FDA approves vaccine for shingles for seniors
The vaccine is not a cure or treatment for shingles.
KNIGHT RIDDER NEWSPAPERS
PHILADELPHIA -- With a potential market of millions of aging Baby Boomers, Merck & amp; Co. Inc. won federal approval Friday to market the first shingles vaccine to people 60 and older.
Shingles is the recurrence of the chickenpox virus in adults, mostly elderly, and causes roughly 1 million new cases a year of blistering rashes and pain that can persist for weeks or years.
The Food and Drug Administration approved the vaccine, which will be marketed under the brand name Zostavax, on Friday.
Zostavax, to be manufactured at Merck's suburban Philadelphia complex, is an injected adult version of Merck's chickenpox vaccine and has been shown to prevent roughly half the outbreaks. Among people who get shingles despite being vaccinated, it can reduce its severity, Merck said in a statement.
Zostavax is not a treatment or a cure. It works by boosting the immune system's ability to suppress the virus in nerve roots but does not eliminate it, Merck said. Its most frequent side effect is soreness at the injection site.
For Merck, which is struggling to recover from the recall of its blockbuster pain pill Vioxx, the approval was a needed boost. The company, based in Whitehouse Station, N.J., is staking its rebirth partly on vaccines such as Zostavax and Gardasil, its cervical cancer vaccine awaiting FDA approval. Shares of Merck closed Friday at $34.56, up 17 cents.
Zostavax's potential market is large. Merck said more than 90 percent of adults carry the chickenpox virus, or roughly 41 million Americans in the over-60 group approved for treatment, according to census figures.
Barbara Ryan, a pharmaceutical analyst at Deutsche Bank Equity Research, in a note to investors called Zostavax "a meaningful revenue contributor" to Merck with potential worldwide revenues of $650 million by 2009.
Merck said it will price a single dose initially at between $145 and $155. Addressing the possibility that some elderly people may have trouble paying that price, Merck also Friday announced a new charity program to provide its vaccines free to low-income uninsured people. The company already operates other patient assistance programs to provide free medications to uninsured people.
It said the program will begin providing Zostavax in the third quarter this year. The program also will provide other Merck vaccines to uninsured people, it said.
Effect on another company
Another Philadelphia-area company has a big interest in Merck's vaccine. Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., produces a prescription pain patch for shingles, Lidoderm, sales of which may be reduced over time if there are fewer people with shingles.