Merck Files Biologics License Application for PROQUAD® With U.S. Food and Drug Administration

Released on = November 4, 2004, 11:32 am

Press Release Author = Merck & Co., Inc.

Industry = Pharmaceuticals

Press Release Summary = Merck Files Biologics License Application for PROQUAD® With U.S. Food and Drug Administration

Press Release Body = WHITEHOUSE STATION, N.J., Nov. 4, 2004 - Merck & Co., Inc. today announced it has filed a Biologics License Application for PROQUAD® [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] with the U.S. Food and Drug Administration. PROQUAD is an investigational vaccine for simultaneous vaccination against measles, mumps, rubella and varicella in children 12 months to 12 years of age. PROQUAD combines two established Merck vaccines, M-M-R II® (Measles, Mumps, Rubella Virus Vaccine Live) and VARIVAX® [Varicella (Oka/Merck) Virus Vaccine Live].

Merck submitted the application for PROQUAD to the FDA on Aug. 31 and received notification of the FDA's acceptance of the application this week. Merck anticipates an FDA action on the application by early July, based on a standard 10 to12-month FDA review.

Important information about M-M-R II and VARIVAX
M-M-R II is indicated for simultaneous vaccination against measles, mumps and rubella in individuals 12 months of age or older. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of M-M-R II at 12 to 15 months of age and administration of the second dose of M-M-R II at four to six years of age. M-M-R II is contraindicated in individuals with a history of hypersensitivity to any component of the vaccine, including gelatin. M-M-R II is contraindicated in individuals with blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems. Due caution should be employed in administration of M-M-R II to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided. The following adverse reactions, which have been reported without regard to causality, include: fever, headache, dizziness, rash, injection-site reactions, anaphylaxis and anaphylactoid reactions, thrombocytopenia, arthritis and febrile convulsions. For a list of adverse reactions, please read the attached prescribing information. As for any vaccine, vaccination with M-M-R II may not result in protection in 100 percent of vaccinees.

VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older. VARIVAX is contraindicated in individuals with a history of hypersensitivity or an anaphylactoid reaction to any component of the vaccine, including gelatin or neomycin, or with any immunodeficient condition or receiving immunosuppressive therapy. The duration of protection from varicella infection after vaccination with VARIVAX is unknown. There are insufficient data to assess the rate of protection against the complications of varicella (e.g., encephalitis, hepatitis, pneumonia) in children. In children, adolescents and adults monitored for up to 42 days post vaccination, the adverse effects most frequently reported were as follows: fever, injection-site complaints; varicella-like rash (injection site) and varicella-like rash (generalized). For a list of adverse reactions, please read the attached prescribing information. Vaccination with VARIVAX may not result in protection of all healthy susceptible children, adolescents and adults.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

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, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which the company incorporates by reference.


PROQUAD® is the Merck registered trade name for Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live.
M-M-R II® is the Merck registered trade name for Measles, Mumps, Rubella Virus Vaccine Live.
VARIVAX® is the Merck registered trade name for Varicella (Oka/Merck) Virus Vaccine Live.

Web Site = http://www.merck.com

Contact Details = Merck & Co., Inc. (www.merck.com)