Promethera Biosciences SA announced Health Canada has confirmed a cGMP compliance status for the company’s production facility in Durham, North Carolina. The Durham facility will be focused on developing and producing the starting material of HepaStem as a treatment for chronic liver disorders such as Non-alcoholic steatohepatitis (NASH) and Acute-on-chronic liver failure (ACLF). As part of this strategy, the company has decided on a full out-licensing of the Heparesc program to a commercial partner, and hence cancelled its New Drug Submission (NDS) before a final decision was reached by Health Canada in order to keep full negotiation flexibility with a future partner.
“The confirmation of our Durham factory’s cGMP compliance status brings us a step closer to commercial capabilities for the production of our HepaStem treatment,” says John Tchelingerian, PhD, President & CEO of Promethera Biosciences SA. “HepaStem’s multiple mechanisms of action could be a potential alternative to reverse the NASH disease process forming a possible solution for the damage inflicted by advanced NASH or other chronic liver diseases that can lead to ACLF. With our new focus, we decided the time was right to bring in a commercial partner that would carry the Heparesc technology across the regulatory finish line.”
“Our experienced manufacturing and quality teams in the US continue to work in line with very high-quality standards, as evident in our cGMP status confirmation, helping the site continue to play an important role in the overall group structure,” said Mark Johnston, Managing Director, Promethera Biosciences.