¿ Alkermes Inc., of Cambridge, Mass., said results from the first clinical trial of Medisorb Naltrexone, the company's injectable sustained-release formulation of its alcoholism and opiate abuse treatment, produced positive results, indicating the formulation maintained therapeutic levels in the bloodstream for a month following injection. The project is funded in part by the National Institute on Alcohol Abuse and Alcoholism.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., completed enrollment in its 110-patient, multicenter Phase III trial of 3-month Leuprogel in treatment of prostate cancer. The product uses Atrix's Atrigel delivery system to administer a 3-month sustained-release dose of leuprolide acetate subcutaneously. The company plans to submit a new drug application for 3-month Leuprogel late next year.
¿ Biacore International AB, of Uppsala, Sweden, said its Japanese subsidiary, Biacore KK, was selected by the Japanese New Energy and Industrial Technology Development Organization to participate in a protein function research project. The Protein Function Analysis project is aimed at developing new technology to study protein function and the establishment of a foundation of biological materials and information for the development of a bioindustry.
¿ Cellular Technology Analyzers LLC, of Cleveland, entered a collaboration with Becton, Dickinson and Co. through its subsidiary PharMingen Inc., of San Jose, Calif., to market products that measure cellular immune response. The companies will co-develop reagents and kits for distribution by BD Biosciences, PharMingen's parent division, and BD Biosciences will also co-market Cellular Technology's ImmunoSpot Series One Analyzer system and related products.
¿ Columbia Laboratories Inc., of New York, will begin Phase III trials in Europe of its testosterone hydration buccal tablet in about a week. The multicenter trial is expected to be complete in April 2001, and a second Phase III trial is planned to begin in the U.S. in January. The trial is designed to compare Columbia's buccal tablet with existing transdermal testosterone patches.
¿ Dow Chemical Co., of Midland, Mich., acquired The Collaborative Group's Biotechnology Services Division, including all assets of BioAlliance Inc. and Collaborative Smithfield Corp. Financial terms were undisclosed. Dow said it completed the acquisition to expand its capabilities and build its presence in contract biopharmaceutical development and manufacturing.
¿ D-Pharm Ltd., of Rehovot, Israel, and Nycomed Amersham plc, of London, entered a research collaboration to discover novel imaging agents. D-Pharm will apply its proprietary lipid vector technology to early stage compounds discovered by Nycomed, and design and synthesize imaging agents with improved delivery to target sites. Financial terms were undisclosed.
¿ Elitra Pharmaceuticals Inc., of San Diego, withdrew its public offering estimated at $86.2 million. The functional genomics company focused on antimicrobial therapeutics filed for an IPO in September. (See BioWorld Today, Sept. 6, 2000.)
¿ Enteric Products Inc., of Westbury, N.Y., received FDA clearance for its test for Helicobacter pylori, the leading cause of peptic ulcer disease. The PP-CAP IgA enzyme immunoassay complements the company's HM-CAP EIA test for IgG antibodies to H. pylori.
¿ Epoch Biosciences Inc., of Bothell, Wash., acquired Synthetic Genetics from the Immune Complex Corp. for $3.1 million in cash. The acquisition gives Epoch probe manufacturing and marketing capabilities that can be merged with its proprietary technology. Epoch serves the research market with modified oligonucleotides, including probes.
¿ IVAX Diagnostics Inc., of Miami, a wholly owned subsidiary of IVAX Corp., agreed to merge with b2bstores.com, of Long Beach, Calif., to form IVAX Diagnostics Inc. b2bstores.com will issue 20 million shares to IVAX Corp. in exchange for all outstanding shares of IVAX Diagnostics, and IVAX Corp. will retain a 68 percent stake in the new company, which will focus on development, manufacture and marketing of diagnostic reagents, instrumentation and software.
¿ Ligand Pharmaceuticals Inc., of San Diego, said the Committee for Proprietary Medicinal Products recommended granting Ligand European Commission Marketing Authorization for Targretin (bexarotene) for treatment of skin manifestations of advanced-stage cutaneous T-cell lymphoma refractory to at least one systemic treatment. Ligand has agreed with Grupo Ferrer Internacional SA, of Barcelona, Spain, to market Targretin. Ligand submitted a marketing authorization application to the European Agency for the Evaluation of Medicinal Products in November 1999. The FDA approved Targretin in December 1999.
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., appointed Roy Levitt as president and chief executive officer. Levitt is the former head of research and development at Magainin, and has been a corporate officer and a member of the executive management team there for five years. He replaces Michael Dougherty, who will assume the role of nonexecutive chairman of the board and continues as a director.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., said underwriters exercised their overallotment option to purchase an additional 802,500 shares at $70 per share to bring the total of the company's public offering to $430.7 million. Robertson Stephens Inc., of San Francisco, and Lehman Brothers Inc., of New York, led the offering as joint book-running managers, and Prudential Vector Healthcare Group, of New York; Lazard Freres & Co. LLC, of New York; and Adams, Harkness & Hill Inc., of Boston; acted as underwriters.
¿ Structural Bioinformatics Inc., of San Diego, entered into an agreement with DeNovo Pharmacetucicals Inc., of Cambridge, UK, to allow DeNovo access to multiple therapeutic target classes within SBI's ProMax 3-dimensional protein structure database. Financial terms were undisclosed.
¿ The Immune Response Corp., of Carlsbad, Calif., received a recommendation from an independent Data Safety Monitoring Board to continue to conclusion its Phase II trial of Remune in combination with antiretroviral drugs in HIV-infected patients. The double-blind, placebo-controlled, multisite, 243-patient trial in Spain is scheduled to run through May 2001. It is designed to examine the effect of Remune on viral load and CD2 T cells and to determine Remune's efficacy in combination with antiretroviral therapy.
¿ Vasogen Inc., of Toronto, said results to be published in the December issue of the journal Transplantation showed its cell processing technology, VAS981, prevents graft-vs.-host disease and death in animals which received treated T cells. Animals which received untreated cells exhibited a 60 percent death rate. A second study showed that VAS981-treated T cells produced a 50 percent death rate in an animal model compared to the 100 percent death rate exhibited by animals that received cyclosporine or an anti-TNF agent. A third preclinical study showed VAS981-treated human T cells administered in bone marrow grafts produced lower levels of the inflammatory cytokines associated with graft-vs.-host disease.
¿ VidaMed Inc., of Fremont, Calif., completed a private offering of 4.4 million shares at $2 per share for proceeds of $8.5 million. Of that sum, $3.8 million was invested by existing stockholders, and $5 million came from new investors. After the placement VidaMed, developer and marketer of urological condition therapeutics, will have 34.82 million shares outstanding.