The Medicines Company announced the withdrawal of the European marketing authorization application (MAA) for the 200mg 3-7 day daily dose therapy of oritavancin, its investigational antibiotic drug candidate for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram positive pathogens.
The MAA was filed in Europe in June 2008, by Targanta Therapeutics Corp. (Targanta). The Medicines Company acquired Targanta in February 2009. During their review of the MAA this year, the European Medicines Agency (EMEA) expressed concerns similar to those raised by the Food & Drug Administration (FDA) in their complete response letter, issued December 2008, to Targanta's new drug application for oritavancin. Feedback from both agencies indicated that another trial would be required before approval could be considered. The Medicines Company has formally notified the EMEA of its decision to withdraw its MAA for the 200mg daily dose of oritavancin.
The Medicines Company is in dialogue with the FDA regarding plans for a global phase 3 programme. The company also intends to confer with the European regulators to ascertain their support for the programme design. As stated previously, the company anticipates the start of the programme in 4Q 2009, with an expected enrolment period of 1-2 years.
Oritavancin is an investigational, semi-synthetic lipoglycopeptide antibiotic with potent and rapid bactericidal (killing) activity against a broad spectrum of gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA). The Medicines Company is developing an IV formulation of oritavancin for the treatment of complicated skin and skin structure infections caused by gram-positive bacteria. Future indications for the IV formulation may include anthrax, bacteremia, and surgical prophylaxis. In addition, The Medicines Company is developing an oral formulation of oritavancin for the treatment of Clostridium difficile.
The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.