• Ablynx NV, of Ghent, Belgium, and Genencor International Inc., of Palo Alto Calif., entered a cancer drug collaboration in which Ablynx will use its Nanobody technology platform to identify drug candidates against tumor targets specified by Genencor. Ablynx will seek Nanobodies that perform a pre-defined role, while Genencor will handle preclinical and clinical development and commercialization. Ablynx will receive research funding, license fees and potential milestones, as well as royalties.

• Affibody AB, of Bromma, Sweden, entered a license and research agreement with Astra Tech AB, of Mölndal, Sweden, under which it will develop Affibodies - antibody mimics based on the Staphylococcus aureus Protein A domain - that target harmful proteins found in patient blood. Astra Tech will incorporate the Affibody ligands in its autologous blood-transfusion devices. Affibody will receive three years’ research funding, milestone payments and royalties on sales of products arising from the collaboration.

• Australian Cancer Technology Ltd., of Sydney, Australia, undertook a secondary listing on the Xetra exchange, the electronic trading system of the Frankfurt Stock Exchange in Germany. AustCancer contracted the Frankfurt-based securities broker dealer firm, Seydler AG Securities and Financial Services, to act as market maker and designated sponsor for the company’s shares on Xetra. AustCancer is developing oncology-related projects.

• Austrianova, of Vienna, Austria, received European regulatory backing to begin a pivotal trial of its NovaCaps product for pancreatic cancer. The company said the protocol feedback it received ensures that positive data generated by the trial would be suitable for approval. The two-armed, randomized, multicenter, open-label study is designed to evaluate the survival advantage for patients with inoperable pancreatic carcinoma pre-treated with encapsulated, cytochrome P450/2B1-expressing cells that locally convert ifosfamide into tumor-toxic metabolites, as compared to gemcitabine (Gemzar, Eli Lilly and Co.), the current standard therapy. Scheduled to begin in the second half of next year, it will include about 200 patients.

• Bionomics Ltd., of Adelaide, Australia, reported a series of initiatives designed to strengthen its presence in the U.S. market. Bionomics has established a collaborative agreement with the school of medicine at Emory University in Atlanta to study genetic variations associated with severe myoclonic epilepsy of infancy. The company also formed a wholly owned U.S. subsidiary and appointed a U.S. business representative. Bionomics uses its genomic knowledge and technology to develop diagnostics and therapeutics for central nervous system disorders.

• Cambridge Laboratories, of Newcastle, UK, awarded Prestwick Pharmaceuticals Inc., of Washington, the rights to commercialize tetrabenazine in Canada under the brand name Nitoman. Tetrabenazine is a dopamine depletor approved in Canada for the treatment of a series of hyperkinetic movement disorders. Tetrabenazine also is approved for use in the UK, a number of European countries and Australia, and it is undergoing Phase III trials in the U.S. Prestwick plans to file a new drug application in the U.S. later in the year.

• Cellzome AG, of Heidelberg, Germany, began a collaboration with Novartis AG, of Basel, Switzerland, to identify drug targets and leads in a variety of disease areas. Novartis will make an equity investment and provide research funding for two years, with an option to extend the collaboration for two more years, Cellzome said. Both companies will have options on developing compounds that arise, in return for licenses, milestone payments and royalties. Financial terms were not disclosed. Cellzome and Novartis intend to chart the physical and functional protein maps of cellular pathways for several diseases.

• CMC Biopharmaceuticals A/S, of Copenhagen, Denmark, and Resistentia AB, of Uppsala, Sweden, entered a development and manufacturing deal for cGMP production of a fusion protein. The product, which is an immunotherapeutic reagent used for treatment of IgE-mediated allergies, will be manufactured at CMC’s facility in Copenhagen.

• Crucell NV, of Leiden, the Netherlands, and the International AIDS Vaccine Initiative signed an exclusive license agreement to develop an AIDS vaccine based on Crucell’s AdVac technology. Crucell expects to receive development funding, and up-front, annual and milestone payments, as well as royalties on future HIV vaccine sales.

• Cytos Biotechnology AG, of Schlieren, Switzerland, completed a Phase I study that showed that its Immunodrug carrier QbG10 was safe, well tolerated and immunogenic. The investigational agent CYT003-QbG10 consists of the virus-like particle Qb packaged with an immunostimulatory DNA sequence called G10. The trial compared different doses and formulations of QbG10 in five study groups with seven volunteers in each group.

