Hoffmann-La Roche Submits Application To U.S. FDA for Pegasys


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Hoffmann-La Roche Submits Application To U.S. FDA for Pegasys(TM) Peginterferon alfa-2a) Investigational Hepatitis C Therapy
Once-weekly Injection May Offer Sustained Response Rate of 35 Percent And Better Quality of Life -

NUTLEY, N.J., May 22 /PRNewswire/ -- Hoffmann-La Roche announced today it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market PEGASYS(TM) (peginterferon alfa-2a) for the treatment of chronic hepatitis C in non-cirrhotic and cirrhotic patients with compensated liver disease.

In clinical studies to date, PEGASYS has attained response rates that may be in the same range as those reported with currently available combination therapy. Clinical studies have demonstrated favorable results versus monotherapy with standard interferon, even in cirrhotic patients, the most difficult to treat. PEGASYS, a ready-to-use solution, is expected to be administered as a once-weekly subcutaneous injection taken for one year, in comparison to standard interferon, which must be taken three times per week.

"PEGASYS is backed by ten years of Roche research in sophisticated drug design," said Myron Holubiak, president, Roche Laboratories. "If approved, it will bolster the hepatitis C marketplace by giving potentially hundreds of thousands of patients in the U.S. a desperately-needed therapy option. It could be an important advance that may ultimately provide patients with impressive response rates and the convenience of once-weekly injections."

Clinical Data
A pegylated interferon, PEGASYS is a longer-lasting form of interferon for the treatment of hepatitis C virus (HCV). In rigorous intent-to-treat analyses of three pivotal clinical studies involving a total of more than 1,400 patients, those treated with 180 mcg. of PEGASYS had overall sustained virological responses of 35 percent in patients without cirrhosis and 30 percent in patients with cirrhosis. Virological response was defined as undetectable HCV RNA as measured by the AMPLICOR HCV Monitor(TM), version 2.0. Standard interferon therapy has proven effective in only 11-19 percent of hepatitis C patients in the general population and in 5 percent or less of patients with cirrhosis.

In the largest prospective study (n=271) to include only hepatitis C patients with cirrhosis - the most difficult group of hepatitis C patients to treat - data showed that PEGASYS may achieve a sustained response rate nearly four times higher than standard interferon - 30 percent (26 of 87) verses 8 percent (7 of 88).

In addition, data from two other studies show that patients treated with PEGASYS exhibited improved liver histology in post-treatment liver biopsies. In a study examining 184 adult hepatitis C patients with cirrhosis, 54 percent (37 of 68) who received 180 mcg. of PEGASYS demonstrated a histological response, while only 31 percent (17 of 55) of participants in the standard interferon arm demonstrated a similar response. In a study examining histology in non-cirrhotics, 63 percent (19 of 30) of patients who received 180 mug. of PEGASYS demonstrated a histological response, versus 57 percent (13 of 23) who received standard interferon. Many researchers believe improved histology may be associated with slowing the progression of liver disease.

"Physicians have very few weapons in their arsenal against hepatitis C," said Mitchell Shiffman, MD, chief, Hepatology Section, Medical College of Virginia. "In clinical studies I've conducted, in addition to seeing response rates several times higher than those attained with standard interferon, patients are able to maintain their daily routine, without living their lives around the three-times-per week injections required of standard interferon."

Adverse events with PEGASYS are similar to those seen with standard interferon regimens, such as fatigue, headache, myalgia/arthralgia, flu-like symptoms, nausea/vomiting, fever, chills, diarrhea, partial alopecia, abdominal pain, depression, irritability, insomnia, and anorexia.

About Pegylation
PEGASYS is made when interferon alfa-2a undergoes the process of pegylation, in which one or more chains of polyethylene glycol (also known as PEG) are attached to another molecule. In PEGASYS, a large, branched, mobile PEG is covalently bound to the interferon alfa-2a molecule and provides a selectively protective barrier, without significantly reducing binding site receptivity. Pharmacokinetic behavior of a pegylated molecule depends on the length of the PEG and the structure of the link between the PEG moiety and the protein. Researchers believe the PEG creates a barrier that shields the interferon alfa-2a from being eliminated from the body too rapidly and maintains its ability to consistently suppress the hepatitis C virus over the one week dosing period. Specifically, clinical trials have demonstrated that PEGASYS may provide longer-lasting levels of drug in the blood -- drug levels following a single dose of PEGASYS last more than one full week (168 hours) as compared to less than 24 hours with standard interferon.

The high molecular weight (40 kilodalton) branched PEG in PEGASYS is believed to provide sustained pegylated interferon alfa-2a exposure at clinically effective levels over the one week dosing period. In contrast, interferons with smaller PEGs are excreted quickly by the kidneys, requiring more frequent dosing, according to earlier Roche studies, using smaller PEGs developed by the company.

The specific "PEG" used in PEGASYS was licensed by Roche from Shearwater Polymers, Inc., in Huntsville, Alabama.

Quality of Life Data
In addition to the virologic and histologic results reported for PEGASYS trials, a self-rated health improvement survey evaluating the quality of life (QoL) of patients with chronic hepatitis C showed improved scores among those treated with once-weekly doses of PEGASYS versus those treated with thrice-weekly doses of standard interferon alfa-2a. Because its symptoms are often debilitating -- including lethargy, loss of appetite, nausea and vomiting, fever and joint pain - chronic hepatitis C can have a profound effect on health-related QoL. Results were collected in a randomized, controlled clinical trial (n=250) comparing PEGASYS to standard interferon. When asked to rate their general health compared to one year before, 48 percent of patients treated with PEGASYS reported feeling better or much better, compared to 26 percent for standard interferon. The QoL data were presented this week at Digestive Disease Week in San Diego.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, is a leading cause of cirrhosis and liver cancer and the number-one reason for liver transplants in the U.S. An estimated four million Americans are infected with the virus, with approximately 35,000 new infections each year. In the United States, the Centers for Disease Control and Prevention estimate that hepatitis C is responsible for eight to ten thousand deaths per year and could increase to 38,000 by the year 2010, surpassing annual HIV/AIDS deaths.

Hepatitis C is a blood-borne virus transmitted through body fluids, primarily blood or blood products, and sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people who are infected with hepatitis C are unaware of it because, like HIV, it may take years for symptoms to develop. In addition, it is estimated that as many as 40 percent of people with HIV may be co-infected with hepatitis C.

About Hoffmann-La Roche, Inc.
Hoffmann-La Roche Inc. (Roche) based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases including obesity and diabetes.

For more information on the Roche pharmaceuticals business in the United States, visit the company's web site at: http://www.rocheusa.com.

SOURCE: Hoffman-La Roche

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