• Amgen Inc., of Thousand Oaks, Calif., submitted a supplemental biologics license application to the FDA supporting once-weekly dosing of Enbrel. The filing is based on results from a Phase III study that demonstrated patients treated with 50 mg of Enbrel once weekly achieved similar efficacy, tolerability and pharmacokinetics as patients receiving 25 mg of Enbrel twice weekly. Enbrel is a fully human anti-TNF receptor approved to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis and to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active rheumatoid arthritis, among other indications.

• BioMarin Pharmaceutical Inc., of Novato, Calif., filed a shelf registration statement for the offer and sale by BioMarin of up to $150 million of its common stock. BioMarin focuses on of therapeutic enzyme products. The company said in its prospectus its plans for any raised proceeds might include funding costs associated with its joint venture with Genzyme Corp., of Cambridge, Mass., for the development and commercialization of Aldurazyme; funding research and development; funding clinical and commercial manufacturing facilities, including related equipment; and funding acquisitions or investing in businesses or products.

• Cambridge Antibody Technology plc, of Cambridge, UK, and MorphoSys AG., of Martinsried, Germany, settled their patent disputes. The settlement covers MorphoSys' past, present and future use and commercialization of all versions of its HuCAL libraries, including HuCAL Gold, and relates to all patents in the ongoing disputes between the companies. This includes litigation in the U.S. regarding CAT's Griffiths, McCafferty, Winter II and Winter/Lerner/Huse patents, as well as oppositions launched by MorphoSys at the European Patent Office against CAT's Winter II and McCafferty patents. Also, MorphoSys will receive a license to the CAT patent estate in respect to previous HuCAL libraries. CAT will receive an annual payment of €1 million over the next five years. It also will receive other financial consideration from MorphoSys' activities related to HuCAL Gold for a defined period of time. CAT will receive milestone and royalty payments under the license for products developed using previous HuCAL libraries. CAT will receive an equity stake of 588,160 ordinary shares in MorphoSys. Separately, CAT said it entered a cross-licensing arrangement for antibody-related technologies with XOMA Ltd., of Berkeley, Calif. CAT and its collaborators receive rights to use XOMA's antibody expression technology for developing products using CAT's phage-based antibody technology, in return for license payments to XOMA. XOMA receives the right to use CAT's phage antibody libraries for its target discovery and research programs, with an option to develop antibodies into therapeutics. Should any therapeutic antibodies be developed by XOMA, license payments would be made to CAT.

• Cell Genesys Inc., of Foster City, Calif., filed a shelf registration statement allowing it to issue, from time to time, up to $150 million of securities, once the registration is effective. The company said it expects to use proceeds for general company purposes, including future Phase III trials of its cancer products and other research and development expenses. Cell Genesys is pursuing three cancer product platforms - GVAX cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies.

• Connetics Corp., of Palo Alto, Calif., said the FDA approved the company's supplemental new drug application to expand the label for OLUX (clobetasol propionate) Foam, 0.05 percent, to include the short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas. OLUX is approved for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, including psoriasis.

• DOV Pharmaceuticals Inc., of Hackensack, N.J., entered a settlement agreement concerning the securities class action lawsuits arising from or relating to its April 25 initial public offering of 5 million shares at $13 per share. Since then, a number of lawsuits alleging violations of the securities laws have been filed in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of New Jersey against DOV and certain of its officers, directors and underwriters. The settlement includes all defendants and covers, as a class, all those who purchased common stock of DOV in or traceable to its IPO through Dec. 20 and suffered damages. The class members collectively will receive $250,000 in cash and 500,000 six-year warrants with a strike price of $10 per warrant. DOV focuses on drugs for central nervous system, cardiovascular and urological disorders. The offering raised $65 million, but DOV's stock fell 33 percent on its first day of trading. (See BioWorld Today, April 26, 2002.)

• Eos Biotechnology Inc., of South San Francisco, filed an investigational new drug application for its therapeutic antibody, Eos200-4. The product has been shown to inhibit angiogenesis in in vitro and in vivo models. The role of the molecular target for Eos200-4 in angiogenesis was discovered and developed using Eos' internal genome-wide target identification and validation capabilities.

