The Medicines Company (MDCO - Free Report) 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).
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 ViroPharma’s 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 Biogen Idec (BIIB - Free Report) and Protalix BioTherapeutics, Inc. (PLX - Free Report) look attractive. Both are Zacks Rank #1 (Strong Buy) stocks.