Merck CEO says still confident on cholesterol drug
NEW YORK, May 1 (Reuters) - Merck & Co (MRK.N) Chief Executive Richard Clark on Thursday expressed confidence that the company's experimental new cholesterol treatment can still be approved for sale in the United States despite its rejection earlier this week.
The U.S. Food and Drug Administration issued a non-approvable letter for the medicine designed to raise levels of HDL, or good cholesterol. The drug, which was to be called Cordaptive, combines long-acting niacin with a novel agent to prevent the uncomfortable side effect of flushing common with niacin.
"We were extremely disappointed in the non-approvable letter but that does not mean Cordaptive will not be approved," Clark said at a Morgan Stanley global healthcare conference in Key Biscayne, Florida.
"We believe there is a pathway forward. We support the product and believe from a safety and efficacy standpoint that it is a good product," Clark said.
Analysts were widely predicting the FDA would approve Cordaptive, and the surprising rejection sent Merck's already battered shares down another 10.4 percent on Tuesday.
The fact that European regulators recommended approval of the drug in the European Union gives Merck confidence as it works to gain U.S. acceptance, Clark said.
He declined to discuss any details of the letter or disclose any of the FDA's concerns, but said a planned meeting with the agency will help determine the company's plans for the medicine.
"Based on the outcome of that meeting, we can better put in place what our capabilities are and the timing of when we can resubmit" an application seeking approval, Clark said.
Asked whether there was a chance Merck could reapply for approval this year, Clark said that was a possibility, but it remained "a function of what the FDA says to us and what they are requiring."
Many Wall Street analysts wiped out all their future sales estimates for Cordaptive and a planned follow-up that would add Merck's older cholesterol fighter Zocor to Cordaptive. Some had estimated the two drugs could eventually garner as much $2 billion a year in sales.
Clark said Merck is moving forward with its development of the follow-up drug.
"The product with simvastatin continues in phase 3," he said, using the generic name for Zocor. "We're still on target to submit in 2008." (Reporting by Bill Berkrot, editing by Gerald E. McCormick)
