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Vertex hepatitis C drug gets glowing endorsement

Thu, 28 Apr 2011 22:07 GMT

Source: reuters // Reuters

* Telaprevir nearly doubles chances of a cure

* FDA panel recommends drug in 18-0 vote

* Sales projections as high as $5 billion a year

* Vertex shares slightly higher in extended trading (Adds analyst comment, detail on drug, share movement)

By Lisa Richwine

SILVER SPRING, Md., April 28 (Reuters) - Vertex Pharmaceuticals <VRTX.O> won a U.S. advisory panel's overwhelming support for a potential blockbuster drug seen transforming hepatitis C treatment by nearly doubling the chances of curing the serious liver disease.

The Food and Drug Administration committee voted 18-0 on Thursday to recommend approval of telaprevir, one of two new proposed medicines offering higher cure rates and often shorter treatment for a virus that can destroy the liver.

The panel vote moves Vertex closer to bringing its first drug to the market and turning its first profit. Some industry analysts project telaprevir sales topping $5 billion a year.

Panelists said the drug's ability to wipe out the virus in 79 percent of newly treated patients clearly trumped concerns about serious rashes seen in a fraction of patients. The cure rate for the current standard of care is about 40 percent.

"I really think this is a stunning success, so I wholeheartedly endorse approval," said Dr. Lawrence Friedman, medicine department chair at Newton-Wellesley Hospital in Newton, Massachusetts.

Others also gushed about the drug's effectiveness and said they were eager to provide the medicine to their patients.

"I'm pinching myself and saying 'am I looking at numbers like this?' Because it's unbelievable," said Dr. Victoria Cargill, director of minority research at the National Institutes of Health's Office of AIDS Research.

On Wednesday, the advisory committee recommended a similar Merck & Co <MRK.N> drug, boceprevir. The FDA usually approves medicines that win advisory panel backing and is due to rule on both drugs in May.

Analysts forecast blockbuster sales of more than $1 billion a year for each of the new medicines but expect telaprevir to dominate with its higher cure rate.

About 170 million people around the world and 3.2 million in the United States are infected with hepatitis C, a blood-borne disease that can lead to chronic liver problems, liver cancer, cirrhosis and death.

LOVE FEST

Sanford Bernstein analyst Geoffrey Porges said he had never heard such positive comments from an FDA panel about a company's data.

He predicted telaprevir's global sales could exceed $5 billion within three years, with at least $2.5 billion to $3 billion in the United States.

"It was virtually a love fest between this panel and the company's application," Porges said.

Analysts expect telaprevir to propel Vertex to its first quarterly profit in the fourth quarter of this year, according to Thomson Reuters I/B/E/S.

Merck's drug was less effective in company studies, curing as many as 66 percent of patients, but was still seen as a major advance by experts on the FDA panel.

"If the FDA listened today and yesterday, telaprevir is going to get a broad label with simple dosing and boceprevir is going to get a label with some limitations," Porges said.

Both the Merck and Vertex medicines must be taken with the current combination therapy of the injectable drug interferon and a pill called ribavirin.

The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate. Many patients who took the newer medicines were able to end treatment after about six months.

Doctors believe tens of thousands of patients have been delaying treatment while awaiting the new drugs.

The main safety concern discussed by the panel was severe rashes in a small number of patients, including three suspected cases of Stevens-Johnson Syndrome, a life-threatening outbreak of blisters. Vertex said the rashes disappeared when telaprevir was stopped.

Panelists urged Vertex to warn about the problem and tell doctors and patients how to spot a serious rash and when to stop treatment if needed.

Hepatitis C is spread mainly through sharing needles, such as those used for illegal drugs and tattoos, or through blood transfusions before 1992, when screening began. Many people who are infected do not know they have the virus and show no symptoms.

Both of the new medicines work by blocking a protein called protease that the virus needs to replicate.

Shares of Vertex rose nearly 1 percent to $56 in extended trading from Wednesday's close, after being halted most of Thursday pending the outcome of the meeting. The stock is up almost 13 percent this week in anticipation of the advisory panel endorsement. (Reporting by Lisa Richwine in Silver Spring, Maryland and Bill Berkrot in New York; Editing by Lisa Von Ahn and Tim Dobbyn)