Neptune and Tetra Bio-Pharma Enter Co-Development Agreement for Purified Cannabinoid Oil-Based Products targeting Pain and Inflammation
Momentum Public Relations
Press Release: February 12, 2018
Tetra Bio-Pharma Inc. (“Tetra”) (TSX VENTURE:TBP)(OTCQB:TBPMF) and Neptune Technologies & Bioressources Inc. (“Neptune”) (NASDAQ:NEPT)(TSX:NEPT) today announced that they entered into an agreement for the co-development, commercialization and marketing of purified cannabinoid oil-based products to address pain and inflammation relief applications for the natural health products and pet veterinary markets.
“We are proud to partner with a company like Neptune. Their know-how in extraction, performed in a state of the art GMP facility, is a great asset to have for the cannabis medicinal/pharma oil market. This combined to Tetra’s expertise in the development of products for the prescription drug and pharma retail market, makes this partnership truly one of a kind. Leveraging our complementary expertise in research, regulatory affairs, science, formulation, and delivery forms, we intend to commercialize these new products in preparation of the forthcoming retail cannabis market in Canada, and a RX veterinary North American market,” stated Bernard Fortier, Chief Executive Officer (CEO) of Tetra.
”We are excited to partner with Tetra, a biopharmaceutical leader in the development of cannabinoid-based novel drugs and treatments. The products that will be co-developed will be supported by research as well as our unique formulation and delivery system knowledge, which are key components of our mission to deliver differentiated science-based, value-added products,” said Jim Hamilton, President and CEO of Neptune.
The veterinary health care market is expected to reach US $39.7 billion by 2021, registering a CAGR of 8.06% during 2017-2022 (the forecast period)1. Veterinary medicines are associated with treatment, diagnosis, and prevention of diseases among animals. It covers a variety of animal species, both, in domestic and wild.
1 | Mordor intelligence October 2017: Veterinary Health Care Market – Growth, Trends and Forecast (2017-2022). |
About Neptune Technologies & Bioressources Inc.
Neptune is a wellness products company, with more than 50 years of combined experience in the industry. The Corporation formulates and develops turnkey solutions available in various unique delivery forms, offers specialty ingredients such as MaxSimil®, a patented ingredient that may enhance the absorption of lipid-based nutraceuticals, and a variety of other marine and seed oils. Neptune also sells premium krill oil directly to consumers through web sales at www.oceano3.com. Leveraging our scientific, technological and innovative expertise, Neptune is working to develop unique extracts and formulations in high potential growth segments, such as medical and wellness cannabinoid-based products.
Neptune is also pursuing opportunities in the prescription drug markets, through its 20% investment in Acasti Pharma Inc. (“Acasti”). Acasti focuses on the research, development and commercialization of omega-3 phospholipid therapies for the treatment of severe hypertriglyceridemia.
The Company’s head office is located in Laval, Quebec.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. More information at: www.tetrabiopharma.com.
Forward Looking Statements
Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Neptune to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “will,” or “plans” to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking information in this press release includes, but is not limited to, information or statements about our ability to successfully develop, produce, supply, promote or generate any revenue from the sale of any cannabis-based products for medical use, as well as the results of any clinical trials associated thereto.
The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement and the “Cautionary Note Regarding Forward-Looking Information” section contained in Neptune’s latest Annual Information Form (the “AIF”), which also forms part of Neptune’s latest annual report on Form 40-F, and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Neptune’s website at www.neptunecorp.com. All forward-looking statements in this press release are made as of the date of this press release. None of Neptune and Tetra undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in Neptune’s and Tetra’s public securities filings with the Securities and Exchange Commission and/or the Canadian securities commissions, as applicable. Additional information about these assumptions and risks and uncertainties is contained in the Neptune’s AIF under “Risk Factors” or in Tetra’s MD&A under “Risk Factors”.
Neither NASDAQ, the Toronto Stock Exchange nor the TSX Venture Exchange accepts responsibility for the adequacy or accuracy of this release.
SOURCE: Neptune Technologies & Bioressources Inc. & Tetra Bio-Pharma Inc.
Neptune Wellness Solutions
Mario Paradis
VP & CFO, Neptune
m.paradis@neptunecorp.com
1.450.687.2262 x236
Investor Relations Contact (Canada)
Pierre Boucher
MaisonBrison
1.514.731.0000
pierre@maisonbrison.com
Investor Relations Contact (U.S.)
Ed McGregor/Jody Burfening
LHA, IR
1.212.838.3777
emcgregor@lhai.com
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@tetrabiopharma.com
O: (438) 899-7575
For media information, please contact:
Daniel Granger
Daniel.granger@acjcommunication.com
ACJ Communication
O: 1 514 840 7990 / M: 1 514 232 1556
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Announces Upsizing of Previously Announced Offering
Momentum Public Relations
Press Release: February 8 2018
Tetra Bio-Pharma Inc. (TSX-V:TBP) (OTCQB:TBPMF) a global leader in cannabinoid-based drug development and discovery, announced today that it has entered into a revised agreement with Echelon Wealth Partners Inc. ( the “Underwriter”), pursuant to which the Underwriter will purchase, on a bought deal basis pursuant to the filing of a short form prospectus, an aggregate of 10,000,000 units (the “Units”) of the Company at a price of $1.00 per Unit (the “Offering Price”) for aggregate gross proceeds of $10,000,000 (the “Offering”).
