The US Food and Drug Administration (FDA) recently shot down Merck’s (MRK) efforts to expand Gardasil’s label for use in women belonging to the 27-45 years age group. The FDA refused to grant approval to Merck’s supplemental Biologics License Application (sBLA). Merck had already received two complete response letters from the FDA for the label expansion.
The agency, instead, updated the “Limitations of Use and Effectiveness” section of Gardasil’s label to include the statement that Gardasil has not been shown to prevent HPV-related CIN 2/3 or worse in women older than 26 years. Moreover, end of study data from the trial conducted in this age group was added to the prescribing information.
Gardasil is currently approved for use in girls and young women 9 – 26 years old for the prevention of cervical, vulvar, vaginal and anal 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.
The product is also approved for use in boys and men ages 9 – 26 years old for the prevention of anal cancer caused by HPV types 16 and 18, the prevention of anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and the prevention of genital warts caused by HPV types 6 and 11. Approval for the anal cancer indication came in Dec 2010.
Gardasil sales have been declining over the past few years. While Gardasil sales declined 12% to $ 988 million in 2010, 2009 sales fell 20% to $ 1.1 billion. Merck has been looking to stem the decline in Gardasil sales by expanding the label for additional indications.
The decline in 2010 sales was mainly due to declines in the US and Australia, which continue to be affected by the saturation of the 13 to 18 year-old female population. Moreover, Gardasil has been facing competition from GlaxoSmithKline’s (GSK) Cervarix.
Neutral on Merck
We currently have a Neutral recommendation on Merck supported by a Zacks #3 Rank (short-term Hold rating). Merck is currently facing issues such as patent expirations of key drugs, EU pricing pressure, US health care reform and pipeline setbacks. Some of the company’s recent launches should start contributing significantly to the top line in the forthcoming quarters.
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
Zacks Investment Research
Be the first to comment