Dare Bioscience Inc (NASDAQ: DARE) arrived into a Cooperative Research and Development Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development for the essential Stage 3 study of Ovaprene®.
Ovaprene® is a trial hormone-free regular intravaginal contraceptive presently in scientific development for the deterrence of the prenatal period. The contract will permit Daré to influence the contraceptive scientific pilot know-how of NICHD while also partaking in the charges of Stage 3 essential study with NICHD.
If Ovaprene® is accepted by the U.S. Food and Drug Administration (FDA), it could be the primary once-a-month non-hormonal contraceptive selection for womenfolk. In addition, the essential Stage 3 study will be buttressed by the NICHD’s Contraceptive Development Program (CDP).
The CDP manages the Contraceptive Clinical Trial Network (CCTN), which was established in 1996 to conduct studies of investigational contraceptives. The Stage 3 study will be led within the CCTN with the NICHD supplier Health Decisions Inc.
Daré will be accountable for providing scientific provisions of Ovaprene® and organizing exchanges with and arranging and acquiescing practical supervisory credentials to the FDA. In addition, Daré and NICHD will provide remedial management for the pilot and concluding data appraisal and investigation. They will work together to formulate the final report of the pilot consequences.
Daré has also agreed to contribute $5.5 million towards the study
Under the CRADA, Daré has also approved to fund $5.5 million towards the total projected cost to conduct the essential Stage 3 study, which will be billed in four disbursements. The first disbursement is owed within 30 days of the actual date of the CRADA, and the concluding disbursement is due by April 1, 2023. NICHD will be accountable for the other charges connected to the conduct of the essential study and will cope with the payment of outgoings to Health Decisions, the scientific sites, and other organizations involved with the study.
Bayer and Daré arrived into a particular licensing contract for U.S. commercial rights to Ovaprene® in January 2020. Under the contract, Daré obtains admittance to Bayer’s wide-ranging scientific and market abilities while holding control over Ovaprene’s growth and supervisory endorsement procedure.