Notice of Business Alliance between Promethera Biosciences SA and MEDIPAL HOLDINGS

 - Bringing Innovative Liver-Focused Cell therapies to Japanese Markets -

Promethera® Biosciences SA (“Promethera®”) and MEDIPAL HOLDINGS CORPORATION (“MEDIPAL”) today announced that they have entered into a business alliance agreement. In conjunction with today’s alliance, MEDIPAL has decided to increase its shareholdings in the Promethera® Group. Details follows below.

 

The purpose of this alliance

Promethera® has been developing its lead liver cell-derived technology (HepaStem™) in an area of high medical need, primarily for Non-alcoholic steatohepatitis (NASH), Acute-on-chronic liver failure (ACLF) and urea cycle disorder (UCD). Promethera® completed the recruitment of 24 patients in its Phase IIa study in Acute-on-chronic liver failure (ACLF) in July 2019. The 3 months follow-up data were presented on 10th November at the AASLD 2019 conference (70th American Association for the Study of Liver Diseases). In addition, the Phase 2a clinical study in patients with late stage NASH with world’s first cell therapy was initiated in May 2019. MEDIPAL will support Promethera® in the commercialization of its products in Japan through the subscription to a private placement of new shares on March 20th, 2019, with the aim to expand the products it handles in the regenerative medicine field going forward.

The purpose of this alliance is to further deepen the cooperative relationship between the two companies by providing access to MEDIPAL’s know-how and capabilities in the distribution of cellular medicines at ultra-low temperatures. MEDIPAL will support Promethera®'s clinical trials and aims to provide a steady supply after its product launch.

"With about 430 cases per year, the percent of patients receiving a liver transplant in Japan is significantly lower than in the US, where some 8,000 patients receive a transplant every year. Rescue solutions for Japanese patients with fatal liver diseases are performing poorly too. An even closer partnership with MEDIPAL will support us in setting up clinical trials in Japan that could positively impact and contribute to a solution for this considerable medical need in Japan. Building on this partnership, we will accelerate the clinical development of HepaStem™ towards a subsequent market launch in Japan, which will be a meaningful new development for Japanese patients suffering from end-stage liver disease,” said Dr John Tchelingerian, President and CEO of Promethera®. “Mastering the entire supply chain is a key requirement for an off-the-shelf allogeneic cell therapy product, and MEDIPAL’s expertise and capabilities in this sector will be very valuable in this regard.”

Promethera®’s HepaStem™ program can potentially become the world’s first therapeutic product using liver stem cells for the treatment of severe liver diseases,” commented Shuichi Watanabe, Chief Executive Officer of MEDIPAL. “Liver disease prevalence is rising in Japan and around the world due to an increase in obesity and other metabolic syndromes. The need to deliver effective treatments such as Promethera®’s is expected to augment rapidly. MEDIPAL’s system enables strict temperature management and traceability by using SDDU (Specialty Drug Distribution Unit: a liquid nitrogen-based ultra-low cold chain system for drug distribution) and has an extensive expertise in this field. We are very pleased with this partnership and the opportunity to support the development and the logistics of this innovative product candidate with our capabilities.

 

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