— U.S. granted patent protection for ophthalmic use;
— U.S. granted patent protection for topical delivery, increased drug solubility and abuse deterrence;
— U.S. FDA provides positive response on painful dry eye development program;
— Panag completes a Phase 3 clinical trial for a topical pain reliever;
— Tetra completes four clinical trials;
— SerenityÃ£ trial to launch in USA and Canada; and
— Promised revenues to meet delivery targets.
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSXV:TBP.VN) (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.”
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 AwayeÃ” 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(TM) 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:
Tetra has been ramping up activities to complete the CAUMZ(TM) Phase 3 clinical trial, called SERENITY(C). 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(TM) 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(C) which is a Head to Head Efficacy Study assessing CAUMZ(TM) versus Fentanyl(R) 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(TM) in breakthrough cancer pain by mid-2021. This will significantly increase CAUMZ(TM) sales in year two.
Tetra will also launch a Phase 2 trial in fibromyalgia in 2020 for its product candidate CAUMZ(TM) 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.
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(TM) 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(C) 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:
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.
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 (TSXV:TBP.VN) (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.
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:
Senior Vice President Marketing & Medical Affairs
Carol Levine, APR, FCPRS
514-288-8500 ext. 226