• Advancis Pharmaceutical Corp., of Germantown, Md., completed a pre-Phase III meeting with the FDA on a pediatric amoxicillin PULSYS program. The pulsatile amoxicillin formulation is similar to Advancis' adult pharyngitis product, except it is dosed in multiparticulate granules. The company expects to start enrolling patients later this month and hopes to file new drug applications by the end of 2005.

• BioInvent International AB, of Lund, Sweden, and ThromboGenics Ltd., of Dublin, Ireland, expanded their collaborative research and licensing agreement to jointly develop a new class of anti-angiogenesis agents under investigation at ThromboGenics, based on inhibition of placental growth factor. The program's lead candidate will enter formal preclinical development next year, and the parties will share costs and revenues according to existing agreement terms. The new program will be added to the ongoing collaboration, which is developing anti-Factor VIII monoclonal antibody as an anticoagulant therapy. They expect to bring the programs through clinical proof of concept prior to seeking a pharmaceutical partnership for further development and commercialization.

• Bionomics Ltd., of Adelaide, Australia, agreed to acquire the French contract research organization business, Neurofit, with the acquisition to be completed in early 2005 and Bionomics taking over operations by March 1. Neurofit's core business is the preclinical testing of developmental therapeutics for central nervous system disorders.

• Callisto Pharmaceuticals Inc., of New York, said preclinical data suggest there is anticancer and anti-angiogenic activities of Atiprimod, its drug for multiple myeloma. The company noted that Atiprimod is more effective in inhibiting proliferation of metastatic cells, compared to the non-metastatic cells from the same tumor type. Atiprimod is in a Phase I/IIa trial in patients with relapsed multiple myeloma.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said a judgment will be announced Dec. 20 in the case involving Humira royalties with Abbott Laboratories, of Abbott Park, Ill., which was heard before the High Court in London Dec. 10. The company agreed with the UK Listing Authority that its ordinary shares will be suspended from trading on the London market until after the judgment is announced.

• Curis Inc., of Cambridge, Mass., said the current online issue of the Journal of Neural Transmission contains an article describing preclinical studies that demonstrate a positive therapeutic benefit following activation of the Hedgehog signaling pathway in Parkinson's disease. The results confirm earlier studies presented at the annual meeting of the Society for Neuroscience held in San Diego. The Hedgehog signaling pathway regulates the normal development of the brain and spinal cord. Curis has developed several small-molecule agonist compounds that can activate the Hedgehog signaling pathway and promote nervous system repair.

• DeCode Genetics Inc., of Reykjavik, Iceland, signed an agreement under which it will conduct a Phase II trial next year of a third-party compound as part of program in asthma. The compound targets the product of a gene that DeCode has shown plays a role in the development of asthma. Enrollment is expected to begin in early 2005. Neither the name of the company or the compound was disclosed.

• DOV Pharmaceutical Inc., of Hackensack, N.J., priced its offering of $65 million of convertible subordinated debentures due 2025 to be sold to qualified institutional buyers. They will bear a 2.5 percent interest rate. The company also granted the buyers an option to purchase up to an additional $15 million worth of notes. DOV plans to use the net proceeds for general corporate purposes, including working capital, research and development, capital expenditures and potential acquisitions or other strategic investments. The sale is expected to close Dec. 22.

• Flamel Technologies SA, of Lyon, France, enrolled the first patient in a Phase I/II study of its Medusa formulation of long-acting interferon-alpha. The company said the study is to evaluate the pharmacokinetic profile of the long-acting interferon for hepatitis and hepatitis C treatment.

• Genmab A/S, of Copenhagen, Denmark, said two of its antibodies were selected as candidates for clinical development by F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The antibodies are for two undisclosed disease areas. If all goals are reached in the 3-year-old collaboration, Genmab could gain $100 million plus royalties. The partners significantly expanded their relationship more than two years ago. (See BioWorld Today, June 7, 2002.)

• GPC Biotech AG, of Martinsried, Germany, and Debiopharm SA, of Lausanne, Switzerland, signed a license agreement for GPC Biotech's preclinical small-molecule MHC Class II antagonist program. Debiopharm will license exclusive global rights to further develop the program, and GPC Biotech will receive an up-front payment plus milestone payments and royalties.

• Inyx Inc., of New York, signed a definitive agreement with Aventis Pharmaceuticals Inc., a unit of Paris-based Sanofi-Aventis Group, to acquire certain assets and businesses of Aventis Pharmaceuticals Puerto Rico Inc. The acquisition is scheduled to close by March 31. Financial terms were not disclosed, but Inyx expects to be able to pay for the acquisition through a financing. The Aventis operations in Manati, Puerto Rico, consist of a pharmaceuticals production center and 330 employees that will provide Inyx with a U.S. base to complement its present development and manufacturing facilities in the UK. The move also will provide the company with favorable tax incentives.

• Mymetics Corp., of Nyon, Switzerland, received approval from the National Institutes of Health's Institute of Allergy and Infectious Diseases to begin preclinical testing of the company's trimeric gp41 vaccine in nonhuman primates. The study will run through the third quarter of 2005, testing the second generation of HIV vaccines in development. Mymetics expects to conduct advanced toxicology testing by the end of 2005 and file an investigational new drug application in 2006.

• Nanogen Inc., of San Diego, and Epoch Biosciences Inc., of Bothell, Wash., completed their merger transaction, with Nanogen issuing about 13.6 million shares. The merger adds Epoch's 25 real-time analyte-specific reagent products and other technologies for genetic analysis to the product line. Nanogen and Epoch agreed in September to a $58 million stock deal to combine Nanogen's diagnostic products with Epoch's genomic analysis products. The stockholders approved the merger a few days ago. (See BioWorld Today, Sept. 9, 2004.)

• Pharming Group NV, of Leiden, the Netherlands, updated its development of a recombinant human C1 inhibitor for hereditary angioedema at its investigator meeting. Results from ongoing trials revealed that patients treated with rhC1INH showed rapid time to beginning of relief (15 minutes to four hours) and time to complete resolution (one hour to 48 hours), as well as favorable evaluation of treatment by both patients and physicians.

• Resverlogix Corp., of Calgary, Alberta, announced a $3.1 million bought deal. The company has entered an agreement with First Associates Investments Inc. to allow the remaining about 1 million shares be available at $3 per share by the investment company and its syndicate. The initial 2.6 million shares were issued Nov. 23.

• Santhera Pharmaceuticals AG, of Liestal, Switzerland, completed the second closing of its €14 million first round of private equity financing, raising an additional €7 million from investors. The second closing was subscribed by a syndicate led by NGN Capital, which included Altana Innovationsfond GmbH, Heidelberg Innovation and a private investor.

• SemBioSys Genetics Inc., of Calgary, Alberta, received $229,000 from AVAC Ltd., also of Calgary, as the third milestone payment toward an agreement worth up to $2.5 million. SemBioSys has received a total of $1.4 million to develop the StratoCapture Protein A Purification System. The company also is developing plans for a cGMP pilot plant for the production and testing of the StratoCapture Protein A Reagent and expects it to be operational by 2005 or 2006.

• Signet Laboratories, of Dedham, Mass., expanded its product line of diagnostic assays and antibodies with the ABP-26 assay for sepsis and the Nephroscreen assay for acute renal failure. Over the past year, the company has launched an array of monoclonal and polyclonal antibodies and ELISA kits for cancer, infectious disease and neurodegenerative disease. Both of the new assays measure levels of adenosine deaminase-binding protein.

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