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Fitch sees dip in drug approvals

Thu., July 26, 2012

TRENTON, N.J. – Fewer new prescription drugs will be approved in the U.S. this year than the 30 approved in 2011, a ratings agency forecasts, adding to the many stresses on the pharmaceutical industry.

The Food and Drug Administration approved only 14 innovative drugs in the first half of this year, down from 18 in the first half of 2011, according to a report released Wednesday by Fitch Ratings.

Fitch wrote that there’s been a slowdown in experimental drugs entering late-stage patient testing, while research on promising drugs for depression, high cholesterol and menopause symptoms has recently been halted due to disappointing results. Since January, about 10 other drugs have run into problems delaying approval, with regulators requiring additional data or a new patient study or, in one case, halting a study because of a patient death.

“Branded pharmaceutical developers’ research success of 2011 will be difficult to repeat,” the report states.

The report comes as big brand-name drugmakers are being squeezed from all sides – and their second-quarter results are showing the effects.

Government and other health plans, particularly in debt-laden Europe, continue to push drugmakers to lower prices. The weak global economy has many consumers delaying treatments or looking for cheaper alternatives. And an unprecedented tidal wave of generic competition for many top-selling drugs is slashing the billions of dollars they had been bringing drugmakers.

Since last October, three of what had been the world’s 10 best-selling drugs have gotten generic competition. Those are the long-time best-seller Lipitor, Pfizer Inc.’s high cholesterol pill, psychiatric drug Zyprexa and blood thinner Plavix. Next week, another top 10 drug, Merck & Co.’s asthma and allergy pill Singulair, will get generic rivals.

Pharmaceutical companies are still very profitable, but that’s mainly because they’ve been on a tear for several years, slashing jobs and closing factories and research centers to cut their costs ahead of what the industry terms the “patent cliff.” Virtually every major drugmaker has recently had drugs with annual sales of $1 billion or more get generic competition.

On Wednesday, Bristol-Myers Squibb Co. and Eli Lilly and Co. reported second-quarter net income dropped by more than 20 percent because of generic competition to blockbuster drugs.

Tags: health

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