Great news came in
The Medicines Company
) way when the FDA approved the company's antibiotic Orbactiv.
Orbactiv was approved in the U.S. for the treatment of adults
suffering from acute bacterial skin and skin structure infections
(ABSSSIs) caused by susceptible designated gram-positive bacteria
including methicillin-resistant staphylococcus aureus (MRSA).
As per The Medicines Co., Orbactiv, expected to be launched in the
U.S. by the end of this year, is the first and only drug approved
in the U.S. for the treatment of ABSSSIs with a single and
Approval was gained on the basis of positive results from the SOLO
I and SOLO II studies. Results from these studies revealed that
Orbactiv demonstrated non-inferiority compared to 7-to-10 days of
Last year, the company had announced that it has gained Qualified
Infectious Disease Product (QIDP) designation for Orbactiv. The
QIDP designation enabled the NDA for Orbactiv to be reviewed on a
priority basis. Orbactiv enjoys an additional five years of
We note that Orbactiv is also under review in the EU for the
treatment of complicated skin and soft tissue infections. A final
decision from the European Commission on the approval of Orbactiv
is expected by the first half of 2015.
We are encouraged by the U.S. approval of Orbactiv. With the
company's lead product Angiomax facing several patent challenges
from companies like Hospira (
) and Mylan (
), Orbactiv's approval comes as a sigh of relief. We believe that
the company's share price will rise on Orbactiv's approval. We also
expect investor focus to remain on the ongoing patent challenges on
Angiomax and Orbactiv's launch process.
The Medicines Co. is a Zacks Rank #3 (Hold) stock. A better-ranked
stock in the healthcare sector is Actelion Ltd. (
), carrying a Zacks Rank #1 (Strong Buy).
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