Staffordshire pharmaceuticals group Clinigen makes anti-MRSA drug available to patients

BURTON-upon-Trent pharmaceuticals business Clinigen Group has made a new drug designed to counteract the effects of MRSA-related conditions available to patients through an access programme.

The group is supplying the anti-bacterial Vibativ to patients in Europe with hospital-acquired bacterial pneumonia (HAP) known or suspected to be caused by MRSA. The programme is being managed by Clinigen Global Access Programs (Clinigen GAP).

Clinigen said HAP was an area where there was considerable unmet need and the programme marked the first time Vibativ was being made available to physicians in Europe to treat eligible patients on an individual named patient basis.

In March 2013 Clinigen licensed Vibativ into its Specialty Pharmaceuticals business, Clinigen SP, from drugs firm Theravance for commercialisation in Europe.

It said that 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.

Following the technical transfer to a new contract manufacturer completed by Theravance, Clinigen said it was now working closely with the European Medicines Agency (EMA) to remove the marketing suspension on the drug and make it commercially available in 2014.

Clinigen SP has drawn on the group’s unique business model, enabling it to provide early access to Vibativ through Clinigen GAP. It said with the time between a patient contracting pneumonia and receiving Vibativ was critical and the group would be using its comprehensive European logistics network to ensure the drug reached patients as quickly as possible.

Clinigen GAP said it would continue to provide access to the drug on a named patient basis until Marketing Authorisation was restored across Europe.

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 Authorisation suspension for Vibativ, the group is able to respond to unmet medical need and provide access to this drug through our Clinigen GAP division.”