REFILE-UPDATE 2-Merck anesthesia-reversal agent faces new delay

(Adds dropped word at end of first sentence)

* FDA needs more time to analyze data -Merck * Merck says no new safety concerns cited by FDA * Shares down 0.7 percent By Ransdell Pierson

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 said.

Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous regulatory delays but is deemed by many analysts and doctors to be 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.

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

Cowen and Co has projected global annual sales for the drug of $575 million by 2016, if it is approved in the United States.

It would be the first in a new class of medicines in the United States known as selective relaxant binding agents. It is designed to inactivate the effects of two widely used anesthesia drugs, rocuronium and vecuronium, and thereby help patients recover far more quickly from anesthesia.

Merck shares were down 0.7 percent at $43.97 on Friday morning on the New York Stock Exchange.

(Reporting by Ransdell Pierson in New York; editing by Gerald E. McCormick, John Wallace and Matthew Lewis)

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

Keywords: MERCK SUGAMMADEX/

View the original article here

REFILE-UPDATE 2-Merck anesthesia-reversal agent faces new delay

(Adds dropped word at end of first sentence)

* FDA needs more time to analyze data -Merck * Merck says no new safety concerns cited by FDA * Shares down 0.7 percent By Ransdell Pierson

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 said.

Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous regulatory delays but is deemed by many analysts and doctors to be 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.

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

Cowen and Co has projected global annual sales for the drug of $575 million by 2016, if it is approved in the United States.

It would be the first in a new class of medicines in the United States known as selective relaxant binding agents. It is designed to inactivate the effects of two widely used anesthesia drugs, rocuronium and vecuronium, and thereby help patients recover far more quickly from anesthesia.

Merck shares were down 0.7 percent at $43.97 on Friday morning on the New York Stock Exchange.

(Reporting by Ransdell Pierson in New York; editing by Gerald E. McCormick, John Wallace and Matthew Lewis)

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

Keywords: MERCK SUGAMMADEX/

View the original article here

UPDATE 2-Merck begins overseas recall of HDL cholesterol drug

* Merck says recalling drug from wholesalers

* Says retail supplies likely available until mid-March

* Says will discourage doctors from prescribing drug

Jan 11 (Reuters) - Merck & Co said it is recalling Tredaptive, its medicine to raise "good" HDL cholesterol levels, in overseas markets where it is sold, after it failed to prevent heart problems in a large study and raised safety concerns.

The medicine is not approved in the United States but the U.S. drugmaker sells it in about 40 countries.

Merck said it would recall stocks of Tredaptive now held by wholesalers, but that pharmacies can continue to dispense their remaining supplies. Even so, the company said it plans to discourage doctors from prescribing the pill 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 cholesterol, but advised patients not to discontinue Tredaptive without first speaking with their physicians.

Merck spokeswoman Pam Eisele said the company expects available retail supplies of Tredaptive to be exhausted by mid-March.

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.

View the original article here