis of acute rejection episodes following renal transplantation and other autoimmune disorders, and it has been launched in several territories for the prevention of renal transplant rejection. Cerimon licensed rights to basiliximab as a therapy for inflammatory bowel disease in February 2006, and a phase IIb trial of basiliximab for the treatment of moderate-to-severe, steroid refractory ulcerative colitis is ongoing.</Text>
<EventTable>
<EventRow>
<EventText>phase change II, USA</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="27">
<Drug Key="2007939">basiliximab</Drug>
<Corporations>
<Corporation>
<Company>Cerimon</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="2" Key="pc II">phase change II</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>uveitis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>USA</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134966" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>Ardea receives approval to initiate phase IIa trial (gout)</Title>
<Text>On 9 July 2008 Ardea announced that it has received regulatory approval to initiate a phase IIa proof-of-concept trial in Europe and Canada evaluating RDEA 806 for the potential treatment of gout patients with hyperuricemia. The randomized, double-blind, placebo-controlled efficacy and safety trial aims to evaluate the serum uric acid (sUA) levels, pharmacokinetics, safety and tolerability of two dosage regimens of RDEA 806, with the primary endpoint of the study an sUA level of less than 6.0 mg/dL after four weeks of treatment. Enrollment onto this study is yet to initiate. ....RDEA 806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is in phase II trials for the potential oral treatment of HIV infection. The uric acid lowering effects of RDEA 806 were observed in phase I and II trials in more than 100 subjects, and its major metabolite, RDEA 594, is believed to be responsible for this effect.</Text>
<Indexes>
<Index Counter="28">
<Drug Key="2029467">RDEA 806</Drug>
<Corporations>
<Corporation>
<Company>Ardea</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="general">general</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
</Index>
</Indexes>
</Report>
<Report Key="134967" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, hairless transgenic, Tokyo Metropolitan Organization for Medical Research, licensing offer</Title>
<Text>At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that researchers at Tokyo Metropolitan Organization for Medical Research (Japan) have developed a hairless transgenic animal model, using a transgene comprising a heparin-binding epidermal growth factor (EGF) gene driven by a type 2 keratin gene promoter. The model can be used in the discovery and development of therapies for dermatitis, including atopic dermatitis. Tokyo Metropolitan Organization for Medical Research granted Japanese rights to the model to an undisclosed Japanese company. The hairless transgenic animal model is available for licensing worldwide, excluding Japan.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="29">
<Drug Key="2030989">drug design technology, hairless transgenic, Tokyo Metropolitan Organization for Medical Research</Drug>
<Corporations>
<Corporation>
<Company>Tokyo Metropolitan Organization for Medical Research</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134968" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>TNIIIA2, licensing offer</Title>
<Text>Researchers at the Tokyo University of Science (Japan) are developing TNIIIA2, a pro-apoptotic 22-mer peptide derived from tenascin-C, as an adjuvant to cancer therapies. In preclinical studies, TNIIIA2 potentiated adhesion of mouse osteosarcoma LM8 cells to the fibronectin substrate by activation of beta1-integrins. The LM8 cells underwent apoptosis when kept adherent on the fibronectin substrate in the presence of TNIIIA2. TNIIIA2 increased the chemosensitivity of LM8 cells to doxorubicin; there was an increased accumulation of doxorubicin in the cells and an increased rate of apoptosis. TNIIIA2mut, an inactive control peptide, had no effect on accumulation of doxorubicin in LM8 cells. TNIIIA2 is available for worldwide licensing, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus, at BIO 2008, 17-20 June 2008, San Diego, USA.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192; Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="30">
<Drug Key="2031006">TNIIIA2</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134969" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>CGEN 25007, preclinical data</Title>
