The Medicines Company
) recently announced the acceptance of its new drug application
(NDA) for its antiplatelet candidate, Cangrelor, by the US Food
and Drug Administration (FDA). The Medicines Co. is looking to
get Cangrelor approved for use in patients undergoing
percutaneous coronary intervention (PCI) and in patients
requiring bridging from oral antiplatelet therapy to surgery.
The NDA was based on data from several studies including four
randomized, double-blind studies (CHAMPION PHOENIX, CHAMPION
PLATFORM, CHAMPION PCI, and BRIDGE).
With the FDA accepting the NDA for review, a response should
be out in the second quarter of 2014. Meanwhile, the company
intends to file for EU approval later this year.
We are pleased with The Medicines Co.'s progress with its
pipeline. The company recently presented positive results on its
phase III antibiotic candidate, oritavancin. Oritavancin was
being evaluated in the phase III SOLO-II study for the treatment
of acute bacterial skin and skin structure infections (ABSSSI)
caused by susceptible gram-positive bacteria, including
methicillin-resistant staphylococcus aureus (MRSA).
Earlier, in Dec 2012, the company had presented positive data
on oritavancin from another phase III study, SOLO- I. With the
SOLO program reporting positive data, The Medicines Co. will file
for US and EU approval in the fourth quarter of 2013 and in 2014,
The Medicines Co. currently carries a Zacks Rank #3 (Hold). At
present, companies like
Protalix BioTherapeutics, Inc.
) look well positioned. All three are Zacks Rank #1 (Strong Buy)
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