• 4SC AG, of Martinsried, Germany, appointed Patrick Schwarz-Schuette chairman of Schwarz Pharma AG, to its supervisory board. Schwarz-Schuette has chaired Schwarz Pharma since 1992. 4SC also appointed Brian Morgan and Holger Reithinger to its supervisory board. Prior to founding a consultancy in 1997, Morgan had been with SmithKline Beecham and its predecessors for 30 years. Before joining the venture capital industry, Reithinger was a product development manager with Biometra/Whatman plc.

• Amrad Corp. Ltd., of Melbourne, Australia, said it received its first $3 million milestone payment under its exclusive license and research collaboration with Merck Sharp & Dohme Pty Ltd., the Australian subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J. That brings the total amount received by Amrad to $8 million since the agreement was signed in June 2003. At that time, the companies entered one of the largest biotechnology collaborations in Australian history with potential milestones of up to $112 million, plus royalties. The collaboration is to develop drugs with therapeutic potential in areas such as asthma and other types of respiratory disease and oncology.

• Argenta Discovery Ltd., of Harlow, UK, entered a new fee-for-service research agreement with Aventis Pharmaceuticals Inc., of Bridgewater, N.J. Aventis and its affiliates will have the ability over a three-year period to order research services that draw on Argenta's chemical and biological research capabilities. Argenta is a drug discovery company that provides contract services in medicinal chemistry and biochemistry to pharmaceutical companies.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Bayer AG, of Leverkusen, Germany, entered a cooperation agreement in mouse genetics. As part of that deal, Artemis will use its ArteMice platform to generate genetically engineered mice for Bayer. Bayer will use the mice in its human drug discovery research activities for gene function analysis as well as for the testing of drug candidates.

• Boehringer Ingelheim GmbH, of Ingelheim, Germany, exercised its first option related to a therapeutic antibody that stems from its collaboration with MorphoSys AG, of Munich, Germany. The latter will develop an antibody for Boehringer against an undisclosed target molecule for inflammatory diseases, such as asthma or rheumatoid arthritis. MorphoSys will select the antibody from the HuCAL Gold library. Boehringer will assume preclinical and clinical development responsibilities, as well as subsequent marketing activities for resultant products, on which MorphoSys will earn milestones and royalties. Financial details of the agreement, which dates to February, were not disclosed.

• Cellectis SA, of Paris, granted a nonexclusive worldwide license to Fermentas UAB, of Vilnius, Lithuania, to manufacture and commercialize the endonuclease I-Scel. The product, a model homing endonuclease, is used in research and genome engineering. Financial terms were not disclosed.

The Centre for Developmental Cancer Therapeutics in Melbourne, Australia, presented preliminary Phase II results at the International Conference on Molecular Targets and Cancer Therapeutics in Boston, jointly sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organization for Research and Treatment of Cancer. The data showed that treatment with a compound called SU11248 resulted in a major response for two patients out of 41, as assessed by the degree of tumor shrinkage. A further 15 patients had benefit defined as no progression of their cancer and continued therapy beyond the 12-week study. Most had improved symptoms or reduced tumor activity, while some also had significant tumor shrinkage that was less than that required to meet the criteria for major response.

• Curasan AG, of Kleinostheim, Germany, will take over the German marketing of Atridox and Atrisorb from Atrix Laboratories GmbH, a subsidiary of Fort Collins, Colo.-based Atrix Laboratories Inc. The transfer of sales rights will take effect Dec. 1. Atridox is a specific local antibiotic, while Atrisorb is a reabsorbant membrane. Curasan said that it expects the products to account for about €1 million in sales in 2004. Specific details of the contract were not disclosed.

• Cyclacel Ltd., of Dundee, UK, presented interim Phase I results at the International Conference on Molecular Targets and Cancer Therapeutics in Boston showing that treatment with its small-molecule CDK inhibitor, CYC202, resulted in stable disease or tumor regression in several patients with advanced tumors who had previously failed several lines of chemotherapy. Separate preclinical data on the use of CYC202 with docetaxel showed that the combination exhibited marked synergy over either treatment alone.

