Complete Response Letter for Gardasil in Women 27-45
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.--(BUSINESS WIRE)--Jan 9, 2009 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration has issued a second 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 has completed its review of the response that Merck provided in July 2008 and has recommended that Merck submit additional data when the 48 month study has been completed. The initial sBLA included data collected through an average of 24 months from enrollment into the study, which is when the number of pre-specified endpoints had been met. Following a review of the final results of the study, Merck anticipates providing a response to the agency in the fourth quarter of 2009. The letter does not affect current indications for Gardasil in females ages 9 through 26 nor does the letter relate to the sBLA that was submitted in December 2008 for the use of Gardasil in males.
"Merck is committed to continuing to pursue the use of Gardasil in this important group of women – many of whom remain at risk for HPV-related disease throughout their lifetimes," said Peter S. Kim, president, Merck Research Laboratories.
Gardasil is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Merck reconfirmed its 2009 total sales (as recorded by the Company) guidance of $23.7 to $24.2 billion. The Company also reconfirmed its full-year 2009 non-GAAP EPS range of $3.15 to $3.30, excluding certain items, and the 2009 GAAP EPS range of $2.95 to $3.17. The Company will update the other elements of its 2009 guidance on its February 3, 2009 earnings conference call.
Additional Important Information about Gardasil
Gardasil is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil.
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.
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, vaginal and vulvar cancers, cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).
Gardasil has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. Gardasil has not been shown to protect against diseases due to HPV types not contained in the vaccine.
Not all vulvar and vaginal cancers are caused by human papillomavirus (HPV), and Gardasil protects only against those vulvar and vaginal cancers caused by HPV types 16 and 18.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0 percent and greater than placebo were fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
In addition, syncope has been reported following vaccination with Gardasil, sometimes resulting in falling with injury. Observation for 15 minutes after administration is recommended.
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 deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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.
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.
Posted: January 2009