Each Unit will consist of one common share (a “Common Share”) in the Company and one warrant (a “Warrant” and collectively the “Warrants”). Each Warrant will entitle the holder thereof to acquire one Common Share at a price of $1.30, for a period of 36 months from the Closing Date.
The Company has agreed to grant the Underwriters an over-allotment option to purchase up to an additional 1,500,000 Units at the offering price, exercisable for a period of 30 days after closing. If the over-allotment option is exercised in full, the gross proceeds from the Offering will be approximately $11.5 million.
“We are extremely pleased to partner with Echelon Wealth Partners in securing this financing agreement. As we are about to initiate our Health Canada’s recently approved phase 3 registration trial for our lead drug candidate, PPP001, in late stage cancer patients, the proceeds from this Offering will enable Tetra to continue, and even accelerate some of the key development projects in our pipeline. This is another milestone in working towards becoming the first biopharmaceutical company in the world to get a smokable dried cannabis product approved as a prescription drug by Health Canada, the FDA and other regulatory agencies around the world,” states Bernard Fortier, CEO of Tetra Bio-Pharma.
The Company intends to use the net proceeds of the Offering to advance the Company’s Phase 3 trial for PPP001 and other clinical trials, to effect the repayment of indebtedness and for general corporate and working capital purposes.
The Offering will be completed by way of a short form prospectus to be filed in all provinces of Canada and on a private placement basis in the United States pursuant to exemptions from the registration requirements of the United States Securities Act of 1933, as amended (the “U.S. Securities Act”).
The Offering is expected to close on or about February 28, 2018 and is subject to due diligence and other customary closing conditions including, but not limited to, the approval of securities regulatory authorities and the TSX Venture Exchange’s approval.
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 securities 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 leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Receives Health Canada Phase 3 Clinical Trial Approval For Smokable Dried Cannabis Prescription Drug
Momentum Public Relations
Press Release: February 5, 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD) Health Canada to its Clinical trial application (CTA) for the Company’s PPP001 prescription smokable dried cannabis product.
Coinciding with World Cancer Day 2018, Tetra is now ready to initiate its Phase 3 clinical trial of PPP001 in terminal cancer patients, the first registration trial in the world for smokable cannabinoid-based drug. This trial is expected to be a landmark study, enrolling a total of 946 subjects, evaluating the therapeutic benefits of a cannabinoid prescription drug in improving quality of life and treating pain in terminal cancer patients.
“This is an especially significant and noteworthy milestone for the lead candidate in our product pipeline,” said Bernard Fortier, Tetra’s CEO, “as it positions Tetra to potentially be the first company with a Health Canada approved, cannabinoid-based drug on the market aimed at treating breakthrough pain in cancer patients. The advanced cancer pain market is a $2.4B market1; this is a significant and important opportunity for the Company as our drug PPP001 has the potential to help reduce the reliance on opioids for the management of severe pain.”
The first and main recruitment center of the trial will be in Montreal at Santé Cannabis, Québec’s first medical clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
The PPP001 Phase 3 trial will evaluate the effects of Tetra’s smokable cannabinoid-based drug made from natural dried cannabis. Tetra previously entered into a supply agreement with Aphria Inc., to use Aphria’s unique blend of dried medical cannabis in its PPP001 clinical trial. Aphria owns an 8.5% stake in Tetra.
As part of the clinical trial, Tetra will also collect the pharmaco-economics evidence required from insurers in order to support the reimbursement of the first cannabis prescription drug. “Today, most private insurance plans do not cover cannabis treatment, nor is public reimbursement available, making this therapeutic option costly for patients. It is very important for us to bring a new therapeutic option for patients in the form of an approved prescription drug and to take action in order to have it reimbursed for patients” commented Bernard Fortier, CEO.
The trial aims to demonstrate that PPP001 eases suffering and facilitates a more serene experience of living and dying in terminal cancer patients. If conclusive, Tetra will submit a filing for a Drug Identification Number (DIN) to Health Canada in 2019, thus providing a new noninvasive treatment to relieve pain for cancer patient. With this approval, Tetra expects to be on time with its previously announced schedule with the development of PPP001, culminating in a potential launch in Canada by Q1, 2020 and in the US by Q3, 2020.
Dr Guy Chamberland, Tetra’s Chief Scientific Officer (CSO) explained that: “The development of PPP001 for patients with advanced cancer is an important commitment for Tetra, given that cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical cannabis has been shown to help patients beyond the immediate benefit of pain relief.”
“With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. It’s important to note that our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. We expect that, once it is approved as a drug under prescription, PPP001 will be included over time ahead of opioids treatment for those patients with terminal cancer pain. The Company will continue to maintain a transparent and direct line of communication with Health Canada and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first, ” added Dr. Guy Chamberland.
Tetra worked with Santé Cannabis physicians to design a clinical trial that would demonstrate the safety and efficacy of PPP001 in terminal cancer patients and have focused the clinical development on a first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis.
