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FDA Pans Prochieve
Feb 28, 12 FDA warningsWatson Pharmaceuticals Inc. said Monday that the Food and Drug Administration has accepted its marketing application for a progesterone gel that is designed to reduce the risk of premature birth.Watson said it expects the FDA to make a decision on the gel, called Prochieve, by Feb. 26, 2012. Prochieve is a gel that is designed to be applied directly to the cervix during the second trimester of pregnancy, and it is intended for women who have an unusually short cervix, which puts them at higher risk for premature birth. The drug is already approved as a treatment for secondary amenorrhea, or the lack of a menstrual period.Prochieve was developed and marketed by Columbia Laboratories Inc., based in Livingston, N.J. Watson acquired the drug in July. It paid Watson $47.5 million upfront, and the acceptance of its marketing application triggers another $5 million payment to Columbia Labs. The deal could be worth as much as $92.5 million, and Columbia Labs would also get royalties on sales if the application is approved.Columbia Labs had asked the FDA to conduct a six-month priority review of Prochieve, but Watson said it withdrew that application.Watson shares fell 18 cents to $65.48 in late morning trading, while shares of Columbia Labs fell 8 cents, or 2.5 percent, to $3.15.
Progesterone, a naturally occurring hormone, which can also be applied as a vaginal gel, reduces the rate of preterm birth in women that have a short cervix, which is a risk factor in these types of incidences. Progesterone, in essence, can prolong pregnancy.
The study found that infants born to women who had received progesterone were less likely to develop respiratory distress syndrome, a breathing complication occurring in preterm infants.
Roberto Romero, M.D., program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch explains:
“Our study demonstrates that progesterone gel reduces the rate of early preterm delivery, less than 33 weeks, in women with a short cervix. Women with a short cervix can be identified through routine ultrasound screening. Once identified, they could be offered treatment with progesterone.”
U.S. health regulators have rejected a vaginal gel from Watson Pharmaceuticals and Columbia Laboratories aimed at reducing the risk of premature birth, the companies said on Monday.
The Food and Drug Administration told the companies that the data was not strong enough to support approval of the Prochieve drug and that they needed to do additional clinical studies, Watson and Columbia said.
“We have formally requested an end-of-review meeting with FDA to determine if a viable path forward can be established for this application,” Watson Chief Executive Officer Paul Bisaro said in a statement.
The decision was not a major surprise after an advisory panel to the FDA recommended in January that the agency reject the drug, already used in some other countries, because there was not enough data to show it worked.
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Federal drug reviewers announced that Columbia Laboratories hormone-based gel appears to be ineffective for preventing premature birth.
The Food and Drug Administration said in an online review that Columbia Labs’ drug failed to show a significant reduction in preterm birth among U.S. women tested in the company’s trial. The company has submitted the progesterone-based gel, called Prochieve, as a treatment to reduce instances of non-full-term births by women with abnormally short cervixes. The company estimates the problem affects 10% to 12% of all pregnancies in the U.S.
The FDA will ask a panel of outside experts to vote on the effectiveness and safety of the drug. The FDA is not required to follow the group’s advice, though it often does. The FDA will make its final decision on the drug later this year.
Columbia is co-developing Prochieve with generic and specialty drugmaker Watson Pharmaceuticals Inc.
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