Tetra Bio-Pharma and Altus Formulation Sign Joint Venture Agreement for Cannabinoid Drug Product Development
Momentum Public Relations
Press Release: April 29, 2019
Tetra Bio-Pharma Inc. (“Tetra” or “TBP”), (TSX VENTURE: TBP) (OTCQB: TBPMF), and Altus Formulation Inc. (“Altus”) today announced the signing of a Joint Venture Agreement under which the two companies will work together to develop a series of cannabinoid-receptor targeted therapeutics addressing multiple areas of high unmet need.
The Joint-Venture will synergize the capabilities of the two companies:
- Products: The companies have identified product candidates in the fields of pain, oncology and ophthalmology, addressing a total market size of over $10BN. (Source: MedTrack™)
- New Routes of Administration: Altus’ SmartCelle™ insoluble drug delivery platform enables intravenous, topical, intra-nasal and oral delivery. Smartcelle’s™ proven ability to enhance the solubility of cannabinoids permits increased oral absorption and enables low volume parenteral and transmucosal delivery. Intellitab™ and Flexitab™ technologies will deliver Safer to Use™ products to patients.
- New Intellectual Property: Altus’ distinct drug delivery technologies provide Tetra with significant strategic advantages over the competition and will enable Tetra to significantly improve some of the current products under development. In addition to SmartCelle™ these include Intellitab™ abuse deterrent technology platform and, Flexitab™ breakable sustained release tablet technology for enhanced dosing flexibility. All platforms are protected by patents enforced globally.
- Commercial Development, Manufacturing and Supply. Combining Altus and Tetra capabilities ensures these essential parts of the value chain are addressed early and efficiently.
Dr. Guy Chamberland, CEO and CSO of Tetra stated, “We are extremely excited about finalizing this agreement which will enable us to improve existing products and will allow us to exploit a number of different delivery mechanisms including Intra-Nasal, Intravenous and Oral Sustained Release Tablets. Furthermore, Altus’ technology will play a key role in strengthening Tetra’s Intellectual Property for its product portfolio. This newly created joint-venture will also serve to benefit our patients, their care providers and help us in our quest to replace the use of opioids.”
Damon Smith President and CEO of Altus Formulations Inc. added, “We believe that by targeting cannabinoid receptors we open up a range of therapeutic pathways unaddressed by today’s medications. Whether alone or in combination, we believe such medications can provide great value to patients, not least to those suffering the blight of undertreated pain. By combining our capabilities and focusing our resources to generate the right drug for the right patient, the Tetra/Altus joint venture overcomes many of the hurdles that have dogged cannabinoid medicine commercialization in the past. We greatly look forward to working with the Tetra team and to bringing these products to the market.
About Altus Formulation Inc.
Altus Formulation is a Quebec based drug formulation and development company using its proprietary and patent protected drug delivery technologies to generate novel, differentiated and cost-effective new products for its partners and their patients. With a focus on Safer to Use™ formulations, Altus’ technologies include Intellitab™ abuse deterrent technology, Flexitab™ breakable extended release tablets and SmartCelle™ technologies for delivery of low solubility large and small molecules.
For more information, please visit www.altusformulation.com
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (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 Health 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.
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, the success of this joint venture, 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 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 Contact:
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
Investors@tetrabiopharma.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Resumes its Phase 3 Clinical Trial Program
Momentum Public Relations
Press Release: April 9, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced it is ready to resume its Phase 3 clinical program in advanced cancer pain patients with the objective to assess Health- Related Quality of Life (HrQoL).
The SERENITY© Study will use a vaporizer, a Health Canada approved Class 2 medical device as a delivery mechanism which is more acceptable to hospitals and palliative care centers. Tetra’s new drug formerly referred to as PPP-001 will be investigated in the SERENITY © Study under the commercial trademark of CAUMZ. In preparation for commercialization, Tetra has decided to brand its investigational drug name for regulatory filing purposes.
In addition, the significant expansion of clinical trial sites to 20 in both Canada and the United States, will accelerate patient recruitment and help expedite Tetra’s submission to regulatory agencies.
