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Merck to seek approval of osteoporosis drug, cites safety risks

By Ransdell Pierson

(Reuters) - Merck & Co said on Tuesday it plans to seek marketing approvals this year for an osteoporosis drug and a product to reverse the effects of anesthesia that have long been delayed by safety concerns.

The No. 2 U.S. drugmaker will seek approval in the second half of the year for odanacatib, its experimental treatment for osteoporosis in postmenopausal women, and will seek approval in 2014 for sugammadex, meant to reverse the effects of muscle relaxants after surgery.

Merck shares were down 2 percent at $57.50 in morning trading on the New York Stock Exchange.

The company is counting on odanacatib, sugammadex and other experimental drugs, including promising treatments for hepatitis C and cancer, to boost its earnings growth following generic competition for its Singulair asthma treatment and other brands.

But Merck research chief, Roger Perlmutter, in a company meeting with investors in Boston to review research projects, said a numerically higher incidence of stroke and atrial fibrillation - a type of irregular heartbeat most common in the elderly - was seen in patients taking odanacatib than those taking placebos in studies.

Perlmutter also said a type of skin thickening and itching called morphea was seen in 0.2 percent of patients taking odanacatib. He said 0.1 percent of patients had fractures in the shaft of the femur, or thigh bone, a greater incidence than seen in the placebo group.

ISI Group analyst Mark Schoenebaum said the half-day Merck research meeting had been relatively uneventful, except for news that Merck would seek approval this year for odanacatib.

"That's an upside surprise," he said in a research note. "But the news was tempered perhaps by their disclosure that there was a numerical imbalance in atrial fibrillation and stroke" and there were skin issues.

Analysts at Cowen and Co have predicted that odanacatib, if approved, could reap Merck annual sales of $1 billion by 2020.

Odanacatib works through a new mechanism of action, by blocking a protein called cathespin K, and would compete with widely used older drugs called bisphosphonates that include Merck's own Fosamax.

Bisphosphonates, leading treatments for osteoporosis, have raised concern because of rare cases of disintegration of jaw bone as well as femur fractures. Merck said the jaw condition had not been seen with odanacatib.

Merck last year said it was delaying its application for odanacatib because it needed additional data from a clinical trial.

As for sugammadex, the FDA declined to approve the injectable product in 2008, citing concerns about its possible association with allergic reactions and bleeding.

Sugammadex has already been approved in more than 50 countries, where it is sold under the brand name Bridion. It generated worldwide sales of $73 million in the first quarter. But analysts believe the medicine, if approved in the United States, could generate annual sales of $500 million or more.

Earlier on Tuesday, Merck said it would sell its consumer healthcare business for $14.2 billion to Germany's Bayer AG, adding to a string of major cross-border deals in the healthcare industry.

Merck's consumer brands include Dr Scholl foot care, Coppertone sunscreen and its Claritin allergy medicine. They were acquired from Merck's 2009 purchase of U.S. drugmaker Schering-Plough.

In addition, Bayer agreed to sell to Merck some rights to its Adempas drug against high blood pressure in the lung, and other experimental cardiovascular drugs, saying it needed a marketing partner.

As part of that alliance, Merck will pay up to $2.1 billion, including $1.1 billion in milestone payments contingent on development achievements.

Merck said it is selling off the consumer products to increase its focus on developing more-lucrative prescription drugs.

(Editing by Bernadette Baum)

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