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European orphan drug applications up 30 per cent

But lower than expected generics applications see EMA reduce new marketing authorisation forecast

The first six months of this year saw a significant rise in the number of drugs being put forward for orphan status in Europe.

The European Medicines Agency (EMA) said applications for orphan designations were 30 per cent above those seen in the first half of 2011

The regulator began 2012 by recommending 16 new medicines to go through its orphan drug process, including what could become the approved first treatment for Prader-Willi syndrome.

Europe's orphan drug measures were introduced in 1999 to spur development of new treatments for rare diseases by incentivising pharma to investigate diseases it might otherwise neglect.

The EMA, which maintains an online database of orphan drug designations issued its 1,000th designation in June this year, while in August a Thomson Reuters report found rare diseases, such as cystic fibrosis, are economically viable for pharma.

The EMA's annual mid-year report also focused on new marketing authorisation figures, which it said were “largely in line with 2011 figures”.

But a lower than expected number of generic drug submissions prompted the regulator to lower its forecast, reducing it from 112 to 101 submissions for the full year.

The European regulator also noted increases in the number of requests for scientific advice and protocol assistance for new medicines, up by 14 per cent and 24 per cent respectively.

The rises confirm “the growing importance for pharmaceutical companies to seek early advice from the Agency on their medicines development programmes,” according to the EMA.

15th October 2012

From: Research, Sales, Regulatory

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