The UK’s Plethora Solutions Holdings has granted Recordati the rights to commercialise its novel treatment for premature ejaculation, in a deal that could be worth 46 million euros, plus royalties.

The deal for the compound, called PSD502, covers Europe, Russia, the Commonwealth of Independent States Turkey and certain countries of North Africa. Plethora will retain rights for the drug, a topical spray containing lidocaine and prilocaine.

In two Phase III studies PSD502 showed a highly significant and clinically meaningful effect increasing mean intravaginal ejaculatory latency time at baseline from 0.5 minutes to 3.2 minutes at week 12. 87% of the patients in the studies were considered as responders with the product being well tolerated with no significant safety issues.

PSD502, which is used five minutes before intercourse, also showed positive effects across a wide range of other parameters including partner satisfaction. Plethora said, noting that the combo was approved by the European Commission in November 2013. Cashwise, it is getting 5 million euros upfront and a further 6 million euros once the European Medicines Agency approves a new six-dose can. As well as the 46 million euros in total payments, Plethora is in line for tiered royalties, ranging from the mid-teens to the mid-twenties.

The Oxfordshire-based group says it hopes to sign other deals elsewhere soon and is working to get US approval. Chief executive Jamie Gibson said Recordati’s “significant experience and marketing reach in men’s health and urology will allow it to successfully launch and commercialise PSD502, paving the way for us to potentially receive an attractive flow of milestones and royalties”.

Last month, Plethora said it hoped to raise around £15.9 million to fund the $25 million acquisition of the royalty rights in PSD502 from Shionogi, Paul Royalty Fund Holdings Capital and Richard Henry. That would be funded by a placing of 177 million new shares at £0.09 each and 88.5 million fundraising warrants exercisable at £0.15, conditional upon Plethora signing a European licensing agreement.