Number of new drugs picks up in Europe and U.S.

LONDON (Reuters) - 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 U.S. 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.

"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 U.S. 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 leukemia, 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.

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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.

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Number of new drugs picks up in Europe and U.S.