Friday, May 20, 2016
Regent Pacific Group Limited, a healthcare and life sciences investment group, is pleased to announce that on 17 May 2016 the European Medicines Agency (“EMA”) approved the Group’s Type IB variation for a reduced dose can version of PSD502®, a prescription treatment for premature ejaculation. The variation approval, which includes the addition of Pharmaserve (North West) Ltd (“PSNW”) as a European Union (“EU”) located manufacturer of the reduced dose PSD502® spray, triggers a €6 million payment from the Group’s commercial partner Recordati S.p.A. (“Recordati”) and brings total payments to €11 million.
The approval enables the Group to commence manufacturing activities with its partner PSNW in the coming months, paving the way for full scale commercial launch of the reduced dose can in the United Kingdom around November 2016, with continental Europe to follow shortly thereafter.
Under the terms of the Group’s licence agreement with Recordati, a payment of up to €10 million in total will also be payable upon the first commercial sales of PSD502® in France, Germany, Italy, Spain and Portugal, which comprises payments of €2 million in respect of each of these countries.
Jamie Gibson, CEO of Regent Pacific said, “We are delighted to have obtained variation approval in the EU for our reduced dose PSD502® Premature Ejaculation spray before our deadline of 30 June 2016, and importantly, without the need to submit additional details to the EMA. This milestone represents the final step in the successful commercialization of a product that will potentially transform the lives of millions of men around the world. Furthermore, it triggers another significant payment from Recordati and marks the start of an attractive flow of royalty payments as we build sales in Europe later this year.
“The Group continues to focus on out-licensing in other major territories and on the submission for approval by the Food and Drug Administration within the USA, and looks forward to providing updates to the market on both fronts in the near term.”
About Regent Pacific
Regent Pacific is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare and life sciences sectors. Its wholly-owned subsidiary, Plethora Solutions Holdings Plc, is a specialty pharmaceutical company whose core product PSD502® is the first EU approved topical prescription treatment for Premature Ejaculation, set to launch in EU in the latter half of 2016. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 18 years of financial reporting since its IPO.For further information, please contact:
Finsbury
James Hill Karen Yu
t : 3166 9888 t : 3166 9866
e : james.hill@finsbury.com e : Karen.yu@finsbury.com
