Tetra Bio-Pharma Inc. Announces Pricing of Unit Offering
Momentum Public Relations
Press Release: June 24, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“), a biopharmaceutical multifaceted corporation with its primary focus in cannabinoid‑based drug discovery and development (TSX-V: TBP) (OTCQB: TBPMF), is pleased to announce the price of its marketed public offering of units of the Corporation (each a “Unit“) previously announced on June 19, 2019(the “Offering“). The Offering will be conducted at a price of $0.30 per Unit.
Each Unit will consist of one common share in the capital of the Corporation (each a “Common Share“) and one Common Share purchase warrant of the Corporation (each a “Warrant“). Each Warrant will entitle its holder to acquire one Common Share by paying an exercise price of $0.40 for a period of 36 months from the date of closing the Offering.
Echelon Wealth Partners Inc. and Paradigm Capital Inc. will conduct the Offering on a commercially reasonable best efforts basis as the Corporation’s agents for the Offering in each of the provinces of Canada, except Québec. The Units may also be offered for sale in the United States on a private placement basis pursuant to an exemption from the registration requirements of the United States Securities Act of 1933, as amended (the “U.S. Securities Act“) and applicable state laws.
Closing of the Offering is expected to occur on or about July 10, 2019. The Offering is subject to a number of conditions, including, without limitation, the entering into of a definitive agency agreement and receipt of all regulatory approvals, including the approval of the TSX Venture Exchange. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.
A copy of the preliminary prospectus (the “Preliminary Prospectus“), which was filed in each of the provinces of Canada, except Québec, contains important information relating to the Offering and the Units, and is available on SEDAR at www.sedar.com or by contacting Echelon Wealth Partners Inc. at ecm@echelonpartners.com. The Preliminary Prospectus is still subject to completion or amendment. There will not be any sale or any acceptance of an offer to buy the Units until a receipt for the final short form prospectus has been issued.
The securities described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Corporation’s securities to, or for the account or benefit of, persons in the United States, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical multifaceted corporation with its primary focus in cannabinoid-based drug discovery and development with a clinical trial program aimed at bringing novel drugs and treatments to patients and their healthcare providers. Tetra Bio-Pharma’s subsidiary, Tetra Natural Health, also focuses on the development and commercialization of natural health and self-care products as well as the sale of its hemp energy drinks.
For more information visit: www.tetrabiopharma.com and www.tetranaturalhealth.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma’s Management Provides Corporate Update Ahead of Annual General Meeting
Momentum Public Relations
Press Release: June 18, 2019
- 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.
OTTAWA, June 18, 2019 (GLOBE NEWSWIRE) — 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.
- Published in News Home, Tetra Bio Pharma
Tetra Bio-Pharma Announces PPP003 Program Update Following Type B Meeting With U.S. FDA
Momentum Public Relations
Press Release: June 17, 2019
Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-derived drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF) today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its non-controlled cannabinoid drug product PPP003 slated for the treatment of painful dry eye. The purpose of the meeting was to obtain confirmation of the Phase II clinical study design and the quality and toxicology requirements for initiating this trial in patients in the USA.
The FDA confirmed the proposed quality information requirements for initiating the Phase II trial in patients. This included a container closure system, stability plans, drug substance and drug product specifications. The FDA also provided feedback on the GLP toxicology requirements to initiate the Phase II trial.
The FDA reviewed the proposed Phase II clinical study and agreed that it was acceptable to evaluate the safety and efficacy of PPP003 Ophthalmic Solution for the treatment of the signs and symptoms of painful dry eye. The FDA also provided guidance on acceptable primary and secondary endpoints.
“This program is a corporate priority for Tetra and Panag since there is a significant unmet medical need for ophthalmic drugs,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “The choice of the non-controlled cannabinoid was important as the Company is aiming for global market penetration. We are extremely pleased that the U.S. FDA validated our ophthalmic research program. This program confirms that our research and development team is on the right track. With this confirmation and guidance, Tetra can now complete the execution of the clinical program for PPP003 intended to target the same important dry eye market as Xiidra™ which was recently acquired by Novartis from Takeda for $3.4Bn with $1.6Bn in potential milestone payments.”
