PARSIPPANY, NJ -- (Marketwire) -- 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.
About Oritavancin
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.