“Throughout my clinical experience assessing and following more than 600 medical cannabis patients, cannabis inhalation remains a critical option to provide rapid relief from a wide variety of symptoms associated with advanced cancer, ” said Dr. Antonio Vigano, Principal Investigator of the trial and Research Director of Santé Cannabis. “We will rigorously assess the safety, efficacy and tolerability of PPP001 to support the population of cancer patients by bringing an important therapeutic tool to the same standard of prescription drugs It is great to be celebrating World Cancer Day 2018 with the first large scale clinical study to prove that medical cannabis can ease the suffering and improve quality of life of many cancer patients, particularly when they most need it.”
About Cancer Pain:
In the USA, 1,5 million patients suffer from cancer pain2. Pain is one of the most frightening of all cancer symptoms for patients and their families3. According to statistics published by the American Cancer Society in 20024, 50% to 70% of people with cancer experience some degree of pain, with a quarter of them actually dying in pain. Without adequate relief of their pain, their quality of life is negatively impacted. Furthermore, the incidence of pain in advanced stages of invasive cancer approaches 80% and it is 90% in patients with bone metastases5.
- https://decisionresourcesgroup.com/report/141466-biopharma-cancer-pain-2015
- Melnikova I. Pain market 2010 ;, doi:10.1038/nrd3226
- Winslow M, Seymour J, Clark D. 2005. Stories of cancer pain: a historical perspective. J Pain Symptom Manage, 29:22-31.
- American Cancer Society. 2002. Cancer facts and figures 2002
- Pharo GH, Zhou L. 2005. Pharmacologic Management of Cancer Pain. JAOA, 105:S21-28.
About PPP001:
PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product. PPP001 is a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with 9,5% THC and 2,5% CBD.
About Aphria:
Aphria Inc., one of Canada’s lowest cost producers, produces, supplies and sells medical cannabis. Located in Leamington, Ontario, the greenhouse capital of Canada, Aphria is truly powered by sunlight, allowing for the most natural growing conditions available. Aphria is committed to providing pharma-grade medical cannabis, superior patient care while balancing patient economics and returns to shareholders.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure 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 strategies, 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. 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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@tetrabiopharma.com
(514) 360-8040 Ext. 210
For media information, please contact:
Daniel Granger
Daniel.granger@acjcommunication.com
ACJ Communication
O: 1 514 840 7990 / M: 1 514 232 1556
- Published in Marijuana, Medical Marijuana, Tetra Bio Pharma
Tetra Bio-Pharma Receives Health Canada Approval for Phase 2 Cannabis Oil Trial in Partnership with Sante Cannabis
Momentum Public Relations
Press Release: January 29, 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce the approval by Health Canada of a Phase 2 clinical trial designed to evaluate the safety and efficacy of different doses and ratios of medical cannabis oil (THC & CBD) to improve uncontrolled chronic pain in cancer and non-cancer patients.
“To our knowledge, this is the first Health Canada-approved phase 2, randomized, double-blind, placebo-controlled clinical trial using encapsulated medical cannabis oil in Canada,” said Bernard Fortier, Tetra Bio-Pharma’s CEO. According to an Eight Capital analysis1, the cannabis oil market is expected to reach 1.5B$ in 2024.
“This is a significant milestone in our mission to become a global bio-pharmaceutical leader in cannabinoids-based drug development. We currently have a strong pipeline of five cannabinoid-based products, all launched last year and using different delivery systems, in various stages towards Health Canada and FDA approval.”
The Phase 2 trial will be conducted with Montreal-based Santé Cannabis, Quebec’s first medical clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
According to Health Canada data2, the annual Canadian cannabis oil production for medical purposes was 22,766 kg between October 1st 2016 and September 30th 2017, and is growing continuously. In the third quarter of 2017, it grew 24% from Q2 (Apr-Jun) to Q3 (Jul-Sep)1.
Dr. Guy Chamberland, Tetra’s Chief Scientific Officer (CSO), also commented that “there is limited scientific and clinical information on the different doses and ratios of medical cannabis oil in the management of pain. This type of clinical trial is required to generate the urgently needed safety and efficacy data required by physicians and pharmacists for the adequate care of patients”.
“We are excited to launch this trial to build the evidence base for medical cannabis in chronic pain, and to demonstrate the leadership of Santé Cannabis on the world stage” said Dr. Antonio Vigano, Research Director of Santé Cannabis and McGill University Associate Professor of Oncology. “At Santé Cannabis, our team observes the impact that cannabis oil has for our patients. For many, medical cannabis can reduce or even eliminate the need for other pharmacological medications. As clinicians and researchers, we must pursue these critical steps to quantify its benefits and to investigate potential risks.”
These studies are part of the Company’s sales and marketing strategy required to effectively penetrate a physician-pharmacist market. The outcome of these studies will also support Tetra’s overall drug development strategy and it is expected that this will allow Tetra to reduce the overall time-to-market for a number of its cannabinoids-based prescription drugs. The company will also use this data to create novel new products that will allow Tetra to further increase its share in the cannabis oil market.
