The Medicines Company (MDCO) recently announced that the US Food and Drug Administration (FDA) has approved the design and planned analysis of the company’s phase III program for oritavancin.

The Medicines Company is looking to conduct phase III studies with oritavancin in patients with acute bacterial skin and skin structure infection (ABSSSI). The studies will be conducted under the FDA’s Special Protocol Assessment (SPA) program.

Phase III Program

The Medicines Company expects to conduct two multi-center, randomized, double-blind studies, SOLO-1 and SOLO-2, which will compare the efficacy and safety of single-dose oritavancin with multiple doses of vancomycin in the treatment of ABSSI.

The primary efficacy endpoint is a combination of resolution of fever and the cessation of the spread of visible infection without any antibiotics having been used 48-72 hours after treatment commences. Secondary endpoints include clinical cure.

About 1,000 patients will be enrolled for each study in which oritavancin will have to demonstrate non-inferiority to vancomycin.

Positive results from these studies would allow The Medicines Company to go ahead with the regulatory filing for the candidate. The company said that it has met with the European Medicines Agency (EMA) which has agreed with major components of the program.

Our Take

Oritavancin became a part of The Medicines Company’s portfolio following its acquisition of Targanta Therapeutics in Feb 2009. We are pleased to see that The Medicines Company is moving ahead with the development of the candidate. We note that oritavancin, a novel, semi-synthetic lipoglycopeptide antibiotic candidate, failed to gain FDA approval in December 2008. Moreover, the company withdrew its marketing application from the EU in 2009.

Oritavancin, if approved, could see initial use in the hospital setting, most likely in the critical care setting in the intensive care unit (ICU), emergency department, or surgical suite.

The candidate could be used in patients with methicillin (MRSA) or vancomycin resistant infections. This is a large and underserved market; with over 100k patients affected annually carrying a 10% – 20% mortality rate.

 
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