{"id":383582,"date":"2020-11-17T20:45:59","date_gmt":"2020-11-18T01:45:59","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=383582"},"modified":"2020-11-17T20:45:59","modified_gmt":"2020-11-18T01:45:59","slug":"regent-pacific-announces-important-commercialisation-progress-on-fortacintm-senstendtm","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/regent-pacific-announces-important-commercialisation-progress-on-fortacintm-senstendtm\/","title":{"rendered":"Regent Pacific Announces Important Commercialisation Progress On FORTACIN(TM) \/ SENSTEND(TM)"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <b><br \/>\n          <u>MAINLAND <span class=\"xn-location\">CHINA<\/span><\/u><br \/>\n        <\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>Regent Pacific to receive a total payment of <span class=\"xn-money\">US$4 million<\/span> upon the receipt of approval from the National Medical Products Administration (NMPA) for conducting human trial <\/li>\n<li>\n          <span class=\"xn-location\">China<\/span> is expected to be the single largest market for Sendstend\u2122<\/li>\n<\/ul>\n<p>\n        <b><br \/>\n          <u><br \/>\n            <span class=\"xn-location\">UNITED STATES<\/span><br \/>\n          <\/u><br \/>\n        <\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>The Phase II validation study of Fortacin\u2122 in the US and submission to the FDA are expected to complete by the end of 2020 and first half of 2021 respectively <\/li>\n<li>The pivotal Phase III study in US is expected to commence in late 2021<\/li>\n<\/ul>\n<p>\n        <b><br \/>\n          <u><br \/>\n            <span class=\"xn-location\">TAIWAN<\/span>, <span class=\"xn-location\">HONG KONG<\/span>, <span class=\"xn-location\">MACAU<\/span><\/u><br \/>\n        <\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>Approval from the Taiwan FDA is expected in early 2021 <\/li>\n<li>Fortacin\u2122 is expected to launch in <span class=\"xn-location\">Hong Kong<\/span> and <span class=\"xn-location\">Macau<\/span> in 2021<\/li>\n<\/ul>\n<p>\n        <span class=\"xn-location\">HONG KONG<\/span>, <span class=\"xn-chron\">Nov. 17, 2020<\/span> \/PRNewswire\/ &#8212; <b>Regent Pacific Group Limited (&#8220;Regent Pacific&#8221; or the &#8220;Company&#8221; and together with its subsidiaries, the &#8220;Group&#8221;;<\/b> stock code: 0575.HK), a specialist healthcare, wellness and life sciences investment group is pleased to announce several important commercialisation progress on SENSTEND\u2122 (the marketing name of FORTACIN\u2122 in mainland <span class=\"xn-location\">China<\/span>), the first prescription treatment for treating premature ejaculation (PE) in mainland <span class=\"xn-location\">China<\/span>, US, <span class=\"xn-location\">Taiwan<\/span>, <span class=\"xn-location\">Hong Kong<\/span> and <span class=\"xn-location\">Macau<\/span> respectively. <\/p>\n<p>\n        <b><br \/>\n          <i>Accelerates the participation in the potentially single largest market for Senstend\u2122<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>The investigational new drug (IND) for Clinical Trial Approval (CTA) has been submitted to the Center of Drug Evaluation of the National Medical Products Administration by \u00a0Wanbang Pharmaceutical Marketing and Distribution Co., Ltd. (&#8220;Wanbang Pharmaceutical&#8221;), a wholly controlled company of Shanghai Fosun Pharma,\u00a0Regent Pacific&#8217;s commercial strategic partner in China\u00a0to seek marketing approval of Senstend\u2122 in <span class=\"xn-location\">China<\/span>. It is expected that the approval would be obtained by the end of Q1 2021. Upon receiving the approval, Regent Pacific will receive a total payment of <span class=\"xn-money\">US$4 million<\/span> (approximately <span class=\"xn-money\">HK$30 million<\/span>) from Wanbang Pharmaceutical as per the terms of the licence agreement. The payment will be divided into two terms, <span class=\"xn-money\">US$800,000<\/span> (approximately <span class=\"xn-money\">HK$6.24 million<\/span>) will be received upon the approval from NMPA to submit IND application for human clinical trial of a licensed product at NMPA. The remaining <span class=\"xn-money\">US$3.20 million<\/span> (<span class=\"xn-money\">HK$24.96 million<\/span>) will be received upon the receipt of the approval from the NMPA to conduct a human clinical trial of a licensed product or written NMPA acceptance as sufficient of provided data without need for conducting a further clinical trial.<\/p>\n<p>\n        <b><br \/>\n          <i>Crucial step towards acquiring necessary regulatory approvals in <span class=\"xn-location\">the United States<\/span><\/i><br \/>\n        <\/b>\n      <\/p>\n<p>In <span class=\"xn-location\">the United States<\/span>, The Phase II validation study of Fortacin\u2122 by the U.S. Food and Drug Administration (&#8220;US FDA&#8221;) is expected to be completed by the end of 2020, followed by the submission to the FDA in the first half of 2021.