World News: 13:00 GMT Thursday 6th December 2018. [Dare Bioscience, Inc. via Globe Newswire via SPi World News]
SAN DIEGO, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in clinical-stage women’s health innovation, today announced that it has entered into definitive agreements with Hammock Pharmaceuticals, Inc., TriLogic Pharma LLC and MilanaPharm LLC under which Daré acquired the global rights to MP-101 for the treatment of bacterial vaginosis (BV), as well as the rights to utilize the underlying proprietary hydrogel drug delivery technology for any vaginal or urological application in humans.
Bacterial vaginosis is a type of vaginal inflammation caused by the overgrowth of bacteria naturally found in the vagina, which upsets the natural balance and is characterized by vaginal discharge, vaginal odor, vaginal itching, and burning during urination.
The proprietary gel system, which consists of a combination of a tri block copolymer and a natural polysaccharide, is designed to take advantage of body temperature to undergo solution-to-gel transition, enabling transformation into a bioadhesive gel formulation featuring extended release of the incorporated drug following application at the site of action. In MP-101 this proprietary technology is formulated with clindamycin, an antibiotic used to treat certain bacterial infections including BV, and has been engineered to produce a dual release pattern after vaginal application, providing maximum duration of exposure to clindamycin at the site of infection. Daré expects to commence a Phase III clinical study of MP-101 in approximately 250 women in the second half of 2019, and if the study is successful, to be in a position to file a new drug application with the U. S. Food and Drug Administration (FDA) in 2020. Based on MilanaPharm’s discussions with the FDA, Daré believes that one Phase III study with sufficient power and size may be sufficient for marketing approval in the U.S.
Current BV therapies typically have a success rate of less than 70%. In an investigator initiated pilot study treating 30 women, MP-101 demonstrated an 88% cure rate with just one administration.
“We believe this Phase III program will allow us to move into a leadership position in an area of great concern for both women and healthcare providers,” said Sabrina Martucci Johnson, President and CEO of Daré. “Studies suggest that nearly 20 million women in the U.S. experience BV and many suffer from episodes of recurrence. Current standard of care is oral antibiotics taken either once or over the course of several days, which can have systemic side effects, or antibiotics delivered vaginally in creams or gels, typically over the course of several days . If a cure rate consistent with the pilot study is demonstrated in the Phase III program, MP-101 has the potential to provide a significant improvement in efficacy over currently marketed BV therapies and enhanced convenience for women.”
“Hammock is excited to announce our partnership with Daré Bioscience. The transaction allows Hammock to focus on our OTC products and to potentially recognize value from MP-101 and the novel hydrogel technology. We look forward to working with the Daré and MilanaPharm teams on the transition and the lead product candidate and possibly other product candidates incorporating the hydrogel technology,” said William R. Maichle, CEO of Hammock Pharmaceuticals.
Under the agreements with Hammock and TriLogic/MilanaPharm, Daré received an exclusive, worldwide, royalty-bearing license to research, develop and commercialize the technology, paid one-time upfront fees of $275,000 and will pay one-time deferred fees of $450,000 within one year. In addition, Daré agreed to make potential future milestone payments through the term of the license based on clinical, regulatory, commercial launch and sales events, and to pay royalties based on commercial sales. Patents covering the licensed technology have been granted with terms through 2028 and additional patents pending would have terms through 2035.
Destum Partners advised Hammock Pharmaceuticals on the transaction.
Hammock Pharmaceuticals is an international branded, specialty pharmaceutical and consumer health company focused on the commercialization of differentiated brands and high value generic products.
MilanaPharm is a specialty pharmaceutical company built upon a proprietary drug delivery platform for numerous active compounds. MP-101 is part of the company’s hydrogel platform which is designed to deliver drugs that remain in place over periods ranging from several hours to several days, depending on the desired delivery profile, in order to achieve an effective treatment outcome.
Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s reproductive and sexual health. The company’s mission is to identify, develop and bring to market a portfolio of novel, differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women in the areas of contraception, vaginal health, sexual health, and fertility.
Daré’s product portfolio includes two potential first-in-class candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive vaginal ring, and Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder utilizing the same active ingredient as Viagra®. To learn more about Daré’s full portfolio of women’s health products, and mission to deliver novel therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré uses these channels to communicate with its investors and the public about the company and other company-related matters. The information Daré posts on its investor relations website may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website.
Investors on behalf of Daré Bioscience, Inc.: Ami Bavishi Burns McClellan email@example.com 212-213-0006
Media on behalf of Daré Bioscience, Inc.: Amanda Guisbond Canale Communications firstname.lastname@example.org 781-405-8775
Source: Daré Bioscience, Inc.
Globe Newswire: 13:00 GMT Thursday 6th December 2018
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