10th Nov 2014 09:50
LONDON (Alliance News) - Plethora Solutions Holdings PLC Monday said it has received the EUR5 million upfront payment from Recordati after the companies recently signed a licensing deal for Plethora's premature ejacuation treatment, and it's still on track for a commercial launch in Europe in the third quarter of next year.
Plethora shares jumped September 16 after it signed the licensing deal with pharmaceutical company Recordati for the commercialisation of premature ejaculation treatment PSD502, now trademarked as Fortacin. Recordati has the rights to commercialise the topical spray in the EU, Russia, the Commonwealth of Independent States, Turkey and some countries in North Africa.
There was a risk that Plethora would have to refund part of the upfront payment and have the deal terminated if certain conditions weren't met, including a satisfactory feasibility report.
"The company is pleased to announce that following delivery by the company to Recordati of a satisfactory feasibility report, Recordati has confirmed that no refund is payable by the company and that Recordati has no intention of terminating the agreement," Plethora said in a statement.
Fortacin was approved by the European Commission in November 2013, but the company is now looking for approval for a variation of the marketing approval for a new six dose canister.
The company also said its manufacturing partner Pharmaserve North West Ltd expects to complete production of the first 'good manufacturing practices' batch of the six dose canisters of Fortacin in a few days time. The manufacturer also plans to start the second batch next week, and therefore Plethora said it remains on track to complete the batch stability and validation studies required for EU variation approval for the six dose canister by the end of 2014.
It therefore still expects the European Medical Agency's Committee for Medicinal Products for Human Use to approve Fortacin during the third quarter of 2015, and this marketing authorisation will trigger the immediate commercial launch of the product in the European Union by Recordati.
Plethora shares were up 0.1% at 141.10 pence Monday morning.
By Steve McGrath; [email protected]; @stevemcgrath1
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