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Standard Review for Merck's V503

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Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

An update on the regulatory front was provided last week by Merck & Co. Inc. (MRK - Free Report) . The company said that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its investigational 9-valent human papillomavirus (HPV) vaccine, V503.
With standard review being granted, a response should be out in the second half of the year. We remind investors that last year, Merck had presented data on V503 from a pivotal phase III study in which the efficacy, immunogenicity and safety profile of the candidate was evaluated in comparison with Merck’s Gardasil, among 16-26 years old females.

Results showed that V503 prevented about 97% of cervical, vaginal and vulvar pre-cancers caused by five additional types of HPV (31, 33, 45, 52, 58), apart from the four original types (6, 11, 16, 18). Gardasil is approved for the prevention of certain diseases which are caused by these four types of HPV.

Merck is working on strengthening its pipeline and has several candidates in advanced stages of development. Some other candidates under FDA’s review include Grastek (Timothy grass pollen allergy) and MK-3641 (ragweed pollen allergy). A response should be out in the first half of 2014.

Merck holds a Zacks Rank #3 (Hold). Some better ranked stocks in the biopharmaceutical sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Biogen Idec Inc. (BIIB - Free Report) and Acceleron Pharma, Inc. (XLRN - Free Report) . While Alexion and Biogen carry a Zacks Rank #1 (Strong Buy), Acceleron holds a Zacks Rank #2 (Buy).

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