• AFG Biosolutions Inc., formerly Advanced Biosystems Inc., of Germantown, Md., and Omnia Biologics Inc., of Rockville, Md., signed an agreement for Omnia to provide AFG with manufacturing and development services. AFG focuses on the research and development of a new generation of vaccines and immunotherapeutics for anthrax, plague, smallpox and tularemia.

• Alkermes Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, began a Phase III trial required for registration of their inhaled insulin system to treat diabetes. The study is designed to evaluate the safety and efficacy of the system compared to injected pre-meal insulin in 400 non-smoking patients with Type I diabetes. Patients will be treated for 24 months, with a two-month follow-up period. The companies expect to begin a second Phase III trial next month to evaluate the inhaled product vs. injected insulin in 600 Type I and Type II diabetes patients with mild to moderate asthma or mild to moderate chronic obstructive lung disease. That trial will last for 12 months, with a two-month follow-up period. Alkermes and Lilly established an alliance in 2001 to develop the system, using Alkermes' AIR pulmonary drug delivery technology.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted Sigma-Aldrich Corp., of St. Louis, a nonexclusive license to provide research products and services in RNA interference under the Kreutzer-Limmer patent family. The patent family, owned by Alnylam, covers short interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells.

• Aphios Corp., of Woburn, Mass., entered a collaboration with two Japanese companies, Bio Research Corp., of Yokohama, and Tokyo Supply Ltd., of Minato, to develop an orally bioavailable cancer therapeutic. Development plans call for a water-soluble paclitaxel prodrug that combines a paclitaxel molecule and a sugar molecule. Terms were not disclosed.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and RiNA GmbH, of Berlin, Germany, started a research collaboration to develop methodologies to knockdown human disease-related genes in the rat via RNA interference. Three laboratories at Artemis, the Max-Delbruck-Center for Molecular Medicine and the Institute for Virology and Immunobiology of the University of Wurzburg in Germany will participate in the program. Artemis will receive a €1.3 million (US$1.6 million) research grant from the German government, and holds all commercialization rights to products that result.

• AVI BioPharma Inc., of Portland, Ore., said studies conducted at the Scripps Research Institute in La Jolla, Calif., showed its Neugene antisense compounds were able to inhibit infection by the severe acute respiratory syndrome coronavirus. Experiments outlined in the August Journal of Virology showed the virus develops resistance to Neugene only after multiple mutations in the viral genome, and that Neugene is less susceptible to viral escape than small-molecule drugs.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the Phase III Tysabri (natalizumab) add-on trial with Avonex (interferon beta-1a) met the two-year primary endpoint of slowing the progression and disability in patients with relapsing forms of multiple sclerosis. The addition of Tysabri to Avonex resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by Avonex alone, and data also demonstrated that Tysabri plus Avonex led to a 56 percent relative reduction in the rate of clinical relapses compared to Avonex alone. Biogen Idec and Elan voluntarily suspended Tysabri from the market and ongoing trials in late February following reports of death linked to progressive multifocal leukoencephalopathy. Two of the patients with confirmed cases of PML had received Avonex and Tysabri for over two years as part of the Phase III trial. The company is conducting an ongoing safety study to determine whether there is a possible link between Tysabri and PML.

• Cell Therapeutics Inc., of Seattle, said it has completed the transaction divesting the Trisenox brand and certain proteosome assets to Frazer, Pa.-based Cephalon Inc. for about $68 million. CTI agreed to sell its oncology product to Cephalon last month. CTI could receive up to an additional $100 million if certain sales and regulatory milestones are achieved. (See BioWorld Today, June 14, 2005.)

• Cel-Sci Corp., of Vienna, Va., said it sold 1.25 million shares of common stock and 375,000 warrants to purchase common stock for a total of $500,000 to one investor. The stock, which will not be registered and will not be resold in the open market for one year, was priced at 40 cents per share, a 21.8 percent discount to the 15-day closing stock price.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, said the FDA granted orphan drug status to CTCE-9908 for the treatment of osteogenic sarcoma. CTCE-9908 is designed to inhibit the growth and spread of cancer, with the potential for use with existing therapies.

• Cylene Pharmaceuticals Inc., of San Diego, initiated a Phase I trial for CX-3543, its lead candidate for the treatment of multiple cancers. CX-3543 is a first-in-class small molecule that selectively induces cancer cell death. The trial is open for enrollment, and the company expects to enroll about 36 patients with solid tumors or lymphomas.

