Regulatory decisions on pipeline candidates play an important
role for investors in the pharma/biotech sector in deciding
whether or not to invest in a particular company. The companies
in the above mentioned sector spend a significant amount in
advancing their pipelines with an ultimate goal of receiving
Last week, the European Medicines Agency (EMA) accepted the
Marketing Authorisation Application (MAA) for
Cubist Pharmaceuticals, Inc.
) antibiotic candidate, tedizolid phosphate. Cubist is looking to
get tedizolid phosphate approved for the treatment of complicated
skin and soft tissue infections (cSSTI).
The candidate, which came to be a part of Cubist Pharma's
pipeline following its acquisition of Trius Therapeutics in Sep
2013, is being developed for both intravenous and oral
administration. A final decision from the European Commission
(EC) on the approval of tedizolid phosphate is expected in the
first half of next year.
The MAA submission of tedizolid phosphate was on the basis of
encouraging data from two phase III studies on the candidate for
the indication. Cubist Pharma is also looking to get the
candidate approved in the U.S. and Canada. While the company has
already sought for U.S. approval, it intends to do the same in
Canada by Jun 30, 2014. The company is looking to get tedizolid
phosphate approved in the U.S. and Canada for the treatment of
acute bacterial skin and skin structure infections (ABSSSI).
In Dec 2013, the U.S. Food and Drug Administration (FDA) granted
a priority review status to tedizolid phosphate for the ABSSSI
indication. A final decision on the approval of the candidate in
the U.S. is expected by Jun 20, 2014.
We note that tedizolid phosphate gained eligibility for priority
review following its qualified infectious disease product (QIDP)
designation granted by the FDA for the ABSSSI indication last
year. The QIDP designation is a part of the Generating Antibiotic
Incentives Now (GAIN) Act, which falls under the 2012 FDA Safety
and Innovation Act (FDASIA). Tedizolid phosphate will also be
eligible for the FDA's "fast track" status and will enjoy an
additional five years of exclusivity once approved. Companies
Forest Laboratories, Inc.
) have also benefited from the signing of the GAIN act.
Cubist Pharma, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). Some better-ranked stocks in the biopharma space
Alexion Pharmaceuticals, Inc.
). Both Alexion and Alkermes carry a Zacks Rank #1 (Strong
ALKERMES INC (ALKS): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
CUBIST PHARM (CBST): Free Stock Analysis
FOREST LABS A (FRX): Free Stock Analysis
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