Bayer and Daré Bioscience Enter Strategic Collaboration to Develop Ovaprene®, the First Investigational Monthly, Hormone-Free Vaginal Contraceptive Ring

January 14, 2020 /Bio ValleyBIOON/ -- German pharmaceutical giantBayer(Bayer) recently announced that it has entered into a licensing agreement with Daré Bioscience, a clinical-stage biopharmaceutical company dedicated to advancing innovative products for women’s health. Under the agreement, once Daré Bioscience’s product Ovaprene® receives U.S.FDAApproved, Bayer will launch the product in the U.S. market. Following the announcement,Daré Bioscience, Inc. Stock Surges 83%.

Ovaprene is an investigational, non-hormonal, monthly vaginal contraceptive product currently in clinical development for the prevention of pregnancy. If approved, it would be the first monthly non-hormonal contraceptive product.

Ovaprene is a hormone-free vaginal ring that is placed in the vagina and releases a locally acting, non-hormonal agent to inhibit sperm motility. It also features a proprietary knitted polymer barrier that physically prevents sperm from entering the cervical canal. Ovaprene recently completed a successful postcoital test (PCT) clinical study, in which it nearly blocked all sperm from entering the cervical canal in all evaluated women and across all cycles, serving as a surrogate marker for contraceptive efficacy. The primary results of the PCT clinical study support the continued clinical development of Ovaprene, which has the potential to become the first hormone-free, monthly contraceptive option for women.

Dr. Marianne De Backer, Member of the Bayer Executive Committee and Head of Business Development and Licensing in the Pharmaceuticals Division, stated: “At Bayer, we are committed to enhancing our organic growth through strategic collaborations, options, and licensing agreements. As a recognized leader in women’s health, our collaboration with Daré Bioscience on Ovaprene represents an excellent strategic fit, aligning with our vision to continue providing women with diverse contraceptive options.”

Under the agreement, Daré Bioscience will receive an upfront payment and gain access to Bayer’s clinical and commercial capabilities, while retaining control over the development and regulatory approval process for Ovaprene. Bayer has the right to conduct keyClinical TrialUpon completion, exclusive rights to commercialize the product in the United States will be obtained. The license option becomes effective after Bayer pays Daré Bioscience $20 million. Daré Bioscience may be eligible for potential total commercial milestone payments of up to $310 million, as well as tiered royalties based on net sales reaching double digits.

Daré Bioscience, Inc. plans to apply for an Investigational Device Exemption (IDE) for Ovaprene in the first half of 2020, and with the U.S. Food and Drug Administration (FDA) Following the review and approval of the Investigational Device Exemption (IDE), a pivotal clinical study to evaluate the contraceptive efficacy and safety of Ovaprene was initiated in the second half of 2020. If successful, Daré Bioscience expects that this study will support regulatory approval for the marketing of Ovaprene in the United States, Europe, and other countries worldwide. (Bioon.com)

Original Source:Bayer and Daré Bioscience enter into exclusive license agreement for U.S. commercial rights to investigational hormone-free, monthly contraceptive Ovaprene®