• Eurand International SpA, of Milan, Italy, entered a feasibility agreement for the development of a modified-release formulation of Zanidip (lercanidipine), a calcium channel blocker for hypertension, from Recordati SpA, also of Milan. Eurand will apply its Diffucaps technology to develop the formulation. Terms were not disclosed.

• Evogene Ltd., of Rehovot, Israel, and the Israeli seed company Zeraim Gedera signed a collaboration for the joint development and commercialization of salt-tolerant tomato rootstocks and seed varieties. The companies will jointly develop tomato lines tolerant to high-salinity levels. Zeraim will be responsible for the breeding of the varieties and rootstocks by contributing its existing commercial tomato germplasm.

• ExonHit Therapeutics SA, of Paris, signed a site-license agreement with Tokyo-based Mitsubishi Pharma Corp., granting the company use of its Safe-Hit microarray-based system for evaluating and ranking compounds for toxicity. ExonHit derived the content of the Safe-Hit microarray by applying its DATAS (differential analysis of transcripts with alternative splicing) profiling technology to a model of cellular stress. Mitsubishi Pharma already evaluated Safe-Hit in a one-year pilot study on its compounds. Financial terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, reached two milestones in its collaboration with Basel, Switzerland-based F. Hoffmann-La Roche Ltd., as proof of concept has been established for two human antibodies generated by Genmab. They are the third and fourth antibodies in the collaboration to reach that stage. Under the agreement, Genmab is creating human antibodies to disease targets identified by Roche, and receives milestone and royalty payments based on successful products. If all goals are reached, the value of the collaboration to Genmab could be $100 million, plus royalties.

• GenOway, of Lyon, France, completed a €4 million fund raising (US$4.9 million). CDC Enterprises Innovation, of Paris, led the round, and Siparex Ventures, the venture capital subsidiary of Sigefi Private Equity, also participated. The funds will support the development of custom transgenic mice and rats and the launching of mice and rat models.

• Global Genomics AB, of Stockholm, Sweden, entered an agreement with Rheoscience A/S, of Roedovre, Denmark, for the use of tangerine gene-expression profiling to study targets in metabolic diseases. Financial terms were not disclosed.

• Glycart Biotechnology AG, of Schlieren, Switzerland, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, entered an agreement in which Glycart will use its GlycoMAb antibody-enhancement technology to boost the performance of an antibody-based product candidate discovered by Roche. Roche has an option to develop and market worldwide antibodies generated by Glycart, while Glycart will receive an up-front fee, research funding, milestone payments and royalties on product sales. Glycart focuses on a method of boosting the therapeutic effect of monoclonal antibodies through modulating their glycosylation patterns.

• Hexal AG, of Holzkirchen, Germany, and the European subsidiary of Labopharm Inc., of Laval, Quebec, finalized a deal to market and sell Labopharm’s once-daily tramadol formulation in Germany. Terms are similar to previously reported deals, including an initial milestone payment due upon regulatory approval in Europe.

• Idea AG, of Munich, Germany, began a Phase III study testing IDEA-033, a targeted analgesic and anti-inflammatory product. Researchers will evaluate the safety, efficacy and compliance of IDEA-033 applied on the skin to treat joint and musculoskeletal pain, as well as soft-tissue inflammation. The trial will enroll up to 400 patients with osteoarthritis of the knee. They will be treated for up to 18 months. IDEA-033 employs ultra-deformable carriers to penetrate the skin driven by the local water gradient. The carriers, or Transfersomes, remain intact during the process and transport the drug into the peripheral target tissues.

Immuno-Designed Molecules SA, of Paris, has been authorized by the FDA to initiate a Phase II trial in the U.S. of its therapeutic vaccine Uvidem, which it is co-developing with the French pharmaceutical company Sanofi-Aventis. The vaccine, which consists of mature dendritic cells loaded with lysates extracted from tumor cell lines, is to be tested on 37 patients suffering from Stage III or IV melanoma whose disease is progressing and who have evaluable lesions.