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 cannabinoids 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
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
- Published in News Home, Tetra Bio Pharma
Panag Pharma Completes Phase 3 Trial With Awaye™
Momentum Public Relations
Press Release: June 11, 2019
Panag Pharma Inc., a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced completion of Panag 001, its Phase 3 clinical trial evaluating the safety and efficacy of Topical-A, now branded as Awaye™ for the treatment of pain caused by osteoarthritis of the knee. The last patient will be finished the open label phase this week and the last follow-up visits will be completed by the end of the third week of June. Panag will complete the analysis of the results and will communicate them to the market in the coming weeks. While the clinical study investigated the use of Awaye™ for osteoarthritis of the knee, it is currently approved by Health Canada for expanded indications including muscle and joint pain from arthritis.
About the Phase 3 Trial
The Phase 3 trial was a randomized, double-blind, placebo-controlled crossover trial with a 3-week open label extension. It was designed to demonstrate the safety and efficacy of its Awaye™ topical cream in participants with Osteoarthritis (OA) of the knee as per the criteria of the American College of rheumatology. The study design included 3 arms: placebo, Awaye™ and a third arm with a Beta-caryophyllene proprietary formulation. Patients received Awaye™ during the open label extension phase. Patients enrolled in the trial had osteoarthritis of the knee as per criteria established by the American College of Rheumatology. The Primary Endpoint of the study was the change in the mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment average for each treatment arm. Multiple Secondary Endpoints assessing pain, patient satisfaction and global impression of change were performed.
“This is the second study performed by Panag to demonstrate the safety and efficacy of Awaye™ in patients suffering from local pain,” says Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “Panag has been working with Tetra’s commercialization team and expects to bring this product to consumers in the fourth quarter of 2019. We are also in discussions with potential commercialization partners from around the world. Awaye™ will be marketed by Tetra Natural Health, a subsidiary of Tetra Bio-Pharma.”
About Panag Pharma:
Panag Pharma Inc. is a Canadian-based life sciences company recently acquired by Tetra Bio-Pharma that is 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 comprised of Ph.D. 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 the clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for application to the skin, the eyes as well as other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Awaye™ over the counter (OTC) cream provides a new approach to the treatment of chronic pain and inflammation.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with 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 and www.tetranaturalhealth.com
- Published in Tetra Bio Pharma
Tetra Bio-Pharma to Present Key Research Findings as Part of Food and Drug Administration (FDA) Public Hearing on CBD
Momentum Public Relations
Press Releases: May 30th, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), will present key findings from its three Phase 1 and its Phase 2 cancer and non cancer investigational trials with cannabinoids, before the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Part 15 Public Hearing on Friday, May 31, 2019. The meeting will take place in Silver Spring, Maryland.
The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds to inform the FDA’s regulatory oversight of these products. This hearing is particularly important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334 (so called Farm Bill), which, among other things, removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act. Given the lack of safety evidence in the published literature, the FDA will hear from important stakeholders including patients, academia, manufacturing, retailers, public health and government bodies who will contribute by providing their data and experience. More than 400 different groups and entities made requests to present before the hearing.
Tetra’s presentation will be made by Rola Mazloum, Director of Regulatory Affairs and will comprise but not be limited to the following:
- Demonstrate that:
- inhalation via smoke or vapor achieves significantly superior delivery to the patient than the oral or sublingual routes;
- the oral route with capsules achieves less absorption than that of sublingual delivery;
- Provide a comparison of:
- side effects when given single dose versus repeat daily dosing.
- smoked versus vaped product;
- Present pertinent safety findings from the Phase 1 trials;
- Provide data that suggests a mechanism of tolerance to side effects;
- Present the impact of dose titration comparing smoked versus oral;
- Summarize the mycotoxin (fungi impurities) findings and how Tetra now manages this issue.
