In a Jan. 13 research note, Dawson James Securities analyst Jason Kolbert reported that Daré Bioscience Inc. (DARE:NASDAQ) partnered with Bayer, the company behind the Marina intrauterine device, to advance Daré's Ovaprene, a hormone-free, intravaginal contraceptive ring. "Bayer's track record with this device makes it an ideal partner to commercialize Ovaprene," he added.
Kolbert explained the deal, which goes into effect when and if Bayer pays Daré $20 million for clinical expenses. Daré will get access to Bayer's clinical and market capabilities, including talent working with Daré on next steps. Daré will retain control of the clinical development and regulatory process of Ovaprene. The arrangement also includes milestone payments of up to $310 million and tiered, double-digit royalties on net sales.
As for what's next regarding Ovaprene, Kolbert pointed out, Daré will file an investigation device exemption, in H1/20 it said. Then in H2/20, assuming acceptance by the U.S. Food and Drug Administration, Daré will commence a pivotal contraceptive effectiveness and safety clinical study of Ovaprene, "the goal being to, based on this trial, pursue U.S., European and other key countries."
Kolbert indicated the progress of Daré's other candidates in the pipeline. DARE-BV1, being developed as a gel treatment for bacterial vaginosis, is expected to enter Phase 3 in the clinic this year. "With high cure rates (as high as 86%), the product appears superior to the standard of care treatments that average 50%," Kolbert highlighted.
Daré's Sildenafil cream for female sexual arousal disorder (FSAD) is slated to enter a Phase 2b study this year. Sildenafil "has shown efficacy to address a segment of the female population (10 million-plus sexually active women) that is currently living with the disorder," noted Kolbert. Today, no therapeutics are on the market for FSAD.
Finally, Kolbert outlined the order in which Dawson James expects commercialization of these there Daré products. DARE-BV1 will be first, in 2021 in the U.S., followed by Ovaprene in 2023 in the U.S. Next would be Sildenafil in 2024 in the U.S., Ovaprene in 2025 in the European Union (EU) and, finally, Sildenafil in 2026 in the EU.
Dawson James has a Buy rating and a $4 per share price target on Daré Bioscience, whose stock is currently trading at around $1.39 per share.
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Disclosures for Dawson James Securities, Dare Bioscience, January 13, 2020,
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