“I am extremely pleased with Tetra’s ability to quickly resolve the problem that required us to suspend our clinical trial in advanced cancer pain. With great challenge comes great opportunity and what we are now able to deliver is a better and more reliable product,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “The continuation of our research is excellent news, not only for those suffering with advanced cancer pain and other symptoms but also for our investors. I look forward to the day when Tetra’s cannabinoid-derived drugs will help reduce, if not eliminate the reliance on drugs like Fentanyl®, Oxycodone® or morphine and that hopefully the study drug will be able to bring serenity to patients in their difficult journey through the disease.”
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, News Home, Tetra Bio Pharma
Two in Three (65%) Canadians Would Take a Drug Containing Cannabis if Prescribed by a Doctor and Covered by Insurance
Momentum Public Relations
Press Release: February 26, 2019
When It Comes to Cannabis, Trust in Doctors’ Judgement Runs High
- Majority of Canadians (54%) believe taking cannabis for medical reasons without consulting a doctor poses a risk.
- Knowledge of Canadian clinical trials investigating cannabis medicines is low.
- Slim majority of Canadians agree that their doctor is informed enough to treat them with cannabis.
- Majority of Canadians do not consider themselves as cannabis users.
OTTAWA, Feb. 26, 2019 /CNW/ – According to a recent Ipsos poll commissioned by Tetra Bio-Pharma, it seems that Canadians believe that Doctor Knows Best when it comes to recommending cannabis for a medical ailment, even though they are less convinced that they are well enough informed to treat them with it. That concern should change as cannabinoid derived prescription drugs become approved by Health Canada, available in pharmacies and covered by private and/or public drug plans. That time is soon approaching as numerous clinical trials investigating the safety and efficacy of cannabinoid-derived drugs are currently underway.
The study revealed that two in three (65%) Canadians would be willing (36% very/29% somewhat) to take a pharmaceutical drug containing cannabis that their doctor prescribed, if it was approved by Health Canada and covered by either public or private insurance. Those more likely to be willing to take these drugs include men (69%), those aged 18-34 (72%), and residents of Ontario (71%). By contrast, if these drugs were not covered by public or private insurance and patients had to pay out of pocket, four in ten (38%) would still be willing to do so (14% strongly/25% somewhat), particularly among men (44%), those aged 18-34 (51%), and residents of BC (50%).
According to Dr. Guy Chamberland, Chief Executive Officer and CSO of Tetra Bio-Pharma, a global leader in the discovery and development of cannabinoid-derived products, the Ipsos results reinforce current understanding of consumer and physician behaviors. “Patients are open to cannabis as a medical treatment but want their healthcare professional to be in charge. On the flip side, doctors, medical bodies and payors need the safety and efficacy data that they expect from any drug they prescribe. Treatment with cannabis is complex, which is why the pharmaceutical pathway assures precise dosing and consistent formulation.”
Tetra Bio-Pharma undertook the research to gain a better understanding of the attitudes, behaviours and opinions of Canadians on cannabis drugs, including their confidence in taking them, the incidence of medical conditions they have where cannabis treatment could be used, as well as any barriers to cannabis drugs.
While much attention has been paid to the recent legalization of recreational cannabis in Canada, the Ipsos study shows that 69% of respondents do not consider themselves to be cannabis users. Of those that do, half say they use it for recreational purposes. Approximately a quarter of these users report taking it exclusively for medical purposes. If that number seems low, it could be because medical doctors and medical associations are still waiting for scientific data before recommending cannabis to their patients.
New Avenues for Pharmaceutical Research
Canadians seem confident that cannabis has a therapeutic benefit and would be willing to take it for pain and associated symptoms. An overwhelming majority (82%) of Canadians agree (34% strongly agree/48% somewhat) that cannabis can reduce pain and other symptoms. Furthermore, over two-thirds (68%) of Canadians are willing (30% very/38% somewhat) to take cannabis to help manage chronic pain, insomnia, anxiety, or depression. This is potentially interesting for those who suffer from conditions that could be treated with cannabis-based medicines. Not surprisingly, this proportion reaches 84% (60% strongly/24%) among those who suffer from three or more conditions that have been linked to treatment with a cannabis-based medicine.
