• Acambis plc, of Cambridge, UK, said the FDA designated its joint project with Baxter Healthcare Corp., of Deerfield, Ill., to develop a modified vaccinia ankara (MVA) vaccine as a fast-track program. MVA is a weakened form of smallpox vaccine that is being developed for use in people for whom the traditional smallpox vaccine is contraindicated. Acambis is co-developing its MVA vaccine candidate with Baxter under a contract with the U.S. National Institute of Allergy and Infectious Diseases.

• Alliance Pharmaceutical Corp., of San Diego, restructured a recently completed private placement with investors who purchased the company's common stock and warrants in June. Concurrently, Alliance and the same investors entered a senior convertible note purchase agreement in which the company will issue senior convertible promissory notes in like investment amounts to the same investors. As part of the transaction, Alliance also agreed to file a registration statement with the SEC to register the resale of the stock issuable upon conversion of such senior convertible notes.

• Applied Biosystems Group, of Foster City, Calif., released its LS*LIMS software, a workflow management and process automation solution designed to increase productivity, improve data quality and integrate data from different sources for genomics and proteomics laboratories. Applied Biosystems is a unit of Applera Corp., of Norwalk, Conn.

• Athlon Pharmaceuticals Inc., of Birmingham, Ala., said it subpoenaed Ernst & Young LLP's working papers, which support both the original financial statement and the restated financial statement of aaiPharma Inc., of Wilmington, N.C. In a separate development, Athlon received and said it complied with an inquiry from the SEC concerning the fraud aspect of its claim against aaiPharma. Athlon recently amended its $36 million counterclaim against aaiPharma for its breach of a service agreement entered on July 16, 2003, to include fraudulent inducement. Athlon alleges that aaiPharma had undisclosed liabilities and contingencies at the time of the execution of the agreement, which has precluded aaiPharma from meeting its financial obligations to Athlon.

• Cardiome Pharma Corp., of Vancouver, British Columbia, began dosing in its Phase I study of a controlled-release formulation of oral RSD1235, a product for atrial fibrillation. The study is an open-label, cross-over evaluation of two controlled-release formulations in comparison to an immediate-release formulation and is designed to enable the company to evaluate and select which formulation to move forward.

• CompleGen Inc., of Seattle, signed an agreement with DuPont Crop Protection, of Wilmington, Del., allowing CompleGen access to a large chemical library in exchange for a series of CompleGen's XenoGene assays. XenoGene assays are genetically modified yeast requiring a foreign gene to grow, allowing the high-throughput screening of compounds to identify those that act specifically on the protein encoded by the foreign gene. DuPont gains rights to certain assays and all compounds discovered in the agricultural field of use. CompleGen has all rights in the pharmaceutical field to discoveries that come from the library.

• FibroGen Inc., of South San Francisco, entered an agreement with Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, to license FG-2216, an erythropoietic small molecule that is undergoing clinical development as a treatment for anemia. Yamanouchi gains exclusive rights to develop and market FG-2216 and certain other FibroGen compounds with a similar mechanism of action to treat anemia in Japan. FibroGen retains rights in the rest of the world. Financial terms were not disclosed.

• Genentech Inc., of South San Francisco, and Wyeth Pharmaceuticals, of Collegeville, Pa., a division of Wyeth, entered a manufacturing agreement for Genentech's Herceptin (trastuzumab). Wyeth will manufacture Herceptin bulk drug substance at its production facility in Andover, Mass. Financial terms were not disclosed. Herceptin is an antibody treatment approved by the FDA in 1998 for women with HER2-positive metastatic breast cancer.

• Gen-Probe Inc., of San Diego, said it withdrew its patent litigation against Vysis Inc., of Downer's Grove, Ill., and agreed to pay $22.5 million for a license on future sales of amplified products for clinical diagnostics and blood screening. Gen-Probe expects the agreement to be accretive to earnings next year with the strong growth of products such as Aptima Combo 2, Procleix and Procleix Ultrio. The patent expires in 2015. Since 1999, Gen-Probe has been paying Vysis a 3 percent royalty associated with U.S. Patent No. 5,750,338, but has disputed its obligation to do so. The payment will eliminate any future obligations to pay Vysis royalties after the third quarter.

