¿ AeroGen Inc., of Sunnyvale, Calif., initiated Phase II studies of its AeroDose insulin inhaler in Type II diabetic patients. The trials in the U.S. and in Europe are designed to characterize the delivery and efficacy of inhaled insulin in those patients.
¿ Affymetrix Inc., of Santa Clara, Calif., and Genomic Solutions Inc., of Ann Arbor, Mich., entered a license agreement giving Genomic Solutions rights to Affymetrix technology for commercializing low- and medium-density DNA arrays. Genomic Solutions gets a nonexclusive, worldwide, royalty-bearing license to manufacture, sell and use the arrays for gene expression analysis for an undisclosed up-front fee and royalties on sold arrays paid to Affymetrix. Further discussions on collaboration issues continue between the companies. Financial details were undisclosed.
¿ Aquasearch Inc., of Kailua-Kona, Hawaii, entered an agreement with the University of Hawaii to develop new pharmaceuticals from a collection of more than 2,000 strains of microalgae, rights to which are held by UH. The university will receive royalties on any drug candidates discovered by Aquasearch. Further financial details were unavailable.
¿ Aurora Biosciences Corp., of San Diego, granted further access to its ion channel technology to the R.W. Johnson Pharmaceutical Research Institute, a member of the Johnson & Johnson family of companies. Aurora will provided the institute with additional instrumentation, voltage sensing probes and ongoing scientific and technical support. Financial terms were undisclosed.
¿ Avant Therapeutics Inc., of Needham, Mass., began a placebo-controlled Phase IIb trial of its lead complement inhibitor, TP10, in about 30 infants undergoing high-risk cardiac surgery using cardiopulmonary bypass. The objective is to assess the effect of TP10 prior to the initiation of a pivotal trial later this year. A study in a lower-risk infant population is expected to begin soon, also before the pivotal trial.
¿ BioChem Pharma Inc., of Laval, Quebec, said partner GalxoSmithKline plc, of Brentford, UK, received marketing approval from the European Commission for Trizivir, the triple-drug HIV treatment tablet. Trizivir combines abacavir sulphate (300 mg Ziagen), lamivudine (150 mg) and zidovudine (300 mg Retrovir).
¿ BioMarin Pharmaceutical Inc., of Novato, Calif., said the Committee for Orphan Medical Products of the European Agency for the Evaluation of Medicinal Products gave a positive opinion on the company's application for orphan designation for rhASB (recombinant human arylsufatase B), an enzyme replacement therapy for treatment of mucopolysaccharidosis VI. The FDA granted both fast-track and orphan status for the drug candidate in October.
¿ Biotechnology Industry Organization, of Washington, said it selected ChemNavigator, of San Diego, as a preferred provider to BIO members. ChemNavigator is the creator of a web-based environment called the iResearch System comprised of a cross-indexed database of more than 1 million commercially available drug-like compounds and more than 500,000 data records. ChemNavigator will provide BIO members favorable pricing memberships to the system.
¿ Cangene Corp., of Mississauga, Ontario, said its tender offer to acquire all the outstanding shares of Chesapeake Biological Laboratories Inc., of Baltimore, expired at midnight Wednesday. Cangene subsidiary AC Acquisition Subsidiary Inc. accepted for payment all CBL shares validly tendered and not withdrawn as of the expiration. More than 6.8 million shares were tendered pursuant to the offer, representing more than 93 percent of the company's total outstanding stock. Cangene intends to complete the merger on Feb. 9.
¿ Cell Genesys Inc., of Foster City, Calif., received a $6 million payment following the completion of its first Phase II trial of GVAX, its prostate cancer vaccine, from the pharmaceutical division of Japan Tobacco, of Tokyo, in connection with the companies' worldwide collaborative agreement signed in 1998. That trial demonstrated the anticancer activity of the compound in advanced-stage prostate cancer patients.
¿ Cel-Sci Corp., of Vienna, Va., gained permission from Mexican authorities to start a Phase II trial in Mexico of the immunotherapy drug Multikine in head and neck cancer patients. The study will enroll up to 20 patients in two dose groups.
¿ CeNeS Pharmaceuticals plc, of London, licensed exclusive North American rights for Moraxen, its once-daily hydrogel product for treatment of severe pain, to Amarin Corp. plc, of London. The deal calls for an up-front cash payment to CeNeS and royalties on future sales. Further financial details were undisclosed.
¿ Delsys Pharmaceutical Corp., of Monmouth Junction, N.J., appointed David King president and director. King is the former CEO of Principia Pharmaceutical Corp., of Norristown, Pa., and a 25-year alum of the law firm of Morgan, Lewis & Bockius LLP.
¿ Geron Corp., of Menlo Park, Calif., said collaborative researchers at the Texas Southwestern Medical Center at Dallas showed that model telomerase inhibitors may be useful in preventing cancer occurrence. The study was reported in the January 2000 issue of the Journal of the National Cancer Institute.
