Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Health Decisions, Inc., a full-service contract research organization (CRO) specializing in women’s health clinical research and diagnostic development, today announced that the companies have signed a partnership agreement under which Health Decisions will exclusively provide CRO services within the United States to support the clinical development of Daré’s innovative pipeline of novel programs designed specifically to address persistent unmet needs in the areas of contraception, fertility, and broader gynecological disorders. Daré and Health Decisions have successfully worked together on prior Daré clinical studies, including the post-coital test clinical study of Ovaprene®. The partnership agreement provides for dedicated resources and new pricing structures, which, together with Health Decisions’ expertise, site network and relationships with key opinion leaders and investigators, are expected to accelerate clinical development of key programs in a capital-efficient manner.
“One of the clear goals of this strategic partnership is to leverage Health Decisions’ expertise in clinical development of women’s health products,” said Sabrina Martucci Johnson, President & CEO of Daré Bioscience. “Health Decisions is the Statistical and Clinical Coordinating Center for the Contraceptive Clinical Trials Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a unit of the National Institutes of Health (NIH), and in this capacity they have conducted more than 40 clinical trials in contraception, as well as a number of other therapeutic areas aligned with Daré’s broad and diverse portfolio of women’s health programs. We believe their deep domain expertise coupled with their clinical and technical acumen will enable us to accelerate clinical development activities across our portfolio. Further, we believe the pricing structure under the partnership agreement will result in cost savings in our clinical development expenditures.”
Under the terms of the agreement, Health Decisions will be Daré’s exclusive provider of CRO services within the United States for all of Dare’s reproductive health assets for an initial three-year period, provided that Health Decisions has the expertise, resources and availability to perform the clinical research services that Daré requires. This includes the assets that Daré has or may have in development for pregnancy and delivery, contraception, infertility, polycystic ovarian syndrome and endometriosis during that period. In exchange for CRO exclusivity, Health Decisions will provide a core team of personnel dedicated to supporting all of Daré’s development programs covered by the agreement, including Daré’s pivotal clinical study of Ovaprene®, a hormone-free, monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer, and the planned DARE-BV1 Phase 3 study in bacterial vaginosis, with topline data expected in 2020.
“It is an honor for Health Decisions to be selected as a partner by Daré,” said Dr. Patrick Phillips, Chief Executive Officer of Health Decisions. “Our like-minded commitment to women’s health has allowed us to foster an already highly productive relationship, and we look forward to supporting the acceleration of Daré’s unique pipeline with even greater efficiency moving forward.”