Hyphens Pharma to develop and commercialise Byfavo® procedural sedation drug in Singapore
Singapore, 17 May 2023–Hyphens Pharma International Limited (“Hyphens Pharma”, “凯帆药剂国际有限公司”, or the “Company”, and together with its subsidiaries, the “Group”), Singapore’s leading specialty pharmaceutical and consumer healthcare group, would like to announce that its subsidiary, Hyphens Pharma Pte. Ltd., has signed an exclusive sub-license and supply agreement with Hana Pharm Co., Ltd. to develop and commercialise Byfavo® 20mg (remimazolam besylate 20mg) in Singapore.
Byfavo® is an ultra-short-acting intravenous benzodiazepine anaesthetic drug that is used to induce and maintain sedation in adults undergoing short medical procedures such as colonoscopy. Clinical data has demonstrated that remimazolam has a rapid onset and offset of action combined with a favourable cardio-respiratory safety profile1.
Mr TaeHong Choi, CEO and President of Hana Pharm, said: “We are delighted to begin new partnership with Hyphens, which has expertise in gastroenterology market. By solidifying the partnership between the two companies, we will move up approval and launching period as much as possible in Singapore, and take it as a bridgehead to enter the endoscopic procedural sedation market in other Southeast Asian countries.”
Mr Lim See Wah, Executive Chairman and CEO of Hyphens Pharma, said: “Byfavo® 20mg is a welcome addition to boost our specialty pharma segment. We are happy to develop and commercialise Byfavo® 20mg in Singapore as it strengthens our gastroenterology portfolio that consists of brands like Vivomixx®. Byfavo® is a novel agent that we can offer to gastroenterologists and colorectal surgeons who perform colonoscopies. Byfavo® works quickly after administration, with rapid recovery and less drowsiness and grogginess after a procedure. Its favourable safety profile helps to reduce the risk of complications and adverse events during and after a procedure.”
In the U.S., a comprehensive Phase III clinical programme for procedural sedation was conducted, where the safety and efficacy of Byfavo® was evaluated in three pivotal studies involving patients either undergoing colonoscopy (two studies) or bronchoscopy (one study).
Byfavo® 20mg was approved in South Korea for procedural sedation in adults in 2021 and has been approved by other key agencies including U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2020 and 2021 respectively. It has also been commercialised in these three markets.
The exclusive sub-license and supply agreement will not have a material effect on the net tangible assets or earnings per share of the Group for the financial year ending 31 December 2023.
1In the human body, remimazolam is rapidly metabolised to an inactive metabolite by tissue esterases and not metabolised by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anaesthesia, if necessary.
About Hana Pharm Co., Ltd.
Hana Pharm, founded in 1996 is a public listed (KOSPI, 293480), science-led and fully integrated pharmaceutical company with proven track record for R&D and in-licensing of innovative new drug candidates for commercialisation in South Korea.
With sales revenue of approximately US$160 million in 2022 and operating profit margin of 15%, Hana Pharm can be seen as a rapidly growing and one of the most profitable pharmaceutical companies with a deep-rooted heritage in opioid analgesics and anaesthetic agents.
There are approximately 674 employees as of December 2022, and this specialty company is continuously strengthening its product portfolio in the major therapeutic areas such as Pain, Anaesthesia, Cardiovascular, Gastrointestinal, Respiratory system, etc.
For more information, please visit www.hanaph.co.kr/eng/index.do
About Hyphens Pharma International Limited
Hyphens Pharma International Limited and its subsidiaries (the “Group“) is Singapore’s leading specialty pharmaceutical and consumer healthcare group, leveraging on its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 10 other markets – Bangladesh, Brunei, Cambodia, China, Hong Kong S.A.R., Macau S.A.R., Myanmar, Oman, South Korea and Sri Lanka.
Singapore is the Group’s regional headquarters, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group’s core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients’ homes.
For more information, please visit www.hyphensgroup.com
Issued on behalf of Hyphens Pharma International Limited
For media enquiries, please contact:
Mr Derek Chng, Tel: (65) 6704 9285, Mob: (65) 9638 8635, Email: [email protected]
Mr Gerald Woon, Tel: (65) 6704 9268, Mob: (65) 9694 8364, Email: [email protected]
This media release has been reviewed by the Company’s sponsor, SAC Capital Private Limited (the “Sponsor”). It has not been examined or approved by the Singapore Exchange Securities Trading Limited (the “SGX-ST”) and the SGX-ST assumes no responsibility for the contents of this media release, including the correctness of any of the statements or opinions made or reports contained in this media release.
The contact person for the Sponsor is Ms Lee Khai Yinn (Tel: (65) 6232 3210) at 1 Robinson Road, #21-00 AIA Tower, Singapore 048542.