¿ Amersham Pharmacia Biotech, of Piscataway, N.J., said the U.S. Department of Energy¿s Joint Genome Institute will change its DNA template preparation process to Amersham¿s TempliPhi DNA amplification kit. The institute began using the kit three weeks ago to increase productivity and expects to complete the conversion and full automation before the end of the month.
¿ Applied Molecular Evolution Inc., of San Diego, adopted a stockholders rights plan designed to protect AME shareholders. The plan, the company said, is designed to protect AME stockholders against abusive, coercive or other takeover tactics not in the best interest of AME or its stockholders.
¿ BIO, the Biotechnology Industry Organization, of Washington, said the U.S. Senate declared May 13-20 National Biotechnology Week. The week is meant to recognize biotechnology¿s importance to research and development of medical, agricultural, industrial and environmental products.
¿ BioChem Pharma Inc., of Laval, Quebec, said its merger with Shire Pharmaceuticals Group plc, of Andover, UK, successfully closed Friday. The companies announced their intent to merge in a $4 billion deal in December. (See BioWorld Today, Dec. 12, 2000.)
¿ Durect Corp., of Cupertino, Calif., completed the clinical portion of its Phase II program for its lead product, DUROS sufentanil. Data analysis is under way. The trial evaluated the safety and efficacy of a continuous dose of sufentanil, an approved opioid for chronic pain, through a subcutaneously implanted DUROS sufentanil system.
¿ Gliatech Inc., of Cleveland, said the FDA issued a warning letter to a study site that participated in the U.S. trial of Adcon-L. The letter noted three items: failure to notify the institutional review board within three days regarding an unanticipated adverse event, a cerebrospinal fluid leak; failure to conduct the study according to the investigational plan by enrolling patients in an order different than their chronological surgery dates; and failure to notify the institutional review board of protocol amendment changes.
¿ InforMax Inc., of Bethesda, Md., said it signed a license agreement with Abgenix Inc., of Foster City, Calif., for GenoMax enterprise software. GenoMax is InforMax¿s modular family of analysis programs designed to work with sequence information, gene expression data, protein structure and protein-protein interactions.
¿ Institute for Systems Biology researchers demonstrated the feasibility of integrating genomic, proteomic and other biological data for the creation of a model of the network of interactions that make up a living cell. The research, featured in the May 4, 2001, issue of Science, made it possible to verify a large body of prior findings, findings that took more than 20 years to accumulate through traditional research, in merely a year. Researchers said the breakthrough is significant enough to call ¿revolutionary.¿
¿ InterMune Pharmaceuticals Inc., of Burlingame, Calif., entered an agreement with MoliChem Medicines Inc., of Chapel Hill, N.C., to jointly develop and commercialize MoliChem¿s Moli1901 (duramycin) for treatment of a range of pulmonary indications including cystic fibrosis. Moli1901 induces the transport of chloride and water in the lungs, facilitating the removal of mucus from the lungs. InterMune will make a $1.5 million up-front payment to MoliChem and milestone payments for each indication of use. The companies will develop and commercialize the product worldwide and share equally in expenses and profits. Moli1901 is in a Phase I safety and pharmacokinetics study in cystic fibrosis patients, and the companies expect to begin a Phase II trial in the second half of 2001.
¿ KS Biomedix Holdings plc, of Guildford, UK, received approval to commence a European Phase IIb trial of KSB302 for treatment of rheumatoid arthritis. The trial is expected to conclude early next year. KSB302 is a small-molecule modulator of RA-associated biochemical imbalances. The Phase IIb study will enroll 300 patients at 20 to 25 centers across four countries in Europe.
¿ Novartis Opthalmics, of Bulach, Switzerland, and QLT Inc., of Vancouver, British Columbia, said the American Journal of Ophthalmology published favorable two-year results from a Phase III trial of Visudyne (verteporfin for injection) indicating the treatment is beneficial in age-related macular degeneration patients presenting with occult but without classic choroidal neovascularization. The findings, Novartis said, should broaden Visudyne¿s use.
¿ PPGx Inc., of Morrisville, N.C., expanded the capabilities of its GeneTrials bioinformatics software to give users integrated access to gene expression analysis. PPGx integrated GeneSpring, a software solution for gene expression data mining created and marketed by Silicon Genetics Inc., of Redwood City, Calif.