Shares of The Medicines Company (MDCO) continued to gain on the announcement regarding the receipt of Qualified Infectious Disease Product (:QIDP) designation for oritavancin.
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 2014.
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 ViroPharma’s (VPHM) 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, companies like AMAG Pharmaceuticals, Inc. (AMAG) and Actelion Ltd. (ALIOF) look well-positioned with both being Zacks Rank #1 (Strong Buy) stocks.