MONDAY, SEPTEMBER 26, 2016

Clinigen initiates early access program for pneumonia patients

Clinigen Group plc, a global pharmaceutical company, announced the initiation on Wednesday of an early access program to provide its antibacterial drug to European patients with hospital-acquired bacterial pneumonia.

The program, which is managed by Clinigen Global Access Programs, will provide VIBATIV, also known as telavancin, to patients with HAP known or suspected to be caused by Methicillin-resistant Staphylococcus aureus. The program will mark the first time VIBATIV is available to European physicians to treat eligible patients on an individual named patient basis.

Clinigen is working with the European Medicines Agency to remove a marketing authorization suspension and make VIBATIV available commercially in 2014.

"VIBATIV is a drug that can be used when other alternatives for HAP are not suitable," Shaun Chilton, the chief operating officer for Clinigen Group, said. "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."

Clinigen is using Clinigen GAP, its dedicated global access programs business, to provide early access to VIBATIV. Clinigen said the time between contracting pneumonia and receiving treatment is a critical factor to effective treatment. The company said it will use its comprehensive European logistics network to make sure patients in need receive the drug quickly.

''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," Mark Corbett, the senior vice president of Clinigen GAP, said.