• Accelrys Inc., of San Diego, released the Accord Enterprise Webkit, its latest software solution for chemical and biological information management.

• Biogen Idec Inc., of Cambridge, Mass., said Australian regulatory authorities approved Amevive (alefacept) for sale in that country to treat adult moderate to severe chronic plaque psoriasis patients who are candidates for phototherapy or systemic therapy. Approved in the U.S. early last year, it was the first biologic therapy approved for moderate to severe chronic plaque psoriasis in adults. (See BioWorld Today, Feb. 3, 2003.)

• CalbaTech Inc., of Irvine, Calif., said its wholly owned subsidiary, Molecula, moved into a new facility in Sterling, Va. The new site will allow the company to become a fully compliant cGMP oligo manufacturer of siRNA, and other oligo products, by increasing laboratory, manufacturing and warehouse space, it said.

• Cerus Corp., of Concord, Calif., said initial results of an independent review and analysis of data from its previously reported Phase III trial of the Intercept Blood System for platelets showed no statistically significant differences in respiratory adverse events between test and control groups when applying consistent diagnostic criteria. Also, the application of objective criteria used to assess specific respiratory adverse events also showed no statistically significant differences between the groups. The assessments differed from events drawn from patient records, which showed statistically significant differences in specific respiratory events. The company plans to submit a final report of the analysis to the FDA for review as a next step in the submission process for the technology, which is being developed to protect against transmission of infectious diseases through platelet transfusions. Last summer, Cerus and its partner, Baxter Healthcare Corp., of Deerfield, Ill., stopped a Phase III trial of their pathogen-inactivated red blood cell program after two patients developed antibodies to red blood cells treated with S-303, a compound used in the system. (See BioWorld Today, Sept. 5, 2003.)

• Chiron Corp., of Emeryville, Calif., said it plans to raise about $350 million through an offering of 30-year convertible debentures. The notes will be convertible under certain circumstances into a combination of cash and common stock, if applicable. Also, the company might raise up to about $35 million more through an option to acquire additional convertible debentures to be granted to the initial purchasers. Chiron said it would use the proceeds for general corporate purposes.

• CoTherix Inc., of South San Francisco, decided to postpone its initial public offering based on adverse market conditions. The company filed for its IPO in March, hoping to raise $70 million. Earlier this month, it began a Phase II trial of Ventavis in combination with Tracleer in patients with pulmonary arterial hypertension. (See BioWorld Today, March 16, 2004.)

• DelSite Biotechnologies Inc., of Irving, Texas, a wholly owned subsidiary of Carrington Laboratories Inc., presented data on its GelSite polymer and the GelVac nasal powder vaccine delivery system at the 31st annual meeting of the Controlled Release Society in Honolulu. One set of data described the interactions of the GelSite polymer with different salts in solution and in gels, which might lead to tailoring of formulations to specific peptide or protein agents to achieve desired delivery profiles. Other data showed the GelVac formulations conferred sustained antigen release and significantly increased serum IgG and lung IgA responses against inactivated influenza antigen in animal models.

• Diversa Corp., of San Diego, reported the U.S. launch of Cottonase enzyme, an environmentally friendly product for cotton-based textile processing. Diversa will manufacture the product and market it worldwide through regional distributors. Cottonase enzyme is designed to increase the efficiency of textile processing.

• Enkam Pharmaceuticals A/S, of Copenhagen, Denmark, will receive a portion of a €9.7 million grant that is being applied toward Alzheimer's disease research. Specifically, the efforts are aimed at a molecule called NCAM, which orchestrates memory and learning. The European Union is backing the Promemoria Project, which will include a consortium of 18 research teams from 11 EU countries.

• Genentech Inc., of South San Francisco; Biogen Idec Inc., of Cambridge, Mass.; and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said The New England Journal of Medicine published results of a Phase IIa study showing that two doses of Rituxan (rituximab) administered two weeks apart improved symptoms in patients with moderate to severe rheumatoid arthritis for up to 48 weeks when combined with methotrexate, compared to methotrexate alone. Preliminary findings, first presented at the 2002 and 2003 meetings of the American College of Rheumatology, included both a primary analysis of patients at week 24 and an exploratory analysis at week 48.

• Guilford Pharmaceuticals Inc., of Baltimore, completed a second Phase II trial of Aquavan Injection in patients undergoing colonoscopy. Aquavan provided rapid onset and recovery from procedural sedation without serious adverse events, the company said. The trial was an open-label, multicenter study of a fixed-dose regimen.

• ILEX Oncology Inc., of San Antonio, reported the opening of a multicenter Phase II trial of ILX-651 in patients with hormone-refractory prostate cancer whose disease has progressed after first-line treatment with Taxotere (docetaxel). ILX-651 is a tubulin-interactive agent that has shown preliminary activity in a range of solid tumors. Two additional Phase II studies with ILX-651 are ongoing in metastatic melanoma and non-small-cell lung cancer. The study will enroll about 40 patients.

