MORRISVILLE, N.C. (January 31, 2012) - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced that the European Commission endorsed the positive opinion adopted by the Committee for Human Medicinal Products (CHMP) on October 18, 2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending national approvals, the marketing authorization for the Priligy doses can be granted in the European Union Member States where the drug has not yet been approved, and also in Norway and Iceland. The indication for Priligy approved by the EC is the on-demand treatment of premature ejaculation in men between the ages of 18 and 64.
"We are pleased with the decision of the European Commission," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "This decision will make Priligy, the only approved medication for premature ejaculation, available to a wider market in the EU."
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. 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 a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed - one to three hours before sexual intercourse is anticipated - rather than every day. The drug is specifically developed for the on-demand treatment of PE and was extensively evaluated in five randomized, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial program to date for a drug therapy to treat PE. Priligy is the first oral medication (tablet) to be approved for this condition in a growing number of countries around the world. Priligy is marketed by Janssen-Cilag, a division of Johnson & Johnson.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of internal and partnered drug programs by advancing them through the drug discovery and development process in a cost-efficient manner. 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 strong, diversified product portfolio and pipeline with multiple therapeutic candidates including late-stage assets and two 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.
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: failure of our partner to successfully obtain regulatory approval to market and sell its product in the individual EU countries; time required to gain regulatory approvals; the demand for our potential products, if and when approved; the risks and expense of continuing the research and development activities of dapoxetine; the progress of Priligy in commercialization as it relates to receiving future milestone and royalty payments; 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.