GlobeNewswire 15-Feb-2018 11:06 AM
SAN DIEGO, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc.(NASDAQ:DARE), a clinical-stage, womens biopharmaceutical company, today announced that it has met the funding requirement for obtaining an exclusive worldwide license to advance SST-6007 (5% Topical Sildenafil Citrate Cream), a potential treatment for Female Sexual Arousal Disorder (FSAD). The funds will be used to advance SST-6007 (5% Topical Sildenafil Citrate Cream), a potential treatment for Female Sexual Arousal Disorder (FSAD), through the next phase of clinical development.
Dar announced a license and development agreement with Strategic Science & Technologies to develop SST-6007 earlier this week. SST-6007 incorporates sildenafil, the same active ingredient in Viagra, in a proprietary cream formulation that is specifically designed to locally increase blood flow to the vulvar-vaginal tissue in women, leading to a potential improvement in genital arousal response and overall sexual experience. If approved, Dar believes SST-6007 would be the first FDA approved treatment for FSAD. FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty.
Dar plans to pursue the 505(b)(2) regulatory pathway for SST-6007 in the U.S. and leverage the existing data and established safety profile of the Viagra brand. Dar anticipates commencing a Phase 2b clinical trial in the second half of 2018 utilizing the proceeds from the investment that closed today.
SST-6007 is the second product in Dars growing portfolio of novel therapeutic candidates that address unmet needs in womens reproductive and sexual health. Dars first product candidate undergoing clinical development in the United States is Ovaprene, a non-hormonal contraceptive ring with the potential to be the first non-hormonal product to provide monthly contraceptive protection.
The addition of Topical Sildenafil to our portfolio reflects our commitment to develop unique and differentiated products for womens reproductive health, including contraception, sexual health and vaginal health. Our innovative pipeline of products has the opportunity to unlock value for Dars equityholders and deliver medicines that are more aligned with womens specific needs. We continue actively identifying and evaluating additional candidates that, like Ovaprene in contraception and Topical Sildenafil for FSAD, have the potential to address important gaps in the treatment options, said Sabrina Martucci Johnson, President and CEO, Dar Bioscience.
About Strategic Science & Technologies, LLC
Strategic Science & Technologies, LLC (SST) is a clinical-stage biotechnology company with an innovative topical drug delivery technology. The company's patented delivery technology provides targeted local delivery of known drugs at therapeutic levels. SSTs product portfolio includes Topical Ibuprofen and Topical Sildenafil, both in clinical development. SST is headquartered in Cambridge, MA and remains privately funded by its original investors. For more information please visit www.strategicscience.com.
About Dar Bioscience
Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens reproductive health. The company is driven by a mission to identify, develop and bring to market a diverse portfolio of novel 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 lead product candidate, Ovaprene, is a non-hormonal, monthly contraceptive ring that is currently in clinical studies. The company is headquartered in San Diego. For more information please visit www.darebioscience.com.
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995 regarding matters that are not historical facts, including statements relating to Dar's expectations regarding the anticipated market demands for its products, the safety and effectiveness of its products, market acceptance of Dar's products and the qualifications and expertise of Dar's management team. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the initiation and completion of clinical trials; availability and timing of data from ongoing and future clinical trials and the results of such trials; whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals; claims of infringement and other risks relating to Dar's owned and licensed intellectual property rights, and other factors discussed in the "Risk Factors" section of Dar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2017. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Dar's reports to the Securities and Exchange Commission, including Dar's reports on Forms 10-Q, 8-K and 10-K. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. Dar specifically disclaims any obligation to update any forward-looking statements included in this press release.
Media Contact: Amanda Guisbond Vice PresidentCanale CommunicationsAmanda@canalecomm.com781-405-8775
Source: Dar Bioscience
Source: Dare Bioscience, Inc.
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