Clinigen gains approval to re-launch Telavancin pneumonia drug

18th Mar 2014 09:24

Clinigen Group said Tuesday that the European Commission (EC) had agreed to lift the Europe-wide suspension of marketing authorisation for Vibativ, its Telavancin treatment used to treat hospital-acquired pneumonia. The group said it consequently anticipates the commercial launch will begin in the second quarter of 2014 and continue over the next 18 to 24 months as local pricing and reimbursement positions are agreed.In March 2013, Clinigen in-licensed telavancin into its speciality pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialisation in Europe.Tuesday's decision comes after the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) in January announced it believed the ban, which was imposed in 2012, should be removed. In 2011 telavancin had been approved in Europe by the EMA. However, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug had not been launched into the market and therefore was never previously available in Europe. Shaun Chilton, Chief Operating Officer, Clinigen Group said: "The lifting of the suspension is an important step in the phased commercial launch of telavancin throughout Europe. We are working closely with the contract manufacturer to produce stock to prepare for the launch and beyond."He added: "In the period before the commercial launch our global access programme business, Clinigen GAP, will continue to manage a named patient programme in Europe to provide access to telavancin for individual eligible patients via their healthcare professional."NR