Bayer Wins U.S. Approval of New Type of Contraceptive

Bayer AG, Germany’s largest drugmaker, won U.S. clearance to sell a new type of contraceptive pill.

The Food and Drug Administration approved Natazia, which is the first in the U.S. to deliver doses of its two female hormones at four times during the drug’s 28-day treatment cycle, the agency said today in a statement.

Natazia, available in Europe since May 2009 under the name Qlaira, is part of Bayer’s effort to protect its share of the global birth-control market after a U.S. judge invalidated a patent on its Yasmin pill in 2008. Bayer is the world’s biggest seller of contraceptive pills and Yasmin and Yaz, a newer version of the drug, are its top-selling prescription medicines.

“Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives,” Scott Monroe, director of the FDA’s Division of Reproductive and Urologic Products, said in the statement. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”

Annual U.S. sales of the drug may peak at 500 million euros ($631 million), Phil Smits, head of the company’s women’s health unit, said in a February interview.

New Hormone

Natazia is the first oral contraceptive to use a synthetic estrogen called estradiol valerate in combination with a progestin called dienogest, Bayer said today in an e-mailed statement. Other birth control pills sold in the U.S. contain ethinyl estradiol, the company said.

“Every woman’s body reacts differently to hormones, so it is important that they have a choice in birth control options,” Anita Nelson, a professor of obstetrics and gynecology at the Harbor-UCLA Medical Center in Torrance, California, said in Bayer’s statement.

The drug also may offer a new treatment option for women who suffer from heavy or prolonged menstrual periods, Bayer said in October after presenting clinical trial data at the World Congress of the International Federation of Gynecology and Obstetrics. The tablet reduced menstrual bleeding in a study of 231 women who were given Qlaira or a placebo over 90 days.

The 2008 patent ruling prompted Bayer to sign an agreement letting Teva Pharmaceutical Industries Ltd.’s Barr unit sell Yasmin and Yaz under its own label. Yasmin and Yaz generated $1.7 billion in sales for Leverkusen, Germany-based Bayer last year. The U.S. Supreme Court declined to review the patent ruling on May 3.

--With assistance from Naomi Kresge in Zurich, Angela Cullen in Frankfurt and Greg Stohr in Washington. Editors: Andrew Pollack, Donna Alvarado

source: bloomberg