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.
). 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,
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.
Biogen Idec Inc.
Acceleron Pharma, Inc.
). While Alexion and Biogen carry a Zacks Rank #1 (Strong Buy),
Acceleron holds a Zacks Rank #2 (Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
ACCELERON PHARM (XLRN): Free Stock Analysis
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