• Genelabs Technologies Inc., of Redwood City, Calif., submitted a marketing authorization application for its lupus drug, Prestara (prasterone, GL701), to the European Agency for Evaluation of Medicinal Products. If approved, the product would be marketed in Europe under the trade name Anastar. The company is seeking approval for the improvement of systemic lupus erythematosus (SLE) disease activity and/or reduction in glucocorticoid doses in women with active SLE. In late August, the FDA issued an approvable letter to Genelabs for Prestara contingent on, among other things, the successful completion of an additional clinical trial providing sufficient evidence to confirm the positive effect of prasterone on bone mineral density that was observed in women with mild to moderate SLE while on glucocorticoids. (See BioWorld Today, Sept. 3, 2002.)

• Keryx Biopharmaceuticals Inc., of Cambridge, Mass., appointed Michael Weiss chairman and CEO, replacing Benjamin Corn, who is resigning his position as CEO and president. Morris Laster, Keryx's executive chairman, also is resigning. Weiss plans to consolidate senior management in the U.S. and will relocate headquarters from Jerusalem to New York. Keryx Biopharmaceuticals focuses on therapies for the treatment of medical conditions, including cancer and diabetes.

• Neurocrine Biosciences Inc., of San Diego, reported results from its second trial of IL-4 Fusion Toxin (NBI-3001) for the treatment of glioblastoma multiforme malignant brain tumors. The study of 32 patients was designed to explore an improved delivery regimen and to determine a safe and optimal dose for Phase III trials. Median survival for the 90-mcg dose group was greater than six months with the majority of patients still alive at the time follow-up data were last analyzed. Results indicated a safe and well-tolerated dose has been determined and that the compound is ready to enter advanced trials with survival as the endpoint. Neurocrine also has been conducting a Phase I safety dose-escalation study with NBI-3001 in patients with peripheral solid tumors that overexpress interleukin-4 receptors, such as kidney and lung carcinoma.

• Novartis AG, of Basel, Switzerland, said the FDA approved Gleevec (imatinib mesylate) for first-line treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). The FDA approval was based on 12-month data from a study comparing Gleevec to a combination of interferon-alpha and cytosine arabinoside. Gleevec also is indicated for the treatment of patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. In February, Gleevec received FDA approval for the treatment of patients with Kit (CD 117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.

• Oncolytics Biotech Inc., of Calgary, Alberta, reported positive interim safety results from a Phase I study of Reolysin in recurrent malignant glioma. The company said Reolysin appeared to be well tolerated when surgically delivered into the brain during the treatment of the first six patients. Oncolytics said it is planning future trials.

• Oxigene Inc., of Watertown, Mass., said it started a Phase II trial of its lead vascular targeting agent, a tumor-starving compound called Combretastatin A4 Prodrug (CA4P), in patients with a rare and often incurable form of thyroid cancer. About 32 patients are expected to be enrolled in the study, which will be conducted at the Ireland Cancer Center at University Hospitals of Cleveland. Researchers will evaluate CA4P's effectiveness in extending the survival of patients with advanced anaplastic carcinoma of the thyroid. One objective will be to determine whether CA4P can double to 12 months the median survival of patients with advanced stages of the disease.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., entered an agreement with Serono SA, of Geneva, to use Regeneron's Velocigene technology platform to provide Serono with knockout and transgenic mammalian models of gene function. Serono will pay Regeneron up to $3 million annually for up to five years. In return, Regeneron will use Velocigene to provide knockout and transgenic models for target genes to be specified by Serono. Separately, Regeneron said its Cytokine Trap technology is detailed in a paper that will appear in the January 2003 issue of Nature Medicine. The article is available online now.

• SIGA Technologies Inc., of New York, was awarded a U.S. Army government contract for $1.6 million to develop a smallpox antiviral drug. The development work will be performed at SIGA's research facility in Corvallis, Ore.

• ZymoGenetics Inc., of Seattle, and Amgen Inc., of Thousand Oaks, Calif., signed an agreement with under which Amgen is granted a license to ZymoGenetics' Ig-fusion protein patents. ZymoGenetics and Amgen also terminated the patent infringement lawsuit filed by ZymoGenetics in March against Immunex Corp. (now owned by Amgen) for Enbrel (etanercept). Amgen and, separately, Wyeth, will receive a nonexclusive, worldwide license to ZymoGenetics' patents claiming immunoglobulin fusion proteins in exchange for an undisclosed payment to ZymoGenetics.