Aphria Exercises Warrants for Gross Proceeds of $1.3 Million to Further Fund Tetra’s (TBP:CSE) Clinical Trials
Aphria Exercises Warrants for Gross Proceeds of $1.3 Million to Further Fund Tetra’s Clinical Trials
– Momentum Public Relations –
Press Release: March 20, 2017
Tetra Bio-Pharma Inc. (“Tetra Bio” or “the Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) is pleased to announce that Aphria Inc. (TSX VENTURE:APH)(OTCQB:APHQF) has exercised their 5,000,000 warrants for aggregate gross proceeds of $1,300,000. The proceeds from the warrant exercise will be used to advance the clinical trials being developed in PhytoPain Pharma Inc., a subsidiary of Tetra.
“We would like to thank Aphria for their continued support and investment in the research and development being conducted by the science team at Tetra,” said Andre Rancourt, CEO of Tetra Bio-Pharma Inc. “By exercising their warrants ahead of schedule, this further confirms Aphira’s commitment to accelerate Tetra’s development work. I am pleased to report to shareholders that Tetra is in a solid financial position with over $4 million to continue advancing its strategic plan of becoming a leading bio-pharma organization focused on cannabis.”
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. We are committed to providing pharma-grade medical cannabis, superior patient care while balancing patient economics and returns to shareholders. We are the first public licensed producer to report positive cash flow from operations and the first to report positive earnings in consecutive quarters. For more information, visit www.Aphria.com.
About Tetra Bio-Pharma:
Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma (TBP:CSE) Enters into Binding Term Sheet for Two Products with Panag Pharma
Tetra Bio-Pharma Enters into Binding Term Sheet for Two Products with Panag Pharma
– Momentum Public Relations –
Press Release: March 14, 2017
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), announced today it has entered into a binding term sheet with Panag Pharma Inc. for the development and commercialization of novel cannabinoid based formulations for the treatment of pain and inflammation. Combined total market potential of both products in the USA in 2014 is estimated over US$5.5 billion.
Per the binding term sheet, Tetra will have exclusive access to sell the ocular and topical drug products in North America with right of first negotiation for outside U.S. and Canadian territories. In addition, Tetra will have a right of first negotiation for future products.
Tetra will be working in close collaboration with Panag’s team of experts to ensure a rapid and successful development. Tetra shall be responsible for 100{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of the research and development of the Licensed Products. Tetra will own and control all regulatory approvals in the Territory, including the application and any other marketing authorizations within the Territory and shall be responsible for all aspects of commercializing the drug products.
Panag has developed potential new cannabinoid-based therapies for ocular and topical anti-inflammatory and pain markets. The total ocular anti-inflammatory market was estimated at over $3 billion in the USA in 2014 and includes conditions such as post-op inflammation, allergic conjunctivitis and inflammatory dry eye. Panag also developed a cannabinoid topical drug product for the treatment of local neuropathic and non-neuropathic pain. In 2014, the over the counter sales of topical analgesics were estimated at over $2.5 billion according to IMS.
“This announcement further demonstrates Tetra’s commitment to shareholders to add future products to our product portfolio in an effort of building a leading bio- pharmaceutical organization,” said Andre Rancourt, CEO of Tetra Bio-Pharma. “This will further allow Tetra to generate revenues in 2017 through its partnership with Panag. Tetra is going to work closely with Panag to exploit its innovative technology that indirectly acts on the CB2 receptor with the goal of launching several products in the retail market. This is in-line with Tetra’s goal of commercializing products pending legalization.”
According to Guy Chamberland, Chief Scientific Officer of Tetra Bio-Pharma, “We are going to prioritize the development of the ocular therapy as this is a promising innovative product and the potential financial reward will be significant. Tetra had already positioned itself to become a leader in topical pain relief with its PPTGR technology. With the Panag partnership, Tetra is going to modify its development plans to accelerate bringing an innovative cannabinoid topical drug product to the market. The Panag team is going to strengthen Tetra’s overall scientific knowledge and expertise base making it one of the leading biotechnology companies developing cannabinoid-based therapies.”
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 the area of 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.