Last year, Tetra launched a number of drug development programs that are expected to lead to the commercialization of cannabinoid-based prescription drugs, making it one of the world leaders in cannabinoid pharmaceuticals. Tetra’s vision is to develop an evidence-based approach similar to that of any other prescription drug, thereby allowing physicians to prescribe, and pharmacists to dispense, these medicines to patients in need.
After receiving approval of a phase 1 clinical trial for its PPP005 cannabis oil program in mid-January of this year, Tetra is now launching a phase 2 trial to assess if cannabis oil treatment will reduce the amount of concurrent pain medications and the need for rescue medications to control chronic cancer and non-cancer pain. This phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of different doses and ratios of medical cannabis oil. In addition, the study will evaluate the effects on improving symptom burden and on cognition and mood in those chronic pain patients.
Tetra and Santé Cannabis have been preparing for several months to initiate this clinical program. The team at Santé Cannabis has grown to include qualified and experienced personnel in the conduct of clinical trials in compliance with Good Clinical Practices. This trial is driven by the medical experts of Santé Cannabis and will provide much needed safety and efficacy data in this patient population, as well as provide Tetra with critical knowledge of the benefits of different ratios of THC and CBD in pain management.
1: Cannabis Sector, Eight Capital Estimates, July 2017
2: Health Canada Market Data, [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/market-data.html]
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure 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 strategies, 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. 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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
- Published in Marijuana, Medical Marijuana, Tetra Bio Pharma
Tetra Bio-Pharma Receives Approval from Health Canada of its Phase 1 Clinical Trial with PPP005 (Cannabis Oil)
Momentum Public Relations
Press Release: January 16,2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD), Health Canada to evaluate the safety, pharmacokinetics and pharmacodynamics of its cannabis oil PPP005.
According to Health Canada data1, the annual Canadian cannabis oil production for medical purposes was 22,766 kg between October 1st 2016 and September 30th 2017, and is growing continuously. In the third quarter of 2017, it grew 24% from Q2 (Apr-Jun) to Q3 (Jul-Sep)1. According to an Eight Capital analysis2, the cannabis oil market is expected to reach 1.5B$ in 2024.
The launch of this trial is the first step in Tetra’s plans to commercialize natural health products with its partners. The corporation will develop cannabis-based supplements for commercialization under the Natural Health Product regulations in Canada and in other countries where regulatory authorities have a recognized pathway for approval and commercialization of such products. The trial will eventually include formulations that will be registered as drugs under Health Canada’s TPD regulatory pathway. “Tetra Bio-Pharma Inc. seeks to become an important player in the retail market post legalization and this clinical trial is part of the sales and marketing strategy required to effectively penetrate the lucrative pharmacy and health stores retail markets,” states Bernard Fortier, CEO of Tetra.
Tetra’s vision is to develop an evidence-based approach, thereby allowing pharmacists to dispense these medicines to patients in need. Despite the growing popularity of cannabis oils, physicians and pharmacists across Canada are still hesitant to support the use of these products because of the lack of data supporting its medical use. Dr. Guy Chamberland, Chief Science Officer, commented: “This trial is part of Tetra’s corporate strategy to develop the science required to commercialize safe and efficacious cannabis oil products post-legalization and to create innovative oral drug formulations for the development of medicines in the management of pain, anxiety and the treatment of cancer.”
In that respect, Tetra’s scientific team is supporting the strategy by initiating a phase 1 clinical trial to characterize the safe use of these cannabis oil medicines in humans. Tetra has worked with Altasciences Clinical Research for the preparation of the Clinical Trial Application (CTA) for the conduct of a double-blind phase 1 study to assess safety, tolerability and pharmacokinetics of single and multiple daily doses of cannabis (Delta-9-tetrahydrocannabinol/Cannabidiol) oil capsules administered to healthy human volunteers. Health Canada issued a No Objection Letter for the conduct of the phase I clinical trial on January 12nd, 2018. Altasciences Clinical Research will be initiating the clinical trial activities in the coming weeks. The cannabis oil is manufactured by Tetra’s partner, Aphria Inc.
1: | Health Canada Market Data, [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/market-data.html] |
2: | Cannabis Sector, Eight Capital Estimates, July 2017 |
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure 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 strategies, 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. 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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
- Published in Medical Marijuana, Tetra Bio Pharma
Tetra Bio-Pharma Enters into Agreement to Acquire Remaining 20% Interest in Phytopain Pharma Subsidiary
Momentum Public Relations
Press Release: January 2, 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development, today announced that it has entered into a share purchase agreement (the “Purchase Agreement”) with entities controlled by André Rancourt, Chairman of the Board of Directors of the Corporation, and Guy Chamberland, Chief Scientific Officer of the Corporation (collectively, the “Vendors”).
Under the terms of the Purchase Agreement, Tetra will acquire from the Vendors all of the remaining issued and outstanding common shares of Tetra’s subsidiary, Phytopain Pharma Inc. (“PPP”), currently held by the Vendors (representing 20% of the issued and outstanding shares of PPP) for an aggregate purchase price (the “Purchase Price”) of $12,425,089 (the “Transaction”). Upon completion of the Transaction, PPP will become a wholly-owned subsidiary of Tetra.