When it comes to expanding access for patients to cannabis medicines through the regulatory pathway, one in six Canadians (17%) say they are closely following the progress being made with Health Canada approving clinical trials for cannabis-based medicines, while just over four in ten (41%) say they have heard of this development, but are not following it at all. Another 18% said they thought cannabis medicines already existed and the remaining one-quarter (24%) said they were not at all aware.
While cannabis is being authorized for medical purposes under the Cannabis Act, the products currently available are not Health Canada approved prescription drugs. Several clinical trials are underway in Canada with a view to investigating the safety and efficacy of cannabinoid-derived pharmaceuticals. Understandably, those suffering from one or more conditions that could be treated with medical cannabis are more likely to be following this news closely. Furthermore, over four in ten (43%) report being willing (23% very/21% somewhat) to participate in a clinical trial testing cannabis-based medicines if these trials are approved by Health Canada and they were qualified for the trial.
Doctor Knows Best
Canadians seem to recognize that turning to cannabis to manage a health condition is not something they should do on their own. Almost nine in ten (88%) believe that there is some degree of risk (25% major/29% moderate/34% minor) in taking cannabis for health conditions without consulting a physician. This should be a comforting thought considering the side effects that cannabis can have for individuals suffering from mental illness, cardiac conditions and diabetes, among other conditions.
Canadians’ level of trust in their doctor remains high when it comes to their judgement over whether to prescribe cannabis. Just under three-quarters (72%) agree (29% strongly /43% somewhat) that they would trust a drug containing cannabis if their doctor prescribed it. Interestingly though, not everyone is fully confident that their doctor is up-to-date on cannabis treatments. Only a slim majority of Canadians agree that their doctor knows how to treat them with cannabis (56%; 14% strongly/42% somewhat) and that their doctor is sufficiently well-informed on how to do so (53%; 13% strongly/41% somewhat). This suggests that Canadians believe there is room for an improvement in knowledge. It is widely believed that the integration of cannabinoid-derived drugs within the Canadian medical system will become a catalyst for the education and training of doctors on how to prescribe cannabis, something that is complex given the need for precise dosing and consistent product quality.
If ordinary Canadians are open to taking cannabis-based medicines, it seems that doctors are also receptive to prescribing them to patients. While only one in ten (11%) Canadians has asked their doctor to prescribe cannabis for a health condition, 45% of those who did so report that their doctor prescribed cannabis willingly. Another 20% said their doctor prescribed cannabis, but was hesitant, while 11% reported that their doctor prescribed another drug instead.
About the Survey
These are some of the findings of an Ipsos poll conducted between December 7 and December 10, 2018, on behalf of Tetra Bio-Pharma. For this survey, a sample of 2,002 Canadians aged 18+ was interviewed online via the Ipsos I-Say panel. The poll is accurate to within ±2.5 percentage points, 19 times out of 20, had all Canadian adults been polled.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-derived 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. Tetra Bio-Pharma has subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals and Natural Health containing cannabis and other medicinal plant-based elements. With patients at the core of its mission, 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 Inc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/February2019/26/c6186.html
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma unit launches Hemp Energy Drink
Momentum Public Relations
Press Release: February 19, 2019
Tetra Natural Health, a subsidiary of Tetra Bio-Pharma Inc., has made its Hemp Energy Drink available in 59 grocery stores and convenience stores in British Columbia, Alberta and Saskatchewan.
Hemp Energy Drink tasting in Kelowna on Feb. 3, 2019
In British Columbia the Hemp Energy Drink is available to consumers in Vancouver, Balfour, Burnaby, Castlegar, Clearwater, Grand Forks, Hope, Houston, Kaslo, Keremeos, Ladner, Langley, Lillooet, Nanaimo, Nelson, North Vancouver, Oliver, Osoyoos, Port Alberni, Robson, Rossland, Salt Spring Island, Simon Fraser University, Slocan Park, Squamish, Summerland, Surrey, Trail, Vernon, Victoria, West Kelowna, Whistler and White Rock.
In Alberta, the Hemp Energy Drink can be found in Athabasca, Banff, Boyle and Langdon, and in Saskatchewan in Kindersley and Tisdale.
