Dar Bioscience Announces Publication of a Peer-Reviewed Journal Article Supporting the Use of the Postcoital Test Study as a Predictor of…

Includes positive clinical findings from a postcoital test (PCT) human clinical study of Ovaprene, an investigational hormone-free, monthly contraceptive

SAN DIEGO, June 24, 2020 (GLOBE NEWSWIRE) -- DAR Bioscience, Inc. (NASDAQ: DARE), a leader in womens health innovation, today announced the publication of a literature review article by Biology of Reproduction that identifies and reviews 10 postcoital test (PCT) studies of vaginal contraceptives involving 9 test products, including Dars investigational hormone-free, monthly contraceptive Ovaprene, currently under a license agreement with Bayer for commercialization in the U.S.

The literature review was conducted with the support and participation of the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas, and Dar Bioscience. Based on the literature review, the article concludes that, for evaluating vaginal contraceptives, the PCT is the closest analogue available as a predictor of contraceptive effectiveness and is the best indicator of whether a test product works before it is evaluated in a contraceptive effectiveness study.

The findings from our review clearly demonstrate that the PCT is predictive of contraceptive effectiveness, and that a test product that performs well in a PCT study carried out in the same manner as recent PCT clinical studies can be expected to demonstrate contraceptive effectiveness in a pivotal study at a level predictive of a highly effective contraceptive product, said Christine Mauck, MD, MPH, Medical Director for Dar Bioscience and co-author of the article. We believe the Ovaprene PCT study completed by Dar last year is the most robust PCT clinical study ever conducted in the field of contraception, and the findings are encouraging in the context of other PCT studies with regard to Ovaprenes potential as an alternative to traditional hormone-based contraceptive options. As summarized in the article, other contraceptives that demonstrated PCT study results comparable to results seen with Ovaprene in last years PCT study, went on to demonstrate six-month typical-use contraceptive effectiveness of 86-91% in their respective pivotal studies, which is similar in range to typical-use effectiveness rates of hormonal methods like pills, patches, and vaginal rings such as the NuvaRing vaginal ring.

The accepted manuscript for the article entitled The Postcoital Test in the Development of New Vaginal Contraceptives is currently available in the Advance Articles section on the journals website, or at https://doi.org/10.1093/biolre/ioaa099

Bayer and Dar Bioscience Exclusive Licensing Agreement for U.S. Commercial Rights to Ovaprene:

In January 2020, Dar announced that it entered into an exclusive licensing agreement with Bayer for U.S. commercial rights to Ovaprene. Under the agreement, Dar received an upfront payment and access to Bayers extensive clinical and market capabilities while retaining control over Ovaprenes development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dar. If Bayer, in its sole discretion, makes payment to Dar of$20 million, which Dar intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Dar will also be entitled to receive commercial milestone payments potentially totaling$310 million, in addition to double digit tiered royalties on net sales.

The PCT Study Background:

The PCT study was initially developed to assess whether cervical factors played a role in infertility and became standard practice in the evaluation of infertile couples for many decades until it was replaced in the 1990s by more predictive testing methodologies and the wider use of in vitro fertilization, which bypasses the cervical mucus-sperm interaction. The World Health Organization describes key aspects of the PCT procedure, including the timing for collection of cervical mucus after intercourse and the method of counting and characterizing sperm found in the mucus. [1] The PCT has been used to evaluate both chemical and mechanical barrier vaginal contraceptive products, including spermicides and diaphragms. [2, 3]

About Dar Bioscience

Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health. The companys mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.

Dars product portfolio includes potential first-in-category candidates in clinical development: Ovaprene, a hormone-free, monthly contraceptive intravaginal ring whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Dars full portfolio of womens health product candidates, and mission to deliver differentiated therapies for women, please visit http://www.darebioscience.com.

Dar 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. Dar will use these channels to distribute material information about the company, and may also use social media to communicate important information about the company, its finances, product candidates, clinical trials and other matters. The information Dar posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors, the media, and others interested in the company to review the information Dar posts on its investor relations website (https://darebioscience.gcs-web.com/) and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Dars website mentioned above.

Forward-Looking Statements

Dar cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, Ovaprenes potential as an alternative to traditional hormone-based contraceptive options, the potential of Ovaprene to demonstrate typical-use contraceptive effectiveness in a pivotal contraceptive safety and efficacy study comparable to current FDA-approved, highly effective contraceptive products, and potential payments and non-monetary benefits to Dar under its licensing agreement with Bayer. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dars actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Dars ability to raise additional capital when and as needed to advance its product candidates and continue as a going concern; the effects of the COVID-19 pandemic on Dars operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on the ability of third parties on which Dar relies to assist in the conduct of its business, including its clinical trials, to fulfill their contractual obligations to Dar; Dars ability to develop, obtain regulatory approval for, and commercialize its product candidates; the risks that the license under the agreement with Bayer may not become effective and, if it becomes effective, that future payments to Dar under the agreement may be significantly less than the anticipated or potential amounts; the failure or delay in starting, conducting and completing clinical trials or obtaining U.S. Food and Drug Administration (FDA) or foreign regulatory approval for Dars product candidates in a timely manner; Dars ability to conduct and design successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; Dars ability to retain its licensed rights to develop and commercialize a product candidate; Dars ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product candidates; developments by Dars competitors that make its product candidates less competitive or obsolete; Dars dependence on third parties to conduct clinical trials and manufacture clinical trial material; Dars ability to adequately protect or enforce its, or its licensors, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dars product candidates which could expose its products to competition from other formulations using the same active ingredients; the risk of failure associated with product candidates in preclinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund; and disputes or other developments concerning Dars intellectual property rights. Dars forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Dars risks and uncertainties, you are encouraged to review its documents filed with the SEC including Dars recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Dar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Dar Bioscience, Inc.

Investors on behalf of Dar Bioscience, Inc.: Lee Roth Burns McClellan Email: lroth@burnsmc.com +1 212-213-0006

OR

Media on behalf of Dar Bioscience, Inc.: Jake Robison Canale Communications Email: jake@canalecomm.com +1 619-849-5383

Source: Dar Bioscience, Inc.

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Dar Bioscience Announces Publication of a Peer-Reviewed Journal Article Supporting the Use of the Postcoital Test Study as a Predictor of...