18th Mar 2014 10:47
LONDON (Alliance News) - Clinigen Group PLC said Tuesday that the European Commission has lifted the Europe-wide marketing suspension on its anti-bacterial treatment, Vibativ.
Clinigen said that the EC's decision follows positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in January this year to lift the stop.
The firm said the commercial launch will now go ahead as planned, expected to begin in the second quarter of 2014 and continue over the next 18 to 24 months as local pricing and reimbursement positions are agreed.
Vibativ is designed for the treatment of adults with hospital-acquired pneumonia including ventilator-associated pneumonia known or suspected to be caused by superbug MRSA.
In January this year the firm said it was seeking to lift the European suspension, and so signed a deal with a new contract manufacturer in readiness for the commercial launch.
"The lifting of the suspension is an important step in the phased commercial launch of telavancin throughout Europe. The decision by the EMA follows many hours of work and demonstrates the dedication and expertise of our Specialty Pharmaceuticals team. We are working closely with the contract manufacturer to produce stock to prepare for the launch and beyond," said Shaun Chilton, Chief Operating Officer.
Shares in the company were trading marginally higher Tuesday morning, up 0.09% at 530.50 pence per share.
By Alice Attwood; [email protected]; @AliceAtAlliance
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