Orgenesis Announces License Agreement with HekaBio in Japan
GERMANTOWN, Md., Oct. 04, 2018 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS), a manufacturer, service provider and developer of advanced cell therapies, today announced that it has entered into a License Agreement with HekaBio K.K., pursuant to the Joint Venture Agreement the parties entered into on July 10, 2018. Under the License and Joint Venture Agreements, HekaBio and Orgenesis will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic products in Japan.
In consideration for the License, HekaBio shall pay Orgenesis royalties equal to ten percent (10%) of all net sales and twelve percent (12%) of any sublicense receipts. Under the License and Joint Venture Agreements, HekaBio will fund, at its sole expense, all costs associated with obtaining the requisite regulatory approvals for conducting clinical trials, as well as performing all clinical and other testing required for market authorization of the products in Japan.
Rob Claar, CEO, of HekaBio, commented, “We look forward to rapidly advancing the clinical and commercial development of Orgenesis’ cell therapies in the Japanese market. We believe that Orgenesis is at the forefront of the regenerative medicine industry, pioneering technologies that could potentially have broad application across many indications, including diabetes, as well as other autoimmune diseases. Japan represents a significant market opportunity for cell therapies. Importantly, we believe that Japan has a favorable regulatory environment allowing, in some cases, a conditional market approval following safety trials, which may help to accelerate our path to commercialization.”
Vered Caplan, CEO of Orgenesis, further commented, “We are delighted to partner with HekaBio, which has an in-depth understanding of the cell therapy environment in Japan. We appreciate both the operational and financial support HekaBio plans to provide. HekaBio specializes in product in-licensing, clinical and regulatory development, as well as commercialization, which will help facilitate our entry into the cell therapy market in Japan.”
Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and support services. Through its Israeli subsidiary, Orgenesis Ltd., Orgenesis is developing technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, Insulin Producing Cells (IPCs). Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. Through its Masthercell Global subsidiary, a global contract development and manufacturing organization (CDMO), Orgenesis is able to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modeling, GMP manufacturing, process development, and quality management, Masthercell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients. Masthercell operates in a validated and flexible facility located in the strategic center of Europe within the Walloon healthcare cluster, Biowin. This integrated approach supports the Company's business philosophy of bringing to market significant life-improving medical treatments. For more information, visit www.orgenesis.com.
HekaBio’s mission is to connect world-leading healthcare innovations to unmet medical needs in Japan, with broad category development expertise in pharma, medical device, diagnostics and cell & gene therapies. HekaBio targets innovations in oncology, CNS and autoimmune disease that have high potential for significant therapeutic benefit and healthcare cost reduction. For more information, visit www.hekabio.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act of 1934, as amended t. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended November 30, 2017, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.
Contact for Orgenesis:
Crescendo Communications, LLC
Contact for HekaBio:
Mari Tanaka, Corporate Communications
Released October 4, 2018