Regulators Move to Remove Restriction on Some Uses of Psilocybin

The political push for the legalization of psychedelic products is now underway. Earlier this week, an Oregon ballot measure to legalize the use of psilocybin, a naturally occurring psychedelic prodrug compound, in a therapeutic setting has attracted enough signatures to be featured on the November ballot, under the condition that these signatures can be verified. “Pioneering research at institutions like Johns HopkinsNYU, and UCLA has shown the significant promise of psilocybin therapy,” said a press release put out by the campaign Monday, according to Oregonlive. “especially for people whose depression or anxiety hasn’t responded to other available treatments.” If successful, Oregon will become the first state to legalize a psychedelic substance, which is currently classified as a Schedule I drug. Previously, only cities like Oakland and Denver have decriminalized the use of psilocybin. Earlier in May 2019Denver, Colorado has passed a ballot measure decriminalizing psilocybin. Just less than a month after, the city council of Oakland, California passed a similar resolution. Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO), Novartis AG (NYSE: NVS), Pfizer Inc. (NYSE: PