CHICAGO, Nov. 11, 2016 (GLOBE NEWSWIRE) -- The Female Health Company/Veru Healthcare (NASDAQ: FHCO ) today announced that it has accepted an invitation from the U.S. Food and Drug Administration (FDA) to present at the Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on December 6, 2016. The FDA uses advisory committees to obtain independent expert advice on scientific, technical and policy matters.
The announced agenda of the meeting: The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis. The company intends to present an overview of its drug candidate for male infertility, MSS-722, including the design and primary endpoints of its planned Phase 2 clinical trial.
Background material for this meeting will be available on the FDA website prior to the meeting.
The Female Health Company recently completed a transformational merger with Aspen Park Pharmaceuticals (APP), a company focused on the development and commercialization of pharmaceutical and consumer health products for men’s and women’s health and oncology. APP’s drug development portfolio includes MSS-722, an oral drug product candidate for the treatment of hypogonadism. The company intends to utilize the 505(b)(2) regulatory pathway, which has the potential to significantly accelerate and substantially lower the cost and risk of developing of MSS-722.
“Male infertility is an underserved market, affecting approximately 6.1 million couples in the United States,” said Mitchell Steiner, M.D., President and Chief Executive Officer of The Female Health Company/Veru Healthcare. “We expect to commence the Phase II clinical study for MSS-722 in late fiscal 2017.”
MSS-722 is being developed as the first oral agent for the treatment of low sperm count (impaired spermatogenesis) in men who have secondary hypogonadism as a cause of male infertility.
Edward Kim, M.D., Professor of Surgery/Division of Urology, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee will make the presentation to the FDA on behalf of the company.
About The Female Health Company The Female Health Company is a diversified therapeutics and medical device company. The combined company will be organized as follows: Veru Healthcare will manage the Pharmaceuticals and Medical Devices division, which will focus on the development and commercialization of pharmaceutical and medical device products for men’s and women’s health and oncology, as well as the Consumer Health division, which will commercialize sexual health products for the consumer market, including FC2 and PREBOOST ™ . The Female Health Company will manage the global Public Health sector FC2 business, which markets the FC2 Female Condom ® (FC2) to government and quasi-governmental health agencies around the world.
More information about the Female Health Company and its products can be found at www.femalehealth.com , www.veruhealthcare.com and www.femalecondom.org . For corporate and investor-related information about the company, please visit www.FHCinvestor.com .
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release which are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements relating to the Company's increased financial flexibility. These statements are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: timing and expected completion of the Phase 2 clinical trial for MSS-722, success of the Phase 2 clinical trial or future clinical trials, product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2015. Actual events affecting the Company and the impact of such events on the Company's operations may vary from those currently anticipated.
Contacts: Mitchell Steiner, MD, 901-581-5872 Kevin Gilbert, 312-366-2633
