The Female Health Company / Veru Healthcare Receives New Tender Award For FC2 Female Condoms from Brazilian Municipality
November 30 2016 - 8:30AM
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.
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 ComércioSemina
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
HealthcareThe 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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