Daré Bioscience, Inc. (NASDAQ: DARE) is making the most of its partnership agreements.
On June 30, the women’s health innovation company announced that the exclusive license for its XACIATO medication for bacterial vaginosis with global women’s healthcare company Organon became fully effective. Under the agreement, Organon has global rights to the product and Daré will receive a $10 million upfront payment and is eligible to receive potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales.
XACIATO is expected to be available commercially in the U.S. in Q4 2022.
“Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S.,” said Sabrina Martucci Johnson, president and CEO of Daré.
“The Daré team identified bacterial vaginosis as an area in need of new treatment options,” the CEO added. “We are thrilled to be collaborating with Organon, one of the premier companies in women’s health, as we believe Organon’s commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition.”
Martucci Johnson said Daré chose to partner with Organon on XACIATO because the product “aligned” well with what the company is best at doing.
“Organon is working on building a premier company in women’s health with robust commercial capabilities,” she said, adding that Organon can expand treatment opportunities in communities that are underserved. “Any organization that has a footprint with those healthcare providers that are seeing those women, that’s really a great fit.”
XACIATO is Daré’s first product to be approved by FDA and go to market. Martucci Johnson said partnerships with companies like Organon are important in helping biotech companies with the “heavy lift” of commercialization of approved medications, especially in getting “novel” women’s health products in front of healthcare providers.
Organon CEO Kevin Ali also described the agreement as aligning well with its own long-term growth strategy “focused on delivering new options for women where therapeutic gaps exist. Organon will bring its commercial expertise to this collaboration so that we can deliver this option to women, specifically in a condition like bacterial vaginosis where more treatment choices are needed.”
More Partnerships in Pipeline
In addition to the XACIATO partnership with Organon, Daré has a commercialization partnership agreement with Bayer for women’s contraceptive product Ovaprene Daré’s most advanced contraceptive out of four in its pipeline. Although Ovaprene is still in development, currently in phase 3 trials, Bayer is “doing the work getting in front of payers,” Martucci Johnson said.
Daré signed a licensing deal with Bayer in 2020 for Ovaprene – a device a woman inserts herself vaginally that sits against the cervix and works by creating an “inhospitable environment for sperm,” Martucci Johnson said, adding that it differs from other monthly contraceptives like rings because non-hormonal.
“Ovaprene was designed to have a method that could approach – by combining some different methodologies – the level of effectiveness of hormonal methods, which is 91% in typical use versus 72% in vaginal gels or 82% with condoms,” she added.
In addition to the commercialization bump Ovaprene will see from the partnership with Bayer, it is also getting help in the development phase from the National Institutes of Health (NIH), which has granted Daré $7.5 million for its clinical trials and is co-running the phase 3 studies at their sites.
The NIH has also provided grant money to Daré to develop an injectable contraceptive designed to be predictably effective for six months.
“This one does use hormones because we’re big believers In needing a lot of different options out there,” Martucci Johnson said.
“With 35 to 45 percent of pregnancies are unintended, we need to do better in having products out there.”
Another option for women Daré hopes to get out there is an implant device that goes in the arm and is designed to remotely allow the user or clinician to pause contraception by turning off the micro vials that release the contraceptive agent and then turn it back on on-demand as well.
“Other than tubal ligation or vasectomy, implants are the most highly effective form of contraception by far,” Martucci Johnson said. “But the challenge is a woman has to undergo a medical procedure to get them and another to get then removed.”
The device, which uses technology that came out of MIT and is being funded with a $50 million grant form a private foundation, is currently in the preclinical stage of development although “some proof-of-concept work has been completed,” Martucci Johnson said.
Daré’s developments in its contraceptive pipeline comes at a time when the investment community is taking a longer look at women’s health products following the Supreme Court ruling overturning Roe v. Wade. On July 13, Martucci Johnson was a panelist for a discussion titled “A Tipping Point in Women’s Health – Does the SCOTUS Outcome Change the Paradigm in Contraception?” presented by the Maxim Group LLC.
Martucci Johnson said she wanted to make sure investors knew the facts about contraception and the affect the high court’s ruling will have on women’s choices.
“Part of the problem is there are so many unintended pregnancies,” she said. “So removing one means of managing those does not solve the problem and is not aligned with what the medical practitioners who are most astute at evidence-based medicine in the field would recommend as a course of action.”
Martucci Johnson also pointed out that despite the many forms of contraception available today, there are still high numbers of unintended pregnancies.
“What that speaks to louder than anything is that we need more [contraceptives],” she said. “If unintended pregnancies are happening despite the methods that are available today, we have not offered all of the methods that might be best suited to people’s needs – either the side effect profile is something that people can’t tolerate or the way the product is administered is not going to work in her unique situation or whatever the case may be – and as an industry there is an opportunity to do better.”
Taking away the option for abortion for millions of women “in some ways has increased the total addressable market” and has turned the heads of not only retail investors but fundamental healthcare investors as well, Martucci Johnson said, adding that there had been a perception in the investment community that “women’s health was all taken care of.”
“This has opened their eyes to [see] this is an interesting time to look at what innovation is out there, what are some of the cutting-edge possibilities in contraception that could really be game changers in how we reduce the number of unintended pregnancies and give women additional options,” she said.
Daré Bioscience, Inc.
CEO: Sabrina Martucci Johnson
Headquarters: San Diego, UTC
Business: Women’s health-focused biotech
Stock: DARE (NASDAQ)
Revenue: Pre-revenue in FY 2021
Notable: Daré’s pipeline consists of women’s health therapeutics, devices and diagnostics.