“Upon completion, this transaction will be a significant milestone for Tetra Bio-Pharma and all our stakeholders,” said Bernard Fortier, Tetra’s CEO.
“The two selling shareholders – our Chairman and our Chief Scientific Officer – are both committed to the long-term success of Tetra as evidenced by their agreement to accept shares in Tetra in lieu of an all- cash transaction. As well, a percentage of those shares are going to be released once certain key milestones for the company have been reached,” he said.
“This transaction will allow Tetra to gain 100% control of Phytopain Pharma, a key asset in the development of our pipeline of cannabinoid-based drugs and gives our company full flexibility to enter into other partnerships or agreements in the future.”
The Transaction is subject to customary closing conditions including, but not limited to, approval of the TSX Venture Exchange (“TSXV”) and any other approval that may be required by the TSXV.
The Transaction
Under the terms of the Purchase Agreement, the Purchase Price for the Transaction is comprised of the following:
- Cash: An aggregate cash payment of $248,000 (the “Cash Payment”). Under the terms of the Purchase Agreement, the Cash Payment is payable in escrow as of the signature of the Purchase Agreement and has been paid to the Vendors’ legal counsel in trust for the Vendors pending receipt of approval for the Transaction from the TSXV. In addition, Tetra has agreed to pay the Vendors, immediately upon signature of the Purchase Agreement, a non-refundable amount of $200,000, payable out of the funds available for the Cash Payment, to induce the Vendors to provide an exclusivity of negotiation to the Purchaser for the Transaction.
- Promissory Notes: Promissory notes issued by Tetra to the Vendors in an aggregate principal amount of $2,236,696 (the “Notes”), which Notes are payable in accordance with a specified milestone schedule as described in the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, the Notes have been delivered to the Vendors’ legal counsel in trust for the Vendors pending receipt of approval for the Transaction from the TSXV.
- Tetra Shares: Common shares of Tetra (“Common Shares”) will be issued to the Vendors as follows:
- Upon completion of the Transaction, an aggregate of 2,485,218 Common Shares will be issued to the Vendors.
- Upon completion of the Transaction, 7,455,653 Common Shares will be issued to
Computershare Trust Company of Canada, as escrow agent (the “Escrow Agent”), to be held in escrow and released by the Escrow Agent under the terms and conditions set forth in the Purchase Agreement and the terms and conditions of an escrow agreement to be executed at closing by the Vendors, the Corporation and the Escrow Agent.
The Vendors under the Purchase Agreement are entities controlled by André Rancourt, Chairman of the Board of Directors of the Corporation, and Guy Chamberland, Chief Scientific Officer of the Corporation and are therefore considered “non-arm’s length parties” under the rules of the TSXV. Mr. Rancourt and Mr. Chamberland have properly disclosed their respective interest in the Transaction to the board of directors of the Corporation.
The Transaction constitutes a “related party transaction” within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions (“MI 61-101”). While MI 61-101 would generally subject the transaction to minority shareholder approval and formal valuation requirements, the Corporation will avail itself of the exemptions applicable under Section 5.5(a) of MI 61- 101.
Mr. Rancourt currently has ownership or direction and control over (i) an aggregate of 465,000 Common Shares, (ii) 1,600,000 options to acquire Common Shares and (iii) 4,000,000 Common Share purchase warrants, representing approximately 0.37% of the issued and outstanding Common Shares on a non- diluted basis and approximately 4.66% of the issued and outstanding Common Shares on a partially diluted basis. Further to the completion of the Transaction, and assuming that all of the Common Shares issued in escrow and allotted to Mr. Rancourt are released to Mr. Rancourt or an affiliate of Mr. Rancourt in accordance with the Purchase Agreement, Mr. Rancourt would then have ownership or direction and control over (i) 5,435,436 Common Shares, (ii) 1,600,000 options to acquire Common Shares and (iii) 4,000,000 Common Share purchase warrants, representing approximately 4.20% of the issued and outstanding Common Shares on a non-diluted basis and approximately 8.17% of the issued and outstanding Common Shares.
Mr. Chamberland currently has ownership or direction and control over (i) an aggregate of 1,250,000 Common Shares, (ii) 350,000 options to acquire Common Shares and (iii) 4,000,000 Common Share purchase warrants, representing approximately 1.00% of the issued and outstanding Common Shares on a non-diluted basis and approximately 4.32% of the issued and outstanding Common Shares on a partially diluted basis. Further to the completion of the Transaction, and assuming that all of the Common Shares issued in escrow and allotted to Mr. Chamberland are released to Mr. Chamberland or an affiliate of Mr. Chamberland in accordance with the Purchase Agreement, Mr. Chamberland would then have ownership or direction and control over (i) 6,220,436 Common Shares, (ii) 1,600,000 options to acquire Common Shares and (iii) 4,000,000 Common Share purchase warrants, representing approximately 4.78% of the issued and outstanding Common Shares on a non-diluted basis and approximately 8.70% of the issued and outstanding Common Shares.