• Immunicon Corp., of Huntingdon Valley, Pa., entered an addendum to its development and license agreement with Twente University in Enschede, the Netherlands, and STW, a research funding agency of the Dutch government. As a result, STW will provide the university with up to about $1 million toward developing an HIV monitoring instrument that will include an additional application of Immunicon's CellTracks EasyCount system, which was developed through its collaboration with the school. Immunicon will contribute to the research effort with personnel, equipment and supplies, and has rights to commercialize resulting products.

• Inverseon Inc., of Overland Park, Kan., received a seed round from the Kansas Technology Enterprise Corp., of Topeka. Inverseon is a new biopharmaceutical company that focuses on the development of inverse agonists. Its lead candidate, INV-102, is an orally available small molecule for the treatment of asthma. The company was created and initially funded by EGB Advisors LLC, of San Francisco.

• Lorus Therapeutics Inc., of Toronto, completed enrollment in its Phase III trial of Virulizin in combination with gemcitabine for advanced pancreatic cancer. More than 400 patients have been enrolled in North America, South America, Europe and Russia, exceeding the original target enrollment. The study's primary efficacy endpoint is overall survival, while secondary endpoints include progression of symptoms of pain, deterioration of performance status and weight loss. Also, the activity of natural killer cells is being evaluated. The company plans to submit an application to the FDA in the first half of 2006.

• MDS Nordion, of Ottawa, Ontario, and Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., signed a development and contract manufacturing agreement to produce BMIPP. BMIPP is Molecular Insight's lead molecular imaging pharmaceutical. BMIPP is in a multicenter Phase IIb trial in the U.S. for the detection of cardiac ischemia in the emergency department setting.

• Mirus Therapeutics Corp., of Andover, Mass., acquired exclusive rights to formulation and drug delivery technologies from Formatech Inc., also of Andover. Mirus, which said the technologies are directed at enhancing drug solubility and/or bioavailability, without the use of excipients such as cremaphore, ethanol and others, will use them to develop and commercialize improved therapeutics such as paclitaxel and cyclosporin. The privately held company also plans to make the technologies available to partners via license for use in injectable, oral, pulmonary and/or topically administered products.

• Orchid BioSciences Inc., of Princeton, N.J., said the UK government renewed Orchid's scrapie genotyping contract for two more years. Orchid will continue genotyping services offered to UK sheep farmers under the government's national scrapie plan, which is designed to help British farmers breed sheep with reduced susceptibility to the prion disease scrapie.

• OriGene Technologies Inc., of Rockville, Md., added the cytochrome P450 CloneSet, a complete set of more than 60 full-length cytochrome P450 cDNA clones, to its TrueClone Collection product line.

• Phoenix Biosciences Inc., of Hollywood, Fla., changed its name from MP-1 to Phoenix Biosciences. The change reflects the company's growth and its continued focus on testing its compound drug PBS119, which was developed as an approach for treating HIV/AIDS. Phoenix is focused on developing, testing and offering treatments for immune dysfunctions.

• Point Therapeutics Inc., of Boston, initiated a Phase II trial of the company's lead therapeutic compound, talabostat (PT-100) for the treatment of advanced metastatic melanoma. The study is designed to evaluate the antitumor and hematopoietic activity of talabostat in combination with cisplatin in patients with advanced metastatic melanoma. The trial design is a single-arm, two-stage study in up to 54 patients with advanced metastatic melanoma.

• Protez Pharmaceuticals Inc., of Malvern, Pa., said Ben Franklin Technology Partners of Southeastern Pennsylvania invested $300,000 of convertible debt in Protez. The company is discovering and developing antibiotics for difficult-to-treat infections. It is focused on injectable and oral small-molecule antibiotics with a long-term goal of marketing the therapies in the hospital segment.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Aventis SA, of Strasbourg, France, said the multiple sclerosis therapy Copaxone (glatiramer acetate injection) now is available in Europe in a pre-filled, ready-to-use syringe. Copaxone PFS contains the same active ingredient and dose as the lyophilized form of Copaxone. Aventis said Copaxone has demonstrated sustained effect on both reducing relapse rate and preserving physical function.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., was named as a defendant in a class-action lawsuit. It alleges that the company and certain of its officers and directors issued materially false statements concerning a business condition, inflating the company's stock price by concealing negative material information concerning both the safety and efficacy of its antifungal drug Anidulafungin. Vicuron's stock recently fell as a result of an FDA rejection of a new drug application for the drug. (See BioWorld Today, May 25, 2004.)

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