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seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.
Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.
Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper. Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.
Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.
Until next time…
Good Luck and Good Job Hunting!!!!!!!!
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As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been battered in the past several months by the Singular flap, precipitous drops in Vytorin and Zetia sales and, most recently, FDA’s rejection of its follow-up Cordaptive anti-cholesterol drug. This has left the drug maker with little choice but to cut an additional 1,200 jobs from its rapidly shrinking US sales force. 