Yesterday, The Medicines Company (MDCO) announced that it has withdrawn its European marketing authorization application (MAA) for the 200mg 3-7 day daily dose therapy of oritavancin.

The company is developing oritavancin, a novel, semi-synthetic lipoglycopeptide antibiotic candidate for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram positive pathogens. Currently available therapies include Cubist Pharma’s (CBST) Cubicin. Oritavancin became a part of The Medicine Company’s pipeline following the February 2009 acquisition of Targanta Therapeutics.

Oritavancin, if developed successfully, could be used in the hospital setting, most likely in the critical care setting in the intensive care unit (ICU), emergency department or surgical suite. It is primarily designed for patients with methicillin-resistant staphylococcus aureus (MRSA) or vancomycin resistant infections, which represents a large and underserved market.

The withdrawal of the European marketing application did not come as a major surprise, as the company has already failed to receive approval for the candidate in the U.S. In December 2008, the U.S. Food and Drug Administration (FDA) had issued a complete response letter (CRL) stating that the new drug application (NDA) did not demonstrate the safety and efficacy of oritavancin for the treatment of cSSSI.

The FDA requested another well-controlled clinical study to demonstrate both efficacy and safety before they would grant approval. The European Medicines Agency (EMEA) has also indicated that another trial will be required to gain approval.

The company is currently in discussions with the FDA regarding a global phase III program. The study is scheduled to commence later this year. We believe it will take at least a couple of years before the company will be in a position to re-submit the NDA on oritavancin. 

The past few months have been difficult for The Medicines Company, which specializes in acute care hospital cardiology products. The company faced a major setback in May 2009 following the discontinuation of a phase III study with its late-stage pipeline candidate, Cangrelor.

Given the recent pipeline and regulatory setbacks, management is under significant pressure to find new opportunities for growth beyond the Angiomax U.S. patent expiration in late 2010.
Read the full analyst report on “MDCO”
Read the full analyst report on “CBST”
Zacks Investment Research