09:59 Thursday 09 January 2014

Company gets green light for MRSA drug

Written byROB SMYTH

A BURTON-based pharmaceutical giant has revealed it has been given the green light for its MRSA beating drug to be used across Europe.

Clinigen, based in Centrum 100, revealed to the Mail that its global access programs arm has been given approval to provide the anti-bacterial VIBATIV to patients in Europe with hospital-acquired bacterial pneumonia (HAP).

Known or suspected to be caused by MRSA, HAP is a condition that is hard to tackle and this new drugs will allow physicians in Europe to treat people on an individual named patient basis.

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 need and could make a huge difference to critically ill patients.”

In March 2013, Clinigen licensed VIBATIV to be part of its speciality pharmaceuticals business from firm Theravance for commercial sale 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 to remove the marketing authorisation suspension and to make the product commercially available in 2014.

In a bid to get the product to patients who need it, bosses at the firm designed a ‘unique business model’ that allowed doctors to use it.

The news that the firm’s plans have now been approved will drastically reduce the time e between a patient contracting pneumonia and receiving VIBATIV.

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