The UK’s CeNeS Pharmaceuticals has announced positive late-stage data for M6G, its lead product, which is for the treatment of post-operative pain.
The company said that preliminary results of a pan-European Phase III trial of M6G (morphine-6-glucuronide) in 517 patients “has delivered very strong results” and shows its benefits over morphine in the management of post-operative patients, as it reduces nausea and vomiting.
CeNeS’ chief executive Neil Clark said that the firm intends to file an investigational New Drug Application for M6G with the US Food and Drug Administration in the next few weeks, claiming that “ it has a substantial data package that differentiates M6G from morphine which will be attractive to a larger pharma partner to licence.”
The company noted that it has commissioned “a number of qualitative market research studies on M6G,” support CeNeS’ view that potential global peak sales of the compound in post-operative pain could reach $400 million. It added that it is in discussion with a number of potential partners and the data that has been unveiled will help CeNeS “secure valuable licensing agreements for Europe and North America with partners able to offer strong specialist marketing capabilities within the hospital sector.”
The firm concluded by saying that with any licensing agreement, it is interested in the possibility of retaining promotion or co-promotion rights within certain territories.
