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Pin to quick picksGlaxosmithkline Share News (GSK)

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Share Price: 1,733.50
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Number of new drugs picks up in Europe and U.S.

Tue, 18th Dec 2012 17:20

* EU agency sees more new drug applications in 2013 * U.S. new drug approvals running at eight-year high * Encouraging signals for industry as patent losses peak By Ben Hirschler LONDON, Dec 18 (Reuters) - The number of new medicinesapproved or pending approval is on the rise on both sides of theAtlantic, painting an encouraging picture for the global drugsindustry as it emerges from a wave of patent expiries. European regulators said on Tuesday that they expect anincrease in new drug applications to about 54 in 2013. In theUnited States, a total of 34 new drugs have been approved forsale so far in 2012 - the highest level in eight years. The sector badly needs a pick-up in productivity ascompanies try to refill their medicine chests after a wave ofpatient expiries that have peaked this year, depriving leadingU.S. and European drug companies of more than $30 billion ofrevenue. "It bodes well," said Standard & Poor's (S&P) analyst OlafToelke, who predicts that strong pipelines will allow most largedrugmakers to emerge unscathed from the spike in sales losses. "It shows that companies are addressing the need to find newdrugs to replace those facing patent expiration. They have donetheir homework and it looks as if the industry will be at leaststable in future and not fall off the threatened patent cliff." The U.S. Food and Drug Administration (FDA), gatekeeper tothe world's biggest pharmaceuticals market, still has just overa week to add more approvals to this year's tally - and thereare signs that the number will increase further. Three new products for leukaemia, anthrax and Cushing'sdisease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone,and the FDA is scheduled to hand down decisions on a furtherfour drugs before the end of the month. FEWER GENERICS A green light for all these would take the 2012 tally of newmolecular entities (NMEs) approved by the agency's Center forDrug Evaluation and Research to 38 - two more than the 2004total of 36. The European Medicines Agency painted a different picture ofimproving productivity by announcing that its work programme forthe year ahead included a forecast for 54 new drug applications,up from 52 in 2012, 48 in 2011 and 34 in 2010. These figuresexclude medicines designated for "orphan", or rare, diseases. Significantly, the London-based agency is also expecting asharp drop in the number of applications from companies to sellgeneric versions of drugs, to 20 in 2013 from 39 in 2012, giventhe slowdown in patent expiries next year. Major U.S. drug companies will lose a total of about $21billion in revenue this year from lucrative medicines coming offpatent, while the hit for European businesses is about $10billion, according to S&P. This year's expiries have included Sanofi andBristol-Myers Squibb's heart drug Plavix andAstraZeneca's antipsychotic Seroquel. Winning approval from regulators, however, is only part ofthe battle for drugmakers. Investors will also be watching closely to see how the newdrugs perform commercially once they reach the market, sincesecuring payment for innovative medicines is an increasinglytough fight - especially in austerity-hit Europe. An analysis by Deloitte and Thomson Reuters this month foundthat while new drug approvals were increasing, this was offsetby lower expected revenues from many individual products. (Editing by David Goodman)
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