About Tetra Bio-Pharma:
Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Announces that the Delay in Legalization of Marijuana Does Not Affect its Drug Development & Commercialization Plans
Tetra Bio-Pharma (TBP:CSE) Announces that the Delay in Legalization of Marijuana Does Not Affect its Drug Development & Commercialization Plans
– Momentum Public Relations –
Press Release: March 9, 2017
Tetra Bio-Pharma Inc. (“Tetra”, “TBP” or the “Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a biotechnology company specialized in the development and commercialization of Cannabis-based prescription drugs announced that the delay in legalization of marijuana does not affect its commercialization plans for 2017. AgroTek Health (AGT) for the over-the-counter self-care consumer markets is on schedule for the launch of its first Cannabis-derived (THC- and CBD-free) product in 2017.
Based on Tetra’s experience in government affairs, the Company had anticipated delays in the legalization due to the complexity associated with this endeavour. Subsequent to this assessment, Tetra had initiated a plan to commercialize THC- and CBD-free Cannabis derived products. In addition, Tetra entered into a partnership with McGill University and Ford’s Family Pharmacy and Wellness Centre to ensure timely commercialization of these products. Tetra is also discussing with several Licensed Producers to ensure a supply of Cannabis and or to enter into a partnership with AGT.
“Tetra is making tremendous progress in the execution of its strategy to become a leading biopharmaceutical company in developing and commercializing cannabis prescription drugs,” said Mr. Andre Rancourt, CEO of Tetra Bio-Pharma Inc. “I am proud to report to shareholders that AGT is on schedule to bring cannabis-derived products to the OTC market after it strategically developed its commercialization plans to partner with Drs. Peter Ford and Stan Kubow after anticipating delays in the legalization of marijuana. We look forward to keeping shareholders updated on our future plans of strengthening Tetra into a bio-pharmaceutical organization.”
All TBP partners and any future partners or suppliers of Cannabis will be subject to regular quality audits to ensure compliance with Canadian regulations and that the Cannabis raw material conforms to quality standards for an oral pharmaceutical product. The quality audit includes third party independent testing for impurities such as pesticides. All of these Licensed Producers will be subject to potential inspections by Health Canada’s Inspectorate or the USA Food and Drug Administration. TBP and its partners recognize that this is part of the responsibility of bringing quality safe products to consumers.
In autumn 2016, TBP announced that it had entered into a partnership with Dr. Stan Kubow, School of Nutrition and Dietetics, McGill University after obtaining an NSERC ENGAGE grant for the development of proprietary Cannabis-extracts for the development and commercialization of nutritional and heath care supplements as well as topical natural products and cosmetics. In February 2017, Controlled Drug Substances, Health Canada, issued the exemption required for the development of these proprietary extracts. This innovative project is expected to deliver at least one commercial nutritional supplement later this year. AGT is also working with Ford’s Family Pharmacy and Wellness Centre to commercialize one or more topical THC- and CBD-free products.
About Tetra Bio-Pharma:
Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma (TBP:CSE) Announces the Initiation of its Phase I Trial of PPP001 (dried Cannabis)
Tetra Bio-Pharma Announces the Initiation of its Phase I Trial of PPP001 (dried Cannabis)
– Momentum Public Relations –
Press Release: February 23rd, 2017
PhytoPain Pharma (PPP), a subsidiary of Tetra BioPharma Inc. (“Tetra” or the “Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce the launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers.
The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial. This study is a pivotal safety trial as it will allow Tetra to understand the adverse effects of smoking Cannabis and associate the outcomes, such as cognitive function, to plasma levels of THC and CBD. The study will provide Tetra with the data necessary to discuss with Health Canada and FDA the potential risks in patient populations and discuss marketing requirements for specific indications.
The pharmacokinetic profile and safety data generated by the Phase I trial will allow Tetra to finalize the design of its Phase II-III clinical trial that will assess the safety and efficacy of PPP001 in cancer patients with uncontrolled pain. PPP001 is being developed for cancer patients with moderate-to-severe pain and that are not adequately controlled with the standard of care. Approximately 50{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over $5 billion USD.
“We are very pleased to announce that the start of the Phase I clinical trial activities as this keeps the company on track in its development of PPP001”, commented Mr, Andre Rancourt. “With PPP001 and the mucoadhesive AdVersa® controlled-release tablet, Tetra is positioning itself to become a major player in the cancer pain therapy market,” added Mr. Rancourt.
