16th Sep 2013 08:34
LONDON (Alliance News) - Specialist pharmaceuticals company Clinigen Group PLC said Monday that European marketing authorisation transfers had been completed for two drugs, Cardioxane and VIBATIV.
Clinigen recently acquired the rights to the drugs and in a statement describes the transfers as "significant progress" in the handover of the products. The transfers had progressed in line internally agreed timelines and both projects were continuing on schedule, the company said.
Clinigen acquired Cardioxane from Novartis, and in-licensed VIBATIV from Theravance, Inc., in March of this year. Cardioxane is an oncology support therapy, while VIBATIV is an anti-bacterial used for MRSA infections.
The company said that marketing authorisations for France, the UK, the Netherlands, and Poland had been transferred for Cardioxane, giving Clinigen the right to manufacture, register, distribute and commercialise the drug in those countries. Clinigen expects to transfer all marketing authorisations from Novartis, and to fully manage global supply, by the end of 2014.
The European Commission has also granted approval for the VIBATIV marketing authorisation transfers. However, the drug has been suspended for use in the EU since 2012 following a suspension of operations at the contract manufacturer. The firm Monday said that it was working closely with the European Medicines Agency to remove the marketing suspension and expects to have the product available in Europe in the first quarter of 2014.
Clinigen said that in countries where the drugs did not have marketing authorisation it would use its Global Access Programs business,Clinigen GAP, to supply the medicines on a named patient basis.
Shares in Clinigen were down 2.7%, or 10.84 pence, at 390.16p Monday morning.
By Philip Nye; [email protected]
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