Provides Tetra with stable supply of
high-quality ingredients and regulatory-approved services to
satisfy clinical trials and prescription products
Diversifies Akanda into cancer pain medical
market as a specialized manufacturer of cannabis-based drugs for
use in FDA clinical trials and pharmaceutical markets
Akanda Corp. ("Akanda") (NASDAQ: AKAN) and Tetra Bio-Pharma
(“Tetra”) (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), today jointly
announced that Akanda will supply Tetra with pharmaceutical grade
cannabis flower in a microdose cap form, for use in a Storz &
Bickel Mighty Medic Vaporizer for global commercialization of
Tetra’s QIXLEEFTM and related products. In addition, Akanda will
act as a Contract Development and Manufacturing Organization (CDMO)
for Tetra’s clinical drug and commercial supply programs. With this
project, Akanda becomes a CDMO in addition to being an EU GMP
cannabis manufacturer, marking Akanda’s first entry into
cannabinoid drug development, which is a new and growing market
opportunity for the company, while Tetra secures a stable supply of
high-quality ingredients and regulatory-approved services to
satisfy clinical trials and commercialization.
This press release features multimedia. View
the full release here:
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QIXLEEF (TM) product has been designed
specifically for use in the Storz & Bickel Mighty Medic
Vaporizer, the first medically approved portable cannabis vape,
pictured here with dosing capsules filled at Holigen. (Photo:
Business Wire)
QIXLEEF™ is a proprietary botanical inhaled investigational new
drug currently being studied in two U.S. Food and Drug
Administration (FDA) authorized clinical trials: 1) REBORN©1, a
Phase 2 study authorized by the FDA to evaluate inhaled
cannabinoids against a class of immediate-release oral opioids for
the management of breakthrough cancer pain, and 2) PLENITUDE©, a
Phase 2 multicenter clinical trial authorized by the FDA to
evaluate the safety and efficacy of inhaled cannabinoids to relieve
uncontrolled pain in patients with advanced cancer. The companies
estimate the total addressable market (TAM) for QIXLEEF™ to be
nearly $1.7 billion by 20281.
Under the multi-year agreement, Akanda will supply Tetra with
high-quality, premium THC and CBD flower, and will provide
regulatory, quality and pharmaceutical manufacturing services for
the QIXLEEFTM clinical drug development and marketing authorization
from its Portugal operations. The supply of the active
pharmaceutical ingredient starts in [the third quarter of] 2022 and
is anticipated to increase incrementally over the succeeding years
based on growing demand and commercializing of Tetra’s
cannabinoid-derived medicines.
Akanda will provide Tetra with a range of services, including
regulatory affairs, quality control and stability testing through
Akanda’s internal lab, as well as manufacturing capabilities. Upon
FDA approval, the anticipated supply commitments could reach [over
10 metric tonnes] per year.
Tetra, a leader in drug discovery and development for
cannabinoid-based medicines, is focusing on therapeutic areas of
inflammation, pain, ophthalmology and oncology through a robust
pipeline using multiple delivery systems.
“This supply agreement with Tetra is a major milestone in
Akanda’s journey in becoming a cannabis platform company serving
all regulated markets in the EMEA region,” commented Tej Virk, CEO
of Akanda. “In supporting a terrific partner with a mission to
improve patient health and quality of life though
cannabinoid-derived medicine, we are demonstrating that cannabis
can fit into the traditional public sector model, with the
expectation of reimbursement. Simultaneously, we are productively
utilizing our diverse capabilities to support clinical trials for
pharma grade cannabinoids. If approved, we expect to provide flower
for the authorized compound, potentially creating a significant,
incremental revenue stream for Akanda. This opportunity could only
have been possible with our state-of-the-art facilities that we
gained through the acquisition of Holigen in May.”
“This collaboration transitions our Sintra facility into a
global CDMO for cannabinoid-based pharmaceuticals as we build up
our internal laboratory capacity and manufacturing under EU GMP,”
commented Dr. Akkar-Schenkl, President of Akanda. “Together with
Tetra we are aiming to become the ambassadors for cancer pain
treatment. The pharmaceutical grade flower and the level of
pharmaceutical excellence in manufacturing, quality operations and
regulatory affairs we will be providing into these projects is our
fundamental commitment to worldwide palliative care in pain
treatment in the field of oncology. The bioburden quality of the
flower we will be providing for this delicate patient population
can only be managed under stringent manufacturing conditions,
special regulatory and pharmaceutical know-how.”
