Clinigen plans to launch Vibativ after lifting of EU marketing authorization suspension

UK specialty pharma company the Clinigen Group (AIM: CLIN) today announced that the European Commission (EC) has ratified the positive opinion in January 2014 from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for Vibativ (telavancin).

Clinigen anticipates the commercial launch will begin in the second quarter of 2014 and continue over the next 18 to 24 months as local pricing and reimbursement positions are agreed. In March 2013, Clinigen in-licensed telavancin into its specialty pharmaceuticals business, Clinigen SP, from US partner Theravance (Nasdaq: THRX) for commercialization in Europe.

Vibativ is a bactericidal, once-daily injectable antibacterial agent for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. In 2011 telavancin had been approved in Europe by the EMA. However, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug had not been launched into the market and therefore was never previously available in Europe. Following the technical transfer to a new contract manufacturer, Clinigen has worked closely with the relevant EMA authorities to lift the suspension.