Each of Mr. Rancourt and Mr. Chamberland proposes to acquire the common shares for investment purposes, and has no current intention to increase his beneficial ownership of, or control or direction over, securities of Tetra. These investments will be reviewed on a continuing basis and their holdings may be increased or decreased in the future.
The Transaction is subject to customary conditions including, but not limited to, approval of the TSXV. The Transaction has been unanimously approved by Tetra’s board of directors (with André Rancourt abstaining from voting) and Tetra anticipates that the Transaction will be completed in the first quarter of 2018.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid- based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. More information at: 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 Corporation 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 Corporation’s ability to control or predict, that may cause the actual results of the Corporation 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 Corporation, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Corporation’s business plan; the success of the Rx Princeps™ product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps™ product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Corporation’s public disclosure record on file with the relevant securities regulatory authorities. Although the Corporation 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 Corporation 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 Inc.
Bernard Fortier, MBA
Chief Executive Officer
(514) 360-8040 Ext. 206
bernard.fortier@tetrabiopharma.com
www.tetrabiopharma.com
- Published in Medical Marijuana, Tetra Bio Pharma
Tetra Bio-Pharma Announces the Signature of a Letter of Intent to Monetize GrowPros and its Late Stage ACMPR Application
Momentum Public Relations
Press Release: December 21, 2017
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce that it has entered into a non-binding letter of intent (the “LOI”) with a private Canadian corporation (the “Purchaser”) and has started a transaction to monetize GrowPros (GrowPros MMP Inc., Tetra’s wholly-owned subsidiary) (the “Potential Transaction”), to allow Tetra to focus its activities on the drug development and its clinical trials of its pharmaceutical business. With this transaction, Tetra is expected to receive $350,000 and ensure another supply source of cannabis with pharmaceutical GMP quality for the pipeline of products under development.
It is expected that the Proposed Transaction would include the following main terms:
- Acquisition by the Purchaser of all the issued and outstanding shares of GrowPros held by the Company;
- Tetra will receive $350,0000 for the Potential Acquisition composed of (i) a first installment of $175,000 which was paid at the time of the signing of the LOI, (ii) a second installment of $175,000 which will be paid following signing of the definitive agreement giving effect to the LOI (the “Definitive Agreement”) and (iii) subject to stock exchange and securities regulatory approval and following the Purchaser’ initial public offering, 15,000,000 common shares of the Purchaser which would represent approximately a 33% equity interest in the share capital of the Purchaser post-initial public offering. The intention is for Tetra to eventually distribute these shares as a dividend in kind to its shareholders on a pro-rated basis;
- Purchaser’s responsibility to move GrowPros’ late stage ACMPR application forward (submitted in November 2014) with Health Canada;
- Grant by Purchaser and GrowPros of a right of first refusal to the Company on future cannabis production by GrowPros, which will ensure a second source of cannabis to the Company with pharmaceutical GMP quality for the production of the pipeline of products under development;
- Undertaking by the Purchaser to build a 15,000 square feet production facility located on 145 acres of agricultural land in Venosta, Quebec. The property has been approved for up to 1.5M square feet of production space; the Purchaser will ensure that a dedicated part of that production facility will be in compliance with good manufacturing practices for pharmaceutical product; construction of the production facility is expected to begin in the first quarter of 2018.
“We are very happy to leverage this asset that is Grow Pros. By finding a reliable partner, Tetra expects not only to immediately increase its cash flow, but also to enable its shareholders to maintain an investment in the high growth cannabis industry. As importantly, Tetra is further focusing on its core expertise and strength: the development of prescription drugs through the highest levels of clinical trials. Finally, we expect this deal to allow us to secure our production of dried cannabis for our lead drug candidate for its expected approval and eventual commercialization, and provide us with another partner from which we can supply our active pharmaceutical ingredients (API) for our drug development programs.” says Bernard Fortier, CEO of Tetra.
The Proposed Transaction contemplated by the LOI is subject to a number of significant condition precedents including but not limited to the entering into of the Definitive Agreement on terms satisfactory to both parties, the completion of the Purchaser’s initial public offering and receipt of all requisite approval (including stock exchange and regulatory approvals).
The parties intend to enter into the Definitive Agreement and close the Proposed Transaction by the end of the first quarter of 2018.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure 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 strategies, 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. 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.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
- Published in Medical Marijuana, Tetra Bio Pharma
AREV Nutrition Sciences Inc. Orders Second Extraction System for Jamaica
Momentum Public Relations
Press Release: December 13, 2017
AREV Nutrition Sciences Inc. (” AREV ” or the “Company”) ( CNSX – AREV ), is pleased to announce that a second extraction system (“extractor”) has been ordered from Alternative Extracts Inc. (AEI) for delivery to Jamaica.
The extractor arrived in Quebec today for modifications that will increase its production capacity from 20 litres to 80 litres. Once the modifications are completed, the extractor will be shipped to a preferred partner in Jamaica that is still to be determined. AREV is in discussions with two potential companies and will select the company that aligns with the company’s vision.
