Product and expected sales and marketing schedule
Plethora is the foremost value driver of the Group. Managed by one of the renowned scientists behind Viagra - Dr. Michael Wyllie, the Group’s Chief Scientific Officer, together with the senior management team, Plethora developed its core product Fortacin™, the first EU-approved prescription treatment for PE that does not act on the central nervous system. It is a topical spray containing low doses of two anaesthetics - lidocaine and prilocaine – that takes effect almost immediately upon application, giving users more control without reducing pleasure.
The first batch of Fortacin™ has been launched for commercial sale in the UK, by prescription, from 11 November 2016. Following the launch, Fortacin™ can now be prescribed from a physician either in person or online via an online consultation, with prescriptions to be filled by Chemist 4 U: https://www.chemist-4-u.com/
Furthermore, Regent Pacific has out-licensed Fortacin™ to commercial partner Recordati S.p.A., who is expected to begin sales of the product in Italy, Spain, France, Germany, Portugal, Czech Republic, Slovakia, Poland, Ireland, Romania and Greece in early 2018 and thereafter roll-out in the rest of Europe, Russia, CIS and select countries of North Africa.
The Group is also in discussions with potential new licensees for the distribution of Fortacin™ in other key markets including Asia Pacific, Middle East, Latin America, North America and sub-Sahara Africa. Regulatory approval in a majority of these markets should be secured relatively rapidly, as requirements for costly and time consuming clinical trials are negated by the approval from the European Medicines Agency (“EMA”).
In the United States, the Group continues to push ahead the approval process with the Food and Drug Administration. Approval is expected by late 2019, with a commercial launch to follow shortly thereafter.