The Path to New Drug Discoveries and Development with #Cannabis
Stocks Mentioned: Veritas Pharma Inc. (CSE: $VRT.C; OTC: $VRTHF), Zynerba (NASDAQ: $ZYNE), GW Pharmaceuticals (NASDAQ: $GWPH), Tetra Bio-Pharma (TSXV: $TBP.V; TBPMF), Aphria Inc (TSX: $APH.TO; $APHQF)
Point Roberts, WA - November 21, 2017 (Investorideas.com Newswire) Investorideas.com, a global news source and investor resource covering cannabis and hemp stocks issues a sector news alert on companies with new drug discoveries and developments in the sector.
How will cannabis impact the big pharma industry moving forward? According to a study by the University of Georgia entitled 'Medical Marijuana Laws Reduce Prescription Medication Use in Medicare Part D', it will lower costs.
"The savings, due to lower prescription drug use, were estimated to be $165.2 million in 2013, a year when 17 states and the District of Columbia had implemented medical marijuana laws. The results suggest that if all states had implemented medical marijuana the overall savings to Medicare would have been around $468 million."
In an era where drug costs are skyrocketing in the US and Canada, a lower cost solution that is also potentially easier on the patient's body is creating a stir in the industry.
Veritas Pharma Inc. (CSE: VRT; OTC: VRTHF; Frankfurt: 2VP), an emerging pharmaceutical and IP development company, just announced that its research arm, Cannevert Therapeutics Ltd., signed a letter of intent with the Fundación de Investigación (FDI) in San Juan, Puerto Rico, to conduct the first human study of CTL-X, its lead cannabis strain that targets pain.
Puerto Rico is well-known as one of the world's best known pharmaceutical production and development centers with a growing biotech presence.
The company says the study will be done in two stages to assess the analgesic effects of this lead strain. The first stage will have an open label design to look at the feasibility of two doses of CTL-X in 5 subjects while the second stage will use a randomized, double-blind, crossover design to assess one dose of CTL-X against a placebo control strain in 16 subjects who will be exposed to various modalities of acute pain.
Veritas's CEO Lui Franciosi stated, "We are pleased to see Cannevert's lead strain for pain is finally heading into human trials. It's important to us to move quickly into this next phase of providing clinical proof of cannabis' effectiveness, this after our chemical and animal assays delivered favorable results. FDI is a reputable group of clinicians and clinical trialists with a long history of evaluating treatments for major pharmaceutical companies. The Puerto Ricans are becoming world leaders in investigating and selling cGMP medical cannabis and their insights will be valuable. We aim to provide physicians and patients with scientifically tested and clinically proven cannabis therapies targeting pain. In the next year, Veritas's goal is to have a branded analgesic strain in which its dose and method of administration are standardized to actively compete with over-the-counter analgesics as well as potentially reducing or eliminating opioid use in the acute and chronic pain markets."
On November 14th, 2017 Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), a company developing and commercializing pharmaceutically-produced transdermal cannabinoid medicines reported financial results for the third quarter ended September 30, 2017 and provided an overview of recent operational highlights.
"We announced important data during the third quarter, including remarkable Phase 2 data from our FAB-C study of ZYN002 in children and adolescents with Fragile X syndrome," said Armando Anido, Chairman and Chief Executive Officer. "We achieved the primary endpoint and numerous secondary endpoints with statistical significance compared to baseline, and anticipate moving into a pivotal program in Fragile X in the first half of 2018. Additionally, we look forward to outlining our path forward in Epilepsy, and meeting with the FDA to discuss our OA pivotal program in the first quarter of 2018."
On November 16th, 2017 Tetra Bio-Pharma Inc. (TSXV:TBP.V; TBPMF), a company in cannabinoid-based drug development and discovery, announced that Rx Princeps™, a unique blend of dried medical cannabis used in its PPP001 clinical trials, is now available through licensed producer Aphria Inc. (TSX:APH.TO; APHQF) under Access to Cannabis for Medical Purposes Regulations (ACMPR).
Based on the most recent ACMPR market data from the Government of Canada, it is estimated that the sales of dried medical cannabis in Canada from April 2017 to March 2018 will be over $188M; Tetra is now entering this lucrative market and plans on progressively grabbing a significant share of it over the next two years. Mr Fortier, CEO of Tetra, stated last week "We are expecting to generate around $1.5 million in sales, in fiscal 2018 in our initial launch. Through our promotion and education efforts in Quebec, New Brunswick and part of Ontario, we estimate that over eight thousand patients will start using Rx Princeps™ under prescription from their doctors over in the next twelve months."
Rx Princeps™ is a new option for doctors who want to prescribe medical cannabis. Prescribing Rx Princeps™ with the Rx Princeps™ inhalation device enables their patients to optimize the benefits of medical cannabis through the intake of a fixed dose of product, thereby ensuring consistency of treatment with a standardized high-quality product.
Aphria (TSX:APH.TO; APHQF) grows and produces medical cannabis under a strict quality management program. Tetra chose Aphria as its partner because their production processes were adopted from the highly restricted and regulated pharmaceutical industry, and go above and beyond cannabis industry regulations mandated by Health Canada. As a result, Aphria's products are in line with the strict quality standards Tetra is establishing for the medical community and its patients.
200,000 patients are already registered under the ACMPR program and around 1.5 million adults in Canada suffer from chronic pain and are considered non-responders to opioids; medical cannabis could be a new therapeutic choice for those patients but physicians need bioavailability and safety data to prescribe medical cannabis with confidence. According to Health Canada, less than 3,000 physicians actually prescribe cannabis to their patients. Tetra is committed to provide them rigorous safety and bioavailability data. Tetra has begun educating pain clinics and the medical profession across Canada on Rx Princeps™, including its advantages for patients.
On October 31st, 2017 GW Pharmaceuticals plc (NASDAQ: GWPH), along with its U.S. subsidiary Greenwich Biosciences, announced it had completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epidiolex® (cannabidiol) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.
GW has received Rare Pediatric Disease and Orphan Drug Designations from the FDA for Epidiolex in the treatment of both LGS and Dravet syndrome. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex for the treatment of Dravet syndrome.
"The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions," stated Justin Gover, CEO of GW Pharmaceuticals. "On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW's commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs."
The NDA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies, each of which met their primary endpoint. Epidiolex was generally well tolerated in these trials. The NDA includes safety data on approximately 1,500 patients, with approximately 400 patients on continuous therapy for more than one year. Beyond pivotal safety and efficacy data, the NDA includes a comprehensive clinical pharmacology, pre-clinical and toxicology package. The CMC section of the NDA incorporates the Company's recently expanded UK manufacturing facilities.
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