EU offers benefits of "orphan" disease status to Ebola drugs

Mon Oct 20, 2014 11:05am EDT
 
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LONDON Oct 20 (Reuters) - Europe's medicines regulator said on Monday it was ready to offer Ebola treatments and vaccines the benefits of "orphan" drug status -- including extended market exclusivity -- in a bid to encourage their development.

The European Medicines Agency (EMA) said orphan status could be granted for experimental drugs intended for life-threatening conditions affecting no more than five in 10,000 people in the European Union, as is the case for Ebola.

Securing the designation is financially attractive, since companies get free scientific advice, fee waivers and 10 years of market exclusivity once a new medicine is authorised.

"Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation," the London-based agency said in a statement.

Health authorities around the world are working on ways to accelerate development of drugs and vaccines in the face of the world's worst Ebola outbreak in West Africa. Several products are now in early-stage testing but none are yet proven to work.

Drug developers include biotech firms Tekmira Pharmaceuticals, Sarepta Therapeutics and Mapp BioPharmaceutical, while companies working on vaccines include GlaxoSmithKline, Johnson & Johnson and NewLink Genetics. (Reporting by Ben Hirschler; Editing by Mark Potter)