SAN FRANCISCO & TEL AVIV, ISRAEL -- (Business Wire)
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.
About Kalytera Therapeutics
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.
Cautionary Statements
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180502005572/en/
Contacts:
Kalytera Therapeutics, Inc.
Robert Farrell, 888-861-2008
President,
CEO
info@kalytera.co
or
Colwell
Capital Corp.
Graeme Dick, 1-403-561-8989
graeme@colwellcapital.com
Source: Kalytera Therapeutics, Inc.
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