Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:
TBP) (OTCQB: TBPMF), a bio-pharmaceutical company engaged
in cannabinoid-derived drug discovery and development, is pleased
to provide investors with an update on our research, regulatory and
commercial activities. This market update covers Tetra and its
subsidiaries, Panag and Tetra Natural Health (TNH).
Tetra has grown from a small biotech to a
biopharma with an enviable drug pipeline covering ophthalmic,
chronic pain and oncology. The Company has completed four clinical
trials providing in-depth knowledge on the safety and
pharmacokinetics (how drugs are absorbed in the body) as well as
preliminary data on the efficacy of several THC-CBD combinations.
The Corporation acquired a large base of patent protection through
its acquisition of Panag Pharma, and by forming partnerships with
Altus Formulations (Altus) and Crescita Therapeutics
(Crescita).
“Tetra’s pipeline is focused on large markets
that represent significant potential revenues,” said Dr. Guy
Chamberland, CEO and CSO of Tetra. “Our focus on these large
markets has not precluded us from actively seeking Orphan Drug
Designations. Delivering on our research promises along with
solid patent protection has seen our story resonate with U.S. based
institutional investors."
Patent Equity Developments
The Corporation acquired Panag for its expertise
in drug development as well as its drug pipeline and intellectual
property. “This acquisition is very exciting for Tetra because it
positions the Corporation as a key player in the ophthalmic
inflammation and pain markets with Panag’s U.S. granted patent
(U.S. patent no. 9,765,386 issued on January 24, 2017 for
Compositions and Methods for Treatment of Ocular Inflammation
and/or Pain),” commented Dr. Chamberland. “Our Joint Venture with
Altus brings us multiple U.S. granted patents that cover insoluble
drug delivery as well as drug abuse deterrence. A strong
regulatory strategy along with Panag’s and Altus’ patents provides
Tetra with a solid base of protection to bring these innovative
drugs to market."
Revenues
The Corporation promised revenues at the last
Annual General Meeting of shareholders and has delivered on its
promise with the Hemp Energy Drink. We will update
shareholders on this at the upcoming AGM. "Further, with the
acquisition of Panag this revenue stream is expected to grow before
the end of fiscal 2019 and should exceed the previously promised
target," said Dr. Chamberland. The Corporation entered into a Joint
Venture with Crescita to leverage the Panag topical technology
which Tetra intends on launching multiple products within the
natural health market by the end of this fiscal year.
Similarly, the Corporation will submit several over the counter
(i.e., DIN) drug applications by the end of this fiscal year.
Crescita is also supported with a granted patent protection (U.S.
patent number 8,343,962). Dr. Chamberland further commented,
"The topical product launches will become an important revenue
stream as Tetra moves full speed ahead with its drug development
activities.”
Last week Panag announced the completion of the
randomized controlled Phase 3 trial (PANAG - 001) and Tetra is in
commercial discussions to expand sales of AwayeÔ in Europe.
Data from the Phase 3 trial will allow Tetra to support all
dermatology product candidates with strong evidence for efficacy
claims. Tetra will use Crescitas’ MMPE™ patented delivery
technology to improve the permeability of the active ingredient and
develop the next generation of topical products. The patented
Crescita formulation technology is part of the strategy to create
prescription or OTC drug products for patient care.
Tetra Bio-Pharma Clinical Trial
Updates:
Caumz:Tetra has been ramping up
activities to complete the CAUMZ™ Phase 3 clinical trial, called
SERENITY©. The primary endpoint is to improve Health Related
Quality of Life (HrQOL) in advanced cancer patients suffering from
pain. Tetra has already secured more than 20 clinical sites,
with 10 based in the United States. Tetra continues to plan
for marketing approval by late 2020. We expect to submit regulatory
approval documents beginning in Q4 of 2019. CAUMZ™ is a
cannabinoid-derived medicine using synthetic THC and CBD which will
be delivered using a vaporizer called the Mighty Medic, an approved
Class 2 Health Canada medical device. Tetra is already
involved in several discussions with potential commercialization
partners from around the world.
Tetra is also preparing to resume activities
associated with its Phase 2 trial called REBORN© which is a Head to
Head Efficacy Study assessing CAUMZ™ versus Fentanyl® to study the
onset of action for breakthrough pain in cancer patients.
Tetra has been relocating these clinical activities to the USA with
the objective to secure a second indication for CAUMZ™ in
breakthrough cancer pain by mid-2021. This will significantly
increase CAUMZ™ sales in year two.
Tetra will also launch a Phase 2 trial in
fibromyalgia in 2020 for its product candidate CAUMZ™ in
neuropathic pain as it expands the medical indications for use in
its marketing claims. If approved by regulatory agencies,
this would significantly impact sales by tapping into large
therapeutic areas with unmet needs.
"We have successfully approached large, highly
reputed clinical sites in the USA, a development that will bring
two major advantages to Tetra: global credibility for our trials
and increased speed of enrollment," commented Dr. Chamberland.
PPP002:As reported in Autumn
2018, the U.S. FDA, during both a Type B and Type C meetings, gave
the greenlight to Tetra’s New Drug Application (NDA) under
505(b)(2). Tetra intends to file a New Drug Application (NDA)
to bring PPP002 Dronabinol AdVersa™ to market. The PPP002
product is based on IntelGenX’s proprietary delivery system which
should significantly reduce side effects and improve symptoms for
patients suffering from Chemotherapy Induced Nausea and Vomiting
(CINV).