\u00a0The pivotal Phase III study is expected to\u00a0commence in the latter half of 2021, with New Drug Application (&#8220;NDA&#8221;) submission possible in late 2022, giving a Prescription Drug User Fee Act date at the end of 2023 and contribute to the acquisition of all necessary regulatory approvals needed to commercialise Fortacin\u2122 in <span class=\"xn-location\">the United States<\/span>. <\/p>\n<p>\n        <b><br \/>\n          <i>Steady progress in <span class=\"xn-location\">Taiwan<\/span>, <span class=\"xn-location\">Hong Kong<\/span> and <span class=\"xn-location\">Macau<\/span><\/i><br \/>\n        <\/b>\n      <\/p>\n<p>In <span class=\"xn-location\">Taiwan<\/span>, the Taiwan FDA (&#8220;TFDA&#8221;) has recently approved the Drug Master Files for lidocaine and prilocaine, the active pharmaceutical ingredients of Fortacin\u2122; and also, the plant master file application for the manufacturer of Fortacin\u2122. It is anticipated that the approval could be obtained from TFDA by early 2021 which will trigger a payment of <span class=\"xn-money\">US$300,000<\/span> (or approximately <span class=\"xn-money\">HK$2.34 million<\/span>) to the Group.<\/p>\n<p>In addition, Fortacin\u2122 is expected to be launched in <span class=\"xn-location\">Hong Kong<\/span> and <span class=\"xn-location\">Macau<\/span> in 2021, a delay as a result of the COVID-19 pandemic which significantly affected the number of orders. <\/p>\n<p>\n        <b><br \/>\n          <i>Product sales in the European market gradually resume to normal despite the impact of COVID-19 continues <\/i><br \/>\n        <\/b>\n      <\/p>\n<p>Since Regent Pacific&#8217;s European marketing and distribution partner for Fortacin\u2122 is based in <span class=\"xn-location\">Italy<\/span>, it has been affected by the COVID-19 pandemic. During Q3 2020, the European markets continued to be affected by the pandemic due both to the restrictions imposed to limit contagion in all territories, as well as from a cautious management of stocks by wholesalers. It is expected that the COVID-19 pandemic will continue to affect sales inQ4 2020, but with the sales activities gradually resuming to normal in the latter half of 2021. Necessary measures have been adopted so that the production and distribution activities of the product would not be affected. <\/p>\n<p>\n        <b><br \/>\n          <span class=\"xn-person\">Jamie Gibson<\/span>, Chief Executive Officer of Regent Pacific<\/b>, said, &#8220;We are glad to witness that Fortacin\u2122 \/ Sendstend\u2122 has received remarkable progress in different markets despite the impacts of the COVID-19 pandemic. We will continue to work closely and diligently with our current and prospective commercial partners and will keep shareholders and potential investors informed of any new developments as and when they occur.&#8221;<\/p>\n<p>This press release is distributed by LBS Communications Consulting Limited. <\/p>\n<p>\n        <b>About Regent Pacific<\/b>\n      <\/p>\n<p>Regent Pacific is a diversified investment group based in <span class=\"xn-location\">Hong Kong<\/span> 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 <span class=\"xn-money\">US$298 million<\/span> to shareholders in the 21 years of financial reporting since its initial public offering in May 1997.\u00a0<\/p>\n<p>\n        <b>About Fortacin\u2122 \/ Sendstend\u2122<\/b>\n      <\/p>\n<p>Fortacin\u2122 \/ Sendstend\u2122 is the first solution to premature ejaculation (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 <span class=\"xn-location\">Europe<\/span>, 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\u2122 is now available in <span class=\"xn-location\">France<\/span>, <span class=\"xn-location\">Germany<\/span>, <span class=\"xn-location\">Italy<\/span>, <span class=\"xn-location\">Portugal<\/span>, <span class=\"xn-location\">Spain<\/span> and the UK.<\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CN95787&amp;sd=2020-11-17\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/regent-pacific-announces-important-commercialisation-progress-on-fortacintm--senstendtm-301175471.html\">http:\/\/www.prnewswire.com\/news-releases\/regent-pacific-announces-important-commercialisation-progress-on-fortacintm&#8211;senstendtm-301175471.html<\/a><\/p>\n<p>SOURCE  Regent Pacific Group Limited<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CN95787&amp;Transmission_Id=202011172042PR_NEWS_USPR_____CN95787&amp;DateId=20201117\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire MAINLAND CHINA Regent Pacific to receive a total payment of US$4 million upon the receipt of approval from the National Medical Products Administration (NMPA) for conducting human trial China is expected to be the single largest market for Sendstend\u2122 UNITED STATES The Phase II validation study of Fortacin\u2122 in the US and submission to the FDA are expected to complete by the end of 2020 and first half of 2021 respectively The pivotal Phase III study in US is expected to commence in late 2021 TAIWAN, HONG KONG, MACAU Approval from the Taiwan FDA is expected in early 2021 Fortacin\u2122 is expected to launch in Hong Kong and Macau in 2021 HONG KONG, Nov. 17, 2020 \/PRNewswire\/ &#8212; &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/regent-pacific-announces-important-commercialisation-progress-on-fortacintm-senstendtm\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Regent Pacific Announces Important Commercialisation Progress On FORTACIN(TM) \/ SENSTEND(TM)&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-383582","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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