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: The Canadian Pioneer in Cannabis-Based Pharma for Pain Relief in Cancer Patients
Momentum PR ‘s client, Tetra Bio-Pharma is listed on the Canadian Securities Exchange under the symbol TBP as well as on the OTCQB in the US under the symbol GRPOF
Momentum PR is pleased to have produced an informative and comprehensive report on Tetra Bio-Pharma available on the Momentum PR LinkedIn page.
Tetra Bio-Pharma Highlights:
- – Canadian-based pioneer, innovator and first to market in cannabis-based pharmaceuticals- Global medical marijuana market is estimated to reach US$55.8 billion by 2025- Tetra Bio-Pharma is the first and only bio-pharma company in North-America focused on cannabinoid (CBD) clinical stage pain relief products- Tetra is the only bio-pharma company currently running a double-blind Phase 1 study with organically-grown cannabis
– Positive outcome from trials will result in for North-American Drug Identification Numbers (DIN), thus qualifying prescriptions for insurance coverage.
– Strategic partnership with Aphria Inc. announced in November 2016 and solidified in April 2017
Tetra Bio-Pharma is a Canadian-based pioneer, innovator and first market mover in developing cannabis-based pharmaceuticals. These are used for the treatment of cancer-related pain and the resultant nausea, as well as anorexia and Post Traumatic Stress Disorder (PTSD).
The global medical marijuana market is estimated to reach US$55.8 billion by 2025, according to Grand View Research. Health Canada has stated that they expected a mature medical marijuana market worth C$1.3 billion by 2024 in Canada alone.
Tetra Bio-Pharma is the first and only bio-pharmaceutical company in North-America that is focused on cannabinoid (CBD) clinical stage pain relief products. The Company believes that if all goes well, its flagship drug, PPP001, designed to treat the chronic pain associated with many cancers, will be on the market in 2019. The Canadian Cancer Society is estimating a 35{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} growth rate in cancer cases in Quebec, and 40{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} nationally by 2030. They also advocate for more spending on research on innovative drugs and end-of-life treatment.
Tetra Bio-Pharma is accelerating the acceptance of cannabis-based medical treatments. It is the only bio-pharmaceutical company currently running a double-blind Phase 1 study. It aims to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single and multi-daily ascending doses of cannabis by smoking in healthy volunteers.
Pending a positive outcome, cannabis-based drugs designed to treat cancer pain and nausea from chemotherapy, PTSD and a number of other ailments will qualify for North-American Drug Identification Numbers (DIN). This means that prescriptions would be eligible for insurance coverage.
In addition to developing proprietary products and intellectual property, Tetra Bio-Pharma signed a supply agreement with ACMPR licensed producer Aphria Inc. on November 3, 2016. The Tetra-Aphria partnership was further solidified on April 19, 2017 when plans were announced for the joint distribution of dried medical cannabis for Quebec and the Atlantic Provinces.
The Momentum PR informative and comprehensive report on Tetra Bio-Pharma is available on the Momentum PR LinkedIn page.
If you would like more information on Tetra Bio-Pharma listed on the Canadian Securities Exchange under the symbol TBP with a market cap of C$ 70 million, or would like to arrange an interview with management please contact:
Momentum PR
Juliette Benard, Director Media Relations
+1.450.332.6939
About Momentum PR
Momentum PR is a cutting-edge public and investor relations consulting agency representing companies within the Canadian investment community.
Since 2009, Momentum PR has been servicing small and mid cap Canadian listed public companies, seeking to increase their exposure across North America. The focus at Momentum PR is on building and driving brand awareness. Momentum PR cultivates new audiences in the media and investment communities by proactively engaging interested parties on behalf of client companies through online and offline channels.
Disclaimer:
All editorial content contained herein is solely the responsibility of Momentum PR and does not reflect, in any way, the opinions of TheNewswire.ca Inc., its partner newswires and / or associated news services.
