Kalytera to Enter Medical Cannabis Market With Focus on Treatment of Psoriasis and Menstrual Cramps
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the "Company" or "Kalytera") today announced
that it has entered into an agreement with Beetlebung Pharma, Ltd. ("BPL") for an option to acquire all rights to medical
cannabis products in development by BPL for the treatment of both dermatologic diseases and women's health.
Under this agreement, Kalytera will have the option to license from BPL certain proprietary medical cannabis formulations, which
can initially be brought to market in jurisdictions that have already approved access to cannabis for medical purposes. Kalytera
believes that this will provide a more near-term path to revenues, compared with the lengthier process required for
commercialization following FDA approval.
The collaboration with BPL will bring together Kalytera's expertise in clinical pharmaceutical development, with BPL's
proprietary cannabis technology. Kalytera is a leader in the development and commercialization of cannabinoid pharmaceuticals with
a late-stage clinical program in the prevention and treatment of acute graft versus host disease, and BPL is an Israeli-based
pharmaceutical discovery company conducting world-class research and development in the field of cannabinoid and cannabis-based
therapeutics, with specific expertise in the development of novel formulations of cannabis extract.
“Research has demonstrated that medical cannabis possesses extraordinary therapeutic potential,” stated Robert Farrell,
President and CEO of Kalytera. “However, many of the medical cannabis products currently available have not been shown to be safe
and effective in treatment of specific diseases. There have been few, if any, clinical trials to date conducted in compliance
with GCP standards supporting the safety and efficacy of these products. Kalytera and BPL intend to address these issues and bring
to market proprietary medical cannabis formulations for the treatment of dermatologic diseases and women's health that will meet
the standards of the pharmaceutical industry.”
The strategic aim of the alliance is to expedite development and commercialization of efficacious and low cost medical cannabis
products that can be marketed in jurisdictions such as Australia, Canada, Germany and Israel, where access to medical cannabis has
been legalized.
Kalytera and BPL are already collaborating in the development of a novel cannabinoid-based compound for the treatment of acute
and chronic pain. Patents for this compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an
exclusive, worldwide license for this compound from BPL (the “Pain Therapeutic License”).
BPL is in the process of preparing patent applications for Canada, the U.S. and other jurisdictions that will cover all
compounds invented by BPL in the fields of dermatologic diseases and women's health. Following each such patent filing, Kalytera
may exercise its option to acquire from BPL an exclusive worldwide license for the patent pending compound.
The terms of such license will be substantially similar to the terms of the Pain Therapeutic License. To secure the exclusive
option from BPL, Kalytera has paid BPL an initial fee of US$25,000. If it exercises its option to license, Kalytera will pay an
additional US$25,000 plus any historical patent costs, royalties equal to a single-digit percentage of Net Sales (as defined in the
license agreement), sublicensing fees in the event that Kalytera sublicenses its rights under the license and future contingent
milestone payments payable in cash. Kalytera would also enter into a sponsored research contract with BPL under which BPL would
design, manage and conduct a clinical study of patients (likely in Canada and/or Israel) designed to provide data to be used to
market products covered by the license.
“We are pleased and excited to announce this new alliance,” said Robert Farrell. “BPL is doing world-class research and
development work in the field of cannabinoid and cannabis-based therapeutics, and this alliance will expand our existing
collaboration beyond the field of pain.”
Kalytera’s Exclusive Option to License Proprietary Medical Cannabis Formulation for the Treatment of
Psoriasis
The initial dermatologic product that Kalytera has obtained an option to license from BPL for commercialization on a worldwide
basis is a topical medical cannabis extract for the treatment of psoriasis. Kalytera expects to initially commercialize this
product in Canada.
The global psoriasis drug market is expected to be valued at US$21.4 billion by 2022, according to a new market
research report by Grand View Research, Inc., and the rising prevalence and incidence of psoriasis is anticipated to fuel the
market’s growth.
Severe psoriasis is currently treated with monoclonal antibody therapeutics costing more than US$25,000 per year, and Kalytera
will seek to bring to market a potentially safer, more effective, and less expensive medical cannabis extract for the treatment of
severe psoriasis.
A research review conducted by researchers at the University of Colorado Anschutz Medical Campus, and recently published in the
Journal of the American Academy of Dermatology, concluded that cannabinoids are effective against psoriasis. However, an obstacle
to effective transdermal treatment of psoriasis is the barrier property of the stratum corneum, the outer layer of skin. The
stratum corneum is a thick tissue layer comprising a structured lipid/protein matrix that acts as a barrier for uptake of topically
administered agents. Drug formulations with a particle size exceeding 500 nanometers in diameter are unable to penetrate the
stratum corneum. Most topical cannabis formulations, such as those prepared with coconut oil, which typically have a droplet size
of 1,000–10,000 nanometers, are thus far too large to penetrate the stratum corneum barrier and are of no clinical benefit.