<Text>On 9 July 2008 Compugen reported results from preclinical studies of CGEN 25007. This agent, a peptide antagonist of the gp96 protein, is being developed as a potential treatment of various immune related diseases, including autoimmune diseases, inflammatory diseases, sepsis, cardiovascular diseases and acute transplant rejection. In a preclinical animal model of endotoxemia, CGEN 25007 had potent and dose-dependent anti-inflammatory activity: CGEN 25007 administration resulted in a reduction of about 50% in serum levels of inflammatory cytokines and chemokines (including TNF-alpha, IL-6, interferon gamma, MIP-1alpha and MIP-2). Ex vivo, the agent inhibited the secretion of inflammatory cytokines from human peripheral blood mononuclear cells (PBMCs) which had been challenged with compounds known to activate the immune system: CGEN 25007-treated PBMCs showed greater than 80% inhibition of cytokine secretion (including TNF-alpha, IL-1beta, IL-6, IL-8, IL-12 and MIP-1alpha). The agent had no effect on the secretion of IL-2 and only a 20% inhibitory effect on the secretion of GM-CSF. ....CGEN 25007 was predicted using Compugen's Blockers of Disease-Associated Conformation (DAC Blockers) platform; this discovery platform predicts and selects peptides capable of blocking proteins from adopting their disease-associated conformation.</Text>
<EventTable>
<EventRow>
<EventText>preclinical data</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="31">
<Drug Key="2030999">CGEN 25007</Drug>
<Corporations>
<Corporation>
<Company>Compugen</Company>
<Nationality>Israel</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="preclinical data">preclinical data</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134971" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>periodontal bone disease preventative, Kyushu University, licensing offer</Title>
<Text>Researchers at Kyushu University (Japan) are conducting a program to develop peptide derivatives and their salts, for the potential prevention of periodontal disease. The derivatives inhibit the proteolytic enzymes Lys-gingipain and Arg-gingipain, produced by Porphyromonas gingivalis. A lead series has been identified; discovery stage research is ongoing in Japan. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that this program is available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192; Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="32">
<Drug Key="2030986">periodontal bone disease preventative, Kyushu University</Drug>
<Corporations>
<Corporation>
<Company>Kyushu University</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134973" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>inflammatory disease therapy, Znomics/Oregon Health & Science University, licensing agreement</Title>
<Text>Znomics has established a collaborative drug discovery program with Oregon Health & Science University (USA) relating to the design and development of preclinical compounds for the treatment of rheumatoid arthritis, asthma, and inflammatory bowel syndrome. Under the terms of the agreement, announced on 9 July 2008, Znomics will have the option to exclusively license the rights to the compounds. The program will be funded by Znomics.</Text>
<EventTable>
<EventRow>
<EventText>licensing agreement</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="33">
<Drug Key="2030987">inflammatory disease therapy, Znomics/Oregon Health & Science University</Drug>
<Corporations>
<Corporation>
<Company>Oregon Health & Science University</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
<Index Counter="34">
<Drug Key="2030987">inflammatory disease therapy, Znomics/Oregon Health & Science University</Drug>
<Corporations>
<Corporation>
<Company>Znomics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing agreement">licensing agreement</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="2">Co-developer</Relationship>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134974" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>oligonucleotides, Bioniche Life Sciences, partnering opportunity</Title>
<Text>Bioniche Life Sciences is conducting a program to develop oligonucleotide therapeutics (OLIGOMODULATORS). BT 9925, a lead candidate from a series of non-antisense 6-mer oligonucleotides containing a GpT dinucleotide motif, is in preclinical studies in Canada as a potential therapy for adult acute myeloid leukemia (AML). BT 9925 has proapoptotic and immunostimulant effects. BT 9945 is in preclinical development for the treatment of an undisclosed indication. In an interview at BIO 2008, 17-20 June 2008, San Diego, USA, Graeme McRae, Chairman, President and CEO of Bioniche Life Sciences, and Jennifer Shea, Director of Corporate Communications, Investor and Government Relations at Bioniche Life Sciences, informed R&D Focus that Bioniche Life Sciences' oligonucleotide therapeutics program is available for partnering, worldwide.</Text>
