DARE - Daré Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1 | Benzinga
SAN DIEGO, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced it will receive a payment of approximately $4.5 million as the latest installment under a grant agreement to advance the development of Daré's investigational contraceptive DARE-LARC1 through nonclinical proof of principle studies and other IND-enabling work to allow for the submission of an Investigational New Drug (IND) Application with the FDA, approval of which will be required to commence testing in humans. Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1. Daré received an initial $11.5 million payment in 2021 and aggregate payments of approximately $12.4 million in 2022 under the grant agreement. Additional payments are conditioned on the program meeting specified development and reporting milestones.
"The DARE-LARC1 product candidate is one of a number of novel contraceptive technologies being developed by Daré," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "In addition to advancing important pre-clinical activities to support the DARE-LARC1 program, we're also excited to continue the late-stage development of Ovaprene®, our investigational hormone-free monthly intravaginal contraceptive that is designed to be worn conveniently over multiple weeks, or one menstrual cycle. We are on track to begin patient enrollment in the fourth quarter of this year in the planned pivotal Phase 3 clinical trial of Ovaprene being conducted in collaboration with NICHD. According to market research, 90% of females in the U.S. ages 18-64 have used contraception at some point in their reproductive years and more than 75% have used more than one contraceptive method throughout their lifetime.1 We believe that DARE-LARC1 and Ovaprene have the potential to address important and unique needs not currently being addressed by commercially available options, and we also believe that each has the potential to become a new and unique birth control option, potentially leading to a meaningful expansion of the already recognized 18 contraceptive categories."
Ovaprene® is an investigational hormone-free monthly intravaginal contraceptive in late-stage clinical development. The planned Phase 3 clinical study of Ovaprene is a multi-center, single arm, non-comparative, pivotal contraceptive study to evaluate Ovaprene's effectiveness as a contraceptive device along with its safety and usability. If successful, Daré believes this study will be the single registrational study required to support a premarket approval application (PMA) submission for Ovaprene with the U.S. Food and Drug Administration (FDA). The pivotal Phase 3 study will be conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. In 2020, Daré entered into a license agreement with Bayer relating to the development and commercialization of Ovaprene in the United States, if approved by the FDA. Under the agreement, Daré received 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 received 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. Bayer, in its sole discretion, has the right to make the license effective by paying $20.0 million to Daré. Such license would be exclusive with regard to the commercialization of Ovaprene for human contraception in the U.S. and co-exclusive with Daré with regard to development. Daré will also be entitled to receive commercial milestone payments potentially totaling up to $310 million, in addition to double digit tiered royalties on net sales.
DARE-LARC1 is an investigational, pre-clinical stage contraceptive implant delivering levonorgestrel with a woman-centered design that has ...