• Imugene Ltd., of Sydney, Australia, and the University of Adelaide formed a new company, Biomimic Ltd., to develop human gastrointestinal applications of Receptor Mimic Technology (RMT). RMT is a biological treatment to reduce production animal losses from gastrointestinal diseases such as E. coli. Biomimic will develop RMT for the treatment, prevention and diagnosis of diseases, such as cholera, rotavirus, E. coli diarrhea and antibiotic-associated diarrhea caused by Clostridium difficile. Both the company and the university have a 25 percent ownership in BioMimic, with the remainder owned by the initial financing participants. At the same time, Imugene signed an agreement with Biomimic for license options to extend its RMT to all other animal species, except humans. The licensing agreement originally involved Imugene and the university, but following Biomimic’s formation, it replaced the university as the licensor of the technology. In return, Biomimic is eligible for milestone-based payments and royalties.

• Inovio AS, of Oslo, Norway, entered a collaboration with Shanghai H&G Biotechnology Co., of Shanghai, China, involving the use of its Elgen Gene Delivery system in a preclinical evaluation of DNA vaccines against tuberculosis and a gene-based vaccine targeting the beta subunit of the tumor antigen human chorionic gonadotropin (hCG[beta]). Shanghai Fudan University also is participating in the project and will supply vaccine candidates based on hCG(beta). Shanghai H&G Biotechnology will be responsible for the development of TB vaccines.

• Kirin Brewery Co. Ltd., of Tokyo, through its pharmaceuticals division, expanded an agreement with Nuvelo Inc., of Sunnyvale, Calif. The deal was extended to Dec. 31, 2005, and expanded to include additional secreted protein genes from Nuvelo’s full-length gene portfolio. It is expected to foster development of therapeutic candidates using Kirin’s site-directed transgenic mouse technology to identify and develop secreted proteins and associated antibodies.

• LG Life Sciences Ltd., of Seoul, South Korea, and Anadys Pharmaceuticals Inc., of San Diego, said the first two cohorts have completed enrollment in a Phase II trial of ANA380 in patients with lamivudine-resistant hepatitis B virus infection. ANA380 is an antiviral compound that has exhibited activity against HBV.

• ltana AG, of Bad Homburg, Germany, said that regulatory authorities in Brazil and Mexico have granted marketing approval for Alvesco, an inhaled corticosteroid. The Brazilian and Mexican authorities have approved Alvesco to treat all severity grades of asthma at doses of 80 mcg to 640 mcg.

• MediGene AG, of Martinsried, Germany, hired Uwe Michaelis as head of research. Michaelis previously had been chief of research and development at Munich Biotech AG. Along with Michaelis, MediGene hired 12 additional staff from the insolvent Munich Biotech to continue research on EndoTAG products for cancer treatment, which MediGene also acquired in August as part of Munich Biotech’s bankruptcy. The compounds add neovascular targeting to anti-angiogenesis.

• Morphochem AG, of Munich, Germany, and Migragen, of Tuebingen, Germany, sold to Schering AG, of Berlin, their rights to a patent application covering novel Rho-kinase inhibitors and their application. The intellectual property also includes new uses for known compounds that were discovered with Morphochem’s technologies. Financial details of the transaction were not disclosed. Migragen, which is in liquidation, had focused on the Rho pathway, primarily in relation to spinal cord injury or central nervous system diseases.

• Nautilus Biotech, of Evry, France, appointed Silvano Fumero chairman and Larry Respess a member of the board. Fumero currently is CEO of Creabilis Therapeutics, of Ivrea, Italy, having been head of research and pharmaceutical development at Geneva-based Serono International SA until May 2003. Respess is senior vice president and general counsel at Nanogen Inc., of San Diego.

• Nobel Ilac Sanatii Ve Ticaret A/S, of Istanbul, Turkey, licensed from Amarillo Biosciences Inc., of Amarillo, Texas, rights to oral, low-dose interferon-alpha. The license covers use of the drug for Behcet’s disease in a territory with a population of about 365 million. The area includes Turkey, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Macedonia, Russia, Saudi Arabia, Tajikistan, Uzbekistan and Yugoslavia. Both companies will conduct studies in Turkey under an investigational new drug application submitted by Amarillo to the FDA. Amarillo will seek U.S. approval and will own rights to the drug. Nobel could seek regulatory clearance in each country of the territory.

• Oxford Biomedica plc, of Oxford, UK, extended its license to P450 enzymes in cancer gene therapy with Massachusetts General Hospital, Boston University and the Dana-Farber Cancer Institute, to cover pancreatic cancer, after starting a Phase I/IIa trial in that tumor type. Under a separate agreement, the three licensors subscribed for a total of 352,887 Oxford Biomedica shares of 1 pence each at 15.78 pence per share.

