Health Decisions, Inc.

Partnership Aims to Advance Daré’s Reproductive Health Portfolio in a Timely and Capital Efficient MannerSAN DIEGO and MORRISVILLE, N.C., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and Premier Research International, LLC, a global clinical research, product development, and consulting company, today announced that the companies extended their partnership agreement under which Premier Research will continue to provide on an exclusive basis contract research organization (CRO) services within the United States to support the clinical development of Daré’s reproductive health portfolio. The agreement was originally established with Health Decisions, Inc., which was acquired by Premier Research in 2021. “In 2020, Daré and Premier Research conducted a successful Phase 3 clinical study of XACIATO™ (clindamycin phosphate) vaginal gel 2% despite the challenges posed by a global pandemic. As we approach the start of the pivotal clinical study of Ovaprene®, we are excited to reaffirm our strategic partnership with Premier Research and leverage its deep expertise in the clinical development of women’s health products, including contraception,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Daré is committed to advancing a portfolio of differentiated product candidates that address meaningful unmet needs in women’s health in a timely and cost-efficient manner. This extended partnership has the potential to benefit multiple Daré programs, including those outside of reproductive health, such as the planned Phase 3 study of Sildenafil Cream, 3.6%, through the combination of commitment, clinical development expertise and cost savings.” Premier Research’s women’s health expertise includes more than 100 clinical trials over the past five years, a network of thousands of women’s health sites and a proven track record of working with multiple divisions of the U.S. Food and Drug Administration (FDA). In 2020, Daré and Premier Research collaborated successfully on the Phase 3 clinical study XACIATO™ (clindamycin phosphate) vaginal gel 2%, Daré’s first FDA-approved product. The upcoming pivotal Phase 3 study of Ovaprene®, an investigational hormone-free, monthly intravaginal contraceptive, will be conducted in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and supported by NICHD’s Contraceptive Development Program, which oversees the Contraceptive Clinical Trial Network (CCTN). The pivotal Phase 3 study will be conducted within the CCTN with Premier Research serving as the NICHD’s CRO partner. Under the terms of the extended agreement, Premier Research will continue to be Daré’s exclusive provider of CRO services within the United States for all of Daré’s reproductive health product candidates for another three-year period, provided that Premier Research has the expertise, resources and availability to perform the clinical research services that Daré requires. In exchange for that CRO exclusivity, Premier Research will continue to provide attractive pricing structures, clinical expertise, an extensive site network, relationships with key opinion leaders and investigators, and a core team of personnel dedicated to supporting all of Daré’s development programs covered by the agreement. “Premier Research is thrilled to renew this partnership and continue our successful work with Daré,” said Michael Arlotto, Ph.D., Chief Operating Officer of Premier Research. “This partnership underscores our joint commitment to advancing women’s health by supporting efforts to include women in clinical research and bring novel products to market. We look forward to building on the achievements in our relationship to date and helping further accelerate Daré’s unique pipeline to potentially impact the lives of women everywhere.” About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. Daré’s first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive 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 (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré 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 and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. About Premier Research Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and medtech innovators transform life-changing ideas and breakthrough science into new medical treatments. Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com. Forward-Looking Statements Daré 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,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the potential benefits to Daré of its agreement with Premier Research, including acceleration of the clinical development of its product candidates and cost savings. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s 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, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct 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; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; 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; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s 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 and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s 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 Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s 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. Daré 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. Contacts: Media and Investors on behalf of Daré Bioscience, Inc:Camilla White / Simona KormanikovaDentons Global AdvisorsDareBioscience@dentonsglobaladvisors.com / 1.212.466.6450 Media on behalf of Premier Research: Joe LindroosVice President, MarketingJoe.Lindroos@premier-research.com+1 416 365 2917 Source: Daré Bioscience, Inc.

