The Medicines Company (MDCO - Analyst Report) recently received good news with the company announcing positive results on its phase III antibiotic candidate, oritavancin. Oritavancin was being evaluated in the phase III SOLO-1 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 both the primary as well as the secondary endpoints of the study that was conducted under the FDA’s special protocol assessment (SPA) process. The Medicines Company’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.
Meanwhile, the safety profile of The Medicines Company’s oritavancin was similar to that of Vancocin. While 60% of patients in the oritavancin arm experienced at least one adverse event, 63.8% of patients in the Vancocin arm experienced at least one adverse event. Treatment emergent adverse events were lower in the oritavancin arm (22.8% versus 31.4%).
With The Medicines Company reporting positive results from the SOLO-1 study, the company is now planning to complete enrolment for the SOLO-2 study in the first half of 2013. Results should be out shortly thereafter. Both studies will be used to support regulatory filings in the US and the EU.
We are encouraged by the positive data on oritavancin especially the safety data. Oritavancin became a part of The Medicines Company’s pipeline through its acquisition of Targanta Therapeutics in February 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.
With SOLO-1 meeting its target, we remain optimistic about positive results from the SOLO-2 study. Positive data from SOLO-2 would allow The Medicines Company to file for regulatory approval in the second half of 2013, followed by potential approval in mid-2014. We note that The Medicines Company’s oritavancin will enjoy an additional five years of marketing exclusivity under the Gaining Antibiotic Incentives Now (GAIN) Act.
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