OTTAWA, ON, Oct. 21, 2021 /PRNewswire/ - Tetra Bio-Pharma
Inc. ("Tetra" or the "Company") (TSX: TBP)
(OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug
discovery and development today announced that the European
Medicines Agency (EMA) Committee for Orphan Medicinal Products
(COMP) issued a positive opinion on the Company's application for
Orphan Drug Designation (ODD) for its investigational medicine
QIXLEEF™ as a potential treatment for Complex
Regional Pain Syndrome (CRPS), a chronic neuropathic pain
condition.
Dr. Guy Chamberland, Chief
Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma
said "the positive opinion issued by the COMP is excellent news as
Tetra continues to execute its regulatory strategy in Europe.
An ODD brings several unique advantages, from a cost reduction in
drug development, to an accelerated review process and market
exclusivity for 10 years. Such strategy is cost and time effective
and allows the Company to easily gain market shares in a
competitive free environment. If granted, this would represent
QIXLEEF™'s second ODD as a potential treatment for CRPS, in
addition to the ODD granted by the U.S. FDA in March 2018. We firmly believe that
QIXLEEF™ will be a safe and effective medicine for
pain management and an alternative to opioids."
The positive opinion issued by the COMP will be sent to the
European Commission, which is expected to grant the orphan
designation within 30 days. The Committee based its opinion on
Article 5 of Regulation (EC) No 141/2000 of 16 December 1999. The COMP based on majority of
30 out of 31 votes concluded that QIXLEEF™ satisfies the criteria
for such designation and recommends the granting of orphan
medicinal product designation.
The COMP determined that QIXLEEF™ qualifies as an orphan drug
for CRPS indication as 1) the medicinal product is intended to
treat a chronic debilitating condition, 2) the estimated prevalence
of this rare condition is 4.4 in 10,000 persons in the European
Union, and 3) available data from published literature shows
improvement in peripheral neuropathic pain in patients treated with
cannabinoid-based medicinal products.
The EMA grants orphan drug designation to encourage the
development of drugs intended to treat rare and life-threatening
diseases and therefore provides incentives to sponsors, such as
protocol assistance, a specific type of Scientific Advice that
allows the Agency to address sponsors' questions pertaining to
clinical trials. Moreover, since QIXLEEF™ will be intended to
treat an orphan condition, clinical studies will be preformed with
a significantly smaller number of patients and could be entitled to
conditional approval through a decentralized procedure resulting in
a single decision from the European Commission, valid in all EU
Member States, which would shorten the time to market approval.
Furthermore, once approved the drug will be eligible to 10 years of
market exclusivity. Tetra Bio-Pharma would also benefit from
reduced regulatory fees and administrative and procedural
assistance.
About QIXLEEF™
QIXLEEF™ is a botanical inhaled drug
product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The product
will be first indicated in patients with cancer suffering from
uncontrolled breakthrough pain (REBORN© trials) then in
patients with advanced cancer with inadequately controlled pain
(PLENITUDE© trials). QIXLEEF™, with its innovative and
proprietary dosing data, provides fast acting relief from pain,
offering patients a viable, safer, and non-opioid option for pain
management.
About Complex Regional Pain Syndrome
Complex Regional
Pain Syndrome is an uncommon condition that is affecting
approximately 4.4 in 10,000 persons in the European Union and
where patients experience persistent severe and debilitating pain,
muscle spasticity, swelling, tremors, and weakness. The cause of
CRPS is not completely understood, but the condition is thought to
be caused by an injury to or an abnormality of the peripheral and
central nervous systems. Cannabinoid-mediated therapy can provide
analgesic effect, improve sleep, reduce anxiety and depression as
well as relieve pain, which makes QIXLEEF™ well-suited as a
potential therapy for CRPS.
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. Our
evidence-based scientific approach has enabled us 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 we 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.
For more information visit: www.tetrabiopharma.com
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.
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 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
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.
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SOURCE Tetra Bio-Pharma Inc.