Agreements

Date: 2017-08-07

Type of information: Licensing agreement

Compound: remimazolam

Company: Paion (Germany) R-Pharm (Russia)

Therapeutic area: CNS diseases

Type agreement:

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).
• Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm respectively. For all other markets, remimazolam is available for licensing.

Disease: sedation, general anaesthesia

Details:

• • On October 30, 2013, Paion and R-Pharm have entered into a license agreement for remimazolam which gives R-Pharm an exclusive licence for the development, manufacture and commercialization in the territory of Russia and CIS. R-Pharm will manage the development and marketing approval process in the Territory. R-Pharm intends to market remimazolam in all indications with the lead indication anaesthesia and plans to start a bridging study in anaesthesia as soon as possible.

Financial terms:

• Paion will receive an upfront payment in the amount of € 1 million, potential milestone payments of up to € 3 million and low double digit royalties on net sales in the Territory.

Latest news:

• • On August 7, 2017, Paion announced that its Russian remimazolam licensing partner R-Pharm has informed the company that their first Phase III trial in general anesthesia has started recruitment. The Phase III is a multicentre, single-blind randomized comparative clinical trial of efficacy and safety of remimazolam and propofol in 150 surgery patients undergoing general anesthesia. The trial will be recruited in Russia. • On June 17, 2014,Paion and R-Pharm announced that they have extended their license agreements for remimazolam to include the "MENA Region" (Middle East and North Africa). TR-Pharm, based in Istanbul, an affiliate of Moscow based remimazolam licensee R-Pharm, will manage the development and marketing approval process in the "MENA Region". Paion will receive an upfront payment in the amount of € 1.5 million, potential regulatory and commercial milestone payments of up to € 5.5 million and low double digit royalties on net sales in the Territory. TR-Pharm intends to market remimazolam in all indications with the lead indication anaesthesia and expects an earliest launch of Remimazolam in 2016.
• • On November 26, 2013, Paion and R-Pharm hav announced that they have extended their license agreement for remimazolam to include Turkey. TR-Pharm, based in Istanbul, is an affiliate of Moscow based remimazolam licensee R-Pharm. TR-Pharm will manage the development and marketing approval process in Turkey. TR-Pharm intends to market remimazolam in all indications with the lead indication anaesthesia and plans to start a bridging study in anaesthesia as soon as possible with an expected launch of remimazolam in 2016.

Is general: Yes