Merck anesthesia-reversal agent faces new delay

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Merck anesthesia-reversal agent faces new delay

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Merck veteran named research chief, after drug setbacks

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 will stay on as a company advisor until August.

The appointment represents a homecoming for Perlmutter, 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.

Perlmutter left Amgen in February 2012 and has served since then as a board member of several smaller biotech companies.

But Perlmutter helped Amgen branch out into new areas, including successful development of Prolia for osteoporosis and Sensipar, used to treat dangerously high calcium levels in the blood.

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 of research at Merck.

Merck has had several big successes under Kim's watch, including development of its blockbuster Januvia diabetes medicine 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, the world's biggest biotechnology company, 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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UPDATE 1-FDA OKs Merck OTC version of overactive bladder drug

Jan 25 (Reuters) - U.S. health regulators approved Merck & Co's nonprescription version of Oxytrol to treat overactive bladder in women ages 18 and older, the agency said on Friday.

The U.S. Food and Drug Administration said the over-the-counter version of Oxytrol would be available for women only and that the drug remained available to men by prescription.

Overactive bladder, which affects an estimated 33 million Americans, is a condition in which the bladder squeezes too often or without warning. Symptoms include leaking urine, feeling a sudden and urgent need to urinate, and frequent urination.

Oxytrol for Women is a patch that contains oxybutynin, a medicine that helps relax the bladder muscle, and is designed to be applied to the skin every four days, the FDA said.

Oxybutynin belongs to a class of drugs known as anticholinergics. Pfizer Inc's Detrol is the market leader in the class with annual sales of about $700 million.

Oxytrol will be the first drug in the class to be sold over the counter. Merck licensed exclusive rights to sell OTC Oxytrol from Actavis Inc, the generic drugmaker formerly known as Watson Pharmaceuticals.

Merck said it expected the OTC patch to be available in the fall.

The FDA decided to approve the OTC version of the Merck drug, based on the results of nine studies of women that demonstrated that consumers can understand the information on the label, properly determine whether the product is right for them, and use the drug appropriately, the agency said.

Last week, the FDA approved the popular wrinkle treatment Botox from Allergan Inc to treat overactive bladder in people who cannot tolerate drugs from the class to which Oxytrol belongs or are not helped by these medications.

Merck shares rose 3 cents to $43.03 on the New York Stock Exchange.

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Merck CEO: Significant Need for New Blockbuster Drugs

 Highlight transcript below to create clipTranscript:  Print  |  Email Go  Click text to jump within videoWed 23 Jan 13 | 05:30 AM ET Ken Frazier, CEO of Merck, tells CNBC about the challenges of finding new blockbuster drugs and how any change to Medicare funding must have a sustainable benefit.

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Merck resubmits cholesterol combo pill to FDA

TRENTON, N.J. -- Merck & Co. said Wednesday it has resubmitted its application for a new combination cholesterol drug to the Food and Drug Administration, which rejected the experimental medication in March.

The drugmaker is seeking approval for a pill that combines a generic version of Lipitor, the top-selling drug of all time, with Merck's cholesterol medicine Zetia. The company said in a statement that the FDA judged the drug application complete and ready for review. A decision is expected in the first half of 2013.

Merck's experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke.

Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver. Zetia, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats.

Merck shares rose 40 cents to close at $41.34 in trading Wednesday.

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Merck says cholesterol drug study failed

Dec 20 (Reuters) - Merck & Co Inc said on Thursday a major trial of its Tredaptive medicine to raise "good" HDL cholesterol showed it did not do a better job at preventing heart attacks, deaths or strokes than traditional statin drugs that lower "bad" LDL cholesterol.

Merck said it no longer plans to seek regulatory approval for the drug in the United States and is recommending that providers not start new patients on it.

The failed study had enrolled more than 25,000 patients over more than three years and is a significant setback for the drugmaker because Tredaptive was one of the most important and potentially lucrative of its experimental medicines.

Merck shares were down almost 3 percent at $42.35 compared to Wednesday's closing on the New York Stock Exchange.

(Reporting By Caroline Humer and Ransdell Pierson)

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