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19 December 2012

Number of new drug approvals on the rise

The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry.

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The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries.

European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 - the highest level in eight years.

The sector badly needs a pick-up in productivity as companies try to refill their medicine chests after a wave of patient expiries that have peaked this year, depriving leading US and European drug companies of more than $30 billion of revenue.

"It bodes well," said Standard & Poor's (S&P) analyst Olaf Toelke, who predicts that strong pipelines will allow most large drugmakers to emerge unscathed from the spike in sales losses.

Stable industry

"It shows that companies are addressing the need to find new drugs to replace those facing patent expiration. They have done their homework and it looks as if the industry will be at least stable in future and not fall off the threatened patent cliff."

The US Food and Drug Administration (FDA), gatekeeper to the world's biggest pharmaceuticals market, still has just over a week to add more approvals to this year's tally - and there are signs that the number will increase further.

Three new products for leukaemia, anthrax and Cushing's disease from Ariad Pharmaceuticals, GlaxoSmithKline and Novartis were approved last Friday alone, and the FDA is scheduled to hand down decisions on a further four drugs before the end of the month.

Fewer generics

A green light for all these would take the 2012 tally of new molecular entities (NMEs) approved by the agency's Center for Drug Evaluation and Research to 38 - two more than the 2004 total of 36.

The European Medicines Agency painted a different picture of improving productivity by announcing that its work program for the year ahead included a forecast for 54 new drug applications, up from 52 in 2012, 48 in 2011 and 34 in 2010. These figures exclude medicines designated for "orphan", or rare, diseases.

Significantly, the London-based agency is also expecting a sharp drop in the number of applications from companies to sell generic versions of drugs, to 20 in 2013 from 39 in 2012, given the slowdown in patent expiries next year.

Major US drug companies will lose a total of about $21 billion in revenue this year from lucrative medicines coming off patent, while the hit for European businesses is about $10 billion, according to S&P.

This year's expiries have included Sanofi and Bristol-Myers Squibb's heart drug Plavix and AstraZeneca's antipsychotic Seroquel. Winning approval from regulators, however, is only part of the battle for drugmakers.

Investors will also be watching closely to see how the new drugs perform commercially once they reach the market, since securing payment for innovative medicines is an increasingly tough fight - especially in austerity-hit Europe.

(Ben Hirschler, Reuters Health, December 2012)

Read more: 

Global drug industry tightens anti-corruption code 

New leukaemia drug shows promise

 
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