• Devgen NV, of Ghent, Belgium, was awarded €1.9 million (US$2.3 million) from the Flemish government. The Flemish Institute for the Promotion of Industrial Scientific and Technological Research awarded the grant to further develop Devgen's technology to identify the mechanism of action of human drugs.

• Garching Innovation GmbH, Max Planck Society's technology transfer agent in Munich, Germany, gave Pintex Pharmaceuticals Inc., of Watertown, Mass., exclusive worldwide rights to develop and commercialize technology originated at the Max Planck Research Unit for Enzymology of Protein Folding. Pintex acquired the rights in connection with its work on the Pin1 enzyme. The Pin1 enzyme, which has been linked to numerous human cancers, was described in a recent article in Cancer Research by researchers from Pintex; Harvard Medical School in Cambridge, Mass.; and Baylor College of Medicine in Waco, Texas.

• Genetic Technologies Ltd., of Melbourne, Australia, settled two of the three lawsuits it has filed in the U.S. It dismissed its patent infringement actions against Nuvelo Inc., of Sunnyvale, Calif., and Covance Inc., of Princeton, N.J. Specific terms of the settlements remain confidential. The company added that it remains focused in its efforts against Applera Corp., of Norwalk, Conn. Genetic holds patents in noncoding sequence/intron DNA analysis, noncoding sequence genomic mapping and fetal-cell recovery.

The Gray Cancer Institute in London reported at the International Conference on Molecular Targets and Cancer Therapeutics in Boston that its researchers showed that molecular markers allowed them to identify eight distinct groups of tumors, each with similar biological profiles, within a patient group. One group of tumors had a better-than-average response to radiotherapy, with a success rate of 67 percent at five years compared to a 52 percent overall success rate. A second group showed a poor response to radiotherapy, with a success rate of 37 percent at five years.

• Greenovation Biotech, of Freiburg, Germany, and Dow Chemical Co., of San Diego, will collaborate to develop fully mammalian-like plant glycosylation patterns. Greenovation will license selected Dow intellectual property covering certain modifications of glycosylation patterns in plants, and Dow will receive greenovation's data on its progress of such work in moss. No financial details were released.

• Healthcare Technologies Ltd., of Ashdod, Israel, said it is holding preliminary discussions with ImmvaRx Inc., of Evanston, Ill., in which ImmvaRx would transfer all or a substantial part of its intellectual property to Healthcare Technologies in return for a controlling interest in its shares. Concurrently, Healthcare Technologies' principal stockholder, Gamida for Life BV, would have the option to purchase its respective share in the company's subsidiaries in return for its holdings in Healthcare Technologies, which would have the option to force Gamida to execute the same. ImmvaRx is developing humanized antibody immunotherapies.

• HepCgen Ltd., of Southampton, UK, raised £1.6 million (US$2.7 million) in a second-round funding that values the company at £4.8 million. HepCgen was spun out of the School of Medicine at Southampton University in March 2003 to commercialize diagnostic tests for hepatitis C and liver fibrosis, and to develop treatments for liver diseases. The spin-out was supported by IP2IPO plc, which following the round owns 24 percent of HepCgen. The company says its genotyping test for hepatitis C will enable interferon therapy to be tailored to individual patients and it has also identified blood markers of liver fibrosis that will avoid the need for liver biopsies. HepCgen will use the revenue generated by its testing services to fund development of therapeutic vaccines and immune system stimulants to treat liver diseases.

• Jerini AG, of Berlin, said the FDA granted orphan drug designation to its BK2 receptor antagonist Icatibant (JE049) for angioedema, an indication for which the company plans to file an investigational new drug application. The compound already has orphan drug designation in Europe, where it remains in an open Phase II study in patients with hereditary angioedema.

• Medipharm Biotech Co. Ltd., of Shanghai, China, signed a product development agreement with Avid Bioservices Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals Inc., of Tustin, Calif., for process and product development of tumor necrosis therapy under current good manufacturing practices. Avid will provide its services to assist Medipharm in preparing for commercial launch of its radiolabeled tumor necrosis antibody in the People's Republic of China. Financial terms were not disclosed.

