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Marketing authorisation suspension for VIBATIV® lifted



Clinigen Group plc (‘Clinigen’ or the ‘Group’) (AIM: CLIN) has announced that the European Commission (EC) has ratified the positive opinion in January 2014 from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for VIBATIV® (telavancin).
Clinigen 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 specialty pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialisation in Europe.
Telavancin is a bactericidal, once-daily injectable antibacterial agent for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable.(1)
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. Following the technical transfer to a new contract manufacturer, Clinigen has worked closely with the relevant EMA authorities to lift the suspension.
HAP caused by MRSA is an area of considerable unmet need; there is a limited choice of antibiotic therapies available to treat such serious Gram-positive infections and rates of clinical cure are considered to be low,(2) together with increasing rates of resistance being reported.
“The addition of this novel anti-bacterial to the arsenal of possible therapeutic options for HAP may provide a lifeline for those seriously ill patients who have not responded to previous treatments,” said Professor Robert Masterton of the Institute of Healthcare Associated Infection at the University of the West of Scotland and advisor to Clinigen. “Telavancin’s safety profile compares well with first line treatment vancomycin and it is highly potent against MRSA including the organisms with reduced susceptibility to vancomycin.”
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. 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.”
He added, “In the period before the commercial launch our global access program business, Clinigen GAP, will continue to manage a named patient program in Europe to provide access to telavancin for individual eligible patients via their healthcare professional.”
  1. Annex I: Summary of Product Characteristics – VIBATIV. Accessed:  14 Mar 2014
  2. Muscedere J. Which antibiotic for hospital acquired pneumonia caused by MRSA? BMJ 2014;348:g1469

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