Bloomberg the Company & Products

Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Communications

Industry Products

Media Services

Follow Us

Columbia Labs Falls on U.S. Report Birth Gel Isn’t Effective

Don't Miss Out —
Follow us on:

Jan. 17 (Bloomberg) -- Columbia Laboratories Inc. fell the most in almost five years after U.S. regulators said the company’s progesterone gel to reduce the risk of preterm birth isn’t effective.

Columbia Labs dropped 54 percent to $1.10 at the close in New York, the biggest single-day decline since Feb. 5, 2007. Watson Pharmaceuticals Inc., a partner on the drug, fell 6.8 percent to $57.98, the greatest single-day loss in almost three years.

“The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks,” Food and Drug Administration staff wrote in a Dec. 22 report released today.

The product would compete with KV Pharmaceutical Co.’s gel Makena, approved in February 2010. KV rose 6.2 percent to $1.89.

The FDA staff based its determination on data from narrow groups in a global study, said Amy Raskopf, a spokeswoman for Livingston, New Jersey-based Columbia Labs.

“This is a global study,” she said in a telephone interview. “It was designed as a global study. FDA agreed.”

An FDA advisory panel is set to meet Jan. 20 on Columbia Lab’s gel and weigh the risks and benefits. The agency isn’t required to follow the panel recommendations.

Not Statistically Significant

Of U.S. patients, 16.8 percent using the gel experienced preterm birth at 33 weeks of pregnancy, the endpoint the company and the agency agreed on, compared with 19.2 percent using placebo, not a statistically significant difference, FDA staff said.

“It does not appear that the applicant has identified a population of U.S. women who are likely to benefit from the use of progesterone gel to reduce their risk of preterm birth,” FDA staff wrote.

Columbia Labs said its gel was associated with a statistically significant reduction in preterm birth compared with placebo of 8.9 percent versus 15.2 percent in 465 pregnant women from 10 countries, according to a document from the company.

Preterm birth affects 10 percent to 12 percent of all pregnancies in the U.S., with an economic impact of $26 billion annually, according to the company.

The safety of Columbia Lab’s gel was similar to 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.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.