The Medicines Company (MDCO) recently announced the presentation of data on its antibiotic candidate, oritavancin, at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Oritavancin is being evaluated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA).
Data was presented from the phase III SOLO program comprising the SOLO I and SOLO II studies. Results showed that a single 1200 mg dose of oritavancin was non inferior to 7 to 10 days of ViroPharma’s (VPHM) Vancocin (vancomycin) in treating ABSSSI caused by gram-positive pathogens including MRSA.
While The Medicines Co. had announced results from the SOLO II study in Jul 2013, SOLO I results were released last year in December. 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.
With the SOLO program reporting positive data, The Medicines Co. will file for U.S. and EU approval in the fourth quarter of 2013 and the first half of 2014, respectively. The Medicines Co. is also exploring the possibility of developing oritavancin for additional indications like clostridium difficile, prosthetic joint infections, anthrax and other gram-positive bacterial infections.
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. currently carries a Zacks Rank #3 (Hold). Currently, companies that look well-positioned include Actelion Ltd. (ALIOF) and Biogen Idec (BIIB). Both are Zacks Rank #1 (Strong Buy) stocks.
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