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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (481)	12/4/2000 10:54:27 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 3559

Monday December 4, 5:00 pm Eastern Time Press Release Shearwater Signs Agreement with Regeneron for the PEGylation of AXOKINE HUNTSVILLE, Ala.--(BW HealthWire)--Dec. 4, 2000--Shearwater Corporation (formerly Shearwater Polymers, Inc.) today announced the signing of an agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN - news) of Tarrytown, New York, for the PEGylation of AXOKINE®, Regeneron's obesity drug currently in clinical trials. The agreement provides for Shearwater to use its proprietary PEGylation technology in the development of a PEGylated form of AXOKINE. In addition, the agreement provides Shearwater with license fees, royalties and exclusive rights to supply the PEG (polyethylene glycol) reagent. AXOKINE has recently completed Phase II clinical testing for the treatment of obesity in severely obese patients and Phase III clinical testing is scheduled to commence in 2001. Obesity is a growing and serious medical problem in developed countries. The National Institutes of Health (NIH) report that approximately 97 million American adults, over one-third of the U.S. population, are currently overweight or obese. More than 8% of adults, or approximately 12 million Americans, suffer from clinically severe obesity, and obesity contributes to about 300,000 premature deaths each year. Obesity is a complex chronic disease that contributes to the development of several debilitating and life-threatening complications, such as adult-onset diabetes, hypertension, coronary artery disease, and respiratory problems. Obesity-related conditions rank second only to smoking as a preventable cause of death, and healthcare expenditures for obesity-related conditions now total $238 billion a year in the United States. PEGylation is a technology for the chemical attachment of PEG polymer chains to drug substances such as peptides and proteins. The benefits of attaching PEG to drugs typically include improved solubility and stability, reduced immunogenicity and proteolysis, slowed clearance from the body, less frequent dosing due to greatly increased circulation time and slow absorption from subcutaneous injection site, optimized biodistribution and improved efficacy. Announcing the agreement, Dr. Stephen A. Charles, Shearwater's Vice President for Corporate Development commented, ``We are delighted to have the opportunity to work with Regeneron on this ground-breaking project as AXOKINE appears to be one of the most promising potential treatments for obesity. Currently in clinical trials, AXOKINE is administered once a day by subcutaneous injection. By utilizing our clinically proven drug enhancement technologies, we hope to be able to develop a form of AXOKINE with even better efficacy.'' Founded in 1992, Shearwater is a research-based drug delivery and cGMP manufacturing company focusing on healthcare applications of PEG. Currently, Shearwater's corporate partners, who include Hoffmann-La Roche, Pharmacia, Maxygen and United Therapeutics, have ten PEG products utilizing Shearwater's proprietary technology in fourteen clinical trials. Three of these ten products have now finished Phase III clinical trials and are in the pre-marketing approval stage, and one has been approved by the FDA. Shearwater offers its partners a unique, ``one-stop-shop'' service for their PEGylation requirements. The service includes basic research, optimization of the PEG-product, full-scale cGMP manufacturing and a full regulatory package, including the Drug Master File.