“Tetra has been looking for quite a while to find a Global
strategic CDMO partner, and we believe that Akanda is a perfect fit
from a vision standpoint. This partnership will allow Tetra to
secure a robust and trustable source for its clinical drug supply
and for QIXLEEF™ commercialization plans. Aside from quality,
Akanda will rapidly automate our process and increase our capacity,
resulting in a 67% reduction of our cost of goods sold (COGS),”
commented Guy Chamberland, M.Sc., Ph.D., Chief Executive Officer
and Chief Regulatory Officer at Tetra. “Establishing a defined
source of high-quality ingredients is important for Tetra, and we
are excited to advance a productive collaboration with Akanda as we
advance target drugs through the regulatory process.”
About Akanda Corp.
Akanda (NASDAQ: AKAN) is an international medical cannabis and
wellness platform company seeking to help people lead better lives
through improved access to high quality and affordable products.
Akanda’s portfolio includes Bophelo Bioscience & Wellness, a
GACP qualified cultivation campus in the Kingdom of Lesotho in
Southern Africa; Holigen, a Portugal-based cultivator, manufacturer
and distributor with a prized EU GMP certified indoor grow
facility; and CanMart, a UK-based fully licensed pharmaceutical
importer and distributor which supplies pharmacies and clinics
within the UK. The company’s seed-to-patient supply chain also
includes partnerships with Cellen Life Sciences’ Leva Clinic, one
of the first fully digital pain clinics in the UK, and Cantourage,
which operates a platform for bringing medical cannabis to
Europe.
Connect with Akanda: Email | Website | LinkedIn | Twitter |
Instagram
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) is a
leader in cannabinoid-derived drug discovery and development with a
FDA and a Health Canada cleared clinical program aimed at bringing
novel prescription drugs and treatments to patients and their
healthcare providers. Their evidence-based scientific approach has
enabled them to develop a pipeline of cannabinoid-based drug
products for a range of medical conditions, including pain,
inflammation, and oncology. With patients at the core of what they
do, Tetra Bio-Pharma is focused on providing rigorous scientific
validation and safety data required for inclusion into the existing
biopharma industry by regulators, physicians and insurance
companies.
Connect with Tetra: Email | Website | LinkedIn | Twitter |
Instagram
Forward-looking Statements
Some statements in this release may contain forward-looking
information. All statements, other than of historical fact, that
address activities, events or developments that Akanda and/or Tetra
believes, expects or anticipates will or may occur in the future
(including, without limitation, statements regarding potential
acquisitions and financings) are forward-looking statements.
Forward-looking statements are generally identifiable by use of the
words "may", "will", "should", "continue", "expect", "anticipate",
"estimate", "believe", "intend", "plan" or "project" or the
negative of these words or other variations on these words or
comparable terminology. Forward-looking statements are subject to a
number of risks and uncertainties, many of which are beyond the
ability of either company to control or predict, that may cause the
actual results of the companies to differ materially from those
discussed in the forward-looking statements. Factors that could
cause actual results or events to differ materially from current
expectations include, among other things, without limitation, the
inability of the companies to obtain sufficient financing to
execute their respective business plans; competition; regulation
and anticipated and unanticipated costs and delays, the success of
the companies’ research and development strategies, including the
success of this product or any other product, the applicability of
the discoveries made therein, the successful and timely completion
and uncertainties related to the regulatory process, the timing of
clinical trials, the timing and outcomes of regulatory or
intellectual property decisions and other risks disclosed in the
Akanda’s and Tetra's public disclosure record on file with the
relevant securities regulatory authorities. Although Akanda and
Tetra have attempted to identify important factors that could cause
actual results or events to differ materially from those described
in forward-looking statements, there may be other factors that
cause results or events not to be as anticipated, estimated or
intended. Readers should not place undue reliance on
forward-looking statements. The forward-looking statements included
in this news release are made as of the date of this news release,
and Akanda and Tetra do not undertake an obligation to publicly
update such forward-looking statements to reflect new information,
subsequent events or otherwise unless required by applicable
securities legislation.
Neither the TSX Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Exchange)
accepts responsibility for the adequacy or accuracy of this
release.
1 Source: Derived from DelveInsight data encompassing the seven
major markets, or 7MM, including the United States, Germany,
France, Italy, Spain, United Kingdom and Japan.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220712005519/en/
Akanda Investor Contact Matt
Chesler, CFA FNK IR 1 (646) 809-2183 ir@akandacorp.com
Tetra Investor and Media Contact
Ms. Natalie Leroux – Director 1 (833) 977-7575
investors@tetrabiopharma.com media@tetrabiopharma.com
Akanda U.S. Media Contact Annie
Grant Allison + Partners akanda@allisonpr.com
Akanda Europe Media Contact Imogen
Saunders Irvine Partners imogen@irvinepartners.co.uk
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