Teva's ZOELY oral contraceptive receives EU Marketing Authorization

Aug 2 2011

Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) announced today that its new oral contraceptive, ZOELY^™ (NOMAC/E2 -nomegestrol acetate 2.5 mg/17β-estradiol 1.5 mg), has received a Marketing Authorization in the European Union (EU) for the prevention of pregnancy. This clears the way to allow the product to be launched in Europe by the end of 2011.

Unlike currently available contraceptive pills, ZOELY^™ is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of 2 steroid hormones; 17-beta estradiol, an estrogen that is structurally identical to the major estrogen produced by the ovaries of healthy non-pregnant women, and nomegestrol acetate, a highly selective progesterone-derived progestin. This innovative combination will be made available in a convenient 24 day active and 4 day placebo dosing regimen.

"The EU Marketing Authorization for ZOELY^™ marks an important step in creating a strong women's healthcare franchise for Teva in Europe," said Dr Gerard van Odijk, President and CEO of Teva Europe. "The acquisition of Théramex in January this year gives us a platform to leverage our capability in women's healthcare, and the launch of ZOELY^™ is part of our developing business in this area."

Teva holds exclusive marketing rights for ZOELY^™ in France, Italy, Belgium and Spain and expects the first launch by the end of the year.