The Medicines 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
Results showed that oritavancin met all primary as well as
secondary endpoints of the study that was conducted under the
FDA's special protocol assessment (SPA) process. The Medicines
Co.'s oritavancin was found to be non-inferior to
) Vancocin (vancomycin) where efficacy endpoints as required by
the FDA and the European Medicines Agency (EMA) were concerned.
Other pre-specified endpoints were also met.
We note that the company had presented positive results from
the SOLO I study in Dec 2012. 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, respectively. Combined
SOLO results showed that microbiologically confirmed MRSA
patients on oritavancin achieved the FDA-proposed endpoint of
≥20% reduction of lesion area at Early Clinical Evaluation (ECE)
more frequently than Vancocin-treated patients.
We are encouraged by the positive data on oritavancin.
Oritavancin became a part of The Medicines Co.'s pipeline through
its acquisition of Targanta Therapeutics in Feb 2009.
Oritavancin's single dosing regimen and safety profile could give
it an edge over currently available intravenous treatments which
require multiple-day dosing and are associated with
treatment-limiting adverse events.
We note that The Medicines Co.'s oritavancin will enjoy an
additional five years of marketing exclusivity under the Gaining
Antibiotic Incentives Now (GAIN) Act.
The Medicines Co. currently carries a Zacks Rank #3 (Hold). At
present, companies like
Protalix BioTherapeutics, Inc.
) look attractive. Both are Zacks Rank #1 (Strong Buy)
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