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Furiex Pharmaceuticals to Receive Milestone Payment for Priligy® Launch in France

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By Business Wirevia The Motley Fool

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Furiex Pharmaceuticals to Receive Milestone Payment for Priligy® Launch in France

MORRISVILLE, N.C.–(BUSINESS WIRE)– Furiex Pharmaceuticals, Inc. (NAS: 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 France. Currently, Priligy is marketed for on-demand treatment of premature ejaculation in 16 countries in Europe, Asia and Latin America, and is approved for that indication in 56 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 receive an additional $5.0 million launch milestone and up to $40.0 million in sales-based milestones, plus tiered royalties ranging from the mid-teens to mid-twenties in percentage terms.

“This launch will make Priligy, the only approved medication for premature ejaculation, available to a wider market in the EU,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “We look forward to additional worldwide Priligy launches as Menarini continues to build this 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.

About Priligy

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. Priligy was 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 approved for on-demand treatment of PE in 56 …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Furiex Reports Fourth Quarter and Full Year 2012 Financial Results

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By Business Wirevia The Motley Fool

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Furiex Reports Fourth Quarter and Full Year 2012 Financial Results

Fourth Quarter 2012 Highlights:

  • Royalty revenues of $9.2 million, an increase of $3.6 million (65%) from third quarter 2012.
  • Cash and cash equivalents balance of $25.7 million as of December 31, 2012.

Full Year 2012 Highlights:

  • Milestone revenues of $20.0 million for year end 2012.
  • Royalty revenues of $20.5 million, an increase of $16.0 million (357%) from year end 2011.
  • Total revenues of $40.5 million, an increase of $36.0 million (802%) from year end 2011.

MORRISVILLE, N.C.–(BUSINESS WIRE)– Furiex Pharmaceuticals, Inc. (NAS: FURX) today reported its financial and operating results for the quarter and year ended December 31, 2012.

For the year ended December 31, 2012, Furiex recorded total revenues of $40.5 million. This included milestone revenue of $20.0 million, consisting of $10.0 million related to achievement of marketing approvals for Priligy® in two countries by the Menarini Group and $10.0 million related to acceptance of the submission of a Marketing Authorization Application by the European Medicines Agency for alogliptin (Nesina®).

Furiex recorded fourth quarter royalty revenues of $9.2 million, compared to $2.0 million for the same period in the prior year and $5.6 million in the third quarter of 2012. For the full year 2012, Furiex recorded royalty revenues of $20.5 million, compared to $4.5 million in the prior year. Royalty revenue included royalties related to Nesina and Liovel® sales in Japan, and Priligy sales in various countries outside of the United States.

Research and development expenses were $14.6 million for the quarter ended December 31, 2012, compared to $6.1 million for the same period in the prior year. For the full year 2012, Furiex recorded research and development expenses of $69.5 million, compared to $44.2 million in the prior year. The increase in research and development expenses was due predominantly to Phase III costs associated with the continued development of MuDelta (also referred to as eluxadoline; USAN adopted, INN approval pending), a …read more
Source: FULL ARTICLE at DailyFinance