The Medicines Company Withdraws European Marketing Application for 3-7 Day Daily Dose Oritavancin Therapy
PARSIPPANY, NJ -- 08/20/09 -- The Medicines Company (NASDAQ: MDCO) today 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 program. The Company also intends to confer with the European regulators to ascertain their support for the program design. As stated previously, the Company anticipates the start of the program in 4Q 2009, with an expected enrollment 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.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has two products in late stage development: cangrelor, an investigational antiplatelet agent and oritavancin, a semi-synthetic lipoglycopeptide antibiotic. The Company's pipeline also includes a serine protease inhibitor, CU2010, in early-stage development. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.