SAN FRANCISCO and TEL AVIV, Israel, Oct. 02, 2019 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF) (the “Company” or “Kalytera“) is pleased to announce that the European Patent Office has issued a Notice of Allowance for EU Patent Application Number 14791611.8 covering the use of cannabidiol (â€śCBDâ€ť) in the treatment of graft versus host disease (â€śGVHDâ€ť). Kalytera has exclusive worldwide rights to this patent through an Exclusive License Agreement with MOR Research Applications, Ltd. of Israel.
Securing a European patent for this proprietary technology represents an important step forward for Kalytera in its program to develop and commercialize CBD for prevention and treatment of this serious and life-threatening disease.
â€śWe are delighted to receive this Notice of Allowance from the European Patent Office,â€ť said Robert Farrell, J.D., Kalyteraâ€™s President and Chief Executive Officer.Â “Patients receiving bone marrow transplants are at high risk of developing acute GVHD, a complication that occurs when the transplanted donor cells attack the patientâ€™s organs, including the skin, GI tract, liver, lungs, and eyes. There are currently no FDA approved therapies for the prevention of acute GVHD.â€ť
To complete the procedures for issuance of this EU patent, Kalytera must prepare and file translations of the patent claims into French and German. Kalytera will complete these procedures prior to the January 2020 deadline, and expects that the EU patent will issue shortly thereafter. This will be the third issued patent that Kalytera will have received for the use of CBD in the prevention and treatment of GVHD. In April and May last year, Kalytera announced that it had received notice of issuance from the U.S. Patent and Trademark Office for its two U.S. patents covering the use of CBD in the prevention and treatment of GVHD. In addition to its U.S. and EU patents, Kalytera has also obtained four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe.
Kalytera acquired its program in the prevention and treatment of GVHD in February 2017 through the acquisition of Talent Biotechs, Ltd. of Israel (â€śTalentâ€ś). Under its agreement with the former Talent shareholders, Kalytera is obligated to make additional contingent payments to the former Talent shareholders upon the achievement of certain milestones, including upon the issuance of patents by the EU Patent Office. Upon the issuance of the EU patent, Kalytera will become obligated to make an additional cash payment to the former Talent shareholders. The amount of such additional payment is currently under discussion and negotiation between Kalytera and the former Talent shareholders.
Potential Out-License of GVHD Program to Corporate Partner
Kalytera is pursuing a corporate partnering strategy for its GVHD program, primarily because this could be a source of non-dilutive financing for the planned Phase 3 clinical study that will begin next year, as well as a source of potential revenues from up-front license fees, milestone payments and royalties. The Company is responding to due diligence requests from potential partners, and has engaged Echelon Wealth Partners to assist in managing this process.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on the prevention and treatment of GVHD.
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Robert Farrell President, CEO