<LicensingContact>Cameron Groome, Executive Vice-President, Corporate & Strategic Development, Bioniche Life Sciences, P.O. Box 1570, 231 Dundas St E, Belleville, Ontario K8N 5J2, Canada; Tel: +1 613 966 8058; Email: Cameron.Groome@Bioniche.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="35">
<Drug Key="2015546">oligonucleotides, Bioniche Life Sciences</Drug>
<Corporations>
<Corporation>
<Company>Bioniche Life Sciences</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134975" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>CR 002, partnering opportunity</Title>
<Text>CuraGen informed R&D Focus on 9 July 2008 that CR 002 is available for partnering, worldwide. CR 002 is a fully human monoclonal antibody, which neutralizes platelet-derived growth factor-D (PDGF-D), for the potential treatment of IgA nephropathy, lupus nephritis and diabetic nephropathy. A phase I trial, evaluating the safety and tolerability of the monoclonal, has completed.</Text>
<LicensingContact>Henri Lichenstein, VP Product Development, CuraGen Corporation, 322 East Main Street, Branford, CT 06405, USA; Tel: +1 203 481 1104; Email: business_development@curagen.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>9 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="36">
<Drug Key="2016041">CR 002</Drug>
<Corporations>
<Corporation>
<Company>CuraGen</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080709">9 July 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134978" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, anti-obesity compound screening, Kyushu University, licensing offer</Title>
<Text>Researchers at Kyushu University (Japan) have developed a platform for screening anti-obesity compounds. The platform comprises a transgenic animal model, which expresses ubiquitin ligase E4B in its central nerve system (excluding the cerebral nerve system) and an assay to assess adverse effects of anti-obesity agents. The obesity therapy screening platform is available for worldwide licensing, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus, at BIO 2008, 17-20 June 2008, San Diego, USA.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="37">
<Drug Key="2030983">drug design technology, anti-obesity compound screening, Kyushu University</Drug>
<Corporations>
<Corporation>
<Company>Kyushu University</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134980" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>drug design technology, allergy therapeutics screening, Tokyo University of Science, licensing offer</Title>
<Text>Researchers at Tokyo University of Science (Japan) have developed three cell lines, No N62.5 cells, R cells, and RCCM cells for use in the screening of therapeutics for chronic allergic diseases. The cell lines are similar to basophils or mast cells, they are FcepsilonRIalfa-positive, Fc gamma receptor II/III-positive and c-kit-positive. The cell lines require different growth conditions: No N62.5 cells require normal levels of growth factor, R cells require low levels of growth factor and RCCM cells do not require a growth factor. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that the cell lines are available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="38">
<Drug Key="2031011">drug design technology, allergy therapeutics screening, Tokyo University of Science</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134983" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>dihydronaphthalene-based proteasome inhibitors, Tokyo University of Science, licensing offer</Title>
<Text>Researchers at Tokyo University of Science (Japan) are developing dihydronaphthalene-based proteasome inhibitors, for the potential treatment of cancer, inflammation, immunological diseases, and neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. The dihydronaphthalene compounds can be synthesized with no isomers easily and efficiently. Discovery stage research is ongoing in Japan. At BIO 2008, 17-20 June 2008, San Diego, USA, Nadia Liss, Business Development Director at the Japan Technology Group, informed R&D Focus that this program is available for worldwide licensing.</Text>
<LicensingContact>Nadia Liss, Business Development Director, Japan Technology Group, Port of Technology, Science Center, 3701 Market Street, Suite 340, Philadelphia, PA 19104, USA; Tel: +1 215 701 6349; Fax: +1 215 751 0192;Email: nliss@japantechnologygroup.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>licensing offer, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="39">
