MIAMI, Nov. 30, 2016 (GLOBE NEWSWIRE) -- The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced that, through its exclusive distributor in Brazil, Semina Indústria e Comércio Ltda, it has received a tender award for up to 1.2 million FC2 Female Condoms from the São Paulo Municipal Department of STDs and AIDS.  Orders can be placed against the tender until August 10, 2017, with a one-year extension at the discretion of the São Paulo Municipal Department of STDs and AIDS.  The tender provides that any placed orders will be paid for in advance.

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The Brazilian Ministry of Health also recently distributed a “Joint Informative Note” to the Brazilian national health services network: “The Department of STD, AIDS and Viral Hepatitis, the Secretariat of Health Surveillance and the National Coordination for Women’s Health of the Healthcare Secretariat of the Ministry of Health, recommend to all the State and Municipal Health Coordinations and to the State and Municipal DST and AIDS Coordinations, to adopt measures to expand the supply and use of the female condom targeting all women.”

"This tender award was placed by the local health secretariat in São Paulo, and is separate to previous or possible future orders by the Brazilian Ministry of Health,” said Mitchell Steiner, M.D. President and Chief Executive Officer of The Female Health Company / Veru Healthcare.  “The São Paulo Municipal Department of STDs and AIDS pioneered the introduction and adoption of female condoms.  More recently, the Department, regarded as the gold standard by and for other Brazilian municipalities, has been at the forefront of the effort to expand access to female condoms to the entire population, not only those considered “high risk” or “priority.”

“We continue to see a strong ongoing commitment by Brazilian health officials at the local, state and national levels to expand distribution of, as well as education efforts for female condoms,” said Dimitri Moufarrege, Managing Partner of Semina Indústria e Comércio Ltda.  “We are also very excited about The Female Health Company’s recently completed transaction with Aspen Park Pharmaceuticals and have had conversations with the company’s new management team about expanding our relationship to include, among other things, the possibility of manufacturing FC2 in Brazil.  This would allow for greater access of FC2 to all of South America and Mercosur.”

São Paulo is one of the most populous cities in the world, with more than 12 million people.

The FC2 Female Condom is the only female-controlled product approved for market by the FDA and cleared by the World Health Organization (WHO).  FC2 provides women a non-hormonal option for their contraception and disease prevention needs.  The product’s efficacy is comparable to male condoms in protecting against unplanned pregnancy and sexually transmitted infections (STIs), including Zika.  FHC has an expanded mission to assist in protecting women of all ages - pregnant or not - from being infected by STI’s, including the Zika virus as well as HIV. 

About Semina Indústria e Comércio
Semina Indústria e Comércio Ltda, based in São Paulo, Brazil, is FHC’s exclusive distributor of FC2 Female Condoms in Brazil.  Semina also manufactures and distributes silicon diaphragms, breastfeeding and other female health products.  Semina is also a leading developer and distributor of educational materials focused on reproductive health and family planning.  Semina subscribes to the highest international standards of quality and holds certifications of Good Manufacturing Practices and Distribution and its products are duly registered with ANVISA (Brazilian Regulatory Sanitary Agency). 

About The Female Health Company / Veru Healthcare
The Female Health Company / Veru Healthcare is a medical therapeutics company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway.  The Company does business both as “Veru Healthcare” and as “The Female Health Company” and is organized as follows:

  • Veru Healthcare manages the Pharmaceuticals Division, which develops and commercializes pharmaceutical products for men's and women's health and oncology.
  • Veru Healthcare manages the Consumer Health and Medical Devices Division, which is focused on commercializing sexual healthcare products and devices for the consumer market, including the Company's Female Condom (FC2), which is referred to as the FC2 Female Condom® in the consumer health products sector and as the Female Disposable Contraceptive Device (FC2) in the U.S. prescription market, and PREBOOST® medicated individual wipes which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
  • The Female Health Company manages the Global Public Health Division, which is focused on the global public health sector FC2 business.  This division markets the Company’s Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women 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.  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 size of new orders for FC2 in Brazil or other countries in South America and the possibility of manufacturing FC2 in Brazil, product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company's products are at an early stage of development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including licensing risks; 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; risks related to the costs and other effects of litigation; 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 and the Company's proxy statement filed on August 8, 2016. These documents are available on the "SEC Filings" section of our website at www.veruhealthcare.com/investors

Contact:
Kevin Gilbert
312.366.2633

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The Female Health Company