– See more at: The Newswire
- Published in Blog, 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
Tetra Bio-Pharma Inc. (TBP:CSE) Receives Notice of Authorization from Health Canada
Tetra Bio-Pharma Inc. Receives Notice of Authorization from Health Canada for the Conduct of its Clinical Trial with its PPTGR topical product
– Momentum Public Relations –
Press Release: February 1, 2017
PhytoPain Pharma Inc. (“PPP”), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP), 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 received a Notice of Authorization from the Therapeutic Products Directorate, Health Canada, for its planned clinical trial for PhytoPain Topical Gel Relief (“PPTGR”), being developed as a locally administered therapeutic for the treatment of Chemotherapy-Induced Neuropathic Pain (“CIPN”).
CIPN is a common adverse effect of cancer therapy and a frequent reason why cancer patients stop their treatment early. For some patients, the severity of the symptoms can be reduced by lowering the dose of chemotherapy or temporarily stopping it. In other patients the symptoms of CIPN may last for months or years after the cancer therapy has stopped. CIPN symptoms are managed using the same analgesics used to manage other types of neuropathic pain. Some of these analgesics also cause intolerable side effects in patients. The use of a topical counterirritant may help reduce the symptoms of CIPN and avoid exposing some patients to oral neuropathic pain analgesics.
- Published in Medical Marijuana, News Home, Tetra Bio Pharma
HealthSpace Announces Renewal of Agreement with Health Canada
VANCOUVER, BC / TheNewswire / November 7, 2016 – HealthSpace Data Systems Ltd. (the “Company” or “HealthSpace”) is pleased to announce the renewal of its software and service agreement with Health Canada for a period of one year, worth $168,000. The agreement includes an option to extend an additional two years. If the extension occurs the agreement will exceed a total of $ 500,000.
Healthspace will be responsible for providing data collection systems to track environmental conditions on First Nations communities across Canada and in the far north. The company will also provide tracking software for the First Nations Health Authority in British Columbia.
“We are honoured that Health Canada has entrusted our company to work with them and the First Nations community and believe that our software will enhance their efficiency and quality of work,” commented Joseph Willmott, President of the Company.
About HealthSpace Data Systems Ltd.
HealthSpace is an industry leader providing inspection, information and communication management systems for federal, state, county and municipal governments. Over the last decade the Company has successfully developed both enterprise and mobile internet-based applications currently serving over 300 state and local government organizations across North America. Clients range in size from small county organizations to state-wide systems with over 910 concurrent users, as well as national programs. HealthSpace specializes in the field of developing, installing, and maintaining inspection and regulatory management systems for environmental and public health organizations.
Forward-Looking Statements
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although HealthSpace 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 may differ materially from those in forward looking statements. HealthSpace expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For more information please contact:
Ali Hakimzadeh, Chairman
ali@sequoiapartners.ca
604-682-4600
Peter J. Kletas
PJK & Associates Inc.
866-999-6251-Toll Free
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- Published in Bio technology, Health Space, News Home
InMed Gains Health Canada Exemption for Cannabinoid Use
2015-03-23 08:12 ET – News Release (Marketwired)
INMED RECEIVES EXEMPTION STATUS FROM HEALTH CANADA
InMed Pharmaceuticals Inc. (CSE:IN, OTCQB:IMLFF) has received a notice from Health Canada dated March 12, 2015, approving InMed’s application for an exemption under Section 56 of the Controlled Drugs and Substances Act.
This exemption allows InMed to use a specified quantity of selected cannabinoid compounds including Delta 9 tetrahydrocannabinol and cannabidiol. Importantly this exemption allows InMed to possess the controlled substances and to administer them for research and development purposes, which include in vitro studies as well as the use of these compounds in animal models of human diseases.
Craig Schneider, president and chief executive officer, states, “Obtaining this exemption is a critical milestone for InMed as we prepare for human clinical studies for our lead programs in glaucoma (CTI-085) and arthritis (CTI-091) moving towards the clinical development of their respective proprietary delivery systems.”
The Office of Controlled Substances’ licensed dealer has also been notified so that it may import the controlled substances on behalf of InMed.
