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Press Release from Roche

Press Release from Roche

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Posted by Hepatitis C Outreach Project on January 07, 2000 at 17:27:45:

January 7, 2000

Hoffmann-La Roche Issued the Following Statement Today on a Lawsuit Filed Against Schering-Plough for Pegylated Inferferon Patent Infringement

Hoffmann-La Roche announced today that it has filed lawsuits in the U.S. and France against Schering-Plough Inc. for patent infringement of Roche’s pegylated interferon patents. On January 5, 2000, Schering-Plough announced that on December 23, 1999 it filed a Biologics Licensing Application (BLA) for PEG-INTRON® (peginterferon alfa-2b) for the treatment of hepatitis C with the U.S. Food and Drug Administration (FDA). Recently, Schering-Plough also submitted a centralized Marketing Authorization Application to the European Union's (EU) European Agency for the Evaluation of Medicinal Products (EMEA) seeking clearance to market PEG-INTRON.

Roche holds patents on a worldwide basis for a variety of forms of pegylated interferon, which include the specific type of pegylation used in the Schering product.

"Pegylation" is the attachment of polyethylene glycol (PEG) to a molecule. PEGs can vary in length, form and the type of attachment to the molecule. The Roche patent involved in the litigation includes interferon conjugated to linear PEG via a urethane linkage. Schering’s PEG-INTRON uses a linear PEG with a urethane linkage, which falls within Roche’s patent.

Roche has studied pegylation for more than a decade beginning with linear pegylated interferon which subsequently led to a technologically advanced pegylated interferon using a branched PEG. Roche currently has PEGASYS*, a branched pegylated interferon alfa-2a, in clinical development for the treatment of hepatitis C.

Attaching the PEG helps prevent the body’s metabolic system from rapidly breaking down the interferon protein. Results from clinical studies suggest that with PEGASYS the result is decreased clearance from the body which leads to sustained therapeutic levels of pegylated interferon in the body, and dosing of once per week, rather than three times a week as in the case with standard interferon.

In clinical studies, adverse events with this compound were similar to those seen with traditional interferon regimens, such as fatigue, headache, myalgia/arthralgia, flu-like symptoms, nausea/vomiting, injection site reactions, fever, chills, diarrhea, partial alopecia, abdominal pain, depression, irritability, insomnia, dizziness and anorexia.

Roche expects to file its BLA for PEGASYS with the FDA sometime this year.

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