Clinigen Group sales and marketing update

Clinigen launched Vibativ telavancin in Europe to treat hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. Clinigen said the price of the drug is L645 ($1,054) in the U.K. and EUR774 ($995) in Germany and Austria per 750 mg vial pack. The recommended dose is 10 mg/kg once daily for seven to 21 days.

Earlier this year, the European Commission lifted a suspension on an MAA for Vibativ . The EC approved Vibativ in 2011, but the agency suspended the product's MAA in May 2012 before it was launched after EMA's CHMP issued final recommendations on a Good Manufacturing Practice Certificate to Ben Venue Laboratories Inc. -- the drug's only supplier -- preventing the manufacturer from supplying 12 drugs, including Vibativ. Clinigen has exclusive rights from Theravance Biopharma Inc. (NASDAQ:TBPH, South San Francisco, Calif.) to commercialize Vibativ in the EU and other undisclosed European countries (see BioCentury, Sept. 24, 2012; March 18, 2013 & March 24, 2014). ...