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
- Published in Bio technology, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Reports Approval by Health Canada of its Phase I Trial of PPP001 (dried Cannabis)
Tetra Bio-Pharma Reports Approval by Health Canada of its Phase I Trial of PPP001 (dried Cannabis)
– Momentum Public Relations –
Press Release: February 16, 2017
PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (CSE:TBP)(CSE:TBP.CN), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that the Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis.
Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks.
“We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,” said Dr. Chamberland, Chief Science Officer.
“This trial is part of Tetra’s commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers” said Mr. Rancourt, Chief Executive Officer
Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersa® Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. ²With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain², added Dr. Chamberland.
- Published in Bio technology, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Top 3 Most Attractive Investment Subsets Of The Cannabis Industry
Top 3 Most Attractive Investment Subsets Of The Cannabis Industry
The cannabis industry is expected to reach $50 billion in size by 2026, according to Cowen & Co., making it one of the fastest growing industries in the world. Not surprisingly, cannabis stocks have handily outperformed the market with the Marijuana Index more than doubling over the past year compared to just 24{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} for the S&P 500 index. Investors have taken a growing interest in the industry as legalization has spread across North America.
In this article, we will look at three subsets of the cannabis industry that investors may want to consider for the best risk-adjusted returns.
Licensed Producers
Canada has legalized both medical and recreational cannabis on a federal level. Under the so-called AMCPR, licensed producers have the unique right to legally grow and process dried medical marijuana, cannabis oils, edibles, and other derivatives. These products are sold to registered patients and customers through a mail order process, which makes these companies the most pure-play opportunities for investors in the cannabis industry.
The largest licensed producer is Canopy Growth Corp. (TSX: CGC) (OTC: TWMJF), but emerging producers like Emerald Health Therapeutics Inc. (TSX-V: EMH) (OTC: TBQBF) are well-positioned to capture a piece of the market. The latter recently signed a letter of intent to lease up to 32 acres of land in Metro Vancouver, BC, while completing a 100,000 square foot expansion in two phases that will increase its capacity to about 10,000 kilograms per year.
Finally, aspiring licensed producers like Maple Leaf Green World Inc. (CSE: ML) (OTC: MPEFF) and Invictus MD Strategies Inc. (OTC: IVITF) represent opportunities for investors to gain exposure to Canada’s cannabis industry at lower valuations. Maple Leaf also provides investors with exposure to California’s medical marijuana market, while Invictus MD Strategies owns several related businesses that provide diverse exposure to the industry.
Pharma- & Nutraceuticals
Pharmaceutical companies are notorious for generating hefty profits with high barriers to entry for direct competition. The federal government may consider cannabis a Schedule I Controlled Substance with ‘no currently accepted medical use’, but a growing body of research suggests that components of the plant could be helpful in treating everything from childhood epilepsy to pain and nausea in patients undergoing chemotherapy and other cancer treatments.
GW Pharmaceuticals plc (NASDAQ: GWPH) may be the most popular name in the cannabis-related pharmaceuticals space, but GB Sciences Inc. (OTC: GBLX), InMed Pharmaceuticals Inc. (CSE: IN) (OTC: IMLFF), and Tetra Bio-Pharma Inc. (OTC: GRPOF) are among a handful of other companies with an established presence in the space. These companies are taking various unique approaches to unlock real value for investors.
Other companies are focused on over-the-counter versions of cannabinoid therapies. For example, Medical Marijuana Inc. (OTC: MJNA) provide pure over-the-counter cannabidiol (“CBD”) hemp oils to consumers around the world. The company’s 100{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} hemp-based, THC-free CBD oil products have enabled it to obtain regulatory approvals for importation into countries like Mexico and Brazil, along with the U.S. territory of Puerto Rico.
Functional Foods
Functional foods represent a third industry subset that may be attractive to investors given the increasing interest in energy shots, protein powders, and related products. Cannabis may seem incompatible with these types of products on the surface, but hemp has many attributes that make it an exceptional ingredient for functional foods. For example, the substance is high in protein, provides many antioxidants, and contains potentially-beneficial CBDs.
