Biologics License Application Submitted for the Zoster Vaccine
May 3, 2005 - 9:42:00 AM
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Merck submitted the application for ZOSTAVAX on April 25. Within the next 60 days, the FDA will determine whether it will accept for review Merck's application as submitted.
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By Merck & Co. Inc.,
[RxPG] Merck & Co., Inc. announced today that it has submitted to the U.S. Food and Drug Administration (FDA) a Biologics License Application for ZOSTAVAX(TM) (zoster vaccine live (Oka/Merck)), an investigational vaccine for the prevention of herpes zoster, commonly known as "shingles;" prevention of postherpetic neuralgia (PHN), the persistent, long-term nerve pain that is the most common complication of shingles; and the reduction of acute and chronic shingles-associated pain in adults.
Merck submitted the application for ZOSTAVAX on April 25. Within the next 60 days, the FDA will determine whether it will accept for review Merck's application as submitted.
About Shingles and Postherpetic Neuralgia
Shingles occurs when the varicella-zoster virus that causes chickenpox reactivates after lying dormant in the body, typically after several decades. Shingles may first appear as tingling, itching or pain on one side of the body or face. It then progresses to a blistering rash accompanied by pain in almost every case that varies in intensity and duration. Shingles also can lead to complications, including persistent, often debilitating nerve pain (PHN) that can follow an episode of shingles. Approximately 25 to 50 percent of shingles patients older than 50 years of age develop chronic pain after shingles (PHN).
Shingles can affect anyone who has had chickenpox -- more than 90 percent of adults in the United States -- and occurs most frequently in people over 50 years of age. In fact, up to half of all people living to age 85 will develop shingles during their lifetime. It is estimated that up to 800,000 people in the United States suffer from shingles each year, and the incidence is expected to increase as the population ages.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:
www.merck.com 
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About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
ZOSTAVAX(TM) is the Merck registered trade name for (zoster vaccine live (Oka/Merck)).
Contacts
Merck & Co., Inc.
Media:
Christine Fanelle, 215-652-3203
Janet Skidmore, 908-423-3046
or
Investor:
Graeme Bell, 908-423-5185
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