Bayer bulks up in women's health again with non-hormonal contraceptive deal – PMLiVE


Bayer’s partnering spree shows no sign of letting up, as it agrees a licensing deal with Daré Bioscience for a birth control product that doesn’t rely on hormonal drugs.

Daré’s experimental product – called Ovaprene – takes the form of an intravaginal ring that if approved by the FDA would be the first non-hormonal product to provide protection from pregnancy for a month.

It is designed to slowly release a local-acting agent that reduces sperm motility, coupled with a polymer ‘net’ that physically blocks sperm from entering the cervical canal. In a ‘post-coital’ clinical study it was shown to completely immobilise and block sperm, even though the women enrolled were using no other form of contraceptive.

Bayer is paying $20m upfront for US commercial opt-in rights to Ovaprene after the product completes a registration trial, with Daré also in line for commercial milestone payments of up to $310m, as well as double-digit tiered royalties on net sales.

Shares in San Diego, California-based Daré went into orbit after the deal was announced, ending the day yesterday up more than 100%.

Bayer says Daré plans to file for FDA approval of a pivotal trial of Ovaprene in the first half of 2020 in the hope of starting the study before the end of the year.

If approved, Ovaprene would be a first-in-category therapy for women seeking a hormone-free, self-administered and non-invasive birth control method, according to the biotech’s chief executive Sabrina Martucci Johnson.

“We believe Bayer is best positioned to maximise the market opportunity for Ovaprene,” she added.

The German drugmaker is already a major player in the women’s health market, selling a range of contraceptive products including oral and injectable hormonal products and implants, and is one the market leaders along with Johnson & Johnson’s Janssen division, Merck & Co and Allergan.

Bayer hasn’t had the happiest recent history in the contraceptive implant market however, as it was forced to withdraw its Essure permanent contraceptive implant after reports of injuries led the FDA to place restrictions on its use.

It’s facing product liability lawsuits involving former Essure users as a result, adding to suits filed by users of its Mirena long-term intrauterine contraceptive.

It remains firmly committed to women’s health however, and just last week added to its pipeline in this area by signing a five-year research alliance with Evotec focusing on polycystic ovary syndrome (PCOS), extending their current partnership for endometriosis.

The Evotec and Daré deals sandwiched two other agreements signed in the last few days, including a partnership with Azitra to develop skin microbiome-based treatments for eczema, and another with UK artificial intelligence company Exscientia focusing on drug discovery for cardiovascular and cancer therapies.



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