Bayer, already one of the biggest players in the $8 billion a year contraceptive drug market, is aiming to take on Johnson & Johnson ($JNJ) in Europe with a transparent birth control patch.
The German company said Thursday that it has already gone to regulators there with an application for a low-dose, transparent new patch that a clinical trial of 4,200 women showed was effective and has a good "safety profile." A spokeswoman told Reuters that the company is also in conversations with the FDA about a filing in the U.S.
The company obviously is feeling pretty good about its chances with regulators because last month Swiss drug delivery specialist Acino said it had opened a new $20 million plant at its Miesbach, Germany, site to make the new product.
As Reuters points out, Bayer mixes it up with Teva's Barr Pharmaceuticals, Ireland-based Warner Chilcott ($WCRX) and Johnson & Johnson in the hormonal birth-control pill market. In this case, it is aiming at the existing and potential market that J&J also targets with its Ortho Evra patch, which it sells in Europe and the U.S. FDA advisers have suggested that the agency tell J&J to better explain on the Evra label its risks for blood clots, Reuters says.
Bayer knows about blood clot concerns, itself. The company has been handing out hundreds of millions to settle litigation tied to its Yaz birth control line, which is linked to blood clots. In its earnings report in July, Bayer said it had set aside €500 million ($615.8 million) to cover its Yaz and Yasmin litigation and has settled almost 1,900 lawsuits for a total of $402 million-plus. That is on top of €200 million ($246.3 million) set aside in 2010 and 2011.
But Bayer must believe that the market is lucrative enough to warrant a new product. The company says its research shows that more women want a nondaily form of birth control, and according to Reuters, Bayer estimates that its new patch could produce annual sales of €250 million to €500 million ($325 million to $650 million).
- here's the Bayer announcement
- get more from Reuters