• Gwathmey Inc., of Cambridge, Mass., entered an agreement to establish a core bioanalytics facility with NovoBiotic Pharmaceuticals LLC, also of Cambridge. They expect it to serve as a resource to not only share between them, but also with other biotech companies in the area, and for NovoBiotic, the arrangement gives it access to Gwathmey's in-house capabilities in in vivo and in vitro testing. NovoBiotic has developed a method for growing previously unculturable microorganisms in the laboratory and is using the technology as a platform for antibiotic discovery.

• Novartis Oncology, of East Hanover, N.J., a unit of Novartis AG, said patients taking an 800-mg daily dose of Gleevec (imatinib mesylate) to treat certain forms of gastrointestinal stromal tumor had significantly longer progression-free survival compared to patients taking the 400-mg daily dose. The Phase III study results were published Thursday in The Lancet. Gleevec is indicated to treat patients with KIT-positive unresectable and/or metastatic malignant gastrointestinal stromal tumor.

• OSI Pharmaceuticals Inc., of Melville, N.Y., filed a registration statement for a follow-on offering of 5.5 million shares of its common stock. The company also expects to grant underwriters an option to purchase an additional 825,000 shares to cover overallotments. Net proceeds will be used to support the ongoing development and future commercialization of Tarceva in the U.S., as well as research and development activities, strategic acquisitions and in-licensing opportunities, working capital and general corporate purposes. The underwriters are Merrill Lynch Pierce, Fenner & Smith Inc., Morgan Stanley, Banc of America Securities LLC, Bear, Stearns & Co. Inc. and Lazard.

• Proteoglycan Technologies Inc., of Kirkland, Wash., received a Phase I Small Business Innovative Research award from the National Institute of Arthritis and Musculoskeletal and Skin Disorders branch of the National Institutes of Health. The $264,984 award to ProteoTech will fund a nine-month study to develop a number of small-molecule therapeutics identified as potent inhibitors for a variety of different amyloid diseases, including systemic AA amyloidosis.

• Repligen Corp., of Waltham, Mass., began a Phase I trial to evaluate RG1068, a synthetic human secretin, in patients with obsessive-compulsive disorder. The study will evaluate two dose levels of a subcutaneous formulation of RG1068, administered three times a week for a month in up to 16 patients. It will evaluate the safety, tolerability and potential impact of RG1068 on the disorder's symptoms, including obsessive thoughts and compulsive behaviors. Repligen already is conducting a Phase II trial of RG1068 in patients with refractory schizophrenia.

• Resverlogix Corp., of Calgary, Alberta, raised gross proceeds of C$404,200 (US$317,013) after completing a non-brokered private placement of 188,000 shares at C$2.15 apiece. The financing, which was placed with a small number of individuals, remains subject to approval of the TSX Venture Exchange. Resverlogix is developing products to manage cholesterol and treat cancer.

• St. Jude Children's Research Hospital in Memphis, Tenn., said its researchers published findings in the current issue of the Journal of Clinical Oncology showing that children with the bone tumor osteosarcoma are more likely to experience a recurrence of the cancer after treatment and less likely to survive if the cancer cells are expressing the telomerase gene. Though the results are preliminary, the authors concluded that they might lead to tests that could identify children at high risk for treatment failure or death. The findings were based on a retrospective study of samples taken from osteosarcoma tumors of children treated at St. Jude during a 20-year period.

• YM BioSciences Inc., of Mississauga, Ontario, filed a final short form prospectus in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Nova Scotia in relation to its offering of 6.35 million units at C$3.15 per unit for gross proceeds of about C$20 million (US$15.7 million). Each unit consists of a common share of YM and one-half of a common share purchase warrant, with each whole warrant entitling the holder to acquire one common share of YM at $3.75 per share for 36 months following the date of closing. Dundee Securities Corp. will serve as lead underwriter, while Canaccord Capital Corp., Sprott Securities Inc., Dlouhy Merchant Group Inc. and Haywood Securities Inc. are also participating. (See BioWorld Today, Sept. 15, 2004.)

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