Clinigen to provide first access to anti-bacterial Vibativ in Europe

UK-based specialty pharma company Clinigen Group (AIM: CLIN) has announced the initiation of an early access program, managed by Clinigen Global Access Programs (Clinigen GAP), to provide the anti-bacterial Vibativ (telavancin) to patients in Europe with hospital-acquired bacterial pneumonia (HAP) known or suspected to be caused by MRSA.

In March 2013 Clinigen in-licensed Vibativ into its Specialty Pharmaceuticals business, Clinigen SP, from US company Theravance (Nasdaq: THRX) for commercialization in Europe. It was reintroduced in the USA in August 2013 after manufacturing problems had caused supply shortages. Although the product had been approved in Europe in 2011 by the European Commission, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug was not launched into the market and has never previously been available in Europe. With the technical transfer to a new contract manufacturer completed by Theravance, Clinigen is working closely with the European Medicines Agency (EMA) to remove the Marketing Authorization suspension and to make the product commercially available in 2014.

The early access program means that Vibativ will be available for the first time to physicians in Europe to treat eligible patients on an individual named patient basis.