Lexaria Biosciences Inc. (OTC: LXRP) and NutraFuels Corp. (OTC: NTFU) have focused on increasing the bioavailability of CBDs in functional foods and supplements. Lexaria’s lipid encapsulation technology helps ensure that CBDs are fully digested, while NutraFuels’ oral sprays help CBDs immediately reach the bloodstream through the mouth. These companies are developing many CBD-based products through partnerships and licensing agreements.
Laguna Blends Inc. (OTC: LAGBF) is another company that’s working closely with Isodiol – a private company focused on manufacturing hemp-based CBD oils – to develop a line of CBD-based functional foods and beverages.
Looking Ahead
The cannabis industry has evolved over the past couple of years to include companies in many different sectors. Consulting firms and grow light providers may be the most obvious plays, but investors may want to consider licensed producers, pharmaceutical companies, and functional food makers as alternatives in the space. These companies could offer investors unique opportunities to capitalize on a market projected to be worth $50 billion by 2026.
By Kelly Weimar
- Published in Blog, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra (TBP:CSE), IntelGenx to develop cancer-pain-relief drug
Tetra Bio-Pharma and IntelGenx Announce the Signing of a Term Sheet for the Development and Commercialization of a Dronabinol XL Tablet
– Momentum Public Relations –
Press Release: February 9th, 2017
Tetra Bio-Pharma Inc. (“Tetra“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) and IntelGenx Corp. (“IntelGenx”), (TSX VENTURE:IGX)(OTCQX:IGXT), today announced the signing of a binding term sheet for the development and commercialization of a drug product containing dronabinol. Under the binding term sheet, Tetra will have exclusive rights to sell the product in North America with a right of first negotiation for outside the U.S. and Canada. The U.S. cancer pain market is expected to reach $5 billion in 2018.
Per the Binding Term Sheet, Tetra will make a non-refundable exclusive negotiation payment to IntelGenx, an upfront payment along with set milestone payments based on the completion of an efficacy study, approvals from FDA and Health Canada and launching of the product.
IntelGenx will be responsible for the research and development of the product, including clinical studies and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology. Tetra will be responsible for funding the product development, and will own and control all regulatory approvals, including the application and any other marketing authorizations. Tetra will also be responsible for all aspects of commercializing the drug product.
“We are pleased to partner with Tetra Bio-Pharma to enter the lucrative cannabis market,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “We will work with Tetra to bring this much needed THC product to North American patients suffering from anorexia and cancer chemotherapy-related pain. This announcement is a further testament to the strength of IntelGenx’ scientists who continue to execute the development of innovative products using our advanced oral delivery platforms.”
PhytoPain Pharma Inc., a subsidiary of Tetra will be submitting a request for a Type B pre-IND meeting with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP), Center for Drug Evaluation and Research (CDER), USA Food and Drug Administration (FDA) to discuss the marketing requirements for Dronabinol AdVersa® Mucoadhesive tablet product. Tetra intends on developing Dronabinol AdVersa® Mucoadhesive tablet as an analgesic for the management of Breakthrough Cancer Pain. Once the safety and efficacy is demonstrated in patients, this drug product will be eligible for approval under the 505(b)(2) New Drug Application (NDA) path commented Dr. Guy Chamberland, Chief Scientific Officer and Regulatory Affairs. The 505(b)(2) pathway represents a significant reduction in time and cost to market commented Dr. Chamberland. He added that the company will also be meeting with the Therapeutic Product Directorate, Health Canada to discuss the clinical development and marketing requirements.
Dr. Chamberland further commented that there are many clinical problems associated with the use of currently available form of Dronabinol in patients with anorexia and cancer chemotherapy. It has been demonstrated that psychoactive drugs exert their euphoria, and other psychoactive effects, when the blood levels of the drug rapidly increase. The pharmacokinetic profile of THC and its metabolite significantly affect the abuse potential of Dronabinol. The significant advantage of the Mucoadhesive technology is the controlled-release of THC resulting in a longer time release of the drug avoiding a rapid increase in the blood. There is also an improved bioavailability and potentially reduced gastro-intestinal side effects making the sustained-release THC product a promising alternative in the battle for the reduction of opioids in patients with chronic pain.