The AEI extractor, removes oils without the use of destructive high-temperature, steam distillation or aggressive solvents and is the only known extractor to combine alcohol and CO 2 supercritical and critical technologies in one efficient process. AREV’s first system from AEI is the only known system to use ethanol, supercritical and subcritical CO2 technologies combined in a single system. It also allows more than one extract to be drawn from a single biomass, and for collection of extract fractions. The second system has been designed specifically to meet the needs of AREV’s partners in Jamaica.
“We are very excited to be ordering our second extractor and look forward to expanding our network with a strategic partner in Jamaica,” says Stephane Maher, CEO of AREV Nutrition Sciences Inc.
More details will be announced as final commitments are made. For further information, contact Stephane Maher, CEO at stephane@arevnutrition.com or www.alternativeextracts.com for information on the company’s extraction systems.
On behalf of the Board,
Stephane Maher
Chief Executive Officer & Director
AREV Nutrition Sciences Inc.
Backgrounder of the AEI IP
FFE enables the extraction of fractions that are mostly lost when using common methods. In addition, yields match or exceed industry standards. The process uses food grade solvents that chill the biomass by adiabatic cooling while extracting at low pressures. The solution is passed into a collection chamber, which is held under vacuum. In this chamber the extraction agent evaporates and is recycled online after filtration and cleaning.
FFE technology is elegant, compact, fully scalable and economical compared to other methods. A fully functional plant with the capacity of processing 1,400 tons/annum of biomass can fit on 150 square metres of total floor space, compared with 1,000 square meters needed for similar capacity solvent or CO 2 plant. These systems are fully scalable and can be expanded to process thousands of acres of hemp, hops or cannabis each harvest.
The key competitive advantages of the FFE process are that it:
- 1. Operates at lower temperatures avoiding the destruction of vital components.
- 2. Produces extract of superior quality and yields to those that are heated or x-rayed or micro waved.
- 3. Uses equipment manufacture and less expensive to operate.
- 4. Significantly speeds up the extraction process.
- 5. Does not generate undesirable effluents.
- 6. Can be used on many different biomass types including Cannabis, industrial hemp and hops and coconut meat.
About AREV
ARE V Nutrition Sciences Inc. (“AREV”), produces and delivers functional ingredients from its world-class extraction system. AREV is revolutionizing the current delivery method of coconut oil, whey protein and nutrients through emulsification. These premium ingredients and products are targeted for the natural health, medical, functional food, nutraceutical, sport nutrition and bioceutical markets. AREV is also working with Pharmacy and Dispensary operators with an innovative emulsified base formula to disperse Cannabis oil extracts from specific selected genetic Cannabis strains that address 5 areas of health including Anxiety, Pain management, Insomnia, Central Nervous System Disorders & Sexuality.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
FORWARD LOOKING INFORMATION
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in policies of the CSE) accepts responsibility for the adequacy or accuracy of this release. This news release may include forward-looking statements that are subject to risks and uncertainties. All statements within, other than statements of historical fact, are to be considered forward looking. Although the Company believes the expectations expressed in such forward looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include market prices, exploitation and exploration successes, continued availability of capital and financing, and general economic, market or business conditions. There can be no assurances that such statements will prove accurate and, therefore, readers are advised to rely on their own evaluation of such uncertainties. We do not assume any obligation to update any forward-looking statements except as required under the applicable laws.This press release contains forward-looking statements. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “should”, “believe” and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this press release. Actual results could differ materially from those currently anticipated due to a number of factors and risks various risk factors discussed in the Company’s Management’s Discussion and Analysis under the Company’s profile on www.sedar.com.
- Published in AREV Nutrition Sciences, Marijuana
Tetra Bio-Pharma provides update on status of its Phase 3 Clinical Trial Application of Lead Drug Candidate PPP001
Momentum Public Relations
Press Release: December 11, 2017
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development, announced today that the Company has accepted the suggestion of Health Canada to change the order of its clinical trial application (CTA) review process. As such, the quality certification for the manufacturing of PPP001 will take place prior to the approval of its clinical trial protocol as Health Canada assesses its partner Aphria’s operations for Good Manufacturing Practices (GMP) for pharmaceutical products. Tetra agrees to this change from Health Canada because it is in the best interest of patients.
This change in the usual CTA approval process is expected to potentially extend the review process by 30 days. Tetra continues to expect PPP001 to become the first cannabis-derived inhalation drug to receive a drug identification number (DIN) from Health Canada, as well as pharmaceutical drug status from the FDA. The phase 3 trial should therefore begin in early 2018. The Company expects this change to have only a minor impact on time to market for PPP001.
Tetra received approval for the ethics review board on November 6th and subsequently submitted a Clinical Trial Application (CTA) for its Phase 3 clinical trial in cancer patients. This trial is expected to be a landmark clinical trial and is the first of its kind, enrolling a total of 946 subjects. Dr Guy Chamberland, Tetra’s Chief Scientific Officer (CSO) commented that: “a GMP certification from Health Canada’s drug inspectorate is welcome as this certification will signal to the company that its manufacturing partners comply with GMP requirements for drug approval and increases the measures put in place to ensure patients’ safety.” Once the trial is initiated, The Company will accelerate enrolment by expanding the number of clinical sites as it aims to adhere to its target date for filing PPP001 as a prescription drug (with a drug identification number – DIN) to Health Canada.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Rx Princeps™product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps™product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, 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 Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
www.tetrabiopharma.com
- Published in Medical Marijuana, Tetra Bio Pharma
Tetra signs a letter of intent (LOI) with AES Environment Group
Tetra Engages in Innovative Air Analysis and Development of Specific Air Cleaning Devices with AES Environment for the Commercialization of PPP001 and for Marijuana Consumer Market
OTTAWA, ONTARIO–(Marketwired – Sept. 28, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), today announced that it has signed a letter of intent (LOI) with AES Environment Group to develop and commercialize specific products ensuring the safety of caregivers for patients who will use PPP001 or medical cannabis.
