Dare Bioscience Announces Cooperative Research and Development...
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Dare Bioscience Announces Cooperative Research and Development Agreement for Pivotal Phase 3 Study of Ovaprene

Pharma Tech Outlook | Tuesday, July 27, 2021

 

The agreement will allow Daré to harness the contraceptive clinical trial expertise of NICHD while also sharing the expenses of Phase 3 pivotal study with NICHD.

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FREMONT, CA: Daré Bioscience, a leader in women's health innovation, recently announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive at present in clinical development for the prevention of pregnancy. The agreement will allow Daré to harness the contraceptive clinical trial expertise of NICHD while also sharing the expenses of Phase 3 pivotal study with NICHD. If the US Food and Drug Administration (FDA) approves Ovaprene, it might be the first monthly non-hormonal contraceptive option for women.

"We are thrilled to continue our work with NICHD to advance Ovaprene through this pivotal study," said Sabrina Martucci Johnson, President and CEO, Daré Bioscience, Inc. Grant funding previously provided by NICHD supported the conduct of our pre-pivotal clinical study of Ovaprene. With this CRADA, we have the opportunity to leverage NICHDs experience in the design and execution of contraceptive studies, as well as continued funding to support the development of Ovaprene. We look forward to collaborating with NICHD, along with our partner Bayer, to advance the development of additional non-hormonal contraceptive options for women."

The NICHD's Contraceptive Development Program will fund the crucial Phase 3 study (CDP). The Contraceptive Clinical Trial Network (CCTN), founded in 1996 to perform experimental contraceptives, is overseen by the CDP, and NICHD contractor Health Decisions Inc. will undertake the Phase 3 study within the CCTN. Daré will provide Ovaprene clinical supplies, organize discussions with the FDA, and compile and submit supporting regulatory documents. Daré and NICHD will each offer medical oversight for the trial and final data review and analysis and collaborate on the trial's final report.

Daré has also committed to contributing 5.5 million dollars to the entire expected cost of conducting the key Phase 3 trial, which will be paid in four installments under the CRADA. The first payment must be made within 30 days of the CRADA's effective date, and the last payment must be made by April 1, 2023. The NICHD will be responsible for all other expenditures associated with the pivotal study's conduct, as well as the reimbursement of charges to Health Decisions, the clinical locations, and other study participants.

In January 2020, Bayer and Daré signed an exclusive licensing agreement for Ovaprene commercial rights in the United States. Daré will have access to Bayers' vast clinical and market capabilities while maintaining control over the development and regulatory approval of Ovaprenes under the terms of the agreement. Following the completion of Daré and the NICHD's pivotal clinical trial, Bayer has the right to secure exclusive rights to market the product in the United States.

"This collaboration between Daré and NICHD marks an important milestone in Women's Healthcare Innovation. Women are at the center of everything we do and we are so pleased to continue to partner with Daré in support of our mission Were For Her to provide women with education and access to contraceptive options," said John Berrios, Bayer's Head of Women's Healthcare.

The exclusive license to commercialize Ovaprene in the United States will become effective if Bayer pays Daré 20 million dollars, which Daré wants to use to compensate its portion of the clinical research and manufacturing costs. Daré will also be eligible for commercial milestone payments of up to 310 million dollars and royalties on net sales in the double digits. Ovaprene will be evaluated as a contraceptive device and its safety and use in a multi-center, single-arm, non-comparative, pivotal Phase 3 contraceptive research. The business intends to file an IDE for Ovaprene in the fourth quarter of 2021 and begin the crucial study of Ovaprene in 2022, pending FDA assessment and approval of the IDE. Daré expects the pivotal trial will support Ovaprene marketing authorization in the United States and other countries if it is successful.

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