UPDATE 1-Merck anesthesia-reversal agent faces new delay

March 15 (Reuters) - The U.S. Food and Drug Administration will not complete its review of Merck & Co's experimental medicine to reverse the effects of anesthesia until the second half of 2013, representing a three-month delay, the drugmaker.

Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous previous regulatory delays but is deemed by many analysts and doctors as one of the biggest advances in anesthesia in decades.

The FDA in 2008 said it could not approve sugammadex until Merck provided more clinical trial data related to allergic reactions and blood clots, possible side effects of the drug. Merck early this year said it had completed the necessary trials and that the FDA had accepted the company's resubmitted marketing application for the drug.

Merck spokeswoman Pam Eisele on Friday said the FDA, in notifying the drugmaker about the expected delay in making a decision on the drug, did not cite any new safety issues.

"We've maintained regular meetings and discussions with the FDA, with a commitment to making sugammadex available in the United States," she said.

The drug is already sold in 75 countries and had 2012 global sales of $261 million. That makes it a modest-sized product for Merck, the second-largest U.S. drugmaker.

Merck shares were down 0.6 percent in morning trading on the New York Stock Exchange.

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UPDATE 1-Merck veteran named R&D chief, after drug setbacks

(Adds analyst comment, details on Merck, Amgen drugs)

By Ransdell Pierson

March 7 (Reuters) - Merck & Co will bring back one of its veterans to head research and development, replacing retiring Peter Kim, who leaves behind a mixed record over the past decade at the drugmaker's highly respected laboratories.

Merck, after recent setbacks for some of its most important experimental drugs, said former Amgen Inc research chief Roger Perlmutter will take over from Kim on April 15, although Kim, 55, will stay on as a company advisor until August.

"This is an acknowledgement by Merck that the status quo wasn't getting desired results," said analyst Barbara Ryan of Barbara Ryan Advisors.

The appointment represents a homecoming for Perlmutter, 60, who joined Amgen in February 2001 after four years with Merck, where he oversaw global basic research and preclinical development. While at Amgen sales of its Epogen and Aranesp anemia drugs plunged due to safety concerns.

But Perlmutter helped Amgen, the world's biggest biotechnology company, branch out into new areas -- including successful development of Prolia for osteoporosis and Sensipar, used to treat dangerously high calcium levels in the blood. It is testing treatments for cancer, cholesterol, psoriasis and a promising new type of osteoporosis drug.

Most of the Amgen drugs are biologics, meaning they are injectable products made in living cells and involve a costly manufacturing process. But biotech drugs command far higher prices than conventional pills, making them an increasing focus for drugmakers.

"Merck may become more aggressive now in acquiring and developing more biotech drugs," with Perlmutter as research chief, Ryan predicted.

Perlmutter became Amgen's research chief only months after Kim, then a 42-year-old professor at the Massachusetts Institute of Technology, was selected to head research at Merck.

Merck has had several big successes under Kim's watch, including development of its blockbuster Januvia diabetes medicine, its Gardasil vaccine to prevent cervical cancer, its Zostavax shingles vaccine and its Isentress treatment for HIV. But more recently, it has been hurt by failed trials of cholesterol treatment Tredaptive and migraine drug telcagepant, and a regulatory delay for a new type of osteoporosis medicine called odanacatib.

Merck's Vioxx arthritis drug was recalled in 2004 after being linked to heart attacks and strokes, forcing Kim to defend controversial clinical trials of the pill that were conducted before his arrival.

New medicines are badly needed at Merck, where sales of its onetime $6 billion-a-year Singulair asthma drug are plunging due to generic competition and other medicines will soon face cheaper generics. Moreover, cost savings from Merck's 2009 purchase of rival Schering Plough have mostly dried up and are no longer able to boost company earnings.

"On balance, most investors we speak with have been disappointed by Peter Kim's tenure as head of Merck's R&D," Leerink Swann analyst Seamus Fernandez said in a research note on Thursday.

"We believe a transition makes sense at this time." Fernandez said he believed Perlmutter's 10-year tenure at Amgen were "constructive. Overall he strikes us as a thoughtful straight shooter and a decisive leader."

Merck praised Kim's tenure. "His contributions have positioned us well for future success."

Shares of Merck were down nearly 1 percent in afternoon trading on the New York Stock Exchange.

(Reporting By Ransdell Pierson; editing by Carol Bishopric)

((ransdell.pierson@thomsonreuters.com)(646 223 6030)(Reuters Messaging: ransdell.pierson.thomsonreuters.com@reuters.net))

Keywords: MERCK PERLMUTTER/

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RPT-UPDATE 1-Merck steers doctors away from HDL cholesterol drug

Jan 11 (Reuters) - U.S. drugmaker Merck & Co said it is taking steps to suspend availability of its drug Tredaptive after the medicine, used to raise "good" HDL cholesterol, failed to prevent heart problems in a large study.

The medicine is not approved in the United States but is sold in about 40 countries.

Merck said it is recommending that doctors stop prescribing Tredaptive, based on negative findings from the trial which were announced last month. The study followed more than 25,000 patients in Europe and China for almost four years.

The company said it will encourage doctors to consider alternative treatments to control their cholesterol, but advised patients not to discontinue Tredaptive without first speaking with their physicians.

Merck did not say, in its press release, when it plans to halt shipments of Tredaptive.

Tredaptive combines an extended-release form of niacin with another drug meant to reduce facial flushing, a side effect of niacin. The medicine has annual sales of less than $20 million. That makes it a tiny product for Merck, which has global annual revenue of about $50 billion.

Merck in December said Tredaptive did no better in the study at preventing heart attacks, deaths or strokes than traditional statin drugs that lower "bad" LDL cholesterol.

Moreover, Merck said the medicine significantly raised the incidence of some types of nonfatal but serious side effects in the study. They included blood, lymph and gastrointestinal problems, as well as respiratory and skin issues.

Tredaptive was approved in the European Union in 2008, but the U.S. Food and Drug Administration was unwilling to approve the pill until Merck conducted the costly long-term study to better assess its safety and effectiveness.

Some analysts had expected Tredaptive to capture annual global sales of more than $1 billion, if it were to win approval in the United States.

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