“The ground-breaking research that Tetra has and continues to advance is critical in adding to the scientific safety and efficacy data that regulators like the FDA, Health Canada and the European Medical Authority are looking for,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio Pharma. “Tetra is clearly seen as a world-class leader in conducting robust clinical studies, namely SERENITY© (Phase 3 in advanced cancer pain), REBORN© (phase 2 in breakthrough pain), OPIOSPARE© (Phase 2 to document opioid sparing effect) and others with cannabinoid-derived products to address unmet medical needs. We are privileged to share our insights and add to the body of evidence.”
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
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma names Di Paola as CFO, Lessard retires
Momentum Public Relations
Press Release: May 14, 2019
Bernard Lessard has retired as chief financial officer of Tetra Bio-Pharma Inc. The company has appointed Sabino Di Paola as his replacement effective May 15.
“Bernard recently advised us of his wish to retire after almost two years in his role of Chief Financial Officer. We are grateful for the valuable contribution that Bernard made during his time with us, bringing the Company from a start-up to what it is today. His drive and focus on performance have strengthened Tetra, and the Company is now well positioned to pursue its growth in this dynamic industry. We wish him the best in his retirement, “said Guy Chamberland, Chief Executive Officer and Chief Scientific Officer.
“We are delighted to appoint Sabino Di Paola to the position of Chief Financial Officer. Sabino was one of the founding members of Tetra and he also contributed to its successful listing on the TSX Venture in 2017. He has a deep understanding of the Company and our industry as well as a profound knowledge of capital markets, having advised many public companies over the years. He joins Tetra at a time where the Company enters another phase of its development. His leadership and experience will be essential in executing our strategic plan and taking the Company to its next level of growth. We are looking forward to working together again,” concluded Mr. Chamberland.
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.
- Published in Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma’s Recently acquired Wholly Owned Subsidiary Panag Pharma Provides an Update on Recent Activities
Momentum Public Relations
Press Release: May 9, 2019
PANAG Pharma Inc. (PANAG), a wholly owned subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V: TBP) (OTCQB: TBPMF), a bio-pharmaceutical company engaged in cannabinoid-based drug discovery and development, is pleased to provide investors with an update on the activities of PANAG including, but not limited, to its innovative and patented formulations for the treatment of uveitis which will enter Phase 2 in late 2019.
The acquisition of PANAG and the products at various stages of development, is a perfect fit for Tetra’s business model by providing a deeper pipeline of products to attract strategic commercial partners to distribute these products in Canada, the USA and around the world.
“As a result of this acquisition, we have added highly qualified experts in cannabinoid science and medicine as well as a wealth of drug discovery and early phase drug development expertise and experience. Panag and Tetra Bio-Pharma will join forces to achieve noteworthy regulatory and clinical milestones. Our long term looks very promising, the synergies of the two companies may yield attractive returns for our investors” said Dr. Guy Chamberland, CEO, CSO of Tetra.
The following Panag products will be available to consumers without a prescription from their physician (e.g., natural product section of the pharmacy) and will be made commercially available in late 2019.
The following products have already been approved by Health Canada and have received a Natural Product Number:
- Topical A, a cream for treating osteoarthritis, joint and muscle pain
- Beta C + Zinc, a gel for the treatment of Cold sores
- Beta C + Benzocaine a cream to be used in treating hemorrhoids
In June 2019, Tetra anticipates completion of Panag’s Phase 3 type clinical trial (Protocol ID: Panag-001) of its Topical-A pain cream.
This study consisted of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating Topical-A against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label Topical-A to be administered over the subsequent 3 weeks. The Primary Endpoint was the evaluation of improvement in pain interference as measured by the Brief Pain Inventory (BPI) in individuals who are experiencing pain due to osteoarthritis of the knee. The Secondary Endpoints were: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.
