Clinigen Group plc (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. HAP is an area of considerable unmet need; for the first time VIBATIV® will be available to physicians in Europe to treat eligible patients on an individual named patient basis.
In March 2013 Clinigen in-licensed VIBATIV® into its Specialty Pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialisation in Europe. 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 therefore 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.
Clinigen SP has drawn on the Group’s unique business model, enabling it to provide early access to VIBATIV® utilizing its dedicated Global Access Programs business, Clinigen GAP. With the time between a patient contracting pneumonia and receiving VIBATIV® a critical factor, Clinigen will use its comprehensive European logistics network to ensure that the drug reaches patients swiftly, providing 24/7 access to the drug for individual named patients.
Shaun Chilton, Chief Operating Officer, Clinigen Group said, “VIBATIV® is a drug that can be used when other alternatives for HAP are not suitable. Our ability to provide access to VIBATIV® on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients. While we are working with the EMA to lift the Marketing Authorization suspension for VIBATIV®, the Group is able to respond to unmet medical need and provide access to this drug through our Clinigen GAP division.”
Mark Corbett, Senior Vice President, Clinigen GAP added: ”We are pleased to be able to implement an access program for the newest of Clinigen’s portfolio products, as we already do for Foscavir® and Cardioxane® in markets where they are not commercially available, in addition to the 30+ other programs we are already managing for other leading pharmaceutical and biotech companies.”