• Pharming Group NV, of Leiden, the Netherlands, said the U.S. Army will evaluate its recombinant form of fibrinogen (rhFIB) for tissue sealant and “novel therapeutic applications.” Based on the outcome of those studies, it also will supply the army with rhFIB. Pharming recently acquired the remaining patent estate of PPL Therapeutics, of Edinburgh, UK, which includes IP, licenses and process know-how related to large-scale GMP production and purification of fibrinogen.

• PowderMed Ltd., of Oxford, UK, began a Phase I trial of a therapeutic DNA cancer vaccine in collaboration with its partner, the Ludwig Institute for Cancer Research. The study, which will include up to 18 patients with non-small-cell lung cancer Stages IIIa, IIIb or IV, forms part of the Cancer Vaccine Collaboration. The product uses DNA encoding for the NY-ESO-1 tumor-specific antigen and the Particle Mediated Epidermal Delivery technology owned by PowderMed.

• Provalis plc, of Deeside, UK, raised gross proceeds of £2.6 million (US$4.7 million) after placing about 33 million ordinary shares at 8 pence each. The company said it would use the funds to provide additional working capital and for its diabetes diagnostic product. Provalis also produces pharmaceutical products.

The Scottish Centre for Genomic Technology and Informatics (GTI) established a £4.5 million (US$8 million) fund to promote the commercialization of its research. The money comes from Scottish Enterprise, the European Union Regional Development Fund and the University of Edinburgh, where GTI is based. To date, GTI has spun out two companies and aims to create more in the fields of functional genomics, gene chips, biosoftware, proteomics and pharmacogenomics.

• Seven Hills Venture Partners Ltd., of Edinburgh, UK, and San Raffaele Biomedical Park, of Milan, Italy, signed an agreement entitling Seven Hills to seek UK-based commercialization partners for the park’s portfolio of technologies, products and services. San Raffaele, one of Europe’s largest science parks, houses more than 500 research personnel and is adjacent to the San Raffaele Hospital, Italy’s largest private hospital.

• Sinovac Biotech Ltd., of Beijing, filed a new drug application with Chinese regulatory authorities seeking approval of its split flu vaccine. The company said it plans to produce 500,000 doses next year, and then increase to 2 million doses for the 2005-2006 flu season. After the initial production levels, Sinovac said it intends to expand production capacity to as much 20 million doses to meet Chinese demand, a capacity increase that is contingent on securing financing. The split flu vaccine will be sold at about $5 per dose.

• Syngenta AG, of Basel, Switzerland, awarded a $300,000 milestone to Diversa Corp., of San Diego, which identified several lead protein therapeutic candidates in the companies’ research and product development agreement. The companies, which initiated their collaboration in February 2003, will begin early preclinical studies of the candidates. Diversa is entitled to receive a minimum of $118 million in research and development funding over the initial seven-year term and is eligible for milestone payments and royalties for product development and commercialization.

• UCB Pharma SA, of Brussels, Belgium, saw positive preliminary results in its second Phase III trial of CDP-870 as a monotherapy in rheumatoid arthritis patients with moderate to severe disease who were not responding to methotrexate or other disease-modifying anti-rheumatic drugs. The study met its primary endpoint of a 20 percent reduction in the American College of Rheumatology (ACR) score at 24 weeks. The ACR response was seen at week one and was maintained for the rest of the study. UCB acquired CDP-870 when it took over Celltech Group plc, of Slough, UK, in May and will not release further data until the Phase III program in RA is completed. An earlier Phase III trial in combination with methotrexate also was positive. A further trial is planned to assess the impact of CDP-870 on disease progression in RA. CDP-870 remains on track for filing in RA in 2006, but the anti-TNF-alpha pegylated antibody fragment is expected to be filed in Crohn’s disease in 2005. Enrollment in the double-blind Phase III trial in Crohn’s will be completed by the end of 2004.

• Wilex AG, of Munich, Germany, started a Phase I trial of WX-671, an oral non-cytotoxic cancer compound. The study will evaluate the oral bioavailability, pharmacokinetics and safety of the drug in 12 male volunteers. WX-671 is a second-generation serine protease inhibitor that targets the urokinase plasminogen-activator system, which has been shown to play a role in metastasis and solid-tumor growth.

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