<Drug Key="2030992">dihydronaphthalene-based proteasome inhibitors, Tokyo University of Science</Drug>
<Corporations>
<Corporation>
<Company>Tokyo University of Science</Company>
<Nationality>Japan</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="licensing offer">licensing offer</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
<NewDrug>Yes</NewDrug>
</Index>
</Indexes>
</Report>
<Report Key="134984" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>mycobacterial cell wall-DNA complex, partnering opportunity</Title>
<Text>At BIO 2008, 17-20 June 2008, San Diego, USA, Graeme McRae, Chairman, President and CEO of Bioniche Life Sciences, and Jennifer Shea, Director of Corporate Communications, Investor and Government Relations at Bioniche Life Sciences, informed R&D Focus that mycobacterial cell wall-DNA complex (MCC) for use in the treatment of bladder cancer is available for worldwide partnering. MCC, which is formulated from Mycobacterium phlei, is undergoing phase III development for the treatment of bladder cancer in Canada, under the trade name UROCIDIN. The bladder cancer indication is the primary focus of Bioniche Life Sciences' research efforts. MCC is also under development for the treatment of prostate cancer (as PROSTACIDIN) and other cancers.</Text>
<LicensingContact>Cameron Groome, Executive Vice-President, Corporate & Strategic Development, Bioniche Life Sciences, PO Box 1570, 231 Dundas St E, Belleville, Ontario K8N 5J2, Canada; Tel: +1 613 966 8058; Email: Cameron.Groome@Bioniche.com</LicensingContact>
<EventTable>
<EventRow>
<EventText>partnering opportunity, Worldwide</EventText>
<EventDate>17 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="40">
<Drug Key="2007102">mycobacterial cell wall-DNA complex</Drug>
<Corporations>
<Corporation>
<Company>Bioniche Life Sciences</Company>
<Nationality>Canada</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="partnering opportunity">partnering opportunity</ReportEvent>
<ReportEventDate CCYYMMDD="20080617">17 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>bladder cancer</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Worldwide</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134985" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>PF 00299804, clinical data (phase I)</Title>
<Text>Phase I results for Pfizer's PF 00299804 for the treatment of nonsmall cell lung cancer (NSCLC) were reported at the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA. In this US and Dutch dose-escalation trial in 43 NSCLC patients, diarrhea (71%), and rash and other skin-related events (65%) were the most common treatment-related adverse events reported. Disease control was observed in half of the patients and durable partial responses were reported in four of 42 patients. ....PF 00299804 is an orally available selective and irreversible inhibitor of the HER family of kinases. In February 2008, a phase II trial of PF 00299804 was initiated in patients with NSCLC in South Korea and in April 2008, a second phase II trial in NSCLC patients was initiated in the USA. Further trials are planned in second- and third-line treatment of advanced NSCLC and in front-line advanced NSCLC (adenocarcinoma, non-smokers); combination trials with targeted agents are also planned.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase I)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="41">
<Drug Key="2027349">PF 00299804</Drug>
<Corporations>
<Corporation>
<Company>Pfizer</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="1">Developer</Relationship>
<IndicatedFor>
<Indication>NSCLC</Indication>
</IndicatedFor>
</Index>
</Indexes>
</Report>
<Report Key="134986" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>LORAMYC, marketed</Title>
<Text>On 10 July 2008 BioAlliance Pharma announced that it has launched LORAMYC, its once-daily, extended-release, mucoadhesive buccal tablet formulation of the antifungal miconazole, in Denmark and Germany for the treatment of oropharyngeal candidiasis in immunocompromised patients with cancer or HIV infection. LORAMYC is already marketed in France and the UK, and has been granted marketing approval for the same indication in several other European countries.</Text>
<EventTable>
<EventRow>
<EventText>marketed, Denmark, Germany</EventText>
<EventDate>10 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="42">
<Drug Key="2022771">LORAMYC</Drug>
<Corporations>
<Corporation>
<Company>BioAlliance Pharma</Company>
<Nationality>France</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="7" Key="pc Launch">marketed</ReportEvent>
<ReportEventDate CCYYMMDD="20080710">10 July 2008</ReportEventDate>
<Relationship Code="1">Licensor</Relationship>
<IndicatedFor>
<Indication>candidiasis</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>Denmark</Region>
<Region>Germany</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134987" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>ranolazine, registered</Title>
<Text>CV Therapeutics announced on 10 July 2008 that it has received marketing approval from the EMEA for ranolazine for the treatment of patients with chronic angina in all 27 EU countries. This authorization follows a recommendation from the EMEA's CHMP in April 2008. Ranolazine has been approved for use in the EU as add-on therapy for the symptomatic treatment of stable angina pectoris patients who are intolerant to or inadequately controlled by their current antianginal therapies. ....Ranolazine, a partial inhibitor of fatty acid oxidation, is marketed in the USA for the treatment of chronic angina under the trade name RANEXA.</Text>
<EventTable>
<EventRow>
<EventText>registered, EU</EventText>
<EventDate>10 July 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="43">
<Drug Key="2001961">ranolazine</Drug>
<Corporations>
<Corporation>
<Company>CV Therapeutics</Company>
<Nationality>USA</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="6" Key="pc Reg">registered</ReportEvent>
<ReportEventDate CCYYMMDD="20080710">10 July 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>angina</Indication>
</IndicatedFor>
<AppliesToRegion>
<Region>EU</Region>
</AppliesToRegion>
</Index>
</Indexes>
</Report>
<Report Key="134988" Status="Major" ReportType="NR">
<PublicationDate CCYYMMDD="20080721">21 July 2008</PublicationDate>
<Title>denenicokin, clinical data (phase I), clinical data (phase II)</Title>
<Text>ZymoGenetics and Novo Nordisk presented results for denenicokin, a recombinant interleukin-21 (rIL-21), at the American Society of Clinical Oncology Annual Meeting 2008, 30 May-3 June 2008, Chicago, USA. In a two-stage Australian phase IIa trial in treatment-naive patients with advanced malignant melanoma, one patient, among the 14 patients enrolled in stage 1 of the study, achieved a confirmed complete response (CR). Ten additional patients were enrolled in stage 2. Best tumor response any time on study included one patient with confirmed CR and one with confirmed partial response (PR). Overall response rate was 8.3%; there were eight patients with stable disease (33.3%) and 14 patients had progressive disease (58.3%). Denenicokin 30 mcg/kg/day was well tolerated. ....Final results from the cohort expansion (second part) of a phase I trial conducted in 15 patients with relapsed/refractory indolent lymphoma showed that the combination therapy with denenicokin 100 mcg/kg and rituximab 375 mg/m2 was well tolerated. Among the 13 patients evaluable for efficacy, 38% had objective response rate (one complete response, one unconfirmed CR and one PR). Eight patients had stable disease. ....In an ongoing dose-escalation Danish and UK phase I trial of subcutaneous denenicokin conducted in 11 patients with renal cell cancer and 12 patients with malignant melanoma, two of seven patients had dose-limiting toxicities at 300 mcg/kg. Among the 14 patients evaluable for efficacy, one patient with malignant melanoma achieved a CR lasting eight months and two patients with renal cell cancer had PR.</Text>
<EventTable>
<EventRow>
<EventText>clinical data (phase II)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
<EventRow>
<EventText>clinical data (phase I)</EventText>
<EventDate>3 June 2008</EventDate>
</EventRow>
</EventTable>
<Indexes>
<Index Counter="44">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
<Indication>renal cancer</Indication>
</IndicatedFor>
</Index>
<Index Counter="45">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase II)">clinical data (phase II)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
</IndicatedFor>
</Index>
<Index Counter="46">
<Drug Key="2019223">denenicokin</Drug>
<Corporations>
<Corporation>
<Company>Novo Nordisk</Company>
<Nationality>Denmark</Nationality>
</Corporation>
</Corporations>
<ReportEvent EventSequence="0" Key="clinical data (phase I)">clinical data (phase I)</ReportEvent>
<ReportEventDate CCYYMMDD="20080603">3 June 2008</ReportEventDate>
<Relationship Code="3">Licensee</Relationship>
<IndicatedFor>
<Indication>melanoma</Indication>
<Indication>renal cancer</Indication>
<Indication>non-Hodgkin lymphoma</Indication>
</IndicatedFor>
</Index>
<Index Counter="47">
<Drug Key="2019223">denenicokin</Drug>
<Corporat