¿ Abgenix Inc., of Fremont, Calif., entered a manufacturing agreement with Lonza Biologics, of Slough, UK, for five years of exclusive access to Lonza's cell culture production suite within Lonza's facility in Slough. Abgenix will use the production suite to manufacture antibody products.
¿ Alexion Pharmaceuticals Inc., of Cheshire, Conn., said interim results of its Phase II trial in patients with rheumatoid arthritis treated with 5G1.1, its anti-inflammatory C5 inhibitor monoclonal antibody, showed the study met its prospectively identified primary endpoint. The endpoint, improvement in American College of Rheumatology 20 score, was met in one of the treated groups after three months of treatment. The double-blind, randomized, placebo-controlled trial enrolled 209 patients at 28 sites in the U.S.
¿ Altus Biologics Inc., of Cambridge, Mass., entered a research agreement with Triangle Pharmaceuticals Inc., of Durham, N.C., to develop biocatalytic processes for use in the synthesis of compounds in Triangle's drug development pipeline. In exchange for specific worldwide commercialization rights on processes developed from the collaboration, Altus will receive funding and also is in discussions with a manufacturer of Triangle's drug Coviracil to supply biocatalysts for commercial production.
¿ Antisoma plc, of London, started the first clinical study of TheraFab, a treatment for patients with non-small-cell lung cancer used in combination with external beam radiotherapy to treat solid tumors. The Phase I study is ready to enroll patients in Australian and European clinics.
¿ Aphios Corp., of Woburn, Mass., received a Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases of the NIH. Aphios is using the grant to develop a controlled-release vehicle for HIV vaccines by utilizing biodegradable and biocompatible polymeric nonospheres to protect and sustain the release of HIV viral antigens.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., began enrollment for its Phase III study of Leuprogel four-month, 30 mg, leuprolide acetate for subcutaneous depot injection for treatment of advanced prostate cancer. The therapy is designed to use the company's Atrigel delivery system to administer a four-month sustained-release dose of leuprolide acetate in a more patient-friendly way than the deep intramuscular injections currently available.
¿ Aviron Inc., of Mountain View, Calif., sold 161,060 shares of its common stock to Acqua Wellington North American Equities Fund Ltd., of New York, worth $8 million. In January 2000, Acqua Wellington committed up to $48 million in equity financing to Aviron. In June 2000, Acqua Wellington increased its commitment to $84 million. This $8 million is the final transaction under the $84 million commitment.
¿ Bavarian Nordic Research Institute A/S, of Copenhagen, Denmark, and Vaccine Solutions Pty. Ltd., of Brisbane, Australia, entered a license agreement with the right to sublicense, develop, produce, manufacture and market HIV vaccines incorporating Vaccine Solutions' Polytope technology. Bavarian Nordic pays up-front, milestone and royalty payments to Vaccine Solutions, and has an option to license the technology for four other vaccines for infectious diseases and oncology, including malaria and malignant melanoma.
¿ Celera Genomics, of Rockville, Md., entered a multiyear agreement with the University of California, giving investigators from the university access to all of Celera's database products. Financial terms were undisclosed.
¿ Cel-Sci Corp., of Vienna, Va., said its cooperative research and development agreement with the National Cancer Institute (NCI) to jointly test Cel-Sci's L.E.A.P.S. peptide antigen delivery technology in NCI animal models for mammary and prostate cancers has been renewed and extended. The collaboration has been extended to confirm and expand on data seen in earlier tests.
¿ Columbia Laboratories Inc., of New York, said a European Phase III trial has commenced and will compare Columbia's PHBT testosterone with existing transdermal patches as well as provide patient acceptability data. The U.S. three-month Phase III trial is designed to confirm that Columbia's buccal testosterone can maintain physiologic levels in men 24 hours a day over an extended period of time.
¿ CytRx Corp., of Atlanta, said it is collaborating with researchers at the University of Cincinnati Medical Center to study CytRx's investigational drug, CRL-5861, in the treatment of muscular dystrophy. CRL-5861 is an investigational agent that acts to stabilize membranes and may protect dystrophin-deficient muscle cells from breakdown. Initial funding for this collaboration will come from a grant from the Muscular Dystrophy Association.