Repurposing Product Candidates
Tetra is currently repurposing existing topical products which will benefit from the addition of ß-caryophyllene (a powerful terpene) and the Multiplexed Molecular Penetration Enhancer (“MMPE™”), a patented technology developed by Tetra’s partner Crescita™. The MMPE™ will provide increased permeability of active ingredients through the skin thereby providing an improved delivery to the therapeutic target (joints & bones, muscles etc.).
Milestones (NPN products) | Key dates | |||
Results of Panag-001 (Topical-A) | June 2019 | |||
Ongoing negotiations with commercial partners | Summer 2019 | |||
Launch of two repurposed products (NPN) | Q1 2020 |
The following products are regulated as drugs and, if approved, will be prescribed (Rx) by physicians.
A pilot study with PPP-003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals
On May 2, 2019 Panag Pharma announced that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has been authorized by the Veterinary Drugs Directorate (VDD), Health Canada. VDD granted the Experimental Studies Certificate to the veterinary ophthalmologists that will be performing the clinical study for Panag.
Repurposing Product Candidates
Tetra is also currently repurposing existing topical prescription drug products which will benefit from the addition of ß-caryophyllene combined again with the Multiplexed Molecular Penetration Enhancer (“MMPE™”), a patented technology developed by our partner Crescita™. The MMPEÔ will provide increased permeability of active ingredients through the skin thereby providing improved delivery to the therapeutic target (joints & bones, muscles etc.).
Interstitial Cystitis Product Candidate
Panag has also developed therapies, along with intellectual property, for the treatment of interstitial cystitis. Tetra plans to start commercializing some of these products in 2020
Milestones (Drug development) | Key dates |
||||
Launch of the Veterinary Pilot Study in indolent corneal ulcers | June 2019 | ||||
Pre-IND Meeting with the FDA on the ophthalmic program | June 2019 | ||||
Launch of the Phase 1 and 2 in Uveitis and Painful Dry Eye | Q4 2019 | ||||
Filing of two repurposed (DIN) products with Health Canada | Q4 2019 | ||||
Medical food approval Interstitial Cystitis Milestone (first generation product) |
Q1 2020 |
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
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma’s Subsidiary, Panag Pharma, Obtains Health Canada Authorization to Commence Its First Veterinary Clinical Study
Momentum Public Relations
Press Release: May 2, 2019
Panag Pharma Inc. (Panag), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has been authorized by the Veterinary Drugs Directorate (VDD), Health Canada. VDD granted the Experimental Studies Certificate to the veterinary ophthalmologists that will be performing the clinical study for Panag.
“Panag has developed a series of cannabinoid-based drugs for the pharmaceutical market,” stated Dr. Melanie Kelly, Co-Founder, Panag Pharma. “Over the last year, we have worked with Tetra to develop an ophthalmic pipeline for pain and inflammatory conditions of the eye. PPP003 is one of the most important assets in our ophthalmic portfolio.”
“PPP003 is a new chemical entity which, in addition to patent protection, would benefit from 6 years data exclusivity plus 2 years marketing exclusivity granted under the Canadian drug regulations,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “This product candidate comes from our collaboration with Panag. The granting of this authorization by VDD further reinforces the importance of our recent acquisition and our ability to meet milestones.”
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 cannabinoids 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 AOTC 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 PPP003 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:
Guy Chamberland, Ph.D.,
Chief Executive Officer and Chief Scientific Officer
514-220-9225
Investors@tetrabiopharma.com
Investor Contact:
Pierre Boucher, CPA, CMA
Partner, Executive Vice-President
514-731-000 ext. 237
Investors@tetrabiopharma.com
Media Contact:
Energi PR
Carol Levine, APR, FCPRS
514-288-8500 ext. 226
Carol.levine@energipr.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Closes the Acquisition of Panag Pharma
Momentum Public Relations
Press Release: May 1, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that it completed today the previously-announced acquisition (the “Acquisition“) of Panag Pharma Inc. (“Panag“) pursuant to a share purchase agreement (the “Agreement“) dated January 30, 2019 between the Company and the shareholders of Panag (the “Vendors“).
