[ET Net News Agency, 5 January 2021] Regent Pacific Group Limited (00575) announced
several key updates of Fortacin/Senstend, the first prescription solution to premature
ejaculation (PE) that does not act on the central nervous system, in China and the United
States respectively.
Regent Pacific received US$0.72 million (approximately HK$5.62 million) from its
commercial strategic partner in China - Wanbang Pharmaceutical Marketing and Distribution
Co., Ltd., a wholly controlled company of Shanghai Fosun Pharmaceutical (02196) to seek
marketing approval of Senstend (the marketing name of Fortacin in China) in China on 29
December 2020.
The Clinical Trial Approval (CTA) of Senstend will be reviewed by the National Medical
Products Administration (NMPA) and is expected to be obtained from the Center of Drug
Evaluation by the end of 1Q 2021.
Upon the successful approval from NMPA to commence the clinical trial, Regent Pacific
will receive a payment of US$3.20 million (approximately HK$24.96 million) from Wanbang
Pharmaceutical.
Regent Pacific will receive US$ 5 million* (approximately HK$39 million) from Wanbang
Pharmaceutical if the clinical study tentatively to be started in April/May 2021 meets its
endpoints of determining the effects of Senstend on the Index of Premature Ejaculation
(IPE) and the Intra-vaginal Ejaculation Latency Time (IELT) and to evaluate the safety and
tolerability of Senstend in Premature Ejaculation subjects and their sexual partners,
together with an import licence for Senstend granted by NMPA.
Regent Pacific will also receive US$2 million (approximately HK$15.6 million) upon the
first commercial sale of Senstend in China from Wanbang Pharmaceutical with tiered
percentage royalties on net sales, ranging from low to the high teens from first
commercial sale.
In addition, Wanbang Pharmaceutical has ordered clinical supplies from Pharmaserve
(North West) Limited (PSNW), the manufacturer of Senstend/Fortacin, with the aim of
supplies being ready for the commencement of the clinical trial. Regent Pacific has also
contracted PSNW to commence development on the commercial scale up to increase the current
batch size per each manufacturing run to 50,000 units from 15,000 units. This is designed
to meet Wanbang Pharmaceutical's requirements for China and Recordati's over-the-counter's
requirements in the European Union and the United Kingdom.
The Phase II validation study in the United States has been completed with 87 randomised
subjects. The study is targeted to submit to the United States Food and Drug
Administration (FDA) during the first half of 2021. It is expected that the pivotal Phase
III study could commence in the latter half of 2021, assuming the trial is sufficient to
convince the FDA that the Premature Ejaculation Bothersome Evaluation Questionnaire serves
as an appropriate measure for support of a label claim; with New Drug Application (NDA)
submission possible in late 2022, giving a Prescription Drug User Fee Act date at the end
of 2023. (KL)