Date: 2016-12-21
Type of information: Licensing agreement
Compound: remimazolam
Company: Paion (Germany) Yichang Humanwell Pharmaceutical (China)
Therapeutic area: CNS diseases
Type agreement: licensing - development - manufacturing - production - commercialisation
Action mechanism:
- benzodiazepine derivative. Remimazolam is a short-acting general anaesthetic/sedative. Sedatives are used, for example, in endoscopic procedures such as colonoscopies. After intravenous administration remimazolam rapidly induces the desired sedation. Importantly, this sedative effect quickly disappears. This rapid offset of the effect of the substance is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body. Remimazolam is being developed as a sedative agent for day case procedures (procedural sedation) as well as for the induction and maintenance of anaesthesia. It could also be used as a sedative for patients in the Intensive Care Unit (ICU).
Disease: sedation
Details:
- • On March 22, 2012, Paion and Yichang Humanwell Pharmaceutical Co. Ltd, China have entered into an exclusive license option agreement for Remimazolam which gives Yichang exclusivity to negotiate with Paion a licence for the development, manufacture and commercialization in the territory of People's Republic of China for an undisclosed option fee. Apart from China Paion is currently exploring cooperation opportunities for the territories outside Japan, where the compound is partnered with Ono Pharmaceuticals. Cooperations are vital for Paion in order to be able to progress the further development of Remimazolam as soon as possible.
Financial terms:
- By concluding the license Paion receives upfront payments totalling € 3 million. These consist of payment for the option in the amount of € 0.3 million (received in April 2012), € 1.5 million are due by the signing of the license agreement and additional € 1.2 million is payable upon completion of technology transfer (reproduction of a small scale manufacturing process) but no later than June 2013. In addition, milestone payments and royalties of 10% have been agreed. The amount of future milestone payments will depend on the eventual development strategy for remimazolam selected by Yichang in China and has a volume of up to € 4million.
Latest news:
- • On December 21, 2016, Paion announced that its Chinese remimazolam licensing partner Yichang Humanwell informed the company that their second Phase I study started in September 2016 has successfully completed recruitment. This Phase I study has tested various infusion rates of remimazolam in healthy Chinese volunteers in order to prepare further studies in general anesthesia. A Phase II study in procedural sedation in China will start shortly.
• On September 6, 2016, Paion announced that its Chinese remimazolam licensing partner Yichang Humanwell has informed Paion that their first Phase I study started in
October 2015 has completed recruitment. In addition Yichang Humanwell has started a second Phase I study with continuous infusion in order to prepare a study in general anesthesia. A Phase II study in procedural sedation in China is in preparation. Yichang Humanwell initially planned to develop remimazolam for general anesthesia for the Chinese market but has now decided to develop remimazolam in procedural sedation as well. The rights to develop and market
remimazolam for the Chinese market were granted to Yichang Humanwell in 2012.
- The completed Phase I study tested a range of single bolus doses of remimazolam in healthy volunteers. The next Phase I study will test various infusion rates of remimazolam, again in healthy Chinese volunteers.
- The Phase II study will be performed with patients undergoing various short procedures where sedation is required and a range of bolus doses of remimazolam will be tested to identify a safe and effective dose for future studies.
- • On March 6, 2013, Paion has announced that based on the license agreement signed with Yichang in July 2012 further €1.2 million are now due to the successful completion of the remimazolam technology transfer.
• On July 18, 2012, Paion and Yichang Humanwell Pharmaceutical have entered into a license agreement for remimazolam which gives Yichang an exclusive licence for the development, manufacture and commercialization in the territory of People's Republic of China.
Is general: Yes
