• Acadia Pharmaceuticals Inc., of San Diego, reported results from a clinical study on the ability of ACP-103, Acadia's 5-HT2A inverse agonist, to reduce the side effects associated with antipsychotic drug treatment with haloperidol. Results showed it reduced motor disturbances and hyperprolactinemia, a condition of elevated prolactin secretion caused by the treatment. Acadia is developing ACP-103 for schizophrenia to be used in combination with available antipsychotic drugs including haloperidol.

• Active Biotech AB, of Lund, Sweden, is proposing a rights issue of 3.7 million convertible debentures, totaling SEK150 million (US$20 million). The debentures will be issued for SEK40 and subscribed at the same price. One convertible debenture can be converted into one new share. The entire issue is to be guaranteed by MGA Holding AB.

• Alfacell Corp., of Bloomfield, N.J., entered a licensing agreement with the National Institutes of Health to evaluate a humanized, single-chain form of a proprietary B-cell-specific monoclonal antibody developed at the National Cancer Institute. Alfacell receives rights to evaluate commercial applications for the antibody, such as immunotherapeutics derived from the combination of the antibody with the company's family of cytotoxic RNases, including Onconase, which is in Phase III trials in malignant mesothelioma. Financial terms were not disclosed.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., said Phase IV data showed Testim-treated patients had greater improvement in overall satisfaction with their sex life, as well as improved erections, compared to patients who remained on AndroGel therapy. The study took place between January and July and enrolled 151 hypogonadal men.

• Biopure Corp., of Cambridge, Mass., raised about $7 million in net proceeds in the sale of about 21.4 million shares of its Class A common stock at 39 cents per share to institutional and individual investors. It also issued warrants for investors to purchase up to 10.7 million shares of common stock at 42 cents each, potentially bringing Biopure $4.5 million in additional proceeds. The shares were sold under a shelf registration statement filed with the SEC. C.E. Unterberg, Towbin acted as the agent. Biopure said its cash on hand should fund operations through January.

• Boston Life Sciences Inc., of Boston, received a written response from the FDA to its Axosine (inosine) investigational new drug application filing. The FDA placed the Phase I study on hold pending the submission of additional pharmacology and toxicology data. Some data already have been compiled, but the company will need to re-process brain tissue samples and specialized histologic staining, which will take about four weeks. Axosine is being studied for its ability to enhance motor function recovery after stroke.

• Ceregene Inc., of San Diego, is receiving funding support from the ALS Association for a preclinical study of CERE-130, to evaluate the viral delivery of insulin-like growth factor-1 (IGF-1) for amyotrophic lateral sclerosis. The gene-therapy product involves the delivery of IGF-1 through an adeno-associated viral vector. The study will evaluate long-term expression and toxicity.

• CMC Biopharmaceuticals A/S, of Copenhagen, Denmark, and Resistentia AB, of Uppsala, Sweden, entered a development and manufacturing deal for cGMP production of a fusion protein. The product, which is an immunotherapeutic reagent used for treatment of IgE-mediated allergies, will be manufactured at CMC's facility in Copenhagen.

• DOR BioPharma Inc., of Miami, said it completed a pivotal Phase III trial of its lead therapeutic, orBec (oral beclomethasone dipropionate), for intestinal graft-vs.-host disease. Top-line data are expected next quarter, and if results are positive, the company expects to file a new drug application as early as the first quarter of next year. The study enrolled 129 patients at 16 bone marrow transplant centers in the U.S. and France. The primary endpoint is a comparison of the two treatment arms of the median time to treatment failure, defined as the need for additional therapies due to uncontrolled signs or symptoms of GvHD.

• Genencor International Inc., of Palo Alto, Calif., is opening an office in Moscow to offer customers in the Russian Federation a portfolio of enzyme products for the cleaning, food, beverage, feed, pulp, paper and specialty industries. Liekel Faber will head the Moscow office.

• Generex Biotechnology Corp., of Toronto, said its wholly owned subsidiary Antigen Express entered a collaboration with Cassian Yee of the Fred Hutchinson Cancer Research Center in Seattle to test the potency of a peptide vaccine for melanoma in stimulating patients' immune cells. Previous animal studies showed more potent immune stimulation compared to prior vaccines investigated in the clinic.

• Genomatix Corp., of Roanoke, Va., added SNP Knockin vectors to it multigenic targeting solutions. The company said it produced the vectors with its UltraVector technology, a modular-vector production platform that enables the construction of multigenic targeting solutions.

