PROMETHERA Biosciences S.A./N.V. And LifeLiver Sign Strategic Alliance To Develop Liver Disease Therapeutics In South Korea

MONT-SAINT-GUIBERT, Belgium & SEOUL, South Korea--(BUSINESS WIRE)--Promethera Biosciences SA, the world-leading cell therapy and regenerative medicine company targeting liver diseases, and LifeLiver, the Korean leader in the field of treatment of severe liver diseases, today announced a strategic alliance to jointly develop Promethera’s suite of cell-based liver disease therapies in South Korea.

“LifeLiver, which also participated strategically in Promethera’s Series C financing extension round, represents the ideal partner to approach the South Korean market early on given their strong position and network in their home market.”

This alliance initially includes:

(a) a licence agreement for HepaStem and H2Stem to develop and commercialize these platforms in Promethera’s main indications in NASH and ACLF in Korea and

(b) a supply agreement to provide Heparesc^® for LifeLiver’s proprietary bioartificial liver (BAL) system.

Promethera and LifeLiver will collaborate on the clinical development of Promethera’s and LifeLiver’s product applications. Initially, LifeLiver will combine Promethera’s human mature hepatocytes liver cell suspension, Heparesc^®, with its proprietary bioartificial liver (BAL) system for the ex vivo treatment of patients with severe liver diseases such as Acute Liver Failure. The therapeutic goal of this approach would be to “humanize” the BAL bioreactor and to boost supply of hepatocytes. Future directions of this strategic alliance will involve other indications currently clinically investigated by Promethera such as urea cycle disorders and will include the HepaStem and H2Stem technologies.

“This alliance represents a great opportunity for Promethera to shape the global commercialization strategy for our novel cell-based therapeutics. Even more importantly, the partnership offers us a way to benefit from the positive environment for such cutting-edge therapies and regenerative medicine in Korea and to drive the development of our novel platforms in this key market,” said Dr. John Tchelingerian, CEO of Promethera Biosciences. “LifeLiver, which also participated strategically in Promethera’s Series C financing extension round, represents the ideal partner to approach the South Korean market early on given their strong position and network in their home market.”

“Combining our bio-artificial liver (BAL) system with Promethera’s current and next-generation human liver-derived cell-based therapies opens up unique future product opportunities to serve patients in Korea in an innovative way. We look forward to combining our expertise with Promethera’s to bring breakthrough cell-based ex vivo and in vivo treatment options to the Korean market,” said Mr. Ha Young Kim, CEO at LifeLiver. “Hepatocytes are among the most difficult cells to preserve for a longer time period. For this reason, having a supply agreement in place with Promethera will allow us to humanize and maintain our BAL technology in a ready-to use state for any emergent clinical situation.”

Promethera’s suite of technologies is designed to intervene in different stages and processes that lead to liver disease:

• Heparesc^® is Promethera’s most advanced pre-commercial product with a New Drug Submission for the Urea Cycle Disorders indication in Canada expected for early 2017. The cell technology is comprised of liver-derived mature hepatocytes (HHLivC). Heparesc allows for the treatment of several patients with one donated liver.
• HepaStem is Promethera’s lead stem cell product in clinical development. The cell therapy product is comprised of Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC). It displays multiple modes of action including anti-inflammatory, anti-fibrotic effects and immunomodulation.
• H2Stem is Promethera’s follow-on hepato-biliary stem cell product currently in pre-clinical development with different features compared to HepaStem.

Financial details of the license and supply agreements were not disclosed.

About Promethera Biosciences

Promethera Biosciences is a clinical stage biopharmaceutical company and the global leader in cell therapy and regenerative medicine for the treatment of inborn and acquired liver diseases with no effective therapeutic cure. Promethera uses allogeneic progenitor cells, stem cells and mature hepatocytes that are harvested and purified from non-transplantable, healthy human livers (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC and Heterologous Human Liver Cells, HHLivC). These technologies have resulted in the development of three different cell products, HepaStem and H2Stem (progenitor/stem cells) and Heparesc^® (mature hepatocytes). Promethera specializes in the development of therapeutic options for the treatment of a broad variety of liver diseases. These range from orphan indications, such as rare inborn metabolic diseases including urea cycle disorders (UCD) to large indications such as acute-on-chronic liver failure (ACLF), and nonalcoholic steatohepatits (NASH)/fibrosis.

Promethera Biosciences is a spin-off of the Walloon Region-based Université catholique de Louvain (UCL) and was founded in 2009 by Prof. Dr. Etienne Sokal and Sopartec, the tech transfer office (TTO) of UCL. Promethera is headquartered in Mont-Saint-Guibert, Belgium with a U.S. based operation and a GMP compliant manufacturing facility in Durham, NC, US. For more information, visit www.promethera.com.

About LifeLiver:

LifeLiver Co, Ltd is a biotechnology company with over seventeen years of research and development experience dedicated to developing renovative biotherapeutics. LifeLiver’s technologies include bioartificial liver (LifeLiver™), hair follicle cell therapy, and surgical hemostats. The company’s lead technology, LifeLiver™, has received investigational orphan designation and is currently undergoing Phase I/IIa clinical trials with Samsung Medical Center in South Korea. LifeLiver™ is an extracorporeal liver support system that provides a bridge to transplant for patients who are unable to receive timely liver transplantation. With the use of spherical aggregate culture and gel bead immobilization techniques, LifeLiver™ has shown remarkable detoxification capacity and sustained hepatic function.

LifeLiver Co, Ltd was founded in 2009 and is located in Seongnam, South Korea. For more information, please visit www.life-liver.co.kr.