US regulators have agreed to review The Medicines Company’s application to market a new intravenous antibiotic called oritavancin.
The company is hoping to get the drug approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
In December 2013, the US Food and Drug Administration designated oritavancin as a Qualified Infectious Disease Product (QIDP), which means a priority review as well as an additional five years of exclusivity upon approval of the drug.
A decision is expected by August 6 this year and, if successful, doctors and patients will no doubt welcome another addition to the threatened antibiotics arsenal.
Meanwhile, The Medicines Co also reported a 16% rise in fourth-quarter revenues to $185.0 million, driven by an 11% rise in Angiomax/Angiox sales to $608.6 million.
However, net income plunged from $20.7 million to $1.2 million on the back of two transactions – the acquisition of Rempex Pharmaceuticals and a co-promotion partnership with Boston Scientific.