• Medivir AB, of Huddinge, Sweden, will assume responsibility for MV026048, a compound in development in HIV in partnership with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Roche will provide guidance while retaining an opportunity to opt into the program at a later date. The ongoing agreement was signed in April 2002. In another collaboration, the partners entered a joint research program to discover new inhibitor compounds for hepatitis C. Separately, Medivir and Jiangsu Hengrui Medicine Co., of Shanghai, China, entered a discovery collaboration to jointly develop protease inhibitor drugs for chronic obstructive pulmonary disease. The collaboration, which extends over several years, will combine Medivir's protease inhibitor program in that indication, screening systems and discovery technologies with Hengrui's medicinal chemistry. Resulting products will be commercialized by Hengrui in China and by Medivir in the rest of the world.

• Merck Eprova AG, a wholly owned subsidiary of Merck KGaA, of Darmstadt, Germany, and BioMarin Pharmaceutical Inc., of Novato, Calif., entered a development and manufacturing agreement to support clinical trials scheduled to begin next year with Phenoptin (6R-BH4), an enzyme cofactor that is a second-generation, oral form of tetrahydrobiopterin, for phenylketonuria (PKU). Eprova will supply Phenoptin to BioMarin for clinical trials and potential commercial operations. The partners will share process development and clinical manufacturing costs, and BioMarin will own and develop the 6R-BH4 product for PKU and other genetic disease indications. BioMarin will pay Merck Eprova a royalty on commercial sales of Phenoptin for PKU or related indications.

• Merck KGaA, of Darmstadt, Germany, opted out of a plan to invest in a new protein production plant in Germany for the time being. Instead, the company said it would secure supply of both its biological cancer drugs, Erbitux (cetuximab) and EMD 72000, by contract manufacturing. Merck contracts with Boehringer Ingelheim GmbH, of Ingelheim, Germany, and ImClone Systems Inc., of New York, for the production of the monoclonal antibody Erbitux. The monoclonal antibody EMD 72000 is in Phase II trials.

• Newron Pharmaceuticals SpA, of Milan, Italy, said positive preliminary Phase II results showed that safinamide was well tolerated in epilepsy patients with medically intractable seizures. No serious adverse events occurred and safinamide did not alter the kinetics of the other anti-epileptic drugs. The interim findings also showed a significant reduction in median seizure frequency from 50 mg progressing up to the highest dose. Should full analysis confirm the data, Newron plans to begin efficacy studies with safinamide at three doses.

• Novuspharma SpA, of Milan, Italy, said preclinical results showed that Pixantrone does not significantly increase existing anthracycline-induced heart damage, while repeat treatment with traditional anthracyclines leads to significant deterioration in heart tissue. The findings reported at the International Conference on Molecular Targets and Cancer Therapeutics in Boston suggest Pixantrone is safe to use in patients heavily pre-treated with existing anthracyclines, the company said, adding that the same conclusion has been reached in clinical trials of Pixantrone for relapsed aggressive non-Hodgkin's lymphoma.

• Peplin Biotech Ltd., of Brisbane, Australia, acquired a portfolio of potential therapeutic products comprising new, synthetic, engineered polyunsaturated fatty-acid compounds. The compounds are the product of an extensive research program at the Women's & Children's Hospital in Adelaide, Australia. In the deal, Peplin secures the rights to 44 compounds and 41 patent filings, represented by seven patent families, including five granted U.S. patents covering molecular structures and their use as human therapeutics.

• Pieris Proteolab AG, of Freising, Germany, reported findings at the BioEurope conference in Frankfurt, Germany, showing that its drug discovery engine generated multiple anticalins against more than half a dozen commercially relevant protein targets with affinities from the low nanomolar range to 130 picomolar, without the need for further maturation steps. Also, first acute toxicity studies in mice revealed a good safety profile.

• Pluristem Life Systems Inc., of Haifa, Israel, said its scientific team has identified new information about the company's 3-D culture technology for stem cell expansion without differentiation vs. the conventional 2-D cultures presently used in research. The scientists documented success in building a 3-D replica of the physiological bone marrow environment and in proving that the 3-D structure is essential for the support of hematopoietic stem cells (HSCs). The company's core technology is designed to expand HSCs for bone marrow transplantations using its 3-D PluriX bioreactor.

• Proteome Sciences plc, of Cobham, UK, announced a collaboration with the UK Medical Research Council to identify differential protein expression in the prion diseases Creutzfeld-Jacobs disease (CJD) and vCJD, as the basis for diagnostics and treatments. The company also said it was awarded a U.S. patent on the use of annexin proteins as serum markers for diagnosing lung, breast and esophageal cancers. Antibodies to those proteins occur in the blood of patients with tumors, but not in healthy individuals. Proteome says it is looking for partners to co-develop diagnostic tests.

• Sanofi-Synthelabo SA, of Paris, and NV Organon, of Oss, the Netherlands, said that Arixtra (fondaparinux sodium) received marketing authorization from the European Commission for an extended duration of prophylactic treatment of venous thromboembolic events (VTE) in patients undergoing hip fracture surgery. Arixtra is indicated in the European Union for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs, such as hip fracture, major knee or hip replacement surgery.

• Sciona Ltd., of Hants, UK, received a license from Genaissance Pharmaceuticals Inc., of New Haven, Conn., for its HAP technology to use in the development and marketing of consumer products. Genaissance will have rights to support Sciona's pharmacogenomic research and customer genotyping. In exchange for a license to its HAP technology, Genaissance obtained a 30 percent fully diluted equity position in Sciona. Genaissance also would receive royalties on any products that incorporate the technology.

• SkyePharma plc, of London, submitted an application to the UK Medicines and Healthcare Products Regulatory Agency for approval of DepoMorphine, its sustained-release injectable formulation of morphine for control of moderate to severe post-operative pain. If granted approval, SkyePharma intends to seek approval in other European countries under the EU's mutual recognition procedure. SkyePharma submitted a new drug application for DepoMorphine to the FDA in July.

• TeGenero AG, of Wuerzburg, Germany, signed a process-development agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to produce materials for a monoclonal antibody (TGN1412) from TeGenero designed to treat immunological disorders. Boehringer will create an adequate cell line, develop processes and manufacture materials for the antibody's clinical trials. TeGenero, founded in 2000, is a drug discovery and development company specializing in immune therapies. Financial details of the agreement were not disclosed.

• Tepnel Life Sciences plc, of Manchester, UK, said its shareholders approved its recently reported $4.3 million acquisition of Orchid Diagnostics, a unit of Orchid BioSciences Inc., of Princeton, N.J. The acquisition, which is expected to be completed in the next two weeks, establishes a direct U.S. sales operation for Tepnel to sell its DNA-purification products and services stateside. In the U.S., Orchid will be renamed Tepnel Lifecodes Corp., while in the UK it will be called Tepnel Diagnostics Ltd.

• The Speedel Group, of Basel, Switzerland, received an undisclosed milestone payment after positive clinical results related to Aliskiren were released by Novartis AG, also of Basel. It said a 650-patient study showed that the renin inhibitor significantly reduced blood pressure in patients with essential hypertension at all doses tested and was either as good as or statistically better than irbesartan in lowering diastolic blood pressure. Novartis said it would begin Phase III development next year, with the submission of a new drug application scheduled for the end of 2005.

• Trigen Ltd., of London, identified two clinical candidates in its direct thrombin inhibitor program for the prevention and treatment of thrombosis. Both TGN167, an oral treatment for chronic use, and TGN255, which is administered intravenously for acute indications, are now in Phase I trials.

• Xantos Biomedicine AG, of Munich, Germany, completed a portion in its expansion of the company's library of cDNA, which now comprises more than 35,000 human cDNA clones in mammalian expression vectors and, according to the company, more than 24,000 distinct human gene loci. The company intends to be able to perform genome-wide functional target discovery and validation with the library and an automated cellular screening platform.

• Xenova Group plc, of Slough, UK, reporting at the International Conference on Molecular Targets and Cancer Therapeutics in Boston, said four abstracts pointing to the mechanism of action of XR5944 (MLN944) show that the new DNA/RNA targeting agent is distinct from current cytotoxic agents. The compound maintains its cytotoxicity in yeast cells deficient in topoisomerases, though it was previously thought to exert its cytotoxic action by dual inhibition of topoisomerases-I and -II. Also, XR5944 arrests human tumor cell lines in both the G1 and G2 phases of the cell cycle, in contrast to topoisomerase inhibitors that arrest at the S/G2 phase. XR5944 is in Phase I development in patients with advanced solid tumors.

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