¿ Antigenics Inc., of New York, received a milestone payment from Elan Corp. plc, of Dublin, Ireland, for its leading immune-stimulating adjuvant, QS-21, the only adjuvant used in an experimental Alzheimer¿s disease vaccine under clinical development by Elan and American Home Products Corp., of Madison, N.J. The milestone was based on the advancement of the vaccine, known as AN-1792, to a Phase IIa trial after the product showed positive results in Phase I studies.
¿ Aradigm Corp., of Hayward, Calif., completed Phase IIb trials of its morphine AERx Pain Management System, which delivers morphine via the AERx pulmonary drug delivery technology to manage acute and breakthrough pain. In a study of 16 patients with breakthrough pain from advanced cancer, AERx morphine demonstrated significantly faster onset of pain control and comparable overall pain relief than immediate-release oral morphine solution. In a separate study of 89 patients with acute postoperative pain, the AERx PMS was shown to provide pain relief comparable to intravenous morphine when given in similar doses.
¿ Cambridge Antibody Technology Group plc, of Melbourn, UK, and Amrad Corp. Ltd., of Melbourne, Australia, entered a product development collaboration focused on the joint discovery and development of human antibody-based therapeutics that neutralize the receptor for granulocyte macrophage-colony stimulating factor. The companies will fund all development jointly through completion of Phase II proof-of-concept studies. CAT then has primary responsibility for further development and commercialization. Amrad has the option to receive milestone and royalty payments from CAT or to participate jointly in further development and commercialization. Amrad will contribute its patent estate, intellectual property and know-how pertaining to the therapeutic target and preclinical and development capabilities to the collaboration, and CAT will contribute its proprietary human antibody phage display technology, high-throughput functional screening, preclinical, manufacturing and development capabilities.
¿ CIMA Labs Inc., of Eden Prairie, Minn., said it signed a definitive master development, license and supply agreement with an unnamed pharmaceutical company for seven new undisclosed prescription products based upon CIMA¿s DuraSolv fast-dissolve drug delivery system. The agreement is expected to result in product development fees between $12 million to $15 million over the next three years. Under the terms, which can be terminated with respect to one or more of the proposed products at the option of the pharmaceutical company, CIMA will be the exclusive manufacturer of these products and will receive royalties based on end-market sales.
¿ Epimmune Inc., of San Diego, completed a private placement of an aggregate 2 million shares of its common stock to selected institutional and other accredited investors. The purchase price was $2.50 per share, with gross proceeds of $5 million. The company now has approximately 13.7 million common shares outstanding on an as-converted basis, assuming conversion of preferred shares. Investors included the State of Wisconsin Investment Board, International Biotechnology Trust, Genencor International Inc., Peter Allard and Ted Greene, the company¿s chairman.
¿ Incyte Genomics Inc., of Palo Alto, Calif., entered an agreement with Cambridge Antibody Technology Group plc, of Melbourn, UK, that gives CAT access to the Incyte LifeSeq Gold database and options for product development rights. CAT will receive access to high-quality, sequence-verified human cDNA clones and rights to use this information for therapeutic antibody product development. CAT also will be able to take several exclusive licenses under Incyte antibody patent rights to discover, develop and commercialize therapeutic antibodies with specificity for target proteins in the database. CAT will pay a license fee, plus milestones and royalties for therapeutic human antibody products developed.
¿ Infigen Inc., of Deforest, Wis., completed a private placement of preferred stock to individuals and institutions. The investment, the first of its kind for Infigen, included funds from several major institutions, including ING Barings Capital and private equity firm Ardshiel Inc. Additional details were not disclosed. Infigen also said another investor, WR Grace, agreed to extend the maturity of its $1 million Series B preferred stock for five years.
¿ InSite Vision Inc., of Alameda, Calif., began a Phase II study of ISV-401 for the treatment of bacterial conjunctivitis. ISV-401 is a DuraSite formulation of a broad-spectrum antibiotic not currently used in ophthalmology. DuraSite is the company¿s patented drug-delivery vehicle offering the benefits of prolonged release of an active ingredient. The multisite, randomized, double-masked Phase II study will compare results of a 1 percent ISV-401 formulation with a DuraSite vehicle. ISV-401 will be administered in the dosing regimen proposed for InSite¿s pivotal Phase III studies.
