LONDON (Alliance News) - Plethora Solutions Holdings PLC, which earlier this week got marketing approval for its premature ejaculation treatment from the European Commission,Friday said it's in talks with several parties, including major pharmaceutical companies, about bringing the product to market.
It predicted that the product, known as PSD502 will hit the market in mid- to late-2014.
The EU approval was a key step in its long-lasting efforts to commercialize the treatment, and it's now seeking the same approval from the US regulator. It wants to start selling the product through partners who have the sales, marketing, and distribution infrastructure to maximise the commercial potential of the product.
"Given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof," the company said.
"The company is, however, confident that given the number of parties with which it is talking and the nature of those talks, one or more partners will be secured to lead to a successful commercialisation of PSD 502," it added.
It said it has now identifies a lead manufacturer for the treatment, and is finalising the manufacturing strategy. It isn't intending to do the manufacturing itself.
"The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales," Chairman Jim Mellon said in the statement.
The pharmaceutical company was founded in 2004 to develop the treatment, also known as Prilocaine Lidocaine Plethora. Two years ago, it won back the right to regulatory and commercial development of PSD502 in Europe and other territories from Japanese pharmaceutical company Shionogi & Co. Ltd and in August, it announced an agreement with Shionogi's U.S. arm, Shionogi Inc., to pursue the regulatory approval for PSD502 globally.
Plethora Solutions shares were up 2.4% at 15.75 pence Friday morning.
By Steve McGrath; stevemcgrath@alliancenews.com; @SteveMcGrath1
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