• Genstruct Inc., of Cambridge, Mass., entered a deal with Berlex Inc., of Montville, N.J., to characterize the regulatory mechanisms for breast cancer. The goal is to uncover causal mechanisms for the initiation of breast cancer to understand the genes, proteins and metabolites that play a role in its development. Genstruct will use its Molecular Epistemics discovery platform to customize its Oncology Knowledge Assembly model for breast cancer. Berlex is a U.S. affiliate of Schering AG, of Berlin. Terms were not disclosed.

• Genzyme Corp., of Cambridge, Mass., and ILEX Oncology Inc., of San Antonio, said Genzyme is in discussions with the Federal Trade Commission regarding the companies' planned merger, and they expect the transaction to close in the fourth quarter. Genzyme is working with the FTC to resolve issues regarding a proposed consent decree focused on certain solid-organ transplant applications for Campath (alemtuzumab for injection). Genzyme announced plans to buy Ilex for $1 billion in March. (See BioWorld Today, March 1, 2004.)

• InNexus Biotechnology Inc., of Vancouver, British Columbia, said its registration statement, filed with the SEC, became effective and permits the secondary trading of the company's shares in the U.S. It also allows InNexus to apply to crosslist on a U.S. stock exchange or trading facility. The company is developing monoclonal antibodies using its SuperAntibody Technology Platform.

• Labopharm Inc., of Laval, Quebec, said that, through its Labopharm European subsidiary, it finalized a deal with Hexal AG, of Holzkirchen, Germany, to market and sell its once-daily tramadol formulation in Germany. Terms are similar to previously reported deals, including an initial milestone payment due upon regulatory approval in Europe.

• MycoLogics Inc., of Denver, released a screening service to identify active antifungal compounds, called MycoDetect, a system of whole-cell and in vitro enzyme assays. It said MycoDetect has screened libraries for antifungal activity from such sources as thermal waters, microbial mats, fumaroles, microalgae and cyanobacteria.

• Nuvelo Inc., of Sunnyvale, Calif., expanded its agreement with the pharmaceutical division of Kirin Brewery Co. Ltd., of Tokyo. The deal was extended to Dec. 31, 2005, and expanded to include additional secreted protein genes from Nuvelo's full-length gene portfolio. It is expected to foster development of therapeutic candidates using Kirin's site-directed transgenic mouse technology to identify and develop secreted proteins and associated antibodies.

• Rosetta Biosoftware, a unit of Rosetta Inpharmatics LLC, of Seattle, released version 5.0 of its Rosetta Resolver Gene Expression Data Analysis System, a data storage, retrieval and analysis solution for gene-expression data. The system is exclusively distributed by Agilent Technologies Inc., of Palo Alto, Calif. Rosetta is a wholly owned subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J.

• SeraCare Life Sciences Inc., of Oceanside, Calif., closed its acquisition of BBI Diagnostics and BBI Biotech Research Laboratories, divisions of West Bridgewater, Mass.-based Boston Biomedica Inc., for $30 million in cash, plus the assumption of certain liabilities. SeraCare financed the acquisition through a $21 million credit facility with Union Bank of California and Brown Brothers Harriman & Co., as well as $4 million in loans from certain subordinated lenders and an $8.2 million private placement of stock. SeraCare said the acquisition strengthens its position in the in vitro diagnostics market and fortifies its Global Repository, which provides fully characterized biological specimens. In June, SeraCare purchased Genomics Collaborative Inc. for $14.3 million. (See BioWorld Today, June 7, 2004.)

• Vasogen Inc., of Mississauga, Ontario, said Phase II results published in the Sept. 15, 2004, issue of the Journal of the American College of Cardiology showed the use of Celacade (immune-modulation therapy) in advanced chronic heart failure patients resulted in a significant reduction in the risk of death (p=0.022; 1 vs. 7 deaths) and all-cause hospitalization (p=0.008; 12 vs. 21 hospitalizations), compared to placebo patients. Analysis of a clinical composite score also showed Celacade-treated patients did significantly better than those on placebo (p=0.006; linear trend). Separately, preclinical results reported at the Heart Failure Society of America meeting in Toronto showed Celacade's ability to reduce heart-muscle inflammation. Specifically, it decreased myocardial levels of the pro-inflammatory cytokine TNF-a and inflammatory cellular infiltrates in heart tissue in a murine model of cardiac inflammation (myosin-induced myocarditis).

• ViroPharma Inc., of Exton, Pa., was notified on Sept. 14 that it has complied with all requirements for continued listing on Nasdaq. It is focusing on treating viral diseases including cytomegalovirus and hepatitis C.

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