AES Environment has expertise in in situ air testing analysis of all kinds of contaminants and development of high level air cleaners for professional and institutional purposes. They design and manufacture effective filtration devices to answer specific needs of professionals in different areas. In the context of a clinical trial with both on site and at home use of PPP001, it is imperative for Tetra to control the quality of the environment of its users and ensure that caregivers, healthcare professionals (HCP) and family members, will not be affected by second hand smoke when patients are inhaling PPP001 or medical cannabis.
Tetra is being proactive in addressing the concerns of physicians and Health Canada regarding potential effects of second hand smoke. It is for this reason that Tetra is partnering with AES Environment who will provide devices that will allow healthcare professionals to safely work alongside patients smoking prescribed medical cannabis. AES Environment will provide masks specifically designed to filter tetrahydrocannabinol (THC), aldehydes and terpenes found in cannabis, allowing caregivers to work alongside patients while they are smoking. These masks can be used for all medical or interventional personnel needing to respond to an emergency situation in a closed environment where there are potentially hazardous levels of THC in the air.
As well, the Companies have signed a letter of intent to set up a partnership for the development and distribution of a specialized air purification device for both residential and professional work environments, ensuring quality of the environment during inhalation of Tetra’s smokable product PPP001. Both Companies are working together to develop a new type of portable air filter that will be used by patients inhaling medical cannabis or Tetra`s prescription drug PPP001. These filters will capture THC, aldehydes and terpene molecules, thereby preventing the exposure of HCP’s and caregivers to hazardous levels of these molecules.
Guy Godin, CEO of AES Environnement stated “I am pleased to work with an innovative company such as Tetra to be able to follow its research and adapt to the needs and standards of an ever-changing industry. This innovative filtration apparatus follows on from research that culminates with the manufacture of an air purifier dedicated to the users of this new analgesic. The device is equipped with a unique filter that absorbs all unwanted airborne particles. This filtration device also eradicates odors and ensures optimal indoor air quality, in accordance with Health Canada’s requests and recommendations”.
In parallel, Tetra and AES Environment will be conducting an extensive on-site testing of air quality, to ensure the efficacy of their devices and to provide data currently lacking, to the healthcare community. All sampling methods developed by AES Environment and Tetra will comply with the standards and regulations of the Research Institute on Health and Safety at Work Quebec (IRSST) and the Regulations on Health and Safety at Work, as well as with Health Canada requirements.
This unique data set will be collected and added to Tetra’s New Drug Submission for PPP001. The Company is confident that these will be well received by Health Canada as they provide data on air quality that currently doesn’t exist and initiate an innovative process to ensure the safety of caregivers.
Bernard Fortier, CEO of Tetra Bio-Pharma noted that “We are very fortunate to be able to work with a leader in the field of environment safety like AES Environment. What is even more exciting is that Tetra is in a position to protect our future patients’ family members, their caregivers as well as any healthcare professional involved in the care of these patients. We understand that bringing a smokable THC medication brings a responsibility to minimize the risks associated with this highly effective delivery method. From a commercial standpoint, we are working closely with our partner AES Environment in bringing a product that we can register with Health Canada as a medical device. This would potentially enable patients to reduce their out-of-pocket expenses as certain types of medical devices can be covered under private and public insurance plans. And for Tetra, this becomes another opportunity to generate a significant stream of revenue within our PPP-001 portfolio”.
With the development of its PPP001 program, Tetra has been building a solid foundation to discover and develop cannabinoid-based drugs that will address unmet medical needs of patients, while ensuring the safety and well-being of those patients who will be enrolled in the clinical trial, as well as their caregivers. With the development of these new devices, Tetra will help protect the patients’ immediate family, their caregivers and HCP workers from second-hand smoke and cannabis’ side effects.
Finally, Tetra is announcing a change to its board of directors. M. André Audet, former Chairman of the Board and one of the original founders of the company, is leaving the Board of Directors effective today. The Company wants to thank Mr Audet for his hard work and dedication in the development of Tetra; he has played a key role in the company’s growth to date. Tetra’s CEO, Mr. Bernard Fortier, will replace Mr Audet.
About AES:
AES Environment’s reputation was first built in the field of indoor air sampling and analysis, and then expanded with the creation of high-performance decontamination products for commercial and military markets. By creating this unique air purifier, the company is expanding its range of services and expertise in a field that is constantly renewing itself.
http://www.aesenvironnement.com/en/
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra has three core expertise: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based drugs.
More information at: 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 Tetra Bio Pharma