About InMed
InMed is a clinical stage biopharmaceutical company that specializes in developing cannabis based therapies through the research and development into the extensive pharmacology of cannabinoids coupled with innovative drug delivery systems. InMed’s proprietary platform technology, product pipeline and accelerated development pathway are the fundamental value drivers of the company.
We Seek Safe Harbor
- Published in Blog, Life Sciences, Medical Marijuana
Patients vs Government -The Battle for Medical Marijuana
By: Frehiwote Negash –
It’s been nearly a year since the Medical Marijuana Purposes Regulation has gone into effect and the debate over who has the “right to grow” has shift into a legal battle about patients’ rights and accessibility versus government oversight. The fight for medical marijuana has taken a decidedly different tone here in Canada compared to our southern neighbor. While U.S senators from both parties are fighting to get medical marijuana passed into law at the federal level, patients in Canada are battling their own government to continue to grow their own cannabis without having to turn to commercially licensed producers. The Harper government lost its latest appeal to prevent registered medical marijuana users from growing their own pot at home. The Federal Court of Appeal unanimously upheld the injunction that allows these exempted patients from purchasing medical marijuana under the new system. That means while the government gears up for another round in the courts, these patients will still be able to produce their own medicine. However, the recent arrest of Bob Dillman and his wife in Dartmouth, N.S has added fuel to the fire. Dillman, who was allowed to produce his own medicine under the old regime, was charged along with his wife with production and possession of marijuana. The take away for users reliant on their own production is that the new regulations view them as criminals, not patients.
The previous medical marijuana system, which came into effect in 2001, allowed patients to either grow their own pot or designate someone to grow it for them should they choose not to purchase their cannabis through Health Canada. The new system allows for patients to purchase their pot from through producers who have been sanctioned by Health Canada while phasing out the home cultivation option. Patients have argued that the new regulations violate Section 7 of the Canadian Charter which protects “life, liberty and security of the person.” They argue that the under the new system, prices for medical marijuana are expensive for the amount they consume. It isn’t just a question of affordability but also of quality control and choice as patients want to decide for themselves what to consume and not have to worry about the limitations on possession. Another issue with the current system is whether there is enough supply to meet the demand as only a handful of the 23 licensed producers have already begun large scale production. With the number of registered users expected to grow ten-fold within the next decade, the system needs revamping but it is not without its merits.
The government argues that with the new system it reduces the need of Health Canada monitoring grow –ops and reduces safety concerns in communities. The process of acquiring a license is difficult as wannabe producers are required to go through a number of security checks. While there are a number of issues with the long wait times, the sense here is that Health Canada’s rigorous process is better for the patient and places license holders under stringent quality control regulations forcing them to be accountable. If medical marijuana is to become a $ 1 billion industry, then government oversight is essential for the safety of the patient. There are merits to both arguments but the crux of the issue how to more clearly define Health Canada’s mandate on the issue.
Source: CBC, Yahoo News
- Published in Blog, Life Sciences
Organigram (V.OGI) and the Massive Deal Everyone Missed
Right?
Organigram (TSX:V.OGI, Stock Forum) essentially secured an LOI for an off-take deal with a chain of ‘healing centres’ that would see them moving up to 4500 kilograms of medical marijuana through 2016, with a 20{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} increase each year beyond that for ten years, for use in the treatment of Post-Traumatic Stress Disorder (PTSD) by veterans, the military, and first-responders.
The math on this is simple: Organigram, even if they sell at a conservative $5 per gram, could sell 3 million grams just in 2016 alone, for $15m in revenue.
In 2015? $7.5 million.
This on top of its ongoing business.
Make no mistake, this is a big deal for two reasons.
- It locks in the first seven-digit revenue agreement in Canadian medical marijuana history, at a time when other companies are struggling to do six figures per quarter across the board.
