• Accelrys Inc., of San Diego, reported plans to release Insight II and Catalyst, Accelrys' premiere modeling and simulation software suites, for the Linux operating system. Accelrys will collaborate with IBM, of Armonk, N.Y., to complete the porting and certify the products on the latest IBM IntelliStation workstations running Red Hat Linux.

• Applera Corp., of Norwalk, Conn., filed a complaint in California Superior Court, County of San Mateo, concerning contract disputes over polymerase chain reaction (PCR) technology with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and certain Roche subsidiaries. Applera also filed a notice of arbitration with the American Arbitration Association. PCR is a technology for amplifying and analyzing DNA.

• Aton Pharma Inc., of Tarrytown, N.Y., said the FDA granted orphan drug designation to Aton's lead product, SAHA, an inhibitor of histone deacetylase to treat multiple myeloma. The company also began enrollment in a Phase I trial of SAHA in patients with advanced multiple myeloma at the Dana-Farber Cancer Institute in Boston.

• Avanir Pharmaceuticals Inc., of San Diego, received a $100,000 grant through the Small Business Innovative Research program of the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, in Bethesda, Md. The grant will be used to develop its fully human monoclonal antibodies to anthrax toxins.

• Borean Pharma A/S, of Aarhus, Denmark, said it reached a milestone by producing protein products with high affinity binding in the 100-200 picomolar range. The results demonstrate the company's platform is capable of generating fully matured and optimized biopharmaceutical product candidates in four weeks instead of six to 12 months.

• ChemoCentryx Inc., of San Carlos, Calif., said the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., awarded the company a $14 million grant to develop first-in-class immune modulatory agents targeting chemokine receptors in infectious diseases that might be caused by biological warfare pathogens. The grant will support drug discovery efforts including small-molecule screening, medicinal chemistry optimization and preclinical development. The grant was made as part of the institute's cooperative research program for the development of new vaccines, adjuvants, therapeutics, immunotherapeutics or diagnostics focused on category A-C Biodefense pathogens.

• Chiron Corp., of Emeryville, Calif., and Berlex Inc., of Montville, N.J., received FDA approval of a new pre-filled diluent syringe for Betaseron, which will be injected in patients with multiple sclerosis. The drug's formulation remains unchanged. Betaseron was first approved in July 1993 and it is the only FDA-approved interferon therapy that is stable at room temperature for more than 30 days. The companies expect the new syringe for Betaseron to be available nationwide in the next few months.

• Diversa Corp., of San Diego, researchers, in conjunction with Yale University in New Haven, Conn., and Celera Genomics, of Rockville, Md., published an analysis of the genome sequence and annotation of the smallest archaeal genome discovered to date, Nanoarchaeum equitans, in the Proceedings of the National Academy of Sciences. The company said that the analysis of that genome sequence provides insight into the simplest known metabolism required by an organism for survival and supports theories that life originated in a very high-temperature environment.

Ligand Pharmaceuticals Inc., of San Diego, said it earned an undisclosed milestone payment from its corporate partner Wyeth, of Madison, N.J., which has decided to advance NSP-989 into Phase II studies for contraception. NSP-989 is a non-steroidal, selective progestin resulting from Ligand's research collaboration with Wyeth.

• MedImmune Inc., of Gaithersburg, Md., and Wyeth, of Madison, N.J., said Phase III clinical data of 5,500 patients treated with an intranasal, cold-adapted trivalent influenza vaccine (CAIV-T) were presented at the 5th International Options for the Control of Influenza Conference in Okinawa, Japan. The data showed the safety, tolerability, efficacy and transmissibility of the vaccine in people of various ages. CAIV-T is manufactured with the same technology used to make the current frozen version of FluMist, which was approved in June. (See BioWorld Today, June 18, 2003.)

• Myogen Inc., of Denver, entered a collaboration with Novartis Institutes for Biomedical Research Inc., an affiliate of Novartis AG, of Basel, Switzerland, for the discovery and development of drugs to treat cardiovascular disease. In exchange for undisclosed signing fees and research funding for three years, Novartis obtained the exclusive right to license new drug targets and product candidates developed. It will fund further development and make milestone payments, as well as pay Myogen royalties on products commercialized.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said clinical data of 29 patients showed Rifaximin was well tolerated and might be an effective treatment for Crohn's disease. The data demonstrated that Rifaximin reduced the mean Crohn's Disease Activity Index score by 43 percent compared to baseline. The nonsystemic antibiotic was well tolerated with one patient experiencing nonserious adverse events that were possibly drug related. The results were announced at the 68th annual meeting of the American College of Gastroenterology. Salix is seeking approval to market Rifaximin in the U.S. for travelers' diarrhea.

• Schering-Plough Corp., of Kenilworth, N.J., said the FDA granted marketing approval to PEG-Intron Redipen, a prefilled pen for administering PEG-Intron (peginterferon alfa-2b) powder for injection, an interferon treatment for patients with chronic hepatitis C. The Redipen is designed to be simpler to use than a traditional vial and syringe. The PEG-Intron product uses PEG technology developed by Enzon Inc., of Bridgewater, N.J.

• VaxGen Inc., of Brisbane, Calif., entered a license agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Md., that gives VaxGen exclusive, worldwide rights to develop and commercialize a recombinant anthrax vaccine candidate based on technology developed by USAMRIID. The agreement obligates VaxGen to pay USAMRIID an execution fee, patent maintenance fees, anniversary fees, milestones and royalties. It gives VaxGen exclusive license to U.S. Patent No. 6,387,665 and an exclusive field-of-use license to U.S. Patent No. 6,316,006 (Asporagenic B, antracis Expression System). VaxGen reported in September that it was awarded an $80.3 million contract by the National Institute of Allergy and Infectious Disease to fund development of the vaccine. (See BioWorld Today, Oct. 2, 2003.)

• Vical Inc., of San Diego, said it was requested to manufacture clinical-grade supplies of an experimental DNA vaccine against the severe acute respiratory syndrome virus for development planned by the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases. The new SARS vaccine manufacturing order is in addition to Vical's other DNA vaccine manufacturing contracts with the NIH. Financial terms were not disclosed.

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