Full Press Release Details
Tetra Bio-Pharma with Pharmaceutical-Grade Cannabis for FDA Trials of QIXLEEF , a Potential Multimillion Dollar Prescription Drug
with stable supply of high-quality ingredients and regulatory-approved services to satisfy clinical trials and prescription products
Akanda into cancer pain medical market as a specialized manufacturer of cannabis-based drugs for use in FDA clinical trials and pharmaceutical
London and Montreal, July 12, 2022 -
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.
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.
1 Source: Derived from
DelveInsight data encompassing the seven major markets, or 7MM, including the United States, Germany, France, Italy, Spain, United Kingdom
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.
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
and services from Akanda's EU GMP Holigen facility will be utilized in this trial.
"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."
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
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.
with Tetra: Email | Website
| LinkedIn | Twitter | Instagram
| Akanda Investor Contact | Tetra Investor and Media Contact |
| Matt Chesler, CFA | Ms. Natalie Leroux - Director |
| FNK IR | 1 (833) 977-7575 |
| 1 (646) 809-2183 | investors@tetrabiopharma.com |
| ir@akandacorp.com | media@tetrabiopharma.com |
| Akanda U.S. Media Contact | Akanda Europe Media Contact |
| Annie Grant | Imogen Saunders |
| Allison + Partners | Irvine Partners |
| akanda@allisonpr.com | imogen@irvinepartners.co.uk |
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.