Easton Pharmaceuticals Is Provided a Manufacturing, Regulatory Filing Update and Forward Sales Estimates for VIORRA
November 04 2013 - 8:30AM
Marketwired
Easton Pharmaceuticals Is Provided a Manufacturing, Regulatory
Filing Update and Forward Sales Estimates for VIORRA
TORONTO, ON--(Marketwired - Nov 4, 2013) - Easton
Pharmaceuticals (OTC: EAPH), a specialty pharmaceutical company
that designs, develops, and markets an array of topically-delivered
drugs and therapeutic healthcare products announced today an update
to its recently announced regulatory filing in Mexico for its
Viorra product through BMV Medica S.A. de C.V. (BMV), a Mexican
Regulatory & Licensing consultancy in Mexico, Latin America and
South-East Asia.
As previously announced, BMV Medica S.A. de C.V. has estimated
the regulatory submission in Mexico will require six to seven
months until an anticipated marketing approval is obtained.
According to BMV, discussions on Easton's behalf have been
initiated to source a distribution partner within Mexico. In
addition, BMV has advised Easton they have also sourced out a
product specific US FDA-approved manufacturing partner and facility
within Mexico which they believe could be more cost effective and
better suited to manufacture Viorra and other products. Although
Easton has previously sourced out a manufacturing company for
Viorra and any of its other products including other products
presently under discussion, BMV believes its Mexico manufacturer is
better suited for the Company's needs as well as providing a boost
to its regulatory filing with the Mexican government. It is
anticipated that Easton will be making a decision on its
manufacturing partner within the next 30 days which will be
required for the regulatory submission.
BMV has provided what it believes to be realistic projections
towards possible sales figures that could be attained once an
approval has been granted by regulatory authorities in Mexico. BMV
believes an approval in Mexico would allow for instantaneous
approvals and acceptance by governments in other parts of Latin
America which opens up another huge potential market for VIORRA.
According to BMV, Sales targets could reach between $10 to $14
million USD within 24 months of launch. These projections are based
around other previously approved products, the size of the market,
and the belief that a VIORRA type product would be eagerly accepted
by women in these markets with a proper distribution partner. As
conveyed by BMV, they have entered into discussions on Easton's
behalf with several targeted distribution companies focused on
sales and marketing in the women's health, sexual arousal disorder
and the sexual wellness market.
Ms. Mendoza Vazquez of BMV, stated: "Once we finalize the
discussions to secure a local high-quality manufacturing facility
here in Mexico, the timelines towards regulatory approval can be
shortened. As in other industries, Mexico has a highly skilled work
force, with advantageous cost structures for pharmaceutical
manufacturing. In addition, if properly marketed we believe Viorra
could be the market leader in this segment, and very quickly attain
the sales levels of similar products marketed for men, which we
have seen to be in the tens of millions of dollars annually."
About BMV Medica, S.A. de C.V.:
BMV was founded in 2009, by a group of pharmaceutical
professionals, whose background includes regulatory approvals in
Mexico for several classes of Health Sector Products, including
Medical Devices, Medicines, and a combination of Drug/Device
products, as well as nutraceuticals, and cosmetic products. In
addition, BMV works with North American and European pharmaceutical
companies to assist them with local regulatory approvals and
distribution agreements. Ms. Mendoza Vazquez, President of BMV, has
previously worked in Marketing, Regulatory and Sales for Schering
Plough Mexico, and other Pharmaceutical companies.
About Easton Pharmaceuticals Inc
Easton Pharmaceuticals is a specialty pharmaceutical company
that designs, develops, and markets a premium array of
topically-delivered Drugs and therapeutic healthcare products,
focused on skin and circulatory conditions that impact a large and
expanding number of consumers including health issues related to
male and female sexual dysfunction, wound healing, pain, motion
sickness, scar and stretch marks, cellulite, varicose veins and
other conditions. The world market for these conditions is in
excess of $10 billion.
The company's gel formulation is thought to be an innovative and
unique transdermal delivery system. Easton Pharmaceuticals'
flagship product, VIORRA, is an over-the-counter aid for
the treatment to restore and improve vaginal moisture and
elasticity which has a very positive effect on women's sexual
desire and arousal, FSAD (Female Sexual Arousal Disorder) the world
market for these female conditions are in excess of $2 billion.
VIORRA is a topical, daily-use product classified by the
FDA as containing Generally Recognized as Safe ingredients.
For More Information Visit http://www.eastonpharma.com
& http://www.ashleybiomedical.com
Safe Harbor
This news release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
(The "Act"). In particular, when used in the preceding of
discussion, the words "pleased," "plan," "confident that,"
"believe," "expect," "should," expect," "anticipate," "intent to"
and similar conditional expressions are intended to identify
forward-looking statements within the meaning of the Act and are
subject to the safe harbor created by the Act. Such statements are
subject to certain risks and uncertainties and actual results could
differ materially from those expressed in any of the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, market conditions, general acceptance of
the company's products and technologies, competitive factors, the
ability to successfully complete additional or adequate financing
and other risks and uncertainties as stated in the company's
financial reports and filings.
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