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Other News To Note
[July 23, 2008]

Other News To Note


(BioWorld Today Via Acquire Media NewsEdge) , of Lund, Sweden, said it plans to appoint Tomas Leanderson, currently the firm's chief scientific officer, as CEO following the resignation of Sven Andr?asson, who has been the CEO since 1999. Andr?asson plans to step down Sept. 1.



? Advanced Cancer Therapeutics, of Louisville, Ky., said it has signed an agreement with the University of Louisville's James Graham Brown Cancer Center for the exclusive worldwide development and commercialization rights to monovalent vaccines derived from the minor capsid protein of human papillomavirus. The L2 protein, in combination with the L1 protein, can assemble into virus-like particles in various expression systems. In addition, ACT signed an agreement with Kentucky BioProcessing LLC, of Owensboro, Ky., for the exclusive worldwide development and commercialization rights to its Geneware plant-based gene expression system for development of an HPV vaccine, which uses a specifically altered tobacco mosaic virus as a vehicle to carry a target protein. Once the altered virus is introduced into the tobacco plant, the natural growth of the plant causes the protein to be reproduced in larger quantities.

? Amgen Inc., of Thousand Oaks, Calif., said that the FDA notified the firm that the approval decision on Nplate (romiplostim) will be delayed. The Prescription Drug User Fee Act action date was July 23. Amgen is seeking approval of Nplate to treat chronic immune thrombocytopenia purpura, a blood-clotting disorder. The company said it is continuing to work with the FDA to assist in the completion of the review process and remained optimistic that a final decision would be made soon. The firm also said it could not speculate on the timing of the FDA's response. Analyst Michael Aberman, of Credit Suisse Securities LLC, noted that the FDA has admitted recently that it has been missing some PDUFA dates, and it simply may need more time to finalize the approval. He doubted the delay would have a material impact on Amgen's stock.


? Avigen Inc., of Alameda, Calif., said it has amended its contract with Sanochemia Pharmazeutika AG, of Vienna, Austria, for AV650 (tolperisone). Under the terms of the amendment, Avigen has agreed to pay up to $5 million in development-based milestone payments for the development of a proprietary, purer form of AV650. Avigen and Sanochemia have filed composition-of-matter and formulation patents in the U.S. for the purer form of AV650, which the company expects to provide exclusivity through 2027. Avigen is developing AV650 under a license and supply agreement with Sanochemia for commercialization in North America to treat neuromuscular spasticity and spasm. Avigen said it expects to announce the results of its Phase IIb trial for AV650 in patients with spasticity associated with multiple sclerosis in the fourth quarter.

? Brain AG, of Zwingenberg, Germany, said it has acquired specific gene-based industrial biotech assets of MerLion Pharmaceuticals GmbH, of Berlin. The assets include selected microbial strains, a substantial gene collection (Tool-Box) encoding modifying enzymes and a huge collection of cosmid libraries comprising more than 800,000 cosmids, harboring some 16 million genes encoding for novel enzymes and biocatalysts. Under the terms of the agreement, Brain will acquire selected Actinomycete strains from Merlion.

? BrainStorm Cell Therapeutics Inc., of New York, said its new therapeutic approach for treating neurodegenerative disease was highlighted in a recent scientific paper published in the journal Stem Cells. The study showed that in a rat model of Huntington's disease, a hereditary neurodegenerative disease, NTF cells that were transplanted at a distance site, migrated toward the lesion at 19 days post-grafting. That finding indicated the survival, integration and migration abilities of NTF cells in the brain.

? Depomed Inc., of Menlo Park, Calif., and partner Rottapharm/Madaus Group, of Monza, Italy, received marketing authorization from the Medical Products Agency in Sweden for ProQuin XR, a once-daily, extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections. The product is also approved in the U.S.

? Emergent BioSolutions Inc., of Rockville, Md., formed a joint venture with the University of Oxford to develop MVA85A, a prophylactic vaccine for tuberculosis. The Oxford-Emergent Tuberculosis Consortium Ltd. expects to begin a Phase IIb trial in 2009 with ?8 million (US$16 million) from The Wellcome Trust and the Aeras Global TB Vaccine Foundation. The university exclusively licensed the vaccine to the joint venture, and Emergent obtained commercialization rights, although Aeras will manage distribution in the developing world.

? Genelabs Technologies Inc., of Redwood City, Calif., has entered a collaborative research agreement with the National Health Research Institutes, a nonprofit foundation established by the Republic of China, and Genovate Biotechnology Co. Ltd., of Taiwan. The collaboration is to jointly conduct research to discover and develop compounds that target the hepatitis C virus (HCV). Genelabs said the collaboration is expected to accelerate the development timelines of its HCV inhibitor pipeline.

? ImmunoCellular Therapeutics Ltd., of Los Angeles, signed a research agreement with Antitope Ltd., of Cambridge, UK, for the humanization of its monoclonal antibodies. ImmunoCellular is advancing its antibodies toward clinical trials, which are expected to start in 2010. Financial terms of the agreement were not disclosed.

? InCode BioPharmaceutics Inc., of San Francisco, reported preclinical results demonstrating that lead candidate rC3-1 in paroxysmal nocturnal hemoglobinuria promotes the enzymatic partial depletion of C3, the hub of the complement cascade. Complement protein C3 is the master regulator of complement C5 that mediates cell damage in PNH patients, and the reduction of C3 has been shown to reduce PNH cell destruction.

? Ipsen SA, of Paris, furthered its proposed $663 million acquisition of Brisbane, Calif.-based Tercica Inc. by purchasing additional shares, exercising warrants and converting notes. Ipsen now owns 42.6 percent of Tercica's outstanding common stock. (See BioWorld Today, June 6, 2008.)

? Medarex Inc., of Princeton, N.J., said that it has received a milestone payment of an undisclosed amount from its licensing partner, Centocor R&D Inc., for the acceptance of an investigational new drug application by the FDA for an undisclosed antibody. The antibody was generated by Medarex's UltiMAb Human Antibody Development System. Medicure Inc., of Winnepeg, Manitoba, said that due to an ongoing restructuring and cost containment measures the company expects its cash position will be sufficient to fund operations to the end of this year.

? Merck KGaA, of Darmstadt, Germany, said that it has received European approval for broader use of Erbitux (cetuximab, ImClone Systems) in metastatic colorectal cancer, including first-line treatment. The approval by the European Commission updates Merck KGaA's license for the treatment of patients with epidermal growth factor receptor -expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapies and who are intolerant to irinotecan.

? MorphoSys AG, of Martinsried, Germany, said that Tokyo-based Astellas Pharma Inc. has exercised a pre-existing option to use MorphoSys's RapMAT technology for faster antibody optimization as part of the existing technology transfer agreements between the two companies. As a result, Astellas will have access to MorphoSys's RapMAT technology module alongside the existing installation of the company's antibody library HuCAL Gold at Astellas' research site in Tsukuba, Japan. MorphoSys will receive annual user fees and continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed.

? NexMed Inc., of East Windsor, N.J., received a non-approvable letter from the FDA regarding its new drug application for the topically applied erectile dysfunction cream, alprostadil. The agency raised concerns about a transgenic mouse carcinogenicity study. Nexmed plans to work with the agency to address the issues and resubmit the NDA.

? PhiloGene Inc., of Summit, N.J., said the FDA has granted orphan drug designation to VEGFb for the treatment of patients with advanced melanoma. That approval is for a larger subset of melanoma patients than was requested, and includes melanoma in stages IIb through IV. Orphan drug status will afford PhiloGene seven years of marketing exclusivity for the drug, once the FDA ultimately approves VEGFb.

? SuperArray Bioscience Corp., of Frederick, Md., has changed its name to SABiosciences Corp. and moved to a new facility in Frederick. The company said the changes reflect its potential and expansion into areas other than gene expression analysis.

? Taligen Therapeutics Inc., of Cambridge, Mass., has named Abbie Celniker as its CEO and has established its headquarters in Cambridge. Celniker previously was global head of Novartis Biologics, and succeeds Woodruff Emlen, a co-founder of the company who remains president. Taligen said it intends to build its late-stage research and development operations in Cambridge while maintaining in Denver its early discovery activities.

? Vical Inc., of San Diego, said it received a $1 million cash payment from its partner, AnGes MG Inc., of Osaka, Japan, for its Collategene angiogenesis program. Vical received an initial up-front payment of $1 million under an exclusive license agreement in 2005, and further advancement may lead to additional milestones and royalty payments.

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