Pursuant to the Agreement, Tetra acquired 100% of the issued and outstanding common shares of Panag held by the Vendors in consideration for, in aggregate, (i) $3,000,000 in cash and (ii) the issuance of 16,304,348 class A common shares of Tetra (“Common Shares“) at a price of $0.552 per Common Share. The Agreement also contemplates the payment by Tetra to the Vendors of an aggregate amount of up to $15,000,000 in cash in milestone payments upon the achievement of operational targets associated with marketing approvals and commercialization of both human and veterinary drug products by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), all as more fully described in the management proxy and information circular of the Company dated March 20, 2019.
All Common Shares issued as part of the Acquisition were issued pursuant to exemptions from the prospectus requirements of applicable securities laws.
Dr. Guy Chamberland, CEO and CSO of Tetra stated, “We are very excited by the closing of the acquisition of Panag Pharma. As of today, Tetra is no longer a small biotechnology company focused on cannabinoid-based drugs delivered by inhalation. We are now a small biopharmaceutical company with a strong pipeline of drugs for the ophthalmic and chronic inflammation markets with a unique portfolio of products ready for commercialization. From Day 1 I believed in the people that made Panag a success story. Today I am extremely proud to count them as part of the Tetra family. As a result of this acquisition, we have added highly qualified experts in cannabinoid science and medicine as well as a wealth of drug discovery and early phase drug development expertise and experience. I am confident the Tetra-Panag family will help take the Corporation to the next level of success.”
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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 AOTC 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 Companybelieves, 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 CAUMZ 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:
Guy Chamberland, Ph.D.,
Chief Executive Officer and Chief Scientific Officer
514-220-9225
Investors@tetrabiopharma.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Natural Health Announces The Arrival of 20 containers of Hemp Energy Drink in Canada
Momentum Public Relations
Press Release: April 30, 2019
Tetra Natural Health, a subsidiary of Tetra Bio-Pharma (TSX VENTURE: TBP) (OTCQB: TBPMF), announces the arrival of twenty (20) containers, or more than 1.7 million cans, of its Hemp Energy Drink in Canada, the first 100% natural energy drink made from hemp in the country. In the coming weeks, Tetra Natural Health will be in a position to supply the entire country from its distribution centres in Montreal (for the Quebec and Maritimes market), Toronto (for the Ontario and central Canada market) and Vancouver (for the Western Canada market).
Since the beginning of the year, Hemp Energy Drink (www.hempenergydrink.ca) has been available in many stores across Western Canada. Consumers have greatly appreciated this refreshing, low-calorie beverage with many natural ingredients that comes in three flavours: classic, mango and raspberry.
“We’re delighted that large quantities of Hemp Energy Drink have finally arrived and look forward to Canadian consumers getting a chance to have easy access to and taste this unique and refreshing beverage,” said Richard Giguère, CEO of Tetra Natural Health. “We thank Canadians for their patience, which will soon be rewarded since Hemp Energy Drink will be available in many stores across the country”.
A photo accompanying this announcement is available at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/a82073ce-d298-49bb-a39e-140f169ed893
About Tetra Natural Health
Tetra Natural Health inc. is a subsidiary of Tetra Bio-Pharma inc. that focuses on identification, development and marketing of hemp natural health products, or cannabinoids-based products authorized for sale by Health Canada. For information: www.tetranaturalhealth.com
About Tetra Bio-Pharma
Tetra Bio-Pharma Inc. (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program 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 cannabinoids 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, visitez: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture 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 this trial, the ability to obtain orphan drug status, 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, the success of various product launches including the one discussed in this release, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.
For more information, please contact:
Richard Giguère
CEO
Tetra Natural Health
W. 348-899-7575 ext. 210
rgiguere@tetranaturalhealth.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma