Columbia Laboratories Inc. and Watson Pharmaceuticals failed to win the backing of advisers to U.S. regulators for the companies' progesterone gel to prevent preterm birth.
The advisers also voted Friday that the companies didn't adequately prove the gel prevents midtrimester births in women with short cervixes.
The Food and Drug Administration is scheduled to decide whether to approve the gel by Feb. 26 and isn't required to follow the panel's recommendations.
The FDA asked the panel to weigh the adequacy of the data after an agency staff report determined the gel didn't work. Watson and Columbia Labs sell the gel as Crinone in the U.S. as part of an infertility treatment.
Management had suggested that peak sales in preterm birth prevention could reach as high as $275 million, Michael Tong, a senior analyst with Wells Fargo, said Tuesday.
"There was basically no treatment effect in the U.S.," said Lisa Soule, FDA's clinical team leader in the reproductive and urologic drugs division. "That concerned us."
The advisers voted 13-4 that the risks of the gel outweighed the benefits and the drug shouldn't be approved. The group also voted 13-4 that the data the companies provided weren't adequate.
Panel members suggested the companies study the product further, particularly comparing different doses and concentrating on the U.S. population.
"Obviously, we're very disappointed," Frank Condella, chief executive of Columbia Labs, said after the meeting. He said the company would work with the FDA to gain approval for the drug.
KV Pharmaceutical Co.'s Makena was approved in February 2010 to reduce the risk of preterm birth in women with a history of the condition.
Bridgeton-based KV faced criticism for charging $1,500 per injection when it first brought Makena to market. The price was as much as 150 times the cost of compounds that pharmacies make outside of normal FDA rules. The company dropped the price to $690 a shot two months after its Feb. 3 approval.