Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in Women Ages 27 through 45
WHITEHOUSE STATION, N.J., June 25, 2008 - Merck & Co., Inc. announced today that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45. The agency issued the letter to advise that it has completed its review of the submission and that there are issues that preclude approval of the supplement within the expected review timeframe. Merck has already discussed with FDA their questions related to this application and expects to respond to the Agency in July. Merck submitted the sBLA for use in this expanded population in January of this year and in March the FDA designated the submission a priority review. The letter does not affect current indications for GARDASIL in females aged 9 through 26.
"Merck is proud that GARDASIL continues to be the world's leading cervical cancer vaccine. We are committed to seeing GARDASIL used to help prevent cervical cancer and other HPV diseases in the currently indicated population," said Beverly J. Lybrand, senior vice president and general manager, Adolescent/Adult Vaccines, Merck Vaccines and Infectious Diseases. "We will continue to pursue this and other supplemental approvals to extend the use of this vaccine to others."
The FDA has also issued a complete response letter regarding the sBLA for the use of GARDASIL against non-vaccine types (cross protection). According to the FDA, the data submitted do not support extending the indication for GARDASIL to include non-vaccine HPV types.
Merck also reiterated its confidence in meeting the Company's goals of compound annual revenue growth of 4 percent to 6 percent from 2005 to 2010, including 50 percent of all joint-venture revenue and double-digit compound annual EPS growth from 2005 through 2010 excluding certain items.
In 2006, GARDASIL became the only approved vaccine to prevent cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18 in girls and women nine through 26 years of age. GARDASIL (sold in some countries as SILGARD®) has been approved in 103 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.
Additional 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.
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. GARDASIL is not recommended for use in pregnant women.
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, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed 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, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia 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 risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.