Columbia Laboratories Inc. and Watson Pharmaceuticals Inc. failed to win the backing of advisers to U.S. regulators for the companies’ progesterone gel to prevent preterm birth. Shares of Columbia Labs fell as much as 67 percent in extended trading.
The advisers also voted at a meeting today in Silver Spring, Maryland, that the companies didn’t adequately prove the gel prevents mid-trimester 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 in the U.S. population. Watson, based in Parsippany, New Jersey, and Livingston, New Jersey-based Columbia Labs sell the gel as Crinone in the U.S. as part of an infertility treatment. Management had suggested peak sales in preterm birth prevention could reach as high as $275 million, Michael Tong, a senior analyst with Wells Fargo & Co. in New York, said Jan. 17.
“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 wasn’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 officer 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. Columbia Labs and Watson said their gel would prevent preterm birth in women with a short cervix.
Watson’s shares fell 3.5 percent to $58.14 at the close in New York. Columbia Labs fell to as low as 52 cents in extended trading. The company’s shares closed yesterday at $1.58 and trading was halted today during the advisory panel meeting. KV rose 9.3 percent to $2.11.
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. The FDA is investigating the safety of the so-called compounded versions made by pharmacies.
“We are acutely aware of the issues related to the pricing,” Kathleen Reape, vice president of medical affairs and women’s health clinical research at Watson, told the panel. “I can assure you that that approach will not be repeated.”
Of U.S. patients, 16.8 percent using Columbia Labs and Watson’s gel experienced preterm birth before 33 weeks of pregnancy compared with 19.2 percent using placebo, not a statistically significant difference, FDA staff said.
A global study found a statistically significant reduction in preterm birth compared with placebo of 8.9 percent versus 15.2 percent, according to a report from Columbia Labs. The company’s final-phase study involved 465 women, including six who dropped out, in 10 countries.
Preterm birth affects 10 percent to 12 percent of all pregnancies in the U.S., according to Columbia Labs. A baby born before 37 weeks is considered preterm, while Columbia Labs, in agreement with the FDA, sought to determine whether the gel worked before 33 weeks.
The safety of the gel was similar to a placebo, according to the FDA staff report. There were no maternal deaths in either the group using the gel or the placebo and the rates of fetal, neonatal and infant deaths were similar.