HONG KONG, Dec. 15, 2021 /PRNewswire/ -- Endurance RP Limited ("Endurance Longevity" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK) announced that Plethora Solutions Limited (Solutions), a wholly owned subsidiary of the Company has entered into an exclusive Licence Agreement with K.S. KIM International (SK-Pharma) Ltd. on 14 December 2021 in respect of the rights to commercialise and distribute Fortacin™, the novel treatment for PE in the Israeli and Balkan regions.
Solutions remains full commercialisation rights for Fortacin™ for the rest of the world not otherwise subject to a licence agreement, including but not limited to the US and Canada, Latin America, the Middle East and Sub-Saharan Africa.
Pursuant to the exclusive Licence Agreement, SK-Pharma shall pay to Solutions a price per each unit of Fortacin™ ordered by SK-Pharma from Pharmaserve (North West) Limited (PSNW) (or otherwise provided by PSNW to SK-Pharma or its authorised recipients). All sums paid to Solutions by SK-Pharma shall be without withholding or deduction of any kind.
SK-Pharma has certain Minimum Marketing Commitments and Minimum Annual Quantities of product to be ordered from PSNW in respect of certain regions within the Israeli and Balkan regions, with failure to comply giving Solutions certain rights and remedies for compensation, as well as removal of regions from the scope of the Licence Agreement or termination in some cases. The Licence Agreement contains customary terms and conditions in respect of intellectual property rights, confidentiality, representations and warranties. In respect of each region within the Israeli and Balkan regions, the Licence Agreement will have an initial term of 5 years after the date when SK-Pharma places the first commercial purchase order for Fortacin™ with PSNW; and thereafter the initial term may be extended automatically by additional successive 2 year terms each time.
Jamie Gibson, Chief Executive Officer of the Company said, "We look forward to bringing on SK-Pharma as a licencee for the Israeli and Balkan regions and further the commercialisation of Fortacin™ around the world."
Other Operations Update
FDA
The Company's clinical research organisation (CRO) in the US has been submitting the highly successful results of the Company's PE Bothersome Evaluation Questionnaire (PEBEQ) study over the last few months, including the Phase II study results, the psychometric evaluations, and the referenced listed drug (RLD) protocol, which will allow the FDA to review the PEBEQ as a clinical study endpoint.
China
The clinical trial of Senstend™ is expected to commence from January 2022. If the clinical study meets its endpoints and the National Medical Product Administration (NMPA) has granted an import licence for Senstend™, then US$5 million (or approximately HK$39 million) before deduction of PRC withholding tax will be payable to the Group from Wanbang Biopharmaceutical.
In addition, upon first commercial sale of Senstend™ in China, US$2 million (or approximately HK$15.6 million) before deduction of PRC withholding tax shall be payable to the Group from Wanbang Biopharmaceutical, while the Group will also generate low to mid-teens royalties of Wanbang Biopharmaceutical's net sales of Senstend™ in China.
Fair value gain in DEVELOP Global Limited (DVP)
As at 13 December 2021, the Company's investment in DVP (formerly known as Venturex Resources Limited) shares and DVP options have increased significantly to approximately US$12.74 million (or approximately HK$99.37 million) from 31 December 2020. The Company's current fair value gain of its holding of DVP shares and DVP options together with the subscriptions and disposals of certain DVP shares during the year is approximately US$14.88 million (or approximately HK$116.06 million), representing an increase of approximately 622.59% from 31 December 2020. The fair value gain for the financial year ending 31 December 2021 is subject to change based on DVP's share price as at 31 December 2021.
About Endurance Longevity (Stock code: 0575.HK)
Endurance Longevity is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness, and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering.
About K.S. KIM International (SK-Pharma) Ltd (SK-Pharma)
K.S. KIM International (SK-Pharma) Ltd operates as part of the SK-Pharma group of companies. The main areas of focus are the registration, commercialization and marketing of pharmaceutical specialty and orphan drugs, by utilizing data driven decision and distributive marketing strategies. The group is operating in 15 countries with a main focus on the Israeli and Russian markets. For further information, please go to https://sk-pharma.com
About Fortacin™
Fortacin™ is the first solution to PE that does not act on the central nervous system and offers bona fide therapeutic efficacy that has been validated through extensive clinical trials in Europe, with over 23,500 doses delivered to trial participants. The solution is a topical spray containing low doses of lidocaine and prilocaine that take effect almost immediately upon application, giving users more control without reducing pleasure. Fully approved by the European Medicines Agency (EMA), Fortacin™ is now available in France, Germany, Italy, Portugal, Spain and the UK.
The English version of this press release shall prevail in case of any discrepancy or inconsistency between English version and its Chinese translation.
