Acquisition of Cytonet’s key assets gives Promethera access to:
• Leading liver sourcing at an industrial level through the U.S. Organ Procurement Organization network relationship
• A U.S. presence with a highly qualified team of 18 people and manufacturing facilities ready for commercial use under GMP conditions
• An additional cell therapy product Heparesc®, a pre-commercial cell therapy for the treatment of early onset Urea Cycle Disorders and a unique cell therapy technology
• A prospect of near term income generation potential both with tissue placement in the U.S. and supply of cryopreserved human liver cells to third parties
Mont-Saint-Guibert, Belgium, April 18, 2016 – Promethera Biosciences SA, a Belgian biotechnology company developing stem cell therapies for the treatment of inborn liver metabolic diseases (ILMD) and acquired liver diseases with high unmet medical needs, today announces it has acquired the key assets of Cytonet GmbH & Co KG, the international cellular therapy company involving primary human hepatocytes. This transaction will result in Promethera becoming the world’s leading and most advanced cell therapy and regenerative medicine company targeting liver diseases. Promethera acquired the Cytonet assets in exchange for Promethera shares. The Hopp family, the lead shareholder of Cytonet, will have up to 13% of the share capital after finalization of the transaction.
This business combination will result in a more diversified and broader Promethera therapeutic pipeline to address a wide range of liver diseases including large indications. These conditions include Fibrosis, Nonalcoholic Steatohepatitis (NASH), Acute on Chronic Liver Failure (AoCLF) and Hemophilia. Promethera will evaluate additional options to target Acute Liver Failure (ALF) and Liver Graft Dysfunction in the future. Promethera will continue to target orphan indications, including Urea Cyle Disorders (UCD), ILMD and A1AT Deficiency (a1-antitrypsin).
By combining the three different cell products resulting from the strategic expansion, human hepatocytes (Heparesc®) and human liver derived stem cells (HepaStem® and H2Stem®) Promethera will mitigate the overall development risk profile of its pipeline whilst strengthening its execution capacities. Adding the advanced pre-commercial stage product candidate Heparesc to the Promethera product portfolio will enable early commercialization. This is targeted for 2017 through a Canadian market approval process and recognition by other countries. There is also the potential to combine the different cellular therapy approaches to develop future liver-targeting robust treatments using cell-encapsulation technologies (a Cytonet asset), including the use of biological scaffolds.
The acquisition of the Cytonet assets will add to Promethera’s Belgian headquarters (HQ) in Wallonia a U.S. facility in Durham, NC with a team of 18 people for organ and tissue processing, product manufacturing, and world-class liver sourcing with the largest existing Organ Procurement Organizations (OPO) network in the U.S. In addition, a team of seven people from Germany will be added to Promethera Belgian HQ to support a filing of a new drug submission (NDS) for Heparesc with Health Canada. Promethera’s team as a whole and its top management is now expanded with highly experienced talents and executives with an average of over 15 years of experience in liver cell therapy, cell therapy product manufacturing and commercialization.
“This acquisition by Promethera is the result of a new vision and an ambitious strategy I introduced to the company from early 2015. This strategy was designed to make it the global leader in liver regenerative medicine with a clear goal of pipeline expansion and offering superior therapeutic options in the liver space based on solid science and innovation. This strategic transaction strengthens our position as the leading and most advanced company in this area with headquarters in Wallonia, Belgium and a solid U.S. presence. In addition, Promethera’s acquisition of Cytonet gives us access to a pre-commercialization stage product Heparesc that has a mechanism of action that complements well with our existing portfolio,” said Dr. John Tchelingerian, Chairman and CEO of Promethera. “We now also have access to a great commercially-driven management team and an experienced pool of scientific talents from Cytonet, which we will be incorporating into the Promethera family. We will announce this new management structure in due course.”
“Cytonet has developed Heparesc, a cell therapy to treat neonatal onset UCD patients and we are delighted that this development will be taken forward by Promethera,” said Dr. Torsten Hombeck, Managing Director of Cytonet GmbH & Co KG. “With the filing for market approval in Canada for Heparesc, Promethera now has the capability to quickly bring an additional important therapy to patients who otherwise have little to no treatment alternatives.”
“The acquisition by Promethera of the Cytonet assets is the key step to build the success of a comprehensive liver cell therapy that is driven by an innovative R&D engine and mindset at Promethera,” said Prof. Etienne Sokal, Founder and Chief Innovation and Scientific Officer of Promethera. “By combining the many years of experience of our new colleagues, we will address both inborn errors of metabolism in children and acquired liver diseases in adults and will cover a wide range of unmet medical needs for the entire community of liver patients.”
Promethera’s broad portfolio of product candidates, intellectual property and cell therapy technologies provides a sustainable and unique liver sourcing and processing platform to support long-term partnerships with pharmaceutical and biotech companies.
About Promethera Biosciences
Promethera Biosciences is a clinical stage pharmaceutical company that develops innovative therapies for the treatment of liver diseases with no effective therapeutic cure. Two cell therapy products, HepaStem and H2Stem , now under development, are based on the use of allogeneic progenitor cells and stem cells isolated from healthy adult human livers (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC). These cells could be used to treat a wide variety of liver diseases, from rare inborn metabolic/orphan diseases to acute on chronic liver failure, fibrosis or nonalcoholic steatohepatits in adults. HepaStem has recently and successfully completed a phase I/II clinical study in UCD and Crigler-Najjar syndrome (CNS). It has already received orphan drug designation from both the European Medicines Agency and from the U.S. Food and Drug Administration for the treatment of UCD and CNS. Promethera Biosciences is a spin-off of the Université Catholique de Louvain (UCL). Founded in 2009 by Prof. Etienne Sokal and the TTO of UCL, Sopartec, it is located in Mont-Saint-Guibert, Belgium. Promethera Biosciences currently has 32 employees led by an experienced management team.
