By Ben Hirschler
LONDON |
Tue Dec 18, 2012 12:41pm EST
LONDON (Reuters) – The series of new medicines authorized or tentative capitulation is on a arise on both sides of a Atlantic, portrayal an enlivening design for a tellurian drugs attention as it emerges from a call of obvious expiries.
European regulators pronounced on Tuesday that they design an boost in new drug applications to about 54 in 2013. In a United States, a sum of 34 new drugs have been authorized for sale so distant in 2012 – a top turn in 8 years.
The zone badly needs a pick-up in capability as companies try to refill their medicine chests after a call of studious expiries that have appearance this year, depriving heading U.S. and European drug companies of some-more than $30 billion of revenue.
“It bodes well,” pronounced Standard Poor’s (SP) researcher Olaf Toelke, who predicts that clever pipelines will concede many vast drugmakers to emerge protection from a spike in sales losses.
“It shows that companies are addressing a need to find new drugs to reinstate those confronting obvious expiration. They have finished their task and it looks as if a attention will be during slightest fast in destiny and not tumble off a threatened obvious cliff.”
The U.S. Food and Drug Administration (FDA), gatekeeper to a world’s biggest pharmaceuticals market, still has usually over a week to supplement some-more approvals to this year’s sum – and there are signs that a series will boost further.
Three new products for leukemia, anthrax and Cushing’s illness from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were authorized final Friday alone, and a FDA is scheduled to palm down decisions on a serve 4 drugs before a finish of a month.
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A immature light for all these would take a 2012 sum of new molecular entities (NMEs) authorized by a agency’s Center for Drug Evaluation and Research to 38 – dual some-more than a 2004 sum of 36.
The European Medicines Agency embellished a opposite design of improving capability by announcing that a work module for a year forward enclosed a foresee for 54 new drug applications, adult from 52 in 2012, 48 in 2011 and 34 in 2010. These sum bar medicines designated for “orphan”, or rare, diseases.
Significantly, a London-based group is also awaiting a pointy dump in a series of applications from companies to sell general versions of drugs, to 20 in 2013 from 39 in 2012, given a slack in obvious expiries subsequent year.
Major U.S. drug companies will remove a sum of about $21 billion in income this year from remunerative medicines entrance off patent, while a strike for European businesses is about $10 billion, according to SP.
This year’s expiries have enclosed Sanofi and Bristol-Myers Squibb’s heart drug Plavix and AstraZeneca’s antipsychotic Seroquel.
Winning capitulation from regulators, however, is usually partial of a conflict for drugmakers.
Investors will also be examination closely to see how a new drugs perform commercially once they strech a market, given securing remuneration for innovative medicines is an increasingly tough quarrel – generally in austerity-hit Europe.
An research by Deloitte and Thomson Reuters this month found that while new drug approvals were increasing, this was equivalent by reduce approaching revenues from many particular products.
(Editing by David Goodman)
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