Date: 2016-06-24
Type of information: Licensing agreement
Compound: remimazolam
Company: Paion (Germany) Cosmo Pharmaceuticals (Ireland)
Therapeutic area: CNS diseases
Type agreement: licensing
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:
Details:
- • On June 24, 2016, Paion and Cosmo Technologies, a subsidiary of Cosmo Pharmaceuticals entered into a license agreement for remimazolam. The agreement grants Cosmo Technologies an exclusive license for the development and commercialization of Paion’s lead drug candidate in the United States. Under the terms of the license agreement, Cosmo has the right to further develop and commercialize remimazolam in the U.S., while bearing all future associated costs for market authorization and distribution. However, Paion will be responsible for and bear the cost associated with the completion of the ongoing U.S. trials in procedural sedation. At the same time, Granell Strategic Investment Fund Limited , another subsidiary of Cosmo, entered into an investment agreement with Paion , pursuant to which it has committed to invest € 10 million in shares of Paion. In this context, Paion resolved to issue 5,064,194 new shares of Paion at a price of €1.90 per share (5-day VWAP) for a total of € 9.6 million to Granell under exclusion of shareholders’ subscription rights. The remaining amount of € 0.4 million will be invested at a later date. Upon completion of the private placement, which is expected to occur on 29 June 2016, Granell will hold approximately 9% in Paion's issued share capital. Under the Investment Agreement, Paion has undertaken, subject to approval by the company’s shareholders’ meeting, to cause the appointment of one supervisory board member proposed by Cosmo to the company’s supervisory board.
Financial terms:
- Under the license agreement, Paion will receive a € 10 million upfront licence fee payment. In addition, Paion is entitled to receive additional payments of up to € 42.5 million contingent upon certain milestones related to the U.S. regulatory approval process and, upon commercialization of remimazolam in the U.S., following regulatory approval, tiered royalties on net sales in the U.S. ranging from 20% to 25%, which may be adjusted under certain conditions but not to below 15% of net sales.
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Is general: Yes
