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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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.

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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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FDA approves Aegerion cholesterol disorder drug

NEW YORK -- Federal regulators have approved Aegerion Pharmaceuticals' treatment for a rare inherited disease that causes extremely high levels of bad cholesterol, the company said Monday.

The company's shares have been hitting annual highs but declined in early trading after the Food and Drug Administration approval of Juxtapid, Aegerion's first drug, was announced.

The availability of the drug will be restricted because of the risk of liver damage in patients and the box will carry a "black box" warning, the FDA's most severe safety warning. Aegerion must certify all health care providers that prescribe it.

Juxtapid is a treatment for homozygous familial hypercholesterolemia in conjunction with other measures to reduce "bad" LDL cholesterol.

Aegerion believes there are about 3,000 people in the U.S. with the disease and treatments like blood filtration are generally not effective. The company said patients often die by the age of 30 because of heart attacks or strokes.

A year of treatment is expected to cost between $200,000 and $300,000 for patients with commercial health insurance. Aegerion plans to start selling Juxtapid in January.

Shares of Aegerion Pharmaceuticals Inc. , based in Cambridge, Mass., fell 46 cents to $25.25, and earlier it declined as much as 7 percent. The stock reached a new 52-week high of $25.74 Friday, and it is up about 80 percent since Oct. 11.

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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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