Cingles Info

FDA Approves Roche Hepatitis C Drug
Tue Dec 3,10:53 PM ET
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites)
said on Tuesday it had approved Roche Holding AG's Pegasys drug in combination
with another anti-viral compound to treat hepatitis C, a potential blockbuster
product for the Swiss-based company.
Up to 4 million Americans are estimated to be infected with the hepatitis C
virus that slowly attacks the liver and sometimes kills.
An FDA advisory panel last month unanimously recommended approval of Pegasys in
combination with the antiviral drug ribavirin. The FDA normally follows the
recommendations of its advisory panels.
Pegasys is a once-a-week, long-acting, injectable version of the antiviral
protein interferon, and daily doses of Copegus, Roche's version of the ribavirin
pill.
The FDA in October gave Pegays clearance as a stand-alone treatment for
hepatitis C but approval for the combination is seen as crucial for Roche to
compete with a similar combination therapy by Schering-Plough Corp.
Pegasys has already received European approval for use alone or in combination
with ribavirin.
"Today, Roche can proudly offer Americans with hepatitis C a new treatment
choice," Hoffmann Roche Inc. President and Chief Executive Officer George
Abercrombie said in a statement.
The drug is especially important for Roche which industry analysts says has a
relatively thin new-product pipeline.
Roche, which has climbed back into the ranks of the world's top 10 drugmakers by
acquiring Japan's Chugai Pharmaceutical Co. Ltd. this year, is counting on
Pegasys and HIV (news - web sites) drug Fuzeon to help it generate double-digit
2003 drug sales growth.
Roche drugs division head William Burns told Reuters last month he expects sales
of its Pegasys drug combined with ribavirin to build slowly toward $1 billion a
year over three to five years once it wins U.S. approval.
Hepatitis C is biggest cause of liver transplants in the United States but the
disease develops slowly, often over 20 years, before symptoms of liver failure
emerge.
Schering-Plough's rival long-acting interferon, called Peg-Intron, is also given
weekly by injection, with patients also taking daily ribavirin pills.
Sales of Peg-Intron and Schering-Plough's brand of ribavirin more than doubled
to $703 million in the third quarter, making hepatitis C the company's biggest
business.
Patients flocked to Schering-Plough's dual therapy after it was launched in
October 2001 because it is more effective and causes fewer side effects than the
company's older treatment using an interferon that had to be taken three times a
week.
Schering-Plough's improved therapy is considered the "gold standard" of
treatment, with about 56 percent of patients taking it eliminating all traces of
hepatitis C after 48 weeks of medication.
With Roche's Pegasys combination, 50 percent of people having no detectable
virus in their blood six months after treatment concluded, Roche officials told
the FDA advisory panel last month. Using an older interferon, injected three
times a week, with ribavirin, only 42 percent of patients cleared the virus.
With Pegasys alone, the treatment was effective in 27 percent of patients.
Roche is also testing Pegasys against hepatitis B, a form of the disease that is
a large problem in Asia.