• Valens to serve as
exclusive supplier of CBD for PMI's clinical trial, which will
measure
anti-inflammatory applications of medical-grade, nano-water
emulsified CBD oil
• Valens will
manufacture and distribute CBD infused and uninfused
PredilifeⓇ prebiotic products for
PMI throughout the country
KELOWNA, BC, Dec. 21, 2021 /PRNewswire/ - The
Valens Company Inc. (TSX: VLNS) (NASDAQ: VLNS) (the
"Company," "The Valens Company" or
"Valens"), a leading manufacturer of cannabis products,
announced today two agreements with PMI Mexico, a subsidiary of Merger Group, one of
the main drug suppliers of the Mexican government. Under the first
agreement, Valens will supply CBD for PMI's ongoing pharmacokinetic
(PK) stage medical trials, which are focused on anti-inflammatory
applications of medical-grade, nano-water emulsified CBD oil. The
clinical trial has already been approved by The Medical Ethics
Board of Mexico. The clinical trial, which is set to begin
once Valens shipments arrive in Q1 of 2022, will be conducted
across private hospitals in Mexico. At the conclusion of the trial, Valens
will be the sole manufacturer and global distributor in
collaboration with PMI.
Under the second agreement, Valens will manufacture and
distribute CBD-infused and uninfused PredilifeⓇ products
globally while PMI will be responsible for distribution of the
PredilifeⓇ products in Mexico. Predilife is an agave-based prebiotic
powder that has been submitted as a drug master file" (DMF) to the
FDA. Valens will manufacture the products at its Green Roads
facility in Florida, where it will
be infused with CBD as required and then packaged and distributed
through Valens' third-party supplier channels across Asia, U.S., Latin
America and Mexico. The
formulation will be offered in both powder and liquid sachets,
initially for human consumption, with animal variations planned for
the second half of 2022.
"The relationship we have built with PMI Mexico marks an
important milestone for Valens' international expansion and the
beginning of our Central and Latin
America strategy," said Tyler
Robson, CEO, Chair & Co-founder of The Valens Company.
"Predilife has significant and unique versatility in terms of reach
and market potential given it can be consumed infused or uninfused
with CBD. This enables unimpeded distribution of the product
regardless of local cannabis regulations, providing Valens access
to several international markets. This agreement diversifies our
global strategy and increases our revenue streams through creative,
non-traditional strategies that separate us from our peers."
Gustavo Bustillo PhD, Scientific Director of PMI said, "In
Valens we found a technological partner that was capable of
providing us not only the required quality but also the technical
support and necessary documents needed to comply with
pharmaceutical regulations. We look forward to initiating our
commercial relationship and watching it expand globally over the
coming years."
At Valens, it's Personal.
About The Valens Company
The Valens Company is a
global leader in the end-to-end development and manufacturing of
innovative, cannabinoid based products. The Valens Company is
focused on being the partner of choice for leading Canadian and
international cannabis brands by providing best-in-class,
proprietary services including CO2, ethanol, hydrocarbon,
solvent-less and terpene extraction, analytical testing,
formulation and product development and custom manufacturing.
Valens is the largest third-party extraction company in
Canada with an annual capacity of
425,000 kg of dried cannabis and hemp biomass at our purpose-built
facility in Kelowna, British
Columbia which is in the process of becoming European Union
(EU) Good Manufacturing Practices (GMP) compliant. The Valens
Company currently offers a wide range of product formats, including
tinctures, two-piece caps, soft gels, oral sprays and vape pens as
well as beverages, concentrates, topicals, edibles, injectables,
natural health products and has a strong pipeline of
next-generation products in development for future release.
Finally, The Valens Company's wholly-owned subsidiary Valens Labs is a Health Canada licensed ISO
17025 accredited cannabis testing lab providing sector-leading
analytical services and has partnered with Thermo Fisher Scientific
to develop a Centre of Excellence in Plant-Based Science. For more
information, please visit https://thevalenscompany.com. The Valens
Company's investor deck can be found specifically
at https://thevalenscompany.com/investors/.
About Merger Group
Merger Group, based in
Newark, Delaware is a pioneer in
developing drugs and supplements with over 20 years of experience
across the pharmaceutical industry. Merger Group is dedicated to
the research, innovation and development of both medicine and
natural and herbal products which can help progress the lifestyles
of its users by improving their health and well-being. PMI Mexico,
a division of Merger Group, is a subsidiary dedicated to the
research, clinical studies, review and integration of technical
documentation to obtain health records, coordination of logistics
and import permits.
Notice regarding Forward Looking Statements
All
information included in this press release, including any
information as to the future financial or operating performance and
other statements of The Valens Company that express management's
expectations or estimates of future performance, other than
statements of historical fact, constitute forward-looking
information or forward-looking statements within the meaning of
applicable securities laws and are based on expectations, estimates
and projections as of the date hereof. Forward-looking statements
are included for the purpose of providing information about
management's current expectations and plans relating to the future.
Wherever possible, words such as "plans", "expects", "scheduled",
"trends", "forecasts", "future", "indications", "potential",
"estimates", "predicts", "anticipate", "to establish", "believe",
"intend", "ability to", or statements that certain actions, events
or results "may", "should", "could", "would", "might", "will", or
are "likely" to be taken, occur or be achieved, or the negative of
these words or other variations thereof, have been used to identify
such forward-looking information. Specific forward-looking
statements include, without limitation, all disclosure regarding
future results of operations, future outcomes of transactions,
economic conditions, and anticipated courses of action. Investors
and other parties are advised that there is not necessarily any
correlation between the number of SKUs manufactured and shipped and
revenue and profit, and undue reliance should not be placed on such
information.
The risks and uncertainties that may affect forward-looking
statements include, among others, whether the Company will be able
to fulfill all of listing requirements of the Nasdaq, Canadian
regulatory risk, Australian regulatory risk, U.S. regulatory risk,
U.S. border crossing and travel bans, the uncertainties, effects of
and responses to the COVID-19 pandemic, reliance on licenses,
expansion of facilities, competition, dependence on supply of
cannabis and reliance on other key inputs, dependence on senior
management and key personnel, general business risk and liability,
regulation of the cannabis industry, change in laws, regulations
and guidelines, compliance with laws, limited operating history,
vulnerability to rising energy costs, unfavorable publicity or
consumer perception, product liability, risks related to
intellectual property, product recalls, difficulties with
forecasts, management of growth and litigation, many of which are
beyond the control of The Valens Company. For a more comprehensive
discussion of the risks faced by The Valens Company, and which may
cause the actual financial results, performance or achievements of
The Valens Company to be materially different from estimated future
results, performance or achievements expressed or implied by
forward-looking information or forward-looking statements, please
refer to The Valens Company's latest Annual Information Form filed
with Canadian securities regulatory authorities at www.sedar.com or
on The Valens Company's website at www.thevalenscompany.com. The
risks described in such Annual Information Form are hereby
incorporated by reference herein. Although the forward-looking
statements contained herein reflect management's current beliefs
and reasonable assumptions based upon information available to
management as of the date hereof, The Valens Company cannot be
certain that actual results will be consistent with such
forward-looking information. The Valens Company cautions you not to
place undue reliance upon any such forward-looking statements. The
Valens Company disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
applicable law. Nothing herein should be construed as either an
offer to sell or a solicitation to buy or sell securities of The
Valens Company.
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SOURCE The Valens Company Inc.