The Medicines Company
) continued to gain on the announcement regarding the receipt of
Qualified Infectious Disease Product (QIDP) designation for
Oritavancin, The Medicines Co.'s antibiotic candidate for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI), was granted QIDP designation by the FDA. Shares were up
3.4% since the news was announced.
The granting of QIDP designation means that the FDA will
review the new drug application (NDA) for the candidate on a
priority basis. Moreover, oritavancin will be eligible for the
FDA's "fast track" status and will enjoy an additional five years
of exclusivity once it is approved.
The Medicines Co. intends to seek FDA approval for oritavancin
by year end. The company will file for the use of oritavancin in
ABSSSI caused by susceptible gram-positive bacteria, including
methicillin-resistant Staphylococcus aureus (MRSA). The EU
marketing application will be filed in the first half of
The Medicines Co. had reported positive data on oritavancin
from two phase III studies - SOLO I and SOLO II. While The
Medicines Co. had announced results from the SOLO II study in Jul
2013, SOLO I results were released last year in December.
This September, data was presented from the phase III SOLO
program - results showed that a single 1200 mg dose of
oritavancin was non inferior to 7 to 10 days of
) Vancocin (vancomycin) twice-daily in treating ABSSSI caused by
gram-positive pathogens including MRSA.
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.
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.
The Medicines Co. is a Zacks Rank #3 (Hold) stock. At present,
AMAG Pharmaceuticals, Inc.
) look well-positioned with both being Zacks Rank #1 (Strong Buy)
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