In Q4 of this year, Tetra will launch the
OPIOSPARE© clinical trial that will document opioid usage when
patients take PPP002. Tetra will then seek to expand the
marketing claims associated with PPP002 in order to increase the
patient pool for its product candidate. In the event the product is
approved, sales will grow as the Corporation provides evidence of
opioid reduction.
PANAG – Tetra Bio-Pharma
Updates:
PPP003:
Panag expects to launch its Combined Phase
1&2 program in painful dry eye in Q4 2019. Panag will
evaluate the safety and tolerability of the product candidate
HU308, a non-controlled cannabinoid-derived medicine which is
expected to provide significant pain relief. Non-controlled
signifies that the product is not considered to be a narcotic. We
have initiated discussions with potential commercialization
partners for this product. In addition, Panag in partnership
with a veterinary ophthalmologist will conduct a proof-of-concept
Phase 2 clinical trial in domestic dogs with HU308. "What is
particularly noteworthy is that the study will involve domestic
pets and not laboratory animals with a goal of providing pet owners
with an alternative ophthalmic pain medication," stated Dr.
Chamberland. As previously announced, Tetra intends to
create a Business Unit in the lucrative veterinary health
market.
PPP009:
Panag expects to launch its Combined Phase
1&2 program in uveitis, an inflammatory eye condition, by Q1
2020. Panag will evaluate the safety and tolerability of a
cannabinoid formulation for the management of this condition.
Patients with uveitis are largely dissatisfied with the current
standard of care and represent a population with a huge unmet
medical need.
Chronic Pain Product
Candidates:
Panag is developing a medical food therapy,
along with intellectual property, for the treatment of interstitial
cystitis. The non-controlled status of the medicinal
ingredient will allow Tetra to target global markets. Tetra
plans to begin commercializing some of these products in 2020 while
Panag continues the development of a prescription drug product for
both humans and pets.
Dermatology Rx and OTC Product
Candidates:
After completion of the Panag Pharma acquisition
in May 2019, Tetra has accelerated its development of PPP004, a
topical formulation of THC and CBD targeting the general
neuropathic pain drug market. On the clinical side, Panag
and Tetra have developed a protocol targeting pain and
inflammation in patients suffering from general neuropathic pain
and have engaged clinical sites capable of running the trial.
In parallel, Tetra has made significant progress in
manufacturing PPP004, including securing supplies of
GMP active pharmaceutical ingredients (APIs; synthetic THC and
CBD), sourcing and purchasing scalable manufacturing
equipment at the Company's manufacturing partner in Moncton, New
Brunswick; and engaging formulation experts to refine the
formulation of PPP004 to underpin the development of a robust line
of topical products that will meet the rigorous quality
requirements of pharmaceutical products. These clinical and
quality/manufacturing activities have allowed Tetra to develop
documentation in preparation for regulatory filing, which is
projected to occur in late 2019.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is
a biopharmaceutical leader in cannabinoid-based drug discovery and
development with a Health Canada authorized, and FDA reviewed,
clinical trials aimed at bringing novel prescription drugs and
treatments to patients and their healthcare providers. The Company
has several subsidiaries engaged in the development of an advanced
and growing pipeline of Bio Pharmaceuticals, Natural Health and
Veterinary Products containing cannabis and other medicinal
plant-based elements. With patients at the core of what we do,
Tetra Bio-Pharma is focused on providing rigorous scientific
validation and safety data required for inclusion into the existing
bio pharma industry by regulators, physicians and insurance
companies.
For more information
visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
About Panag Pharma Panag
Pharma Inc. is a Canadian based bio-tech company focused on the
development of novel cannabinoid-based formulations for the
treatment of pain and inflammation. Panag believes that pain relief
should be safe, non-addictive and above all; effective. The Panag
Pharma team of PhD scientists and medical doctors are among the
world’s leading researchers and clinicians in pain treatment and
management. They bring a combined experience of over 100 years in
research and clinical care of people dealing with chronic pain and
inflammatory conditions. Panag’s current pipeline of pain relief
products include formulations for the topical application to the
skin, the eye and other mucous membranes. Recently approved by
Health Canada and currently undergoing clinical trials, Panag
Pharma’s Topical A OTC provides a new approach to the treatment of
chronic pain and inflammation.
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 the Company 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 Company’s ability to control or predict, that may cause the
actual results of the Company 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 Company to obtain sufficient financing to execute
the Company’s business plan; competition; regulation and
anticipated and unanticipated costs and delays, the success of the
Company’s research and development strategies, including the
success of the products developed by Panag and its other drug
candidates, the applicability of the discoveries made therein, the
successful and timely completion and uncertainties related to the
regulatory process including the applications for Orphan Drug
Designation, the timing of clinical trials, the timing and outcomes
of regulatory or intellectual property decisions and other risks
disclosed in the Company’s public disclosure record on file with
the relevant securities regulatory authorities. Although the
Company has 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 the Company does 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.
Tetra Bio-Pharma Contact:Steeve
Néron Senior Vice President Marketing & Medical
Affairs 514-232-2851 Investors@tetrabiopharma.com
Media Contact:Carol Levine,
APR, FCPRSenergi PR514-288-8500 ext.
226Carol.levine@energipr.com
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