• Cytogen Corp., of Princeton, N.J., entered purchase agreements with certain institutional investors for the sale of 3.1 million shares of its common stock at $4.50 per share, and 776,000 warrants to purchase shares at a price of $6 each, through a registered direct offering. The company expects gross proceeds of about $14 million for general corporate purposes, including sales, marketing and clinical development.

• Cytori Therapeutics Inc., of San Diego, reported preclinical findings demonstrating that adipose-derived stem cells will engraft in injured heart muscle following a heart attack-like injury. Adipose contains a specialized class of stem cells that are comprised of multiple cell types that could promote healing and repair. The results were published in the July 2005 issue of Cytotherapy.

• Emergent Technologies Inc., of Austin, Texas, said Paul DeAngelis, a chief scientist at its portfolio company, Hyalose LLC, of Oklahoma City, was awarded a $227,200 grant from the Oklahoma Center for Advancement of Science and Technology to develop Hyaluronan-assisted targeted systems for drug delivery. The award will be made to DeAngelis' University of Oklahoma Health Sciences Center lab and shared by Hyalose's lab.

• Epimmune Inc., of San Diego, was notified by Syngenta AG, of Basel, Switzerland, that all conditions had been met for the assignment of certain portions of Epimmune's existing agreement with Aeres Biomedical Ltd., of London, to Syngenta. The assignment and restructuring of certain commercial terms of the agreement triggered an undisclosed payment to Epimmune by Syngenta.

• Ferring Pharmaceuticals Inc., of Suffern, N.Y., entered an agreement to market Euflexxa, a non-avian-derived biologic formulation of hyaluronic acid for the amelioration of knee pain due to osteoarthritis. The agreement forms part of a broader transaction in which Ferring acquired the global biologics manufacturing business of Savient Pharmaceuticals Inc., of East Brunswick, N.J., including the worldwide rights to Euflexxa. Ferring and Savient will jointly market Euflexxa, which is FDA approved and will be launched in the fourth quarter.

• Gene Logic Inc., of Gaithersburg, Md., signed an agreement with GE Healthcare for global distribution of its Sciantis System, an online gene-expression analysis system developed for use by academic, government and other nonprofit research organizations. Financial terms were not disclosed.

• GeneThera Inc., of Wheat Ridge, Colo., started its transition from a development company to a commercial enterprise through the signing of its first two contracts with Conifer, Colo.-based Xpention Genetics Inc. to provide research services to Xpention for the development of a commercial cancer-detection test in animals and humans. The first contract runs for one year at $20,000 per month, while the second contract runs for one year at $10,000 per month. A third contract with another company is slated to begin in September.

• Genospectra Inc., of Fremont, Calif., formed an international agreement to develop a panel of optimized delivery reagents with the French National Center for Scientific Research in Montepellier. The parties will jointly develop reagents that are optimized to transfer a wide variety of molecular cargoes into live cells. Genospectra will retain exclusive, worldwide rights to the technology, and to market and sell products developed during the collaboration.

• Genzyme Corp., of Cambridge, Mass., launched a new test to detect very low levels of disease in patients with B-cell chronic lymphocytic leukemia. Study data published in the Journal of Clinical Oncology showed that the elimination of disease to that low level might improve the overall survival and treatment-free survival of patients with that type of leukemia.

• GlycArt Biotechnology AG, of Zurich, Switzerland, said F. Hoffmann-La Roche Ltd., of Basel, Switzerland, signed an agreement to acquire GlycArt. Roche will pay about CHF235 million (US$180.7 million) in cash in exchange for all outstanding capital stock of the privately held company. GlycArt was founded in 2000 to develop a new generation of antibody products using its GlycoMAb technology, designed to increase the biological activity of therapeutic antibodies for the treatment of cancer and autoimmune diseases.

• Human Genome Sciences Inc., of Rockville, Md., said Clinical Infectious Diseases published results that demonstrated that the anthrax vaccine ABthrax is safe, well tolerated and achieves the blood levels predicted by relevant animal models. Certain blood levels are needed to protect people from the lethal effects of the anthrax toxin. ABthrax was studied in a randomized, single-blind, placebo-controlled, dose-escalation Phase I trial in 105 healthy adult volunteers.

• Invitrogen Corp., of Carlsbad, Calif., opened a new cGMP bioproduction facility focused on developing safe and consistent bovine sera products and reagents used in basic research and the production of vaccines and biotherapeutic drugs.

