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Plethora Solutions targets US launch for premature ejaculation treatment

The deal opens up a new market for Plethora to pursue directly. In particular, it can now pursue a launch of the product into America - where, according to the company's estimates, there are 24mln men suffering from premature ejaculation.
Plethora Solutions targets US launch for premature ejaculation treatment

Plethora Solutions (LON:PLE) has agreed a deal with a partner that will allow the AIM quoted firm to take control of the global development and marketing of PSD502, its treatment for premature ejaculation.

The deal opens up new markets for Plethora to pursue directly. In particular it can now pursue a launch of the product into America, where, according to the company's estimates, there are 24mln men suffering from premature ejaculation.

As such, it believes the American market could be worth 'several hundreds of millions of dollars' per year.

Plethora plans to submit a new drug application to the US Food and Drug administration before the end of next year, which, according to Plethora, could mean a 2016 product launch is possible.

The company has already been working towards a European launch, with a market authorisation application currently with the European Medicines Agency, and a decision expected before the end of the year.

As well as North America, the deal also gives Plethora the opportunity to pursue roll outs into South America, Japan, Korea, Taiwan and China.

Under the terms of the agreement revenues will be shared with the partner, although the majority will go to Plethora.

Plethora also told investors that it will seek new partners as well, to ensure the launch of the product in what it calls 'high potential' territories.

"Today's agreement marks an important step in the global commercialisation of PSD502," said chief executive Ronald Openshaw.

"Premature ejaculation is probably the most prevalent male sexual dysfunction, with an estimated 1-in-4 men suffering from this condition.

"We anticipate the European Approval this year and intend immediately to initiate the regulatory and commercial development in the United States."

Prior to this deal Plethora has been working with its partner, Shionogi, since 2007 and it was given the rights for the European market in 2011.

In today's statement Shionogi chief executive Dr John Keller said: "Plethora has made considerable progress in their prosecution of the European Marketing Authorisation Application for PSD502 and their business development activities.

"Given their focus and dedication to achieving the maximum possible potential for PSD502, we are pleased that they will undertake the primary responsibility to successfully register and, with partners as appropriate, commercialise this important potential treatment in territories around the world."

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Plethora Solutions Timeline

Newswire
September 16 2014

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