Bayer has entered into a licence agreement with Daré Bioscience to commercialise investigational contraceptive product called Ovaprene in the US.
Ovaprene is Daré’s investigational hormone-free monthly vaginal contraceptive, which is under clinical development to prevent pregnancy.
Under the exclusive licence agreement, Bayer will commercialise Ovaprene after it is approved by the US Food and Drug Administration (FDA).
As per terms of the deal, Daré will secure an upfront payment, as well as gets access to Bayer’s clinical and market capabilities. Daré will also have control over the development and regulatory approval process of Ovaprene.
Bayer will be provided with exclusive rights to commercialise Ovaprene in the US upon completion of the clinical trial being carried out by Daré.
The licencing option will come into force after Daré receiving a payment of $20m from Bayer.
Daré is also provided with an option to secure commercial milestone payments of up to $310m, in addition to double-digit tiered royalties on net sales.
Daré intends to file an investigational device exemption (IDE) for Ovaprene in the first half of this year with the US drug regulator.
Based on the FDA’s review and clearance, the company plans to begin pivotal contraceptive effectiveness and safety clinical study of Ovaprene in the second half of this year.
The positive data from the trial is believed to support marketing approvals of Ovaprene in the US, Europe and other countries across the world.
Bayer pharmaceuticals division business development and licencing head and executive committee member Dr Marianne De Backer said: “At Bayer we are committed to augmenting our organic growth through strategic collaborations, option and licensing agreements.
“As a recognized leader in Women’s Health, the collaboration with Daré Bioscience on Ovaprene represents an excellent strategic fit with our vision to continue to offer differentiated contraceptive choices to women.”