在全世界，妇科癌症是女性发病率和死亡率的重要原因。虽然妇科癌症的患者比肺癌、乳腺癌或直肠癌患者少，但妇科癌症的影响可能更致命。这是因为妇科癌症通常在疾病后期才得以发现，疗法选择有限，而且晚期或复发性疾病导致预后较差。更早的诊断和更有效的治疗将提高患者的生活质量，在理想情况下，能够延长患者的无进展生存期和总生存期。值得庆幸的是，新型高效靶向疗法和技术为身患这些隐匿疾病的女性带来了巨大希望，发展前景广阔。正值“三八” 国际妇女节到来之际，为帮助改善全世界女性健康状况，全球CRO普米尔医药（Premier Research）专门推出了《应对妇科癌症研究的挑战和机遇》白皮书，旨在推进妇科癌症研究，助力相关疗法的申办方应对妇科癌症研究的关键挑战，把握女性健康市场的机遇。白皮书主要内容包括癌症检测和疗法的挑战临床研究方法趋于灵活疫情推动业界向去中心化试验的过渡增加患者多样性，最大化药物获益治疗和诊断的重大进展扫码免费下载《应对妇科癌症研究的挑战和机遇》完整版白皮书，把握妇科癌症研究的机遇在当前，仍有大量妇科癌症患者的诊断和治疗需求得不到满足。作为一家致力于改善女性健康医疗结果的全球CRO，普米尔医药一直为促进并加速妇科癌症疗法的临床开发贡献着自己的力量。其临床团队了解如何解决这些试验中的关键操作问题以及降低风险的方法，可协助申办方提高研究成功的几率。值得一提的是，普米尔医药于2021年7月正式收购了专注于女性健康研究及诊断双重领域的美国CRO公司Health Decisions，该公司拥有由500家女性健康研究中心所构建的研究网络。此后，普米尔医药将Health Decisions公司在女性健康诊断及研究方面的专业知识进行整合，有助于其向生物技术和医疗器械申办方，尤其是专精于肿瘤学、镇痛和神经科学领域的申办方，提供更理想的CRO和咨询服务。关于普米尔医药  ★普米尔医药（Premier Research）目前已经充分掌握肿瘤学和血液学、罕见病、神经科学、全球开发注册策略等各方面领域。依托 20 年产品开发经验，公司可以提供从初始策略制定、临床开发再到最终监管申报的一站式全方位服务。欢迎微信搜索“Premier Research”，关注了解更多全球领先行业洞见和真实案例分析。

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today! DURHAM, N.C, July 24, 2013 /PRNewswire-iReach/ -- Health Decisions, Inc., the leading clinical research organization focusing on efficiency in execution of clinical development, today announced early completion of enrollment for a 3,384-subject phase III registration study of Evofem LLC's Amphora® nonhormonal contraceptive gel. (Photo: ) The global trial compares Amphora to Conceptrol®, the brand name of nonoxynol-9, and the only spermicidal gel currently approved by the FDA. "We are pleased that our focus on efficiency enabled us to enroll this important study well ahead of schedule," said Health Decisions CEO Michael Rosenberg, MD, MPH. "Our ability to use technology to enroll studies faster and to better retain subjects enables us to generate information more quickly than industry norms. This study is a good example and will provide Evofem with an earlier market entry than would otherwise have been possible." Dr. Rosenberg attributed successful enrollment of the Amphora study to the power of Agile Clinical Development, Health Decisions' award-winning, technology-leveraged approach to running clinical trials based on immediate, actionable information from the field. "Our approach and supporting technologies enable us to enroll over 80% of our studies on time or early when the rest of the industry is enrolling about 80% late," Rosenberg said. "In the Amphora study, our integrated adaptive enrollment techniques enabled us to enroll almost 3,400 subjects three to four times faster than previous trials of similar products that enrolled less than half as many subjects." Health Decisions enrolled the Amphora study at a rate of 125 subjects per month compared with 38 subjects per month and 30 subjects per month for previous large studies of similar products. One such study with a target enrollment of 1,800 subjects was terminated without meeting its enrollment goals. "We are very pleased with the progress on the development of Amphora," said Tommy G. Thompson, former US Health and Human Services Secretary, and Chairman of the Evofem Board of Directors. "Evofem is committed to providing women around the world with greater contraceptive choice and we expect Amphora to fill a critical gap in the market as an inexpensive, easy-to-use product that is woman-controlled and used only when necessary, on-demand." Dr. Rosenberg also noted, "Our integrated adaptive monitoring approach works on the same real-time principles as adaptive enrollment and also provided striking benefits in the Amphora trial, simultaneously reducing monitoring costs and increasing data quality." Health Decisions won the prestigious 2013 CIO 100 Award for its innovative adaptive monitoring technology. About Health Decisions Health Decisions is the leading clinical research organization (CRO) in Agile Clinical Development, providing proactive trial management based on real-time actionable information, enabling decisions that accelerate clinical studies and programs. For the drug and device industries, Agile Clinical Development provides a way to get new products to market faster and at lower cost. For the public, it means earlier access to improved treatments and diagnostics at more affordable prices. Founded in 1989, Health Decisions has conducted a range of successful clinical trials involving tens of thousands of patients, consistently reducing sponsors' financial risk and time to market. Privately held, Health Decisions is headquartered in Durham, NC and operates on all five continents. About Evofem Evofem LLC is a privately held biotechnology company that brings advanced prescription and consumer products to global markets. Through its subsidiaries, Evofem Inc. and Cosmederm Bioscience, Evofem discovers, develops and commercializes prescription and over-the-counter products, in the areas of dermatology, pain management, feminine care, contraception, and the prevention of sexually transmitted infections. In February 2013, Evofem entered into a strategic alliance with WomanCare Global, a nonprofit organization whose mission is to provide access to quality, affordable, women's healthcare products through a sustainable supply chain in over 100 countries, with a particular focus on under-served markets in Africa, Asia, and Latin America. Through this alliance, WomanCare Global provides sales, marketing and global distribution support to Evofem's products. News distributed by PR Newswire iReach: SOURCE Health Decisions Help employers find you! Check out all the jobs and post your resume.