FDA Approval of Merck Vaccine Delayed
Posted on: Friday, 24 February 2006, 15:00 CST
By LINDA A. JOHNSON
TRENTON, N.J. - Federal regulators have delayed a decision on whether to approve Merck & Co.'s experimental vaccine to prevent shingles and reduce pain from the common nerve disorder, sending Merck shares down Friday.
Zostavax is one of four vaccines that company executives have been touting for the last couple years. If successful, it could help replace revenues that will be lost when the struggling drugmaker's top seller, cholesterol treatment Zocor, faces generic competition this spring. Two other vaccines were recently approved, one after a similar delay.
The U.S. Food and Drug Administration was to have decided whether to approve sales of Zostavax by Feb. 23, 10 months after Whitehouse Station-based Merck submitted its application, said Merck spokeswoman Christine Fanelle. This week, FDA notified the company its new target date for a decision is May 25.
"They told us that they need some extra time to review some additional information that we provided," she said.
Fanelle would not discuss the additional information or when it was submitted.
Health care analyst Steve Brozak of WBB Securities LLC said he does not see the delay as a sign of problems and expects the vaccine to be approved.
"I think that this is probably emblematic of the fact that the FDA ... is bordering on being dysfunctional" due to staffing shortages and turnover, Brozak said.
Merck shares initially fell about 1.2 percent from Thursday's closing price, then recovered one third of that loss to $34.14, down 27 cents, by early afternoon.
The world's fifth-biggest drugmaker, Merck has been beset by problems since 2004, when it pulled blockbuster arthritis drug Vioxx off the market over increased risks of heart attack and stroke with long-term use. Merck faces thousands of Vioxx lawsuits, along with the expected loss of most of Zocor's $4.4 billion in annual revenues, other drugs losing patent protection in the next few years and no new blockbusters on the horizon.
Zostavax, a vaccine for adults who have had chickenpox - the same virus that causes shingles - could prove popular as each year there are nearly 1 million new U.S. cases of shingles. If reactivated, the virus causes itching, tingling or burning, usually followed by a rash and painful, fluid-filled blisters. Nearly one-quarter of people with shingles suffer pain, sometimes excruciating, for more than three months.
Merck research showed the vaccine reduced incidence of shingles by half and pain and discomfort by nearly two-thirds.
Merck also is seeking regulatory approval for Zostavax in the European Union, Australia and other major markets, the company said.
Earlier this month, FDA approved Merck's RotaTeq vaccine against a common, sometimes dangerous gastrointestinal virus in children. ProQuad, a combined vaccine against measles, mumps, rubella and chickenpox, was approved in September, and Merck is hoping for an FDA decision by June 8 on Gardasil, a vaccine against human papilloma virus, the main cause of cervical cancer.
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On the Net: http://www.merck.com
Source: Associated Press/AP Online
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