- Daré may be entitled to up to $310 million in commercial milestone payments plus tiered royalties on net sales in the double-digits
- Daré is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health
WHIPPANY, N.J. & SAN DIEGO--(BUSINESS WIRE)-- Bayer, a leader in women’s health, and Daré Bioscience, Inc. (NASDAQ:DARE), a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s health, announced today that the companies have signed a license agreement under which Bayer may commercialize Daré’s investigational contraceptive product, Ovaprene® in the United States once approved by the FDA.
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Ovaprene is an investigational hormone-free monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy. If approved, it could be the first monthly non-hormonal contraceptive product.
"We believe Bayer is best positioned to maximize the market opportunity for Ovaprene, which has the potential to be a first-in-category product for women, as Bayer has with other first-in-category products,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This agreement provides Daré the opportunity to immediately benefit from Bayer’s expertise in development, regulatory, and commercialization, to unlock the program’s full value similar to other innovative contraceptive brands.”
Under the agreement, Daré will receive an upfront payment and access to Bayer’s extensive clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process. Bayer receives the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Daré. If Bayer, in its sole discretion, makes payment to Daré of $20 million, which Daré intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Daré will also be entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double digit tiered royalties on net sales.
“Both Daré and Bayer share an intense passion of developing products and medicines that enhance the lives of women,” said Dr. Sebastian Guth, Bayer’s President of Pharmaceuticals, Americas Region. “Low or no hormones in contraceptives is something many women prefer, and we are proud to collaborate with a partner who shares a similar commitment to bringing products to market that can make a meaningful impact for women, their families and communities.”
Daré plans to file an Investigational Device Exemption (IDE) for Ovaprene in the first half of 2020 and, pending the U.S. Food and Drug Administration’s review and clearance of the IDE, to initiate a pivotal contraceptive effectiveness and safety clinical study of Ovaprene in the second half of 2020. If successful, Daré expects that study to support marketing approvals of Ovaprene in the U.S., Europe and other countries worldwide.
The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.