¿ Amylin Pharmaceuticals Inc., of San Diego, said its lead diabetes drug candidate, Symlin, has been accepted for review by the FDA. The new drug application was submitted on Dec. 7 and Amylin is seeking approval to market Symlin as an adjunctive therapy to insulin for the treatment of people with Type I or Type II diabetes using insulin. (See BioWorld Today, Dec. 8, 2000.)
¿ BioTransplant Inc., of Charlestown, Mass., and Novartis Pharma AG, of Basel, Switzerland, named their newly formed company Immerge BioTherapeutics Inc. The company, based in Boston, began operations on Jan. 2 and will focus on the development and therapeutic applications of xenotransplantation of cells, tissues and organs. (See BioWorld Today, Sept. 27, 2000.)
¿ Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., said they completed enrollment in their pivotal 600-patient Phase III trial of the Intercept Platelet System. The system is being developed to inactivate viruses, bacteria, other pathogens and white blood cells in platelets intended for transfusion. The trial is designed to compare hemostatic function of Intercept platelets to that of control platelets.
¿ Dyax Corp., of Cambridge, UK, said partner Debiopharm SA, of Lausanne, Switzerland, completed a Phase Ib trial of EPI-HNE-4 in Europe. The repeat-dose study found the compound to be well tolerated and have therapeutic activity. The companies also announced the formation of an exclusive license agreement to commercialize EPI-HNE-4, a human neutrophil elastase inhibitor, for treatment of cystic fibrosis.
¿ Elan Corp. plc, of Dublin, Ireland, and Cambridge Antibody Technology, of Melbourn, UK, entered a strategic partnership for the development of neurological disorder therapeutics. The joint-discovery, joint-development agreement is aimed at antibody-based therapeutics, and will focus CAT's proprietary antibody phage display technology and high-throughput screening capabilities on targets provided by Elan. Elan will evaluate the resulting candidates in preclinical models, manage clinical and regulatory development and be responsible for global commercialization. The four-year agreement calls for equal development cost and profit sharing. The companies have already identified more than 40 targets to focus on immediately. Financial terms of the partnership were undisclosed.
¿ Emisphere Technologies Inc., of Tarrytown, N.Y., submitted an investigational new drug application to the FDA for oral heparin tablets using its improved delivery agent, Sodium N[10-(2 hydroxybenzoyl)amino] decanote (SNAD). SNAD is intended to be Emisphere's drug delivery agent for solid dosage formulations of heparin and low-molecular-weight heparin, and is an improved version of Emisphere's delivery agent, Sodium N-[8-(2-hydroxybenzoyl)amino] caprylate, currently in Phase III development with an oral solution formulation of heparin.
¿ Genentech Inc., of South San Francisco, funded a study in which a researcher from the University of Nebraska Medical Center and colleagues from 25 other centers worldwide found Genentech's drug, Activase, successfully dissolves blood clots occluding central venous access devices, called catheters. Efficacy results were presented Thursday at the International Symposium of Endovascular Therapy in Miami.
¿ Gen-Probe Inc., of San Diego, said it won a court decision, issued from the United States District Court for the Southern District of New York, granting summary judgment for Gen-Probe and dismissing a patent infringement lawsuit brought against it in 1999 by Enzo Biochem Inc., of Farmingdale, N.Y. The suit claimed Gen-Probe's products for the detection of Nisseria gonorrhoeae infringed U.S. patent No. 4,900,659 and named several other defendants.
¿ Praecis Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted and filed its new drug application for abarelix depot for the hormonal treatment of prostate cancer, granting the application priority review. It is being developed in collaboration with Amgen Inc., of Thousand Oaks, Calif. (See BioWorld Today, Dec. 14, 2000.)
¿ Hyseq Inc., of Sunnyvale, Calif., said Judge Jeremy Fogel of the U.S. District Court for the Northern District of California issued a Markman order - a procedural step for framing the claims at issue in a patent litigation that occurs before the parties can move for summary judgement - and Hyseq said it now is in a position to seek a ruling of noninfringement on each of Santa Clara, Calif.-based Affymetrix Inc.'s asserted patents. Separately, Incyte Genomics Inc., of Palo Alto, Calif., said it gained a favorable ruling by the same court that limited the scope of Affymetrix patent claims to arrays in which light or another energy source is used to activate a specific region of an array for formation of a polymer. Based on this interpretation, Incyte said other methods of manufacture, such as those employed by Incyte, fall outside the claim.
¿ Immunex Corp., of Seattle, released earnings citing a net income of $154 million for 2000, or 28 cents per share, on record-setting total revenues of $861.8 million. The net income represents more than 100 percent growth compared to 1999 earnings, which came in at $44 million, or 8 cents per share, on revenues of $541.7 million. For the fourth quarter, Immunex reported a net income of $49.2 million, compared to $16.2 million in the same period in 1999. As of Dec. 31, the company had $1.6 billion in cash and marketable securities. Sales of the company's rheumatoid arthritis treatment Enbrel, approved in 1998, exceeded the company's goals, increasing 78 percent from 1999 to $652.4 million in 2000, the second year of marketing for the drug. In separate news, Immunex broke ground at the site of its new research and technology center in Seattle. The $750 million facility, called The Helix Project, will include more than 1 million square feet and is expected to be complete in late 2003.
¿ Micralyne Inc., of Edmonton, Alberta, and MDS Sciex, a division of MDS Inc., of Toronto, reached a multiyear agreement to jointly develop microfluidic technology for use in drug discovery instrumentation. Micralyne will both license existing microfluidic technology and develop new technology for use in frontal affinity chromatography, a high-throughput protein analysis technique being developed by MDS Sciex.
¿ Structural Bioinformatics Inc., of San Diego, entered an agreement with the R.W. Johnson Pharmaceutical Research Institute (PRI), of Raritan, N.J., to give PRI access to SBI's X-ray crystallography program. The agreement covers several undisclosed targets, and aims at solving those targets using the X-ray technology. Financial terms were not disclosed.
¿ Titan Pharmaceuticals Inc., of South San Francisco, began treatment in the first cohort of patients receiving its novel Spheramine product for Parkinson's disease. The Phase I/II study, being conducted at Emory University School of Medicine in Atlanta, has enrolled six patients with moderately severe to severe Parkinson's disease and results are intended to advance the use of Titan's proprietary CCM technology in the treatment of Parkinson's disease and other central nervous system disorders.