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

To: keokalani'nui who wrote (483)	12/5/2000 7:24:32 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 3559

When you deal with NDA and FDA you appreciate value of this: <<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.>> If you do not tried how will you know that it does/does not work? Miljenko

To: keokalani'nui who wrote (483)	12/6/2000 7:25:49 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 3559

The value and how serious is Shearwater work on PEG-formulation, not any PolyMasc. biz.yahoo.com Wednesday December 6, 5:26 pm Eastern Time Press Release SOURCE: Shearwater Corporation Shearwater Announces Publication of Pegasys(R) Phase III Trial Results in New England Journal of Medicine HUNTSVILLE, Ala., Dec. 6 /PRNewswire/ -- Shearwater Corporation (formerly Shearwater Polymers, Inc.) today announced the publication of two papers in the New England Journal of Medicine presenting the results of two Phase III clinical trials for Pegasys (peginterferon alfa-2a) in the treatment of hepatitis C. The first study, published by Zeuzem et al and entitled ``Peginterferon alfa-2a in Patients with chronic hepatitis C,'' describes the results of a Phase III trail with 531 patients comparing the efficacy and safety of poly(ethylene glycol) (PEG) modified interferon alfa-2a with unmodified interferon alfa-2a (Roferon-A®) for treatment of hepatitis C. The PEG modified interferon alfa-2a, manufactured by Hoffmann-La Roche and labeled Pegasys, is prepared by coupling Shearwater's proprietary branched 40kDa PEG moiety to interferon alfa-2a. Earlier studies showed that Pegasys has substantially sustained absorption, reduced clearance, and a longer half-life than unmodified interferon. In the Phase III study, Pegasys was administered once weekly at a dose of 180 mcg for 48 weeks, while Roferon-A was administered thrice weekly for 12 weeks at a dose of 6 million units followed by 3 million units for 36 weeks (the so-called induction regimen). The authors reported that sustained viral clearance was observed in 39% of patients receiving Pegasys compared with 19% of patients receiving Roferon-A. The overall safety and adverse-event profiles of the two agents were similar. The 39% response rate is similar to that seen with the currently accepted standard interferon plus ribavirin combination regimens, and it is hoped that treatment with Pegasys alone may avoid the ribavirin-associated adverse effects of combination therapies. ``It is important to note that this trial used induction dosing in the interferon alfa-2a arm,'' said Dr. Milton Harris, Shearwater's President. ``This dosing was recently approved in the U.S. for interferon alfa-2a, but has been used in Europe for several years now, and is considered the optimal dosing regimen for standard interferon. Other studies using standard interferon without induction dosing have typically found response rates in the range of 10 percent.'' In a second article in the same issue of the Journal, entitled ``Peginterferon alfa-2a in Patients with Chronic Hepatitis C and Cirrhosis,'' Heathcote et al reported results of a Phase II/III trial comparing the efficacy of Pegasys and Roferon-A for treatment of patients with chronic hepatitis C and cirrhosis. This trial is significant because patients with the hepatitis C virus and liver disease are especially difficult to treat with present therapeutic interventions. In the trial, patients received 48 weeks of treatment with Roferon-A, 3 million units thrice weekly (n = 88), or Pegasys, 90 mcg (n = 96) or 180 mcg (n = 87) once weekly, followed by a 24-week treatment-free period. Sustained, undetectable viral clearance was achieved in 8, 15 and 30 percent, respectively, of patients receiving the above treatments. Normalization of liver enzymes (aminotransferases) was seen in 15, 20 and 34 percent of patients, respectively. Liver biopsies showed histological improvement at week 72 in 31, 44 and 54 percent of patients, respectively. All three treatments were similarly tolerated. Thus Pegasys at 180 mcg per week was seen to be significantly more effective than 3 million units of Roferon-A thrice weekly in treatment of patients with chronic hepatitis C and cirrhosis. Pegasys is currently awaiting marketing clearance from the U.S. Food and Drug Administration and, if approved, will be available as a ready-to-use, once-a-week injection. 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 publications, Dr. Stephen A. Charles, Shearwater's Vice President for Corporate Development commented, ``We are delighted with the Phase III results which indicate that Pegasys has the potential to make a real difference in the fight against hepatitis C. In addition, the results provide further clinical validation of Shearwater's drug enhancement technologies.''