The tastings of the Hemp Energy Drink were very popular on Feb. 2 and Feb. 3, during the Wellness Show Vancouver 2019 and at a product presentation in Kelowna. The distribution plan is expected to accelerate the penetration of HED attractive green cans in stores in the coming weeks.
“Our distribution plan is on schedule and the arrival of the Hemp Energy Drink is creating a buzz among consumers as soon as the product becomes available in store,” said Richard Giguere, chief executive officer, Tetra Natural Health. “We will accelerate the deployment of our market opening strategy in a few weeks with the arrival of 1.7 million cans of Hemp Energy Drink, of which more than 600,000 will be quickly shipped to new markets in Canada.”
Hemp Energy Drink is the first energy drink made from hemp in the country. Light, energizing, fresh, Hemp Energy Drink is licensed by Health Canada and contains fewer calories and more natural ingredients than any other energy drink. The product will soon be available in three flavours, classic, mango and raspberry, and it will be accessible in stores in a few months in all regions across Canada.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada-approved, and Food and Drug Administration-reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company has several subsidiaries engaged in the development of an advanced and growing pipeline of biopharmaceuticals, natural health and veterinary products containing cannabis and other medicinal plant-based elements. With patients at the core of what it does, 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 Business, hemp, Marijuana, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Provides Update on its Neuropathic and Chronic Pain Drug Development Program
Momentum Public Relations
Press Release: February 12, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-derived drug development and discovery, today announced accelerated development of its second-generation drug inhalation program for fibromyalgia and uncontrolled pain over the last months.
A Phase 1 study in healthy volunteers using vaporized PPP001 was successfully completed (click here) and the Corporation filed a patent application after unexpectedly discovering the unique composition of cannabis smoke. In July 2018, the Corporation entered into a co-development agreement with Storz & Bickel, widely recognized as the global leader in vaporizer design and manufacturing. Tetra incorporated the vaporizer into its smoke-vapor research program as it aimed to understand how inhaled cannabis relieves pain for patients.
About Neuropathic Pain (Fibromyalgia) and Chronic Pain
Fibromyalgia affects about 4 million U.S. adults or about 2% of the adult populationi. The main symptom associated with the condition is the wide range of pain symptoms that can be deep, sharp, dull, throbbing, or aching, affecting the muscles, tendons, and ligaments around the joints throughout the entire body. Treatments aimed at pain relief are the primary treatment intervention including an increasing use of opioids. Chronic pain is also associated with numerous other medical conditions including rheumatoid arthritis, osteoarthritis, gastro intestinal problems, cancer, surgery, HIV/AIDS. The global fibromyalgia treatment market was valued at approximately $10 billion dollars in 2017ii.
Tetra gained knowledge and understanding as to how smoked and vaporized cannabis works to relieve pain, based on its double-blind randomized placebo-controlled studies of PPP001 administered with the titanium pipe and Mighty Medic vaporizer and the use of smoke-vapor trapping studies to quantify exposure to the respiratory tract. A significant finding of the study was learning how much of each cannabinoid and terpene is delivered to the human body as the result of smoking or vaporizing a dried cannabis product. The key to the success of a smoked cannabis product is closely linked to its speed of delivery to the brain. In addition, the inhalation mode of delivery results in significantly higher maximal plasma levels at the peak of treatment. What does this mean? Essentially, results from our study in humans showed that the peak therapeutic levels show only a 1-minute difference in delivery between the pipe and vaporizer. Combined with the speed, the levels of cannabinoids delivered at this peak of exposure are what results in the benefits seen in patients who suffer from pain.
The pipe or vaporizer delivered important differences in some cannabinoids and terpenes. Tetra is using this insight to accelerate the development of alternative formulations for the treatment of fibromyalgia and uncontrolled chronic pain. This knowledge is incorporated in the filed patent application and based on this, Tetra will use isolates or synthetic-based supplies of cannabinoids and terpenes to develop these prescription cannabinoid-derived medicines.
During the last quarter of 2018, the Corporation began preparations for a research site in the United States to conduct its fibromyalgia clinical trial and we are intent on expanding clinical sites in Canada and in the USA in 2019.