About IntelGenx:
IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilmTM technology platform. Established in 2003, the Montreal-based company is listed on the TSX-V and OTC-QX.
IntelGenx highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx state-of-the art manufacturing facility, established for the VersaFilmTM technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to our clients. More information is available about the company at: www.intelgenx.com.
About Tetra Bio Pharma:
Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
- Published in Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Inc. (TBP:CSE) Enters into Distribution and Supply Agreement with Engen Medical Corporation
Tetra Bio-Pharma Inc. Enters into Distribution and Supply Agreement with Engen Medical Corporation
– Momentum Public Relations –
Press Release: February 6, 2017
Agro-Tek Inc. (“Agro-Tek”) a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announced today it has entered into an five (5) year exclusive Supply and Distribution agreement with Engen Medical Corporation (“Engen”) for the Canadian distribution of its Munchies B Gone gum. In exchange for a payment of $28,000 on signing the agreement and a minimum purchase commitment of $1,580,000 over five years, Agro-Tek will have exclusive sales and distribution rights in Canada. Engen will be responsible for all manufacturing and regulatory aspects.
Approximately $500 million of chewing gum was sold in Canada last year and $3.5 billion was sold in the United States. Sugar-free gum is expected to show the greatest growth within the sector in both Canada and the United States over the next few years. (Source: The Globe and Mail published Wednesday, February 04, 2015).
The worldwide chewing gum market grew by about 20 per cent between 2009 and 2014, reaching $24.7-billion in 2014. And it is projected to grow another 32 per cent to $32.5 billion by 2019. (Source: The EuroMonitor).
“Tetra is excited to be teaming up with Engen to bring Munchies B Gone to the Canadian market. This distribution agreement launches the first line of revenue generating products for Agro-Tek,” said Andre Rancourt, CEO of Tetra. Agro-Tek is currently in negotiations with multiple distributors servicing the over 3,000 cannabis lifestyle and retail stores that exist in Canada and cater to the Cannabis consumer.
“We are extremely excited about working with Agro-Tek to launch our Munchies B Gone gum into the Canadian market,” said Paul Epner, Co-Founder and Managing Director of Engen.
About Engen Medical Corporation. Engen, a privately held United States corporation, owns the global patent and intellectual property rights to several chewing gum products, including Munchies B Gone gum catering to the cannabis and holistic herbal consumer.
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
- Published in Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Inc. (TBP:CSE) Completes Pre-IND Meeting with Food and Drug Administration on PPP001
Tetra Bio-Pharma Inc. (TBP:CSE) Completes Pre-IND Meeting with Food and Drug Administration on PPP001
– Momentum Public Relations –
Press Release: January 30th, 2017
PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has completed its pre-IND meeting with the USA Food and Drug Administration (“FDA”) for its PPP001 dried cannabis drug product. The meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”), Center for Drug Evaluation and Research (“CDER”).
The FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements. Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, commented “We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development. Adhering to the US FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of Cannabis as a prescription controlled drug and the corporations plan to seek reimbursement by insurers for patients.”
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra BioPharma (TBP:CSE) Announces it Has Entered into a Clinical Research Partnership with Sante Cannabis, Quebec’s Leading Medical Cannabis Institution
Tetra BioPharma Announces it Has Entered into a Clinical Research Partnership with Sante Cannabis, Quebec’s Leading Medical Cannabis Institution
– Momentum Public Relations –
Press Release: January 23, 2017
PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“TetraBio” or the “Company” or “TBP“) (CSE:TBP)(CSE:TBP.CN) is pleased to announce that it has entered into a clinical research partnership with Santé Cannabis. Under the partnership, Santé Cannabis will be working with PPP to develop the late phase clinical trial protocols that will be used to obtain substantial evidence of the safety and efficacy of PPP001 required for a new prescription drug approval from Health Canada and the USA Food and Drug Administration (“FDA“). These ground-breaking trials seek to receive the first approval for a Canadian-manufactured cannabis-based prescription medication.
