Bayer gains US FDA approval for new combo oral contraceptive Natazia; enrolls Ph III regorafenib study in colorectal cancer

The US Food and Drug Administration yesterday approved Natazia, a novel combination hormonal tablet for use as an oral contraceptive from Bayer HealthCare Pharmaceuticals, a US subsidiary of Germany's Bayer group.

Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the USA. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.

Bayer said it expects to introduce the new drug in the USA this summer. 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 US judge invalidated a patent on its contraceptive Yasmin (drospirenone/ethinyl estradiol) in 2008, causing the drug major to enter into a supply and licensing deal with US generics firm Barr Laboratories in 2008. Yasmin and Yaz generated 2009 sales of $1.64 billion for Bayer, which expects up to $730 million in annual revenue for Qlaira in Europe.