Sciele Pharma, Inc., a Shionogi Company, has acquired the global rights for PSD502 from Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC. Under the terms of the agreement, Sciele has made payments totaling $8.4 million to Plethora, its debt holders, and the inventor of the product. Sciele will also share development costs for PSD502 for non-US territories and pay Plethora a royalty on non-US revenues. In April 2009, Plethora and Sciele amended the 2007 US license agreement for PSD502, and as a result, Sciele owns the New Drug Application as well as all US rights to the product. Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, “We are pleased to extend our commitment to PSD502 beyond the US market, and we expect to file for regulatory approval in Europe and the US in the first half of 2010. We will look at various options to commercialize PSD502 in Europe and other geographic territories.” About PSD502: PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder reported to affect between 25% and 30% of men in Europe and the USA. Data from the European Phase III Study reported in November 2008 showed that PSD502 demonstrated statistically significant increases from baseline in all three co-primary study endpoints and secondary endpoints. The primary endpoints in the European study are Intra-vaginal Ejaculation Latency Time (IELT), sexual satisfaction and ejaculatory control. Secondary endpoints include sexual quality of life and partner satisfaction. Patient recruitment to the Phase III program in the United States has been completed. Results of the Phase III Clinical Studies are expected in the second half of 2009.