- I’m led to believe this is an INSURANCE BACKED deal. That is, the healing centres are going to be treating the ill with medical marijuana and processing the costs through the patient’s federal insurance.That second point is potentially massive. It locks in ongoing revenues, allows patients to get access to plenty of medicine, and mainstreams the treatment to a point where insurance companies can become quickly conditioned to green-lighting medical marijuana for other conditions.
When insurance becomes part of the MMJ landscape, the profit party begins.
In addition, by moving into this space, Organigram can begin looking south, at a market where PTSD is so prevalent that a large segment of the population is either affected by it, or is close to someone who is.
Also part of the deal: THC will conduct research on medical marijuana and PTSD going forward to help mainstream the treatment.
Organigram, with this deal, graduates, leads and delivers on its promise.
Every other marijuana company out there is looking to grow their patient list, and Organigram just grew theirs by potentially thousands.
Trauma Healing Centers will open 13 centers across Canada as part of their phase one rollout. The first four centers will be in Edmonton, Ottawa, Quebec and the Halifax Region in January, with nine more opening across Canada by June 2015.
Why not open in Vancouver? Because Vancouver has a dispensary on every corner right now, most of which are moving gang-grown product and staffed by guys with neck tattoos and Affliction t-shirts. I’m told there’ll be city wide push to close most of those down in the New Year, which will open the market for real companies that have background checks and follow Health Canada rules to emerge. Good for patients, good for LPs.
I know other companies were talking to Trauma (AKA: THC – did you miss that?) about doing a deal, but Organigram CEO Denis Arsenault told me last week, “They were just treating it like a business opportunity. This is veterans. This is important. We’re going to make money on the deal but we’re not turning the screws, we want the product out there and there’s no greater need than those who’ve served and have PTSD coming home. So we’re working closely with Trauma and we couldn’t be prouder to have got their okay. Every one of us at Organigram considers it an honour to be able to help.”
Not a bad lead-in to Remembrance Day but, oddly, the market pretty much missed the significance of the news.
Organigram stock has been pushing in the green direction for a week or so but, to me, this deal is a company maker. It’s the first nuggets of the gold rush. Yet, the market barely nudged.
Why was that? Well, it’s what wasn’t in the press release: Dollar signs. We don’t know what margin OGI will make on the deal because we don’t have an agreed upon price. In addition, you always have to beware of the words ‘up to’ in any press release.
Organigram’s agreement binds it to supplying ‘up to’ 4500 kilograms through 2016. If THC fails to open its centres, or fails to attracts patients, that ‘up to’ figure could be zero.
Arsenault is convinced that’s not likely. “They’re already hiring, those centres are opening up.”
A casual search would indicate he’s right: Trauma Healing Centres are indeed hiring in Edmonton right now, though there’s no website yet (that I can find anyway). Still, nobody’s taking 3000 kilos of weed for a while yet.
There will be more deals like this, and each one from this point should be fiercely battled for by every licensed producer out there because forging one customer relationship at a time is a fool’s errand. Having reams of new patients handed to you every week is where it’s at.
When I talked to Arsenault, I asked him if this was the tip of the iceberg. He didn’t answer directly, but let’s just say, if you ever get a chance to play poker against him, take that chance.
His poker face is crap.
“We all know it’s going to go recreational legal,” says Arsenault. “When the dust settles, the people with the best product are going to capture a big part of the market.”
Aside from this deal, Organigram’s differentiators are its bilingualism (good for a hard push through the Quebec market, and nearly 30{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of the country’s population), and it has certified organic status, which no other company can boast. The organic thing could be a big help in getting access to doctors. Other producers claim they’re organic too because Health Canada says no pesticides can be used, but certification matters.
The stock, right now, is undervalued, as are almost all the LPs out there (the exception being Mettrum which has held well from its RTO), and a couple that appear to be near term MMPR candidates; Matica (CSE:C.GRF, Stock forum) and Supreme (CSE:C.SL, Stock Forum), for example.
The Canadian weedco marketplace is starting to become a place where real companies do business and, for mine, the rising tide of Organigram just lifted all boats.