• Metabasis Therapeutics Inc., of San Diego, said 24-week interim data reported by Valeant Pharmaceuticals International, of Costa Mesa, Calif., from a Phase II study showed the oral antiviral compound pradefovir gave a robust and significant reduction in viral load when treating compensated chronic hepatitis B patients. Pradefovir is a prodrug of adefovir and it uses Metabasis' HepDirect technology, which allows for higher concentrations of the drug in the liver. Metabasis has licensed pradefovir to Valeant.

• Neurome Inc., of La Jolla, Calif., said it completed work toward a study aimed at understanding how regional gene-expression patterns in the brain are related to brain architecture and organization, including construction of a regional gene-expression atlas of the adult mouse brain. The study, published Tuesday in the Proceedings of the National Academy of Sciences, combines quantitative gene-expression data from 24 specific regions of the mouse brain at high resolution and a coordinate-based brain atlas to permit the visualization of relative gene-expression levels in the context of the whole brain.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, initiated a Phase II trial of OGX-011 in newly diagnosed, previously untreated patients with clinically localized, high-risk prostate carcinoma. OGX-011 is a second-generation antisense drug designed to inhibit the production of clusterin, a cell-survival protein that is up-regulated in response to standard cancer treatments.

• OXIS International Inc., of Portland, Ore., entered a manufacturing agreement with Cambridge Major Laboratories, of Germantown, Wis., to produce Ergothioneine, which OXIS plans to make available as an over-the-counter nutraceutical supplement in 2005.

• Power3 Medical Products Inc., of The Woodlands, Texas, entered a research agreement with The Methodist Hospital Research Institute in Houston to search for biomarkers and develop a suite of tests that directly impact the diagnosis of neurodegenerative diseases.

• Sangart Inc., of San Diego, initiated a Phase II trial involving Hemospan, a hemoglobin-based oxygen carrier designed to serve as an alternative for blood transfusions. The study, involving 40 patients, will be conducted at Johns Hopkins University School of Medicine in Baltimore.

• StemCyte Inc., of Arcadia, Calif., completed a financing round from new investors, raising about $13.7 million. The company and its subsidiary in Taiwan maintain one of the largest and diverse collections of donated cord blood stem cells in the world and have provided transplant and cancer centers with umbilical cord blood units for more than 200 stem cell transplantation procedures worldwide.

• Trimeris Inc., of Morrisville, N.C., and F. Hoffmann-La Roche Inc., of Nutley, N.J., said the FDA accepted the filing of their supplemental new drug application to include information about the Biojector 2000 needle-free injection device in the Fuzeon (enfuvirtide) labeling. The filing is based on a study of Fuzeon administered via the needle-free device compared to standard needle-syringe administration. The companies expect an FDA decision later this year. Trimeris and Roche also plan to begin enrollment of 40 HIV patients in a Fuzeon Wand study to assess the administration of Fuzeon via the B2000 needle-free device.

• Ventria Bioscience, of Sacramento, Calif., introduced a new plant-derived recombinant growth factor for cell culture media that improves productivity and safety. Lacromin is a strong growth factor and outperforms Transferrin, an animal-derived growth factor. Lacromin was introduced Tuesday at the Raw Materials and Disposable Process Systems for Mammalian Cell Products Conference in Kansas City, Mo.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said its collaborator, GlaxoSmithKline plc, of London, received fast-track designation for the HIV protease inhibitor (PI) 640385 from the FDA. GSK plans to initiate a Phase IIb study of 640385 in HIV-infected patients in the third quarter. The PI 640385 is the third, orally active HIV PI to be developed as part of the collaboration.

• Vical Inc., of San Diego, said its licensee Aqua Health Ltd. of Canada, an affiliate of Basel, Switzerland-based Novartis Animal Health, received approval in Canada to sell APEX-IHN, a DNA vaccine to protect farm-raised salmon against infectious haematopoietic necrosis virus. The vaccine had been previously available on a pre-approval basis in support of extensive field trials.

• Xanodyne Pharmaceuticals Inc., of Florence, Ky., said the Bankruptcy Court for the District of Delaware approved its bid to acquire the assets of aaiPharma Inc., of Wilmington, N.C., for $209.25 million cash and additional non-cash consideration. The purchase will add several marketed pain management products to Xanodyne's portfolio, including Darvon and Darvocet, as well as three clinical-stage and one early stage product. The company also added new board members: Ansbert Gadicke, of MPM Capital LP; Steven St. Peter, of MPM Capital LP; Adele Olivia, of Apax Partners; and Dennis Purcell, of Perseus-Soros Biopharmaceutical Fund.

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