Source: Dow Jones
Merck Takes Another Shot At Promoting Shingles Vaccine
By Peter Loftus, Of DOW JONES NEWSWIRES
WEST POINT, Pa. -(Dow Jones)- Merck & Co. (MRK) officials are cautiously hopeful that the shingles vaccine Zostavax will finally live up to its market potential after several years of manufacturing problems that limited the shot's supply.
The Whitehouse Station, N.J., pharmaceutical company has restored supply of Zostavax to the point where it has filled customer back orders. Last week, Merck began running U.S. television commercials aimed at raising awareness of shingles, a sometimes-painful skin and nerve condition that's triggered by the same virus that causes chickenpox.
The ads don't mention Zostavax, but encourage older adults to ask their doctors about shingles. Zostavax, which is approved by the U.S. Food and Drug Administration for people 50 and older, is the only shingles vaccine on the market.
"Getting people protected against shingles is a big opportunity in the U.S.," Julie Louise Gerberding, president of Merck Vaccines, said in an interview this week at the company's vaccine operations in West Point, Pa., outside Philadelphia. "We owe it to our customers to get the vaccine out there."
Some analysts estimate Zostavax could generate annual sales of more than $1 billion for Merck within a few years. That could help offset the expected loss of revenue from its top product, the asthma treatment Singulair, which will soon lose patent protection and face generic competition. Merck recorded $332 million in Zostavax sales for 2011.
"Long term, this will be a much bigger opportunity for them, but it will take time," said ISI Group analyst Mark Schoenebaum.
Merck had high hopes for Zostavax when it started selling the shot in 2006, but it soon ran into a manufacturing snag when a batch of a key ingredient was less potent than required. Merck prioritized production of its chickenpox vaccine Varivax over Zostavax. Customers experienced shipping delays for Zostavax in 2008.
Merck thought it resolved the problems when it resumed normal Zostavax shipping times in 2009, but supply constraints returned. Patient access to the vaccine also has been an issue, and it can be cumbersome for doctors to store and administer. Sales have fallen short of initial analysts' expectations.
Gerberding said Merck made progress restoring a reliable supply last year and could have sold more Zostavax than it did. But the company didn't want to stoke higher demand until it felt more confident about a sustainable supply.
"We're confident enough in Zostavax to come out of back order and launch" the disease-awareness ads, Gerberding said.
In one TV spot, a retired firefighter describes his experience with shingles. "I have never encountered such a burning sensation until I had the shingles," he says. In a voice-over, a narrator says, "If you had chickenpox, the shingles virus is already inside you." The ad directs people to a Merck website, Shinglesinfo.com.
There's no guarantee Zostavax will prevent shingles in an individual, but it does reduce the risk. According to the FDA-approved Zostavax prescribing label, Zostavax reduced the rate of shingles by 51% versus a placebo in a clinical trial of people ages 60 and older, and by 70% in a separate study of people 50 to 59. The shot is associated with risk of hypersensitivity reactions and headaches.
The TV advertising campaign is airing nationally on broadcast and cable networks, said Merck spokeswoman Pam Eisele. Merck plans to run Zostavax branded ads in print and online publications later this year.
Merck has restored supply by expanding vaccine manufacturing at existing sites including West Point; by building new capacity, including a plant in Durham, N.C., and modernizing processes and equipment, said Sanat Chattopadhyay, senior vice president of biologics, vaccines and sterile manufacturing.
Merck is still keeping its foot on the brake in marketing Zostavax, however. The company's sales representatives aren't yet promoting the shot for people ages 50 to 59, Gerberding said, although the FDA last year approved expanding the vaccine's use to that age group.
A vaccine advisory committee to the U.S. Centers for Disease Control and Prevention last year declined to recommend routine vaccination with Zostavax for people 50 to 59, citing the production shortfalls. The committee said it would monitor supply and might update its recommendation.
The CDC's vaccine committee currently recommends people ages 60 and older receive Zostavax.
Zostavax has a catalog price of $159 to $167 per dose. Many Medicare Part D and private health plans help pay for the shot for adults 60 and over, though reimbursement levels vary. Merck offers rebates to qualifying recipients who have out-of-pocket costs.
Merck shares declined 27 cents to $37.99 in recent trading.
-Peter Loftus, Dow Jones Newswires; +1-215-982-5581; email@example.com