“We previously communicated that after reviewing the human clinical data, Tetra anticipated proceeding into phase 2 clinical trials in fibromyalgia patients,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “We are committed to this target and plan to accelerate this development in the USA as well. Tetra has and continues to gain tremendous credibility within the medical community. We earned this credibility because of our clinical studies and exhaustive characterization of the pharmaceutical composition of cannabis-derived smoke and vaporization products. Overall, 2018 was a productive year after completing several clinical trials and we expect 2019 to build on this as we accelerate this program.”
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 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 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
- Published in Business, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Redefines Quality Standards for Pharmaceutical Grade Cannabis-Derived Products
Momentum Public Relations
Press Release: February 05, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced that it has temporarily suspended its phase 3 clinical program due to impurities found in its PPP001 investigational drug being administered to patients. This suspension does not affect the timing of the European application nor the development of the second-generation inhalation products.
Quality standards and process validations are imposed by pharmaceutical Good Manufacturing Practices (GMP). Just like our food chain, botanical drugs have unique challenges because of the potential for microbial contamination known as mycotoxins. Tetra’s investigational drug is composed of raw cannabis materials. In late spring 2018, Tetra initiated a study to monitor the microbial flora in its investigational product in order to validate the storage and drying process used in the fabrication of its investigational product. On December 20th the results of this ongoing study revealed the presence of the 3 mycotoxins in the lot of the investigational drug used for the clinical trials. Tetra communicated these findings within 24-hours of discovery to regulators and acted rapidly to ensure the safety and wellness of patients. As per discussions with Health Canada and the Ethics Review Board, Tetra contacted every patient involved in the ongoing clinical trials to suspend treatment and retrieve the investigational drugs.
Cannabis products that are ultimately sold in the recreational or medical market in Canada, are cultivated, processed and sold under the Cannabis Act, which are subject to Good Production Practices. Under the Good Production Practices, there is only a requirement to test for certain mycotoxins, namely aflatoxin and total content of mycotoxins. The cannabis raw materials purchased by Tetra for use in its investigational drug met the requirements under the Cannabis Act and Good Production Practices and tested below allowable limits.
However, Tetra is administering cannabis to patients as a drug for use in clinical trials which is governed by the requirements of the Food and Drugs Act and related Regulations. The fabrication, processing, packaging and sale of the investigational drug, must be conducted in accordance with the Good Manufacturing Practices (“GMPs”). Such GMPs require the validation of the storage and drying process to ensure the cannabis drug conforms to the quality standard of a prescription drug. Tetra, having acted in accordance with the requirements of the Food and Drugs Act and GMPs, detected the presence of mycotoxins other than aflatoxin in the experimental lot used for the validation. This led to the analyses of every lot being used in its clinical trials to verify for the presence of two other types of mycotoxins (Ochratoxin A, and DON (Deoxynivalenol; Vomitoxin) and the inclusion of this testing into the product specifications.
Tetra Bio-Pharma considers patient health and well-being to be non-negotiable. Tetra will take the next 6 months to assess the situation and propose a robust quality program to Health Canada so that Canadian patients taking its PPP001 prescription cannabis-derived drug are confident in the products’ quality and safety.
Tetra Bio-Pharma CEO and CSO Guy Chamberland holds a Ph.D. in Biomedical Sciences (toxicology) among other academic designations and is a well-respected expert in the field particularly in drug safety stated, “This unexpected development will result in a 6-month delay in the submission of the Canadian New Drug Submission or Drug Identification Number (DIN) application for PPP001. Tetra strongly believes that this delay will lead to a safer and higher quality drug for patients with advanced cancer. Through our research and development efforts, Tetra’s intention is to create higher quality for all cannabis-derived medicinal products. This is Tetra’s commitment to patient safety. We will continue to provide reports to Health Canada so that the Canadian government receives Tetra’s data in a timely manner so that regulators can ensure the safety and wellness of all Canadians consuming recreational and medical cannabis.”
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
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Enters into Definitive Agreement to Acquire Panag Pharma Inc.
Momentum Public Relations
Press Release: January 30, 2019
Tetra Bio-Pharma Enters into Definitive Agreement to Acquire Panag Pharma Inc.
