Watson's Morning-After Pill Wins U.S. FDA Approval
Watson Pharmaceuticals Inc. and HRA Pharma won U.S. approval for an emergency contraceptive that women can take up to five days after sex and will compete with Teva Pharmaceutical Industries Ltd.’s Plan B morning-after pill.
Watson will start selling the pill, to be called Ella, in the final three months of this year, the Corona, California- based company said today in a statement. The drug will be dispensed as a single dose and requires a prescription. Teva’s Plan B, which works for as much as 72 hours after unprotected sex, is available without a prescription for women ages 17 and older.
Closely held HRA, based in Paris, has been selling the drug in 22 European countries since October 2009. Anti-abortion groups urged the Food and Drug Administration to reject the drug for U.S. sale, saying it is chemically similar to the abortion pill RU-486. An FDA panel of outside advisers voted unanimously in June that the drug was safe and found no evidence it was capable of terminating an existing pregnancy.
The drug’s “unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy,” said Fred Wilkinson, Watson’s executive vice president for global brands, in the statement.
Studies showed the treatment lowered the pregnancy rate to 2.2 percent among women who took it 48 to 120 hours after unprotected sex. The expected pregnancy rate is 5.5 percent, Watson said.
Watson controls about 33 percent of the global oral- contraceptive market, which was valued at $4.5 billion to $5 billion last year, Frank Pinkerton, an analyst at SunTrust Robinson Humphrey Inc. in Atlanta, said Feb. 1 in a research note. The drug may add about 45 cents annually to Watson’s earnings per share if it reaches sales of $150 million, Louise Chen, an analyst with Collins Stewart LLC in New York, said in a June 17 research note.
The Family Research Council, a Washington-based advocacy group, denounced the decision, saying the FDA should have required further study before approving it.
“Approval of Ella raises concerns about taxpayer funding of abortions since currently the U.S. government will pay for emergency contraception, but not abortion pills,” Jeanne Monahan, director of the Council’s Center for Human Dignity, said today in a statement.
Ella, whose chemical name is ulipristal, reduced the rate of expected pregnancy by about 60 percent in clinical trials when taken two to five days after unprotected sex, FDA staff said in an evaluation released June 15.
Side effects among the 2,600 women who took part in studies included nausea, headache, abdominal pain and dizziness. Ella shouldn’t be used when a woman is pregnant or suspects she may be, Watson said in the statement. Women who become pregnant or complain of lower abdominal pain after taking the drug should be examined for the possibility that an egg has become fertilized and lodged outside the uterus, the company said.
Plan B and Ella work by stalling ovulation. Watson’s drug delays that process as much as five days, a key because sperm can live that long inside the body, Jeffrey Jensen, a professor at Oregon Health & Science University, said in a June 2 interview.
Watson will release information on Ella’s price and the company’s marketing plans when it begins selling the drug later this year, Watson spokesman Charlie Mayr said today in a telephone interview.
Watson shares rose 27 cents to $42 at 7:02 p.m. in extended trading on the New York Stock Exchange after gaining less than 1 percent to $41.73 at the 4 p.m. close of regular trading.