FDA says Merck hepatitis drug a faster cure

Merck researchers in North Wales and Kenilworth, N.J., received some tentative but good news Monday when Food and Drug Administration staff members reported that Merck's drug to fight the hepatitis C virus cured most patients faster and more completely than older medications during clinical trials.

The hepatitis C virus affects 130 million to 170 million people worldwide - about four times the number with HIV/AIDS - and kills about 350,000 people a year because of damage to the liver, according to the World Health Organization.

"It's wonderful to be on the cusp of a paradigm shift in medical care," said Dr. Eliav Barr, vice president for infectious diseases at Merck Research Laboratories in North Wales. Hundreds worked on this for Merck. Janice K. Albrecht, vice president of hepatology clinical research, is the key member of the research group. "We believe this medicine will have an important impact on therapy for a disease that hasn't had much new in the last decade," Barr said.

Merck & Co. Inc. shares closed up 29 cents at $34.33 on the FDA news about boceprevir, which will carry the brand name Victrelis. Bloomberg reported that sales of boceprevir may surpass $604 million in 2013, according to the average estimate of six analysts surveyed.

Merck is not alone in pursuit of hepatitis C profits. A Merck team will meet Wednesday with an FDA advisory committee, whose vote on whether to recommend approval of the drug would likely be confirmed by the FDA.

But a day later, Vertex Pharmaceuticals Inc., seeking separate approval, will appear before the same advisory panel with its similar compound, telaprevir. Johnson & Johnson has an agreement to market telaprevir for Vertex. Vertex's stock closed down $1.33 at $48.04.

There are several strains of hepatitis. The National Institutes of Health estimates that 4.1 million Americans have at least the antibody that can lead to hepatitis C. The Centers for Disease Control and Prevention say 3.2 million Americans have a chronic form of the virus.

Hepatitis C is spread primarily by contact with infected blood and blood products, but transfusion techniques have improved dramatically since the early 1990s, reducing that mode of transmission. According to NIH, injection-drug use is the most common risk factor for contracting the infection.

Philadelphia's Health Department reported 2,439 confirmed new cases in 2009 and an additional 2,440 were considered probable or had a positive hepatitis C virus antibody test. The total number of reports was a 0.2 percent increase over 2008.

"The American Liver Foundation feels that, upon FDA approval of these new drugs, we welcome having a greater arsenal of treatments available for people with HCV," said Diann Rohde, vice president of communications for the foundation. "People have waited a long time for more ways to fight the HCV, and so we are very pleased."

Merck is also awaiting approval in Europe. The FDA staff report raised questions about anemia, among the side effects, which will likely prompt questions from members of the independent advisory committee. African Americans are more likely to be affected by the virus, and the panel probably will question the success rate among that group.

Peginterferon (injection) and ribavirin (pill) have been the standard treatment for more than 10 years, which Barr said achieved success only 35 percent to 40 percent of the time and required 48 weeks. Boceprevir is designed to work in combination with those two other drugs. Barr said that Merck's studies showed that among patients who were never treated before, boceprevir was successful more than 60 percent of the time in only 24 weeks.

"You need not look any farther than some neighborhoods in Philadelphia, where there are quite a few cases of hepatitis C," Barr said when asked about the worldwide profit potential. "We hope we've developed a therapy for people at home."