Canada NewsWire
ORLEANS, ON, Jan. 30, 2019
The Proposed Transaction is expected to:
- provide Tetra with the most robust Pharmaceutical and Natural Health Products pipeline of any Cannabinoid company;
- provide Tetra with more pharmaceutical and natural health products;
- allow Tetra to sell these products worldwide;
- give Tetra access to Panag’s NHP portfolio which is not included in the present in-licensing agreement with Panag.
ORLEANS, ON, Jan. 30, 2019/CNW Telbec/ – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“), a leader in cannabinoid-based drug discovery and development (TSXV: TBP) (OTCQB: TBPMF), today announced it has entered into a definitive agreement (the “Agreement“) with the shareholders (the “Vendors“) of Panag Pharma Inc. (“Panag“) for the previously-announced acquisition by Tetra of all of the issued and outstanding shares in the capital of Panag (the “Proposed Transaction“). Panag is a Canadian-based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag has developed innovative and patented formulations for the treatment of ocular diseases and other pain conditions such as general neuropathic pain. Their significant formulation expertise in the wellness market will allow Tetra to expand its commercial operations.
Dr. Guy Chamberland, CEO and CSO of Tetra stated, “In completing this acquisition of Panag Pharma we have not only acquired a large portfolio of cannabinoid derived pharmaceutical and natural health products but also a team of scientists that have a substantial amount of expertise in the field. Tetra Bio-Pharma looks forward to incorporating Panag into its operations and accelerating its various drug development programs including our second-generation inhaled program.”
Following the closing of the Proposed Transaction, it is expected that Panag will remain a separate subsidiary owned 100% by Tetra and provide Tetra with additional discovery and early phase drug development capacity. With this robust product pipeline, Tetra intends to continue to implement its out-licensing program to generate additional revenues via upfront payments, milestone payments, and royalties and actively pursue the clinical development of lead products.
According to Dr. Orlando Hung, a co-founder of Panag, “The Panag team is very excited to have this well-timed opportunity with Tetra Bio-Pharma, allowing us to continue our decades of translational cannabinoid research. Utilizing the expertise and support from Tetra Bio-Pharma, we are confident that our partnership and combined skills will position us to bring effective and safe cannabinoid-based medications, as well as more innovative cannabinoid delivery systems to market to help managing patients with pain and inflammation.”
Pursuant to the Agreement, Tetra would acquire 100% of the issued and outstanding shares of Panag for an aggregate consideration of $12,000,000, on a debt-free basis and subject to customary post-closing adjustments. The purchase price would be payable by Tetra delivering to the Vendors, on the closing date of the Proposed Transaction, (i) $3,000,000 in cash and (ii) $9,000,000 payable in common shares of Tetra (“Common Shares“), at a price per Common Share equal to the lesser of (i) the 10-day volume weighted average price of the Common Shares ending as of the date of the Agreement and (ii) the Discounted Market Price (as that term is defined in the policies of the TSX Venture Exchange (“TSXV“)) of the Common Shares as at the date that is three business days prior to the closing date of the Proposed Acquisition. 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). Tetra is committed to fund Panag’s research in an amount no less than $1,200,000 annually for a period of ten years after the closing date of the Proposed Acquisition. The milestone payments would be accelerated in the event of a bankruptcy, insolvency, failure of Tetra to make its funding commitments to Panag, change of control or sale of all of the assets of Tetra at any time until December 31, 2028. In addition, in the event of a change of control of Tetra within 24 months of the closing date of the Proposed Acquisition, the Vendors would be entitled to receive from Tetra an additional $10 million.
Two of the Vendors, Bill Cheliak and Gregory Drohan, are non-arm’s length parties to Tetra within the meaning of the rules of the TSXV. Mr. Cheliak is the Chairman of the board of directors of the Company (the “Board“) and Mr. Drohan is a director of the Company. The Proposed Transaction will not result in the issuance of securities to non-arm’s length parties as a group as payment of the purchase price exceeding 10% of the number of outstanding shares of the Company on a non-diluted basis.