In contrast, medical cannabis extract for treatment of psoriasis developed by Kalytera is expected to have a particle size of
approximately 80 nanometers. If successfully developed, this formulation would be the first in its class intended to allow the
whole-plant resin to pass through the stratum corneum barrier, and to diffuse into the stratum basale (the lowest layer of the
epidermis), where the cannabis compounds are expected to bind to the CB1 and CB2 receptors in the skin, muscle tissue, immune
cells, and sensory nerves. Binding of cannabinoids to these receptors has been demonstrated to reduce inflammation and hyper
proliferation of cells, both of which are the hallmarks of the psoriatic disease process.
To further improve uptake of the cannabis extract, Kalytera intends to enhance the formulation with select naturally-occurring
terpene and sesquiterpene compounds from the cannabis plant that are often lost during the extraction process. This approach should
allow large amounts of terpenes and sesquiterpenes to be co-administered along with the cannabis extract. These terpenes and
sesquiterpenes may contribute to an entourage effect, thereby potentially improving the effectiveness of the cannabis extract.
Kalytera’s Exclusive Option to License Proprietary Sustained Release Medical Cannabis Formulation for the
Treatment of Menstrual Cramps
In the area of women's health, the initial product that Kalytera has obtained an option to license is a medical cannabis extract
for the treatment of severe menstrual cramping, a condition known as dysmenorrhea. Kalytera intends to initially commercialize this
product in Canada, and later on a worldwide basis. Later products in the field of women’s health that Kalytera may license include
additional medical cannabis formulations for post-menopausal female sexual dysfunction, including vaginal dryness and dyspareunia
(pain on intercourse).
According to a report by Market Research Future, the global market opportunity for treatment of dysmenorrhea is expected to
reach US$8.40 billion in 2023 from US$5.68 billion in 2016, with a compound annual growth rate of approximately 12.28% during the
forecast period 2017-2023. In addition to various medical cannabis products marketed for the treatment of dysmenorrhea, other
pharmaceutical treatments include non-steroidal anti-inflammatory drugs (NSAIDs), and various hormonal based oral contraceptive
drugs. As reported by Market Research Future, patients report high levels of dissatisfaction with the currently available
therapeutics.
Extensive medical research has demonstrated that cannabis is effective in relieving pain associated with an array of conditions,
including dysmenorrhea. A number of medical cannabis products are currently available for the treatment of dysmenorrhea, including
vaginal suppositories containing 10 mg of tetrahydrocannabinol ("THC") and 50 mg of cannabidiol ("CBD"). However,
there have been no clinical trials to date supporting the safety and efficacy of these products. Furthermore, these
suppositories are absorbed into the bloodstream rapidly, resulting in only a transient reduction in menstrual cramping reported to
last for only an hour or so, whereas Kalytera believes a more sustained treatment is required.
The product in development for the treatment of dysmenorrhea is a vaginal suppository that will utilize a sustained release
proprietary formulation intended to provide a smooth and consistent release of cannabinoids at steady levels over a period of 8 to
12 hours. Kalytera believes this product could make significant inroads in this market following completion of a clinical study
demonstrating safety and efficacy in the treatment of dysmenorrhea.
If it exercises its option to license this technology, Kalytera expects to work with BPL to conduct an initial clinical study in
Canada and Israel to provide marketing data in support of commercialization for this product in those and other jurisdictions that
have legalized access to medical cannabis. Following initial market launch in these jurisdictions, Kalytera plans to conduct
registration-directed clinical studies for FDA approval, in order to access larger commercial markets.
Kalytera’s Continuing Expansion and Diversification Within the Field of Cannabinoid Therapeutics
The strategic alliance announced today is another step in Kalytera's expansion and diversification of its cannabinoid-based
product development portfolio. Kalytera currently has an ongoing late-stage clinical program with cannabidiol (“CBD”) in the
prevention and treatment of acute graft versus host disease, as well as a pre-clinical cannabinoid-based therapeutic program in the
treatment of pain.
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 acute graft versus host disease and treatment of acute and
chronic pain.
About Beetlebung Pharma
Beetlebung Pharma Limited (BPL), an Israeli affiliate of the Salzman Group, focuses on the discovery and development of
novel cannabis-related pharmaceutical therapeutics. The Salzman Group provides clinical management and other services to Kalytera
in connection with Kalytera’s programs evaluating CBD in the prevention and treatment of graft versus host disease. BPL has
invented a broad range of cannabinoid new chemical entities in therapeutic areas encompassing pain, inflammation, autoimmunity,
ischemia-reperfusion injury, trauma, and central nervous system injury. BPL is also active in the development of novel formulations
of existing cannabinoids, terpenes, and sesquiterpenes that may contribute to the entourage effect. To provide scientific support
for its pharmaceutical programs, BPL carries out biological research on terpenoid cell signaling and pharmacology in its basic
research laboratories. BPL is a private, closely held corporation.
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 may produce unfavourable results, the risk that
Kalytera may not be able to exercise the options described above in the event it is not able to fund the development of the
optioned technology, the risk that development and commercialization of the formulations described herein may not be completed as
expected, the risk that such formulations may not exhibit the expected mechanism of action and may not have the desired safety and
efficacy profile, and other regulatory and market risks. 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.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005240/en/