Hyphens Pharma Limited, Singapore’s leading specialty pharmaceutical and consumer healthcare group, 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.
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.”
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 profile.
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.