The Board formed a special committee (the “Special Committee“) for purposes of evaluating the Proposed Transaction. The Special Committee was composed of Benoit Chotard and Carl Merton, both of whom have no interest in Panag or the Proposed Transaction. On December 24, 2018, the Special Committee received a fairness opinion (the “Fairness Opinion“) from Paradigm Capital stating that the purchase price under the Proposed Transaction is fair, from a financial point of view, to the shareholders of Tetra. In light of the Fairness Opinion and of other considerations and upon the recommendation of the Special Committee, the Board approved the Proposed Transaction. Because of their interests in the Proposed Transaction, Mr. Cheliak and Mr. Drohan recused themselves from all meetings and discussions of the Board relating to the Proposed Transaction and abstained from voting on the resolutions of the Board approving the Proposed Transaction.
The Company expects that the Proposed Transaction will be completed in February 2019. Completion of the Proposed Transaction remains subject to a number of conditions, including the receipt of the approval of the TSXV and such other closing conditions as are customary in transactions of this nature. There can be no assurance that such conditions will be satisfied and that the Proposed Transaction will be completed as described or at all.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) 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 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 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
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.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Confirms Agreements With Multiple Suppliers
Momentum Public Relations
Press Release: December 11, 2018
Tetra Bio-Pharma Inc. (“Tetra” or “TBP”), (TSX VENTURE: TBP) (OTCQB: TBPMF) a leader in cannabinoid-based drug discovery and development confirms its non-exclusive supply agreement for GMP-Grade THC with U.S.-based Rhodes Technologies Inc. The supply will be used for several drug development activities including Tetra’s cannabinoid-derived products PPP002, PPP003, and PPP004, as well as for discovery phase projects. This is additional to having a supply agreement with True North Cannabis Inc. for CBD from hemp which was necessary to meeting the demand associated with the Genacol Corporation transaction.
“With a robust development pipeline, it is essential for Tetra to have a reliable, API supply to support our expanding needs and avoid product shortages,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “Our agreement with Rhodes is predicated on their long history and expertise in the production and sale of active chemical ingredients, particularly in the area of pain management. In terms of CBD, our suppliers are selected based on their ability to provide us with both quality (GMP Pharmaceutical Grade) and volume. Tetra is always mindful of the need to have consistent supply as well as back-ups for each of the products under development.”
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 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 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
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma in Process of Filing Patent Application Exceeding its Data Protection Initial Assumption for its PPP001
Momentum Public Relations
Press Release: December 06, 2018
Tetra Bio-Pharma Inc (“Tetra” or the “Company”) (TSX VENTURE: TBP) (OTCQB: TBPMF), a leader in cannabinoid-based drug discovery and development has announced that it is in process of filing a patent application for its PPP001 drug product. Tetra’s research has led to a significant discovery that allows for patent protection.
“This patent application, if granted, would provide Tetra with full protection of its PPP001 prescription drug product. This will put PPP001 in the same category as any other innovative prescription drug,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “We recognize the inherent value of our intellectual property and the necessity to seek appropriate patents, to the extent possible, to protect our shareholders’ investments in the Company.”
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 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 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
For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514
Investors@tetrabiopharma.com
- Published in Business, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Convenes First National Medical Advisory Board
Momentum Public Relations
Press Release: December 04, 2018
Tetra Bio-Pharma Inc (“Tetra” or “TBP”), (TSX VENTURE: TBP) (OTCQB: TBPMF), – announced that it held its first National Advisory Board meeting in Toronto, on November 30, 2018 as a platform to validate their drug development and commercial programs. Physicians from diverse medical specialties, including oncology, palliative care, as well as mental health, family medicine and anaesthesiology had the opportunity to discuss the place for cannabinoid derived medicines as a potential therapeutic option in pain management. There was a genuine interest into evidence-based medicine to further substantiate their position on cannabinoid derived therapies.
“I am confident that this will be the first of many transparent and collaborative exchanges that Tetra organizes with physicians as we seek to bring cannabinoid-derived medicines into our healthcare system,” said Steeve Neron, Senior Vice-President, Marketing and Medical Affairs. “The level of engagement was encouraging and leads me to believe that physicians are open to consider cannabinoids as a drug they can incorporate into their practice, but without the evidence, they simply will not. This is where Tetra’s scientific data will be invaluable.”
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 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 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