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Merck Filing MK-0518 with FDA in 2nd Quarter 2007
Merck seeks OK of HIV, cholesterol drugs
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BY ANGELA ZIMM
BLOOMBERG NEWS
Merck plans to file with the FDA for MK-0518 in 2Q, 2007. Due to fast track designation for this compound, the FDA is expected to act by end of year.
Merck & Co. the fourth-largest U.S. drugmaker by sales, plans to file for U.S. approval in 2007 of three new drugs to treat HIV, cholesterol and insomnia.
Merck also said today it is testing a cholesterol medicine similar to the experimental drug that Pfizer Inc. withdrew from development after it was linked in a study to a higher death rate. The company disclosed the drug in a statement before an investor meeting at its Whitehouse Station headquarters.
Chief Executive Officer Richard Clark has stepped up the number of drugs in development and sales of new medicines, including the Gardasil cervical cancer vaccine and Januvia diabetes pill. Merck started closing plants and cutting jobs a year ago to save $5 billion. The company forecasts that revenue will grow 4 to 6 percent a year through 2010.
Merck ''is beginning to execute on the efficiency and cost- savings efforts that could drive earnings growth," said Chris Shibutani, an analyst with JPMorgan Securities in New York, in an investment report yesterday. He rates the shares ''neutral."
After four years of declining profits, Merck introduced five new products this year, more than any of its rivals. The company said today that four new medicines will move into the third and final stage of human testing required for regulatory clearance.
In today's statement, Merck repeated its Dec. 6 forecast that 2007 profit, excluding restructuring costs, would be $2.51 to $2.59 a share. Merck also reiterated a 2006 forecast of $2.48 to $2.52.
Top Stock
Shares of Merck gained 15 cents to $44.25 at 9:09 a.m. New York time in trading before the opening of the New York Stock Exchange. The stock has gained 38 percent this year, making it the best performer in the 14-member Standard & Poor's 500 Pharmaceutical Index.
Merck needs new products to make up for revenue declines since the cholesterol pill Zocor, which generated $4.4 billion last year, lost patent protection in June. Merck predicts Zocor sales will sink to as low as $600 million in 2007. Merck's Fosamax osteoporosis drug, expected to generate at least $2.6 billion next year, loses its patent in 2008.
The company's experimental drug to raise HDL, or good, cholesterol is in early clinical trials, Merck said. The medicine, designed to inhibit the cholesterol ester transfer protein, would be similar to Pfizer's torcetrapib, which failed in a late-stage trial. Merck's product ''has shown promise," the company said today.
Cholesterol Drug
Merck plans to seek approval next year of a drug that combines a long-acting version of niacin, which boosts good cholesterol, with a compound to counteract a side effect that causes flushing. The company put off seeking approval of a pill that combines these two drugs with Zocor until 2008.
Merck is also developing an obesity medication similar to Sanofi-Aventis SA's Acomplia. The drug is from a class of medicines that target cannabinoid-1 receptors, which play a role in controlling appetite and body weight. Merck plans to seek U.S. approval of the obesity treatment in 2008, the company said.
Obesity and cholesterol are among the nine disease areas Merck is targeting for new products. Others include Alzheimer's, heart disease, diabetes, vaccines and pain and sleep disorders.
Merck has made acquisitions to add new technologies and drug-discovery tools. This year the company agreed to buy three companies for a combined $1.6 billion, acquiring methods for making antibodies, biotechnology tools and a gene technology. The largest transaction would be the proposed $1.1 billion purchase of Sirna Therapeutics Inc.
Licensing Deals
Merck has also been licensing early-stage experimental compounds, signing more than $1.5 billion in such agreements this year, including an accord with Idera Pharmaceuticals Inc. to add compounds to enhance vaccines.
The company also plans to implement new marketing strategies that reduce the number of sales calls to doctors' offices. The plan is expected to lower spending, Merck said.
An overhaul of Merck's marketing strategy began this year with the appointment of Peter Loescher, 48, former president and chief executive officer of General Electric Co.'s healthcare biosciences division, as president of Merck's Global Human Health unit. Reporting to Clark, Loescher oversees 35,000 employees and is responsible for the company's worldwide marketing and sales divisions.
In July, Merck also replaced departing U.S. drug-sales chief Bradley Sheares with Adam Schechter, general manager of the company's joint venture with Schering-Plough Corp. to sell the cholesterol pill Vytorin
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