Merck experiences heart failure

Major drug companies are declining more than the general market today, but none like Merck & Co. (MRK). Merck's shares dropped 2.5 percent on news it won't seek approval this year for its heart-failure drug rolofylline after preliminary results of a Phase III study failed to meet goals.

"Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. Merck had hoped rolofylline would provide "a useful new approach for these patients."

Merck got rolofylline through the NovaCardia acquisition in 2007. But despite early promise, the drug did not achieve its primary endpoint to improve symptoms of acute heart failure compared to placebo, nor its secondary endpoint to reduce the risk of death or re-hospitalization 60 days after treatment, and incidence of kidney problems.

Merck has been one of the worst performers, if not the worst, among Big Pharma the past year. Its stock lost 33 percent in the past 52-weeks, and for good reason too.

The pharmaceutical giant is trying to overcome a series of challenges highlighted so well in its latest quarterly report. Merck has seen sales declines for many of its top sellers as they have gone off patent and faced competition from generics, or had other issues associated with them. Most notably is the decline in sales of Singulair, a treatment for asthma and allergies, but not just. Sales of Zetia and Vytorin, jointly marketed with Schering-Plough Corp. (SGP), dropped 23 percent in the quarter, cervical cancer vaccine, Gardasil, sales declined 33 percent. Cozaar and Hyzaar, whose patents expire in 2010 and 2009 respectively, also saw sales declines.

So far, Merck hasn't been able to replace lost sales with new ones, not even with promises of new ones. Other than today's rolofylline disappointment, Merck recently delayed the filing of its acute migraine drug telcagepant for U.S. application. Merck has the Cordaptive for atherosclerosis application, but no big Merck drugs are expected to hit the market in 2009, and it seems now that even filings could be scarce. For a at least two years now more bad news than good came out the pharma company. If it was the Vioxx fiasco, disappointing Vytorin study or FDA rejection of Cordaptive among the many other issues that plauged the company.

At least, after Merck has hit so many setbacks in trying to bring new drugs to market, it has finally listened to the common view that it needs to acquire a company to help its ailing operations. The $41 billion acquisition of Schering-Plough would definitely expand its experimental research pipeline. It also seems to be trying to improve its collaborations with other big companies.

One piece of positive news: the World Health Organization recommended vaccines against rotavirus, the main cause of severe diarrhea in preschoolers. This may boost sales for Merck, oh, and for rival GlaxoSmithKline Plc. (GSK) as well.

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