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 anesthetics – lidocaine and prilocaine – that takes effect almost immediately upon application, giving users more control without reducing pleasure.
Endurance RP has out-licensed Fortacin™ to its commercial partner, Recordati S.p.A. ("Recordati"), who launched the product in Italy, Spain, France, Germany and Portugal in early 2018, the UK in early 2019 and Greece in Q4 2019. Recordati is planning to launch Fortacin™ in Romania later in 2020 and it may be rolled out in other European countries over the coming years, subject to the status of the novel coronavirus disease pandemic and the anticipated switch of Fortacin™ to “over-the-counter” status from prescription.
From a business development standpoint and as announced on 3 and 21 December 2018, respectively, exciting new out-licensing deals were also signed in respect of out-licensing Fortacin™ to: (i) Wanbang Pharmaceutical Marketing and Distribution Co., Ltd. (“Wanbang Pharmaceutical”), a wholly-controlled company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., in respect of the rights to commercialise Fortacin™ in The People’s Republic of China, excluding Taiwan, the Hong Kong Special Administrative Region (“Hong Kong”) and the Macau Special Administrative Region (“Macau”); and (ii) Orient EuroPharma Co., Ltd. (“Orient EuroPharma”), a company registered in Taiwan, in respect of the rights to commercialise Fortacin™ in select territories in Asia, being Taiwan, Hong Kong, Macau, Malaysia, Brunei, Singapore, Philippines, Thailand and Vietnam, but excluding The People’s Republic of China.
Wanbang Pharmaceutical is on course for submitting the investigational new drug application for clinical trial approval ("CTA") by Q3 2020, to commence clinical trials in China, meaning that the CTA could be obtained between Q4 2020 and Q1 2021, triggering, as per the terms of the licence agreement with Wanbang Pharmaceutical and announced on 3 December 2018, a payment of US$4 million to the Group.
Orient EuroPharma was granted licensing permission from the Hong Kong Department of Health – Drug Office to market and distribute Fortacin™ in Hong Kong. Also, during the year ended 31 December 2019, Orient EuroPharma was granted permission from the Macau Government – Health Bureau to market and distribute Fortacin™ in Macau. Select other territories in Asia, being Taiwan, Malaysia, Brunei, Singapore, Philippines, Thailand and Vietnam, but excluding The People’s Republic of China, are expected to grant import, distribution and licensing permission as and when the application process is satisfied for each jurisdiction over the coming months and years. Pursuant to the licence agreement with Orient EuroPpharma, the Group will be eligible to receive the remaining payments of up to US$1.15 million, excluding royalties, after achieving certain milestones related to the roll out in each market.
In parallel with the European and Asian roll-out efforts of Fortacin™, the Group has further progressed the approval process with Food and Drug Administration of the United States, with a view to completing the Phase II validation by the end of 2020, commencing Phase III work in the latter half of 2021, making a New Drug Application in the first half of 2022, giving a Prescription Drug User Fee Act date in Q1 2023.
The Group is also in discussions with potential new licensees for the distribution of Fortacin™ in other key markets including the Asia Pacific region, 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.