Please login to the form below

Not currently logged in
Email:
Password:

Bayer bulks up in women’s health again with non-hormonal contraceptive deal

If approved candidate would become a first-in-category therapy

Bayer logo

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.

Article by
Phil Taylor

14th January 2020

From: Sales

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Six Degrees Medical Consulting

For over a decade, our medical communication services have helped pharmaceutical companies optimize their brand, disease and corporate objectives. Building...

Latest intelligence

WHITE PAPER: Why do men die younger?
It’s a commonly accepted fact that women outlive men. Wherever you live, there’s a good chance that men will die on average eight years earlier than women. Is this an...
3 tips to show patient diversity in your clinical trial materials
Here are some useful tips to help get your hands on authentically diverse stock photos....
01 PME-APR21 Cover.jpg
Virtual congresses: video thrilled the cardio tsar
Chris Ross explores the key learnings from a year of virtual congresses...

Infographics