Santé Cannabis is a private clinic specialized in the clinical application of medical cannabis for the treatment of pain and other chronic and terminal health conditions. The clinic’s team of physicians and support staff has unparalleled experience in the assessment and monitoring of medical cannabis patients. Santé Cannabis is the leading medical cannabis research institute in the province of Québec and the primary recruitment site for the province-wide Quebec Cannabis Registry. “Our clinic has provided services to almost 2,000 patients referred by over 1,500 physicians across Québec,” states Erin Prosk, Director of Santé Cannabis. “It is clear that both the medical community and the Quebec patient population are in desperate need of information about the potential benefits and risks of medical cannabis treatments. The status of medical cannabis as an unapproved treatment dissuades many physicians from writing a prescription and requires patients to pay for treatments out of pocket. Of the 2,000 patients that we have seen, there is not one who is not burdened by this financial barrier.”
Dr. Antonio A.L. Vigano, MD, MSc, will lead the Santé Cannabis team to administer the Phase II-III clinical trials in close collaboration with Dr. Irina Kudrina, MDCM, CCFP, CSP, and Santé Cannabis Medical Director Dr. Michael Dworkind, MD, CCFP, FCFP. Dr. Vigano is an attending physician in the Supportive and Palliative Care Service at the McGill University Health Centre and an Associate Professor in the McGill University Department of Oncology. He is the Director of the McGill Nutrition and Performance Laboratory and the Cancer Rehabilitation (CARE) Program. Dr. Vigano has assessed and followed approximately 400 patients during his 18-month tenure at Santé Cannabis. “It has become clear that medical cannabis can be a critical complementary therapy for the treatment of pain,” states Dr. Vigano. “Administering these late phase clinical trials is necessary to rigorously validate the efficacy and tolerability that I observe every day with my patients at Santé Cannabis. If specific medical cannabis products and protocols such as that we will design for PPP001 can withstand the pharmaceutical approval process, it cannot be denied as a valid pain therapy. Cost-coverage should be a logical next step.”
Dr. Irina Kudrina is a McGill-certified pain physician and an attending physician and head of the chronic pain services at the Queen Elizabeth GMF-U and Assistant professor and clinician-researcher at the McGill University Department of Family Medicine. “At present, medical cannabis has already become an important medicine in the fields of oncology, chronic pain, neurology and others. In a clinical review* published in Journal of the American Medical Association (2015), Harvard-based researchers highlighted its use in some medical conditions as being supported by high quality evidence. In Canada, the efforts by regulatory, medical, and pharmaceutical bodies and by the patient advocacy movements have been targeting multiple structural, legal and information barriers still prevailing from the times when long-term high dose opioid therapy was prescribed to chronic pain patients despite its chronic toxicity effects and without high quality evidence for such use. While the clinical use of medical cannabis remains a stigmatized and poorly researched option for some medical conditions, sufficiently large-scale late-phase clinical trials on efficacy, safety and tolerability of medical cannabis are long overdue. These studies might open the door for another class of medications in an attempt to fill the current significant gap for more long-term pharmacological options.”
*(https://www.ncbi.nlm.nih.gov/pubmed/26103031)
PPP entered into this partnership because of Santé Cannabis’ unique expertise and dedication to a pharmacovigilance approach in medicine. The clinic has established clinical practices that help minimize adverse effects in patients and will help design the treatment protocols for the Phase II-III studies. According to Dr. Guy Chamberland, Chief Scientific Officer and Regulatory Affairs, “Adequately designing a late phase clinical trial for the evaluation of the safety and efficacy of inhaled Cannabis requires clinical teams experienced in handling the administration of Cannabis by inhalation to patients. The medical experts of Santé Cannabis complement the scientific and medical experts of our Clinical Advisory Board and provide PPP with an exceptionally solid foundation for the clinical development of Cannabis products as prescription drugs.”
Once authorized by Health Canada, Santé Cannabis will be recruiting participating physicians and patients from the Montreal area throughout 2017. For more information, please contact the clinic by email at info@santecannabis.ca.
About Santé Cannabis:
Santé Cannabis is Québec’s only medical clinic and resource centre dedicated to the clinical practice and research of medical cannabis treatments. Since opening in November of 2014, physicians at Santé Cannabis have assessed almost 2,000 patients referred by more than 1,500 physicians across the province of Québec. Santé Cannabis currently administers several clinical study protocols, including the Québec Cannabis Registry in collaboration with the Research Institute of the McGill University Health Centre and in accordance with the regulations of the Collège des Médecins du Québec.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma