Furiex Pharmaceuticals Announces Priligy® Launch in the United Kingdom by
Launch Triggers $5.0 Million Milestone Payment
MORRISVILLE, N.C. -- October 31, 2013
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX), a drug development collaboration
company, today announced it will receive a $5.0 million milestone payment from
the Menarini Group for the launch of Priligy in the United Kingdom. Currently,
Priligy is marketed for on-demand treatment of premature ejaculation in over
20 countries in Europe, Asia and Latin America, and is approved for that
indication in over 60 countries worldwide.
In May 2012, Furiex entered into a license agreement with Menarini to
commercialize Priligy in Europe, most of Asia, Africa, Latin America and the
Middle East. Under the terms of the license agreement, Furiex is eligible to
up to $40.0 million in sales-based milestones, plus tiered royalties ranging
from the mid-teens to mid-twenties in percentage terms.
"We are pleased with Menarini’s continued success launching Priligy in the EU
market,” said June Almenoff, M.D., Ph.D., president and chief medical officer
of Furiex. "The United Kingdom is a key market for Priligy and we view this
launch as an important step forward in building the franchise."
About Premature Ejaculation
Premature ejaculation (PE) is a distressing sexual dysfunction that can be
present from the first sexual encounter or can develop later in life. It is
the most common male sexual dysfunction, affecting about 30 percent of the
male adult population at some point during their lives. The condition consists
of three major components: a short time to ejaculation, lack of ejaculatory
control and negative personal impact, including distress related to rapid
ejaculation. A combination of physiological and psychological factors is
believed to influence the mechanism of ejaculation. Research suggests
serotonin plays a central role in the timing of ejaculation.
Priligy (dapoxetine) is the first oral medication approved for "on-demand"
treatment of PE. It is a unique, short-acting, selective serotonin reuptake
inhibitor designed to be taken only when needed - one to three hours before
sexual intercourse is anticipated - rather than every day. Over 15,000 men
have received Priligy in pre-marketing and post-marketing clinical studies.
This is the largest and most comprehensive clinical trial program to date for
a drug therapy to treat PE. Priligy is approved for on-demand treatment of PE
in over 60 countries.
Furiex Pharmaceuticals is a drug development collaboration company that uses
innovative clinical development design to accelerate and increase value of
drug development programs by advancing them through the drug discovery and
development process in a cost-efficient manner. Our drug development programs
are designed and driven by a core team with extensive drug development
experience. The company collaborates with pharmaceutical and biotechnology
companies and has a diversified product portfolio and pipeline with multiple
therapeutic candidates, including one Phase III-ready asset, two compounds in
Phase III development, one of which is with a partner, and four products on
the market. The company's mission is to develop innovative medicines faster
and at a lower cost, thereby improving profitability and accelerating time to
market while providing life-improving therapies for patients. For more
information, visit www.furiex.com.
Menarini is an international pharmaceutical company with over 16,000 employees
worldwide and a presence in more than 100 countries in Europe, Asia, Latin
America, Africa and the Middle East. The company was established 125 years ago
and currently markets products in the cardiovascular, gastroenterology,
metabolic, infectious disease and anti-inflammatory/analgesic therapeutic
areas. With a three billion Euro turnover the Menarini Group is one of the
world's largest private pharmaceutical companies. For further details, visit
Except for historical information, all of the statements, expectations and
assumptions contained in this news release are forward-looking statements that
involve a number of risks and uncertainties. Although Furiex attempts to be
accurate in making these forward-looking statements, it is possible that
future circumstances might differ from the assumptions on which such
statements are based. In addition, other important factors which could cause
actual results to differ materially include the following: inability of
Menarini to effectively market Priligy; the demand for Priligy; changes in the
safety profile of Priligy during its post-marketed use in patients; potential
changes by the European Medical Agency to its regulatory guidance; risks,
costs and time required to gain regulatory approvals; our continuing losses
and potential need for additional capital; and the other risk factors set
forth from time to time in the SEC filings for Furiex, copies of which can be
found on our website.
Furiex Pharmaceuticals, Inc.
Sailash Patel, 919-456-7814
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