Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera“) today announced that the U.S. Patent and Trademark Office (“USPTO“) issued U.S. Patent No. 9,956,182 with claims covering the use of cannabidiol (“CBD“) for the prevention and treatment of acute and chronic forms of graft versus host disease (“GVHD“). Kalytera has exclusive worldwide rights to this issued patent through an Exclusive License Agreement with MOR Research Applications, Ltd. of Israel (“Mor”).
GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life and death.
In November 2017, Kalytera announced that it had received notice from the USPTO that the application for this patent would be allowed. The issuance of this patent by the USPTO is the final step in the patent application process, and provides patent coverage to Kalytera for the use of CBD in the prevention and treatment of acute and chronic forms of GVHD through May 2034 under the Exclusive License Agreement with Mor.
This is the second patent covering the use of CBD in GVHD that Kalytera has received in the past three weeks. On April 19, Kalytera announced that the USPTO had issued U.S. Patent No. 9,889,100 B2 with claims covering the use of CBD for the treatment of severe and refractory GVHD.
“We are delighted by the issuance of this second patent for CBD in the treatment and prevention of GVHD,” said Robert Farrell, President and CEO of Kalytera. “We now have very strong intellectual property protection that will provide us with market exclusivity for the use of CBD in GVHD through early 2034.”
Mr. Farrell went on to state that, “Our program for prevention of GVHD is in Phase 2 clinical testing, and later this year we will begin a Phase 3 pivotal registration study in the treatment of GVHD. With our GVHD program advancing into the final phases of clinical testing, we will now begin seeking regional partners for commercialization of this product outside of North America. Such partnering agreements can provide non-dilutive sources of funding through licensing, milestone and royalty revenue opportunities.”
The commercial opportunity for Kalytera’s CBD product in the treatment and prevention of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential size of the market for a successful product in the seven major jurisdictions (the U.S., Germany, France, Italy, Spain, the U.K. and Japan) is estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027.
Kalytera acquired its program in the prevention and treatment of GVHD in February 2017 through the acquisition of Talent Biotechs, Ltd. of Israel (“Talent“). 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 USPTO. Upon the earlier issuance of U.S. Patent No. 9,889,100 B2 by the USPTO, Kalytera became obligated to make a payment to the former Talent shareholders of 2,883,535 common shares, and a cash payment of USD $2 million. With the issuance of U.S. Patent No. 9,956,182 by the USPTO, Kalytera is now obligated to make an additional cash payment to the former Talent shareholders of USD $2 million.
Kalytera Therapeutics, Inc. (“Kalytera“) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on graft versus host disease and the treatment of acute and chronic pain.
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This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected, or at all, or may produce unfavourable results, and the risk that applicable regulatory approvals may not be obtained in a timely manner or at all. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.