¿ ExonHit Therapeutics SA, of Paris, opened its wholly owned subsidiary, ExonHit Therapeutics Inc., in Gaithersburg, Md. The facility will focus on both the commercialization of its product, Safe-Hit, and the extension of the company's therapeutic research programs.
¿ FeRx Inc., of San Diego, said it received orphan drug designation from the FDA for its lead product, MTC-DOX, for the treatment of primary liver cancer. Its proprietary Magnetic Targeted Carriers are microparticles, composed of elemental iron and activated carbon, which serve as delivery vehicles for the site-specific targeting, retention and release of pharmaceuticals, in this case, doxorubicin.
¿ Genta Inc., of Berkeley Heights, N.J., completed a licensing agreement granting access to a portfolio of antisense patents to Atugen AG, of Berlin. The nonexclusive agreement calls for an up-front payment for Genta, annual cash maintenance payments and royalties on any commercialized products rising from the agreement.
¿ IDEC Pharmaceuticals Inc., of San Diego, initiated a multicenter pilot Phase II trial with its investigational agent, IDEC-131, a humanized anti-CD154 monoclonal antibody. The study will evaluate the clinical safety and activity of IDEC-131 in patients with moderate to severe psoriasis.
¿ Immuno-Designed Molecules SA, of Paris, launched a Phase II trial with its cellular vaccine, IDD-3, in patients with malignant melanoma. The vaccine is composed of dendritophages - dendritic cells issued from the patient's white blood cells - loaded in vitro with specific tumor antigens derived from cancer cell extracts, called lysates. Twelve to 17 patients will be included in the trial.
¿ Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., finalized a collaborative agreement with Elan Corp. plc, of Dublin, Ireland, to develop OP2000, a subcutaneously administered ultra-low-molecular-weight heparin. As part of the transaction, Elan purchased $4 million in equity of Incara. (See BioWorld Today, Dec. 28, 2000.)
¿ International AIDS Vaccine Initiative, of New York, received a $100 million challenge grant from the Bill & Melinda Gates Foundation to accelerate the development and delivery of a preventive AIDS vaccine. IAVI now has secured commitments totaling $230 million of its $550 million goal.
¿ Micrologix Biotech Inc., of Vancouver, said CEO Dany Hadary resigned from his post. Hadary will be replaced by William "Bud" Foran, Micrologix's chairman. The board of directors formed a special search committee to find a permanent replacement for Hadary.
¿ Neuron Therapeutics Inc., of Malvern, Pa., initiated a Phase I trial for Revoxyn, an oxygenated fluorocarbon nutrient emulsion, in patients suffering from severe ischemic stroke. It received FDA approval in late 2000 to begin trials.
¿ Sequitur Inc., of Natick, Mass., entered a multiyear, multimillion-dollar agreement to provide Bristol-Myers Squibb Co., of New York, with access to its functional genomics technology. Sequitur will perform biological screening and supply its proprietary antisense compounds and methods to Bristol-Myers for use in its target validation studies.
¿ SYN X Pharma Inc., of Toronto, appointed Sean McNicholas president and CEO. He was corporate vice president of the International Endocrine Care Division of Pharmacia Corp., of Peapack, N.J., and also former vice president of sales, marketing and government affairs in Canada for Eli Lilly and Co., of Indianapolis.
¿ Theratechnologies Inc., of Saint-Laurent, Quebec, enrolled its first patient in the pivotal clinical trial of its ex vivo photodynamic cell therapy system, Theralux, for non-Hodgkin's lymphoma, at Maisonneuve-Rosemont Hospital. Theralux is a non-invasive ex vivo process designed for the treatment of cancers affecting bone marrow.
¿ VaxGen Inc., of Brisbane, Calif., received a $1.1 million Small Business Innovation Research Fast Track grant from the National Institutes of Health, of Bethesda, Md., for the development of subtype C HIV vaccines over the next 2.5 years. Subtype C is the most common type of HIV found in Africa, India and China.