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Watson Says FDA Rejects Progesterone Preterm Birth Gel for Ineffectiveness

Watson Pharmaceuticals Inc. (WPI), the second-biggest U.S. generic-drug maker, failed to win approval for its progesterone gel to prevent preterm birth.

The Food and Drug Administration asked for more information about the gel to prevent early births in women with short cervixes, the company said today. Watson failed last month to win the backing of an advisory panel that said studies didn’t adequately prove the gel was effective.

An FDA staff report released ahead of the panel determined the treatment from Parsippany, New Jersey-based Watson didn’t work in the U.S. population. The gel is sold in the U.S. as Crinone as part of an infertility treatment. Management had suggested peak sales in preterm birth prevention may reach as high as $275 million, Michael Tong, a senior analyst with Wells Fargo & Co. in New York, said in a note to clients Jan. 17.

The complete response letter from the FDA said the effect of the gel in reducing preterm birth “did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial,” according to the statement from Watson.

Watson developed the gel in partnership with Columbia Laboratories Inc. (CBRX) The Livingston, New Jersey-based company transferred full rights and regulatory responsibility on Feb. 10 to Watson, according to a statement from the companies. Mylan Inc., based in Canonsburg, Pennsylvania, is the biggest U.S. maker of generic drugs.

Columbia Labs fell 6.9 percent to 68 cents at 4 p.m. in New York. Watson fell less than one percent, or 23 cents, to $57.94.

Viable Path

Watson plans to work with the FDA and has requested a meeting with regulators to determine if a viable path to approval exists. The agency said additional clinical work would be required, according to the statement.

In a clinical trial, 16.8 percent of U.S. patients using 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 study, the third of three phases usually required for regulatory approval, involved 465 women, including six who dropped out, in 10 countries, Columbia Labs and Watson said.

Preterm birth affects 10 percent to 12 percent of pregnancies in the U.S., according to Columbia Labs. A baby born before 37 weeks is considered preterm. 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.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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