Date: 2013-10-28
Type of information: Licensing agreement
Compound: remimazolam
Company: Paion (Germany) Hana Pharmaceutical (South Korea)
Therapeutic area: CNS diseases
Type agreement: licensing
development
production
commercialisation
Action mechanism: 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, general anaesthesia
Details: * On October 28, 2013, Paion and Hana Pharmaceutical have announced that they have entered into a license agreement for remimazolam which gives Hana Pharm an exclusive licence for the development, manufacture and commercialization in the territory of South Korea. Hana Pharm will manage and finance the development and marketing approval process in South Korea. Hana Pharm intends to market Remimazolam in all indications with the lead indication anaesthesia and with an expected launch of Remimazolam in 2016.
* On July 2, 2013, Paion and Hana Pharmaceutical Co have announced that they have entered into an exclusive license option agreement for remimazolam which gives Hana Pharm exclusivity to negotiate with Paion a licence for the development, manufacture and commercialization in the territory of South Korea for an option fee of € 300.000. If both parties successfully execute a final licensing agreement within a certain exclusivity period, Paion will be eligible to receive upfront payments of € 1 million, potential milestone payments of up to € 2 million and 10% royalties on sales in the Korean market. The option fee of € 300,000 will be deducted from the upfront payment.
Remimazolam is available for licensing outside Japan, China and South Korea, where the compound is partnered with Ono Pharmaceutical and Yichang Humanwell and Hana Pharm has an exclusive option.
Financial terms: By concluding the license PAION receives upfront payments totalling € 1 million. These consist of payment for the option in the amount of € 0.3 million (received in July 2013), and € 0.7 million are due by the signing of the license agreement. In addition, potential milestone payments of up to € 2 million and 10% royalties on sales in the South Korean market have been agreed.
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