¿ Interleukin Genetics Inc., of Waltham, Mass., entered into a research collaboration with Kaiser Permanente¿s Center for Health Research in Portland, Ore., to study genetic risk factors for chronic diseases that are affected by inflammation. Knowledge resulting from this work will enable Interleukin to develop diagnostic tools that physicians and health care organizations can use to assess patients¿ genetic risks for many diseases. Financial terms were not disclosed.
¿ Ligand Pharmaceuticals Inc., of San Diego, submitted a regulatory application to market its anticancer medicine Onzar (denileukin diftitox) in the European Union for the treatment of cutaneous T-cell lymphoma patients. As a result of achieving this milestone, Ligand will receive a $1 million payment from its European marketing and distribution partner, Elan Corp. plc, of Dublin, Ireland. Ligand also said Onzar was granted orphan drug designation by the European Commission. This designation would provide 10 years of market exclusivity upon approval.
¿ MitoKor Inc., of San Diego, said its three-year collaboration with Pfizer Inc., of New York, was extended. The collaboration focuses on the discovery of novel targets and therapeutics based on mitochondrial dysfunction. Established in November 1998, the collaboration called for MitoKor to identify novel molecular targets and to develop screens to discover potential drug candidates for therapeutic intervention in neurodegenerative diseases. Financial terms were not disclosed.
¿ Novavax Inc., of Columbia, Md., reported a multiyear Cooperative Research and Development Agreement with the Stroke Branch of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health, of Bethesda, Md., on an E-selectin anti-stroke project. The purpose is to test whether repeated administration of low-dose, intranasal E-selectin could induce mucosal tolerance to this protein, causing a shift of immune responses, such that delayed type hypersensitivity is suppressed and the numbers of lymphocytes that produce the anti-inflammatory cytokine is increased. It is also designed to evaluate the safety and tolerability of intranasal administration of recombinant human or bovine E-selectin for the secondary prevention of stroke.
¿ Novocell Inc., of Irvine, Calif., closed its Series C financing led by SurModics Inc., of Eden Prairie, Minn. Other investors in the Series C round include Asset Management, Alloy Ventures, BD Ventures LLC, Pacific Horizon Ventures and The Vertical Group. The round is being held open for two new investors. The financing adds to $7 million Series B financing raised earlier this year. In addition, the two companies agreed to a strategic alliance to speed the development of cellular encapsulation systems for treatment of human diseases.
¿ QLT Inc., of Vancouver, British Columbia, appointed Paul Hastings its CEO, president and director, effective Feb. 17. He succeeds Julia Levy, who will continue in a scientific advisory role and as a member of the company¿s board. Hastings was president, CEO and a director of Axys Pharmaceuticals Inc., which was acquired by Celera Genomics.
¿ Sequenom Inc., of San Diego, and the Human BioMolecular Research Institute, also of San Diego, said the results of a joint study they conducted were published in the December issue of Drug Metabolism and Disposition. Findings link a defective human enzyme, flavin-containing monooxygenase (form 3), to the abnormal metabolism of chemicals and drugs. These findings reveal clues to the mechanism of population differences in the susceptibility to abnormal metabolism or adverse drug reactions for chemicals containing this enzyme. FMO 3 is a human drug- and chemical-metabolizing enzyme that influences the biotransformation and disposition of many drugs and chemicals.
¿ Xenon Genetics Inc., of Vancouver, British Columbia, said its scientists discovered two genes relating to metabolic and neurological diseases. Each gene was biologically validated as having an important function in humans, and each represents a genetic target that can be used to identify small-molecule compounds or biologicals for therapeutic use. The genes were discovered using Xenon¿s platform for genetic research, which uses both clinical genomic and comparative genomics approaches in humans and model organisms.