Healthcare Industry News: Papillomavirus
News Release - July 28, 2006
GARDASIL(R), Merck's Cervical Cancer Vaccine, Receives Positive Opinion from the European Medicines AgencyWHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--July 28, 2006--Merck & Co., Inc. announced today that GARDASIL® (quadrivalent human Papillomavirus types 6, 11, 16, 18, recombinant vaccine), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe. The CHMP opinion recommends that GARDASIL be approved for the immunization of children and adolescents aged 9 to 15 years and of adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasia (CIN 2/3), high-grade vulvar dysplastic lesions (VIN 2/3) and external genital warts caused by human Papillomavirus types 6, 11, 16 and 18. Following the CHMP review, the opinion for GARDASIL is transmitted to the European Commission (EC). If the EC approves the opinion, the EC then deliberates on the decision for approval. This decision will be applicable to the 25 countries that are members of the European Union (EU), of which the five largest are the United Kingdom, Germany, France, Italy and Spain.
GARDASIL will be marketed by Sanofi Pasteur MSD (SPMSD), a joint venture between Sanofi Pasteur and Merck & Co., Inc., Whitehouse Station, New Jersey, USA, in EU countries covered by the joint venture and several other European countries. In the remaining European countries, located in central and eastern Europe, GARDASIL will be marketed by Merck Sharp & Dohme as either GARDASIL or SILGARD®.
Worldwide Availability of GARDASIL
On June 8, the FDA approved GARDASIL to prevent cervical cancer and vaginal and vulvar pre-cancers caused by human Papillomavirus (HPV) types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18. GARDASIL is approved in the United States for 9- to 26-year-old girls and women. GARDASIL is approved for use in the U.S., Mexico, Australia, Canada and New Zealand. Additional applications for GARDASIL are currently under review with regulatory agencies in more than 50 countries around the world. Additionally, Merck is actively working to accelerate the availability of GARDASIL in the developing world: in December, Merck announced a partnership with India's Council of Medical Research to study GARDASIL. Merck is also working with PATH and the Gates Foundation to develop HPV vaccination programs that will facilitate the introduction of GARDASIL to the most impoverished nations. Merck will make our new vaccines, including GARDASIL, available at dramatically lower prices to developing world countries.
Selected important information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. As with any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types. The health-care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), and pruritis (3.1 percent vs. 2.8 percent).
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. 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.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and 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, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
GARDASIL® and SILGARD® are registered trademarks of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
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