Full disclosure: I invested in the last Organigram financing and still hold that investment. They’re also a Stockhouse marketing client, and I’ve also consulted with them on marketing strategy, so it’s safe to say I like OGI. You should be aware of that and take it into consideration before you make any purchasing decision based on this story, but you should also understand those three things happened because I believe the company is doing all the right things.
Read more at CEO.CA: Licensed organic grower vies for Canada’s pot prize.
–Chris Parry
http://www.twitter.com/chrisparry
Read more at http://www.stockhouse.com/news/newswire/2014/11/12/organigram-v-ogi-and-massive-deal-everyone-missed#IgIXv2cpjmp2ttXr.99
- Published in Blog, Medical Marijuana
Organigram (TSXV:OGI) Supporting Five-city Cross-Canada Program to Provide Cannabinoid Education
OTTAWA, Nov. 4, 2014 /CNW/ – The Board of Directors of the Canadian Medical Cannabis Industry Association (CMCIA) today announced a partnership with the Canadian Consortium for the Investigation of Cannabinoids (CCIC) to support, through an unrestricted grant, a 5-City Continuing Medical Education (CME) program to be held in February-March 2015.
This educational initiative aims to provide balanced and evidence based cannabinoid education to Canadian healthcare practitioners (physicians and nurse practitioners). The program builds on the portfolio of successful and respected educational sessions led by the CCIC since 2007. The program objectives and contents are developed by a national steering committee and are totally independent from funding sources.
Regulatory changes by Health Canada’s Marihuana for Medical Purposes Regulations (MMPR) that took effect last April made physicians directly responsible for deciding who should legally have access to marijuana for medical purposes.
“As physicians our number one priority is to help patients. It is imperative that physicians have sufficient knowledge about cannabis and cannabinoids in order to engage in informed discussions with patients about the therapeutic use of these drugs” said Dr. Mark Ware, Executive Director of the CCIC. “The CMCIA sponsored education program will build greater awareness of the risks and benefits of cannabinoids among Canadian physicians. We are encouraged to see the industry supporting this important work. We hope this is the beginning of an important partnership between physicians, researchers and the medical cannabis industry” Ware continued.
As the national association representing the majority of licensed producers regulated by Health Canada under the MMPR, the CMCIA is pleased to support unbiased independent research presented directly to physicians by physicians.
“A key area of focus for the CMCIA is to address the identified need for physician education on both the therapeutic risks and benefits of medical marijuana” said Marc Wayne, Chair of CMCIA.
“The time has come to address these gaps head on and work collectively to support members of the medical community so they can provide the best treatment for their patients. I am very pleased to see members of our industry leading this effort and working collaboratively to support these important initiatives. This program will help to reduce the stigma associated with the use of medical cannabis.”
The 5-city tour is expected to travel to Halifax, Montreal, Ottawa, Calgary and Vancouver.
The CMCIA would like to thank the following members who are supporting this important CME Education tour:
ABcann, Agrima, Bedrocan Canada, CannMedica Pharma, MedCannAccess, MedReleaf, Mettrum, OrganiGram, and Tweed.
About the CMCIA
The Canadian Medical Cannabis Industry Association (CMCIA) is Canada’s leading member-driven association for Licensed Producers (LPs) of medical cannabis. We represent the majority of producers currently licensed under the Health Canada’s Marijuana for Medical Purposes Regulations (MMPR), in force as of June 19, 2013.
The CMCIA’s mission is to promote national standards and best practices by supporting the development, growth and integrity of the medical cannabis industry. The association acts as a national voice for our members, and serves as a credible and trusted resource on issues related to medical cannabis industry.
The group shares a philosophy of patient-centered care and improved public health, and is committed to product safety and quality, secure and reliable access for qualified patients, and promotion of the safe and effective use of cannabis for medical purposes.
About the CCIC
The CCIC is a federally registered Canadian nonprofit organization of basic and clinical researchers and health care professionals established to promote evidence-based research and education concerning the endocannabinoid system and therapeutic applications of endocannabinoid and cannabinoid agents.
- Published in Blog
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