• Alkermes Inc., of Cambridge, Mass., said its partner Janssen-Cilag SA, of Madrid, Spain, received approval from French authorities to market Risperdal Consta for schizophrenia. The product will be launched following negotiation of reimbursement pricing. Risperdal Consta is a long-acting injectable form of risperidone that was developed using Alkermes' Medisorb drug delivery technology. Janssen-Cilag is responsible for worldwide sales and marketing of the product. In the U.S., Johnson & Johnson Pharmaceutical Research & Development, of La Jolla, Calif., submitted additional data and analyses to the FDA to fulfill a complete response to the non-approvable letter issued by the FDA regarding the new drug application.

• Amersham plc, of London, said it received an approach from an unnamed suitor, which might or might not lead to an offer for the company. But Amersham added that no agreement has been reached and it plans to make a further announcement when appropriate. The company is a maker of diagnostic products and tools.

• Arpida Ltd., of Muenchenstein, Switzerland, and Polyphor Ltd., of Allschwil, Switzerland, formed a collaboration to find antimicrobial compounds acting on selected targets. The alliance will combine Arpida's multidisciplinary antimicrobial platform with Polyphor's expertise in medicinal chemistry. Terms were not disclosed but the two companies said they would jointly take lead molecules through early preclinical development.

• Avecia Ltd., of Manchester, UK, was awarded a $71.3 million contract to manufacture three million doses of a new recombinant anthrax vaccine for the U.S. National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. The contract builds on a 2002 agreement to produce 2,000 doses for clinical trials. The vaccine is intended to provide immunity to inhalation anthrax and protect against anthrax spores, even if administered after exposure. It is designed to be effective in three or fewer doses, as opposed to the current vaccine that requires six injections over 18 months. Avecia has teamed up with Baxter Healthcare Corp., which will provide regulatory advice and fill and package the vaccine.

• Borean Pharma A/S, of Aarhus, Denmark, said it reached a milestone by producing protein products with high affinity binding in the 100-200 picomolar range. The results demonstrate the company's platform is capable of generating fully matured and optimized biopharmaceutical product candidates in four weeks instead of six to 12 months.

• Cellectricon AB, of Gothenburg, Sweden, granted an exclusive license of its electroporation technology to Axon Instruments Inc., of Union City, Calif. Axon Instruments will incorporate the technology into its Axoporator line of products, used for internalization of DNA, drugs and large molecules into cells. The agreement includes undisclosed license fees and potential future royalties.

• Flamel Technologies SA, of Lyon, France, reported that it closed its offering of about 4.5 million ordinary shares in the form of American Depository Shares at $33.25 per share. The offering included 2 million shares offered by the company, and 1.98 million shares offered by selling shareholders. The underwriters have an option to purchase 588,000 additional shares from the selling shareholders to cover overallotments. Flamel received proceeds of about $62.1 million from the issuance of 2 million shares.

• Ipsat Therapies Oy, of Espoo, Finland, presented positive data from a Phase I trial of its lead compound, P1A, at the BioPartnering Europe event in London. Ipsat is attempting to tackle the problem of bacterial antibiotic resistance by promoting the breakdown of antibiotics in the lower intestine. P1A, an orally administered compound, breaks down residual beta-lactam antibiotics that have not been absorbed into the serum during therapy. The company now is planning a Phase IIa study to evaluate the efficacy of P1A.

• Kyowa Hakko Kogyo Co., of Tokyo, entered an agreement with a U.S. pharmaceutical development venture, NovaCardia Inc., of San Diego, whereby Kyowa Hakko granted NovaCardia an exclusive license to develop and market, outside Asia and Japan, the adenosine-A1 receptor antagonist discovered and developed by Kyowa Hakko. Under the agreement, Kyowa Hakko will receive up-front and milestone payments, and could receive royalties. KW-3902 antagonizes the adenosine A1-receptor that is known to regulate renal function.

• Medical Marketing International, of Cambridge, UK, announced progress in the preclinical development of a ribozyme-based HIV therapy being developed by its joint venture company, Viratis Ltd. Unlike current therapies that act on the virus after it has invaded the cell, Viratis aims to prevent HIV infection by destroying messenger RNA and thus blocking production of two receptors the virus needs to invade the cell. The company has shown its ribozyme product destroys at least 70 percent of messenger RNA in human blood cells. It also has shown high levels of transfection rates of the product in human cells without causing the damage to the cell membrane that occurs with some other products.

• MediGene AG, of Martinsried, Germany, added to its patent estate in cancer therapies by acquiring exclusive worldwide rights for two drug candidates and the underlying technology from the University of Chicago. The company had previously held options on the patents, which is exercised to expand its position in oncolytic herpes simplex viruses (HSV). One candidate, NV1020, has completed Phase I/II trials and a Phase II trial is being readied. The other, G207, has shown positive data in its Phase I trial. The patents protect the use of oncolytic HSVs for treating all types of cancer, combining the viruses with standard therapies and all replicating HSVs expressing therapeutic genes.

• MorphoSys AG, of Munich, said preclinical studies of MOR101 and MOR102 demonstrated promising results of their potency as anti-inflammatory antibodies. The data were presented at the Human Antibodies & Hybridomas Conference in Osaka, Japan. MOR101 and MOR102 target ICAM-1, a cell adhesion molecule involved in several inflammatory diseases.

• NeuTec Pharma plc, of Manchester, UK, is seeking to partner Mycograb, its Phase II antifungal drug targeting the heat shock protein Hsp90 for cancer, following recent advances in understanding of the role of Hsp90 in that disease. Mycograb was developed from antibodies discovered in patients who recovered from severe systemic forms of the fungal infection candidiasis. Mycograb is in a Phase II trial in 38 hospitals in the U.S. and Europe, with results expected next year. NeuTec intends to carry on development in infection by itself, but would like to partner it for cancer. The value of Hsp90 as a cancer target has been questioned because the protein is widespread in the body. But last month Conforma Therapeutics Corp., of San Diego, published a paper in Nature, showing Hsp90 exists in a different conformation in cancer cells, which is distinct from that in normal cells, and can have up to a 1,000-fold greater affinity for Hsp90 inhibitors. The company also is developing Aurograb in hospital-acquired infection MRSA (methicillin-resistant Staphylococcus aureus).

• OncoMethylome Sciences SA, of Liege, Belgium, and Serologicals Corp., of Atlanta, entered an agreement for Serologicals to gain access to cancer research technology. Serologicals' Chemicon International Inc. research division retains all Methylation Specific PCR-based technologies intellectual property rights it has access to, except commercial rights to a field it does not currently serve. Also, Serologicals received a signature payment and gains exclusive rights to all OncoMethylome's current and future MSP-based methylation technologies for commercialization to the research market. More specific financial terms were not disclosed.

• Prima Biomed Ltd., of Melbourne, Australia, reported that its subsidiary, Cancer Vac, entered an agreement with Progen Industries Ltd., of Brisbane, Australia, to begin the scale-up manufacture for a therapeutic vaccine in its Phase II trial. Marcus Clark, CEO of Prima Biomed, said Progen will undertake the scale-up activities to produce a GMP grade of therapeutic vaccine.

• Qiagen NV, of Venlo, the Netherlands, sold the assets of its Pecura business to Merial Ltd., a veterinary joint venture between Merck & Co. Inc., of Whitehouse Station, N.J., and Aventis SA, of Lyon, France. Pecura's technology portfolio includes the veterinary rights to a new class of drugs based on immunostimulatory cytosine-phosphodiester-guanine (CpG) dinucleotides, presented in synthetic oligodeoxynucleotides (CpG-ODN). Qiagen, which retained certain rights to the technologies applicable for research tools, said that, though the assets have the potential as veterinary therapeutics, they are not core to its focus and direction. Financial terms were not disclosed.

• Serono Inc., of Rockland, Mass., the U.S. affiliate of Serono SA, of Geneva, Switzerland, said the FDA approved its new prefilled syringe for Ovidrel (choriogonadotropin alpha injection), making it the first liquid, ready-to-inject therapy for infertility treatment in the U.S. Unlike other infertility treatments, the Ovidrel Pre-Filled Syringe does not require patients to mix medication prior to injection, the company said.

• Sireen AG, of Martinsried, Germany, won a research grant worth €400,000 from the Bavarian Ministry of Economics. The grant will fund a cancer drug discovery program that aims at finding small molecules effective against a variety of cancers. Sireen will work to discover and develop small-molecule inhibitors that target the unregulated growth processes in cancer cells. Sireen already has active drug discovery programs involving colon cancers and leukemia.

• Switch Biotech AG, of Neuried, Germany, and 4SC AG, of Martinsried, Germany, will work together to discover and develop small-molecule compounds to treat psoriasis. Switch Biotech has identified and validated a new target to treat the condition, and the company will use technology from 4SC to find active small molecules. The companies will work to optimize lead compounds, and Switch Biotech will lead clinical development. Switch Biotech will fund research and development, as well as making potential milestone and royalty payments to 4SC.

• Xenova Group plc, of Slough, UK, initiated a second trial for TN-NIC, its therapeutic vaccine under development for nicotine addiction. About 60 smokers will be recruited in the double-blind, randomized, placebo-controlled study. Results of the study will be used to design a Phase II trial to assess the effect of vaccination with TN-NIC on tobacco consumption. The Phase II trial is expected to begin during the second half of 2004.

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