¿ IDEC Pharmaceuticals Inc., of San Diego, initiated a Phase II trial of IDEC-31, its humanized anti-CD154 monoclonal antibody. The multicenter, dose-ranging study is designed to evaluate the clinical activity of the compound and its safety in patients with chronic, refractory immune thrombocytopenic pupura.
¿ Incyte Genomics Inc., of Palo Alto, Calif., said it is making a significant financial contribution to the Gene Ontology project at Stanford University for the development of a scientific standard for describing and querying the functions of genes. The move marks the beginning of a collaboration between Incyte and the Gene Ontology Consortium, of which Stanford is a member. Incyte also will provide Stanford a royalty-free license to its Protein Functional Hierarchy.
¿ InfiMed Therapeutics Inc., of Cambridge, Mass., entered a collaboration with Praecis Pharmaceuticals Inc., also of Cambridge, for drug delivery technologies. InfiMed will apply its Improved Formulation Entity platform for sustained release of protein- and peptide-based drugs to an undisclosed Praecis peptide.
¿ InKine Pharmaceuticals Co. Inc., of Blue Bell, Pa., said the first commercial orders for Visicol have been shipped to wholesalers, drug stores and other customers. The product, approved in September, is a tablet purgative preparation indicated for bowel cleansing prior to colonoscopy.
¿ Ligand Pharmaceuticals Inc., of San Diego, said it drew down $10 million of zero-coupon convertible notes from Elan Corp. plc, of Dublin, Ireland, under the terms of their securities purchase agreement entered into in September 1998. The notes are due in November 2008, bear a per annum interest rate of 8 percent and are convertible at $14.16 per share, callable at accreted value beginning in November 2001. The notes are the final takedown of the convertible note facility, and the funding will be used by Ligand for general corporate purposes. Assuming conversion of all the notes issued to date, Elan would own about 18.5 percent of Ligand.
¿ Medarex Inc., of Princeton, N.J., and Biosite Diagnostics Inc., of San Diego, are using Trans-Phage Technology to generate high-affinity, fully human antibodies to genomics-derived targets provided by Eli Lilly and Co., of Indianapolis. Lilly will provide targets to Biosite for three years. Biosite will receive technology access fees, fees upon target delivery, annual maintenance fees and milestones and royalties. Medarex will receive license fees and milestones, as well as royalties, if products progress through development to commercialization. Medarex and Biosite began collaborating in June on the Trans-Phase technology, a high-throughput method of creating fully human antibodies.
¿ MediGene AG, of Munich, Germany, said it initiated a Phase III trial in the last week of December for Polyphenon E to treat genital warts caused by human papilloma virus. The multicenter, 260-patient, randomized, double-blinded and placebo-controlled study is designed to evaluate two formulations of the compound's safety and efficacy in the treatment of external genital warts.
¿ NeoTherapeutics Inc., of Irvine, Calif., said newly formed subsidiary NeoOncoRx Inc. singed a letter of intent to acquire the anticancer compound EO9 and 79 of its analogues from NDDO Research Foundation, of the Netherlands. NeoOncoRx will receive the patent and worldwide rights for the compound and its analogues, which the company has named Neoquin. Financial details were unavailable.
¿ Neurogen Corp., of Branford, Conn., and Pfizer Inc., of New York, extended the funded research portion of their gamma-aminobutryic acid collaboration, the goal of which is to develop drugs to treat anxiety disorders, Alzheimer's disease and insomnia by exploiting Neurogen's GABA neurotransmitter system. The extension, the fifth since the collaboration began in 1992, will bring Neurogen $2.9 million in funding this year.
¿ StemCells Inc., of Sunnyvale, Calif., named Martin McGlynn president and CEO, effective Jan. 15, 2001. McGlynn is the former president and CEO of Pharmadigm Inc.
¿ Syrrx Inc., of San Diego, formed a five-year strategic alliance with the Genomics Institute of Novartis Research Foundation (GNF). They will co-develop automated systems to streamline and industrialize the protein structure determination process. Syrrx was granted a worldwide, exclusive license to tools developed by GNF in the field of structural proteomics. GNF will take a minority equity position in Syrrx and a seat on its board.
¿ V.I. Technologies Inc., of Watertown, Mass., received a $4 million equity milestone payment from Pall Corp., of East Hills, N.J., related to enrollment of the first subject in a Phase II trial of the Inactine Pathogen Inactivation product for red blood cells.
¿ Variagenics Inc., of Cambridge, Mass., entered an agreement with Amgen Inc., of Thousand Oaks, Calif., to apply Variagenics' Variagenic Impact Program to the development of an Amgen therapeutic. The technology incorporates genetic variance into drug development decision making. Financial details were undisclosed.
¿ Vertex Pharmaceuticals Inc., of Cambridge, Mass., began a dose-ranging Phase II trial in rheumatoid arthritis patients of VX-745, a small-molecule inhibitor of p38 MAP kinase, which regulates the production of tumor necrosis factor-alpha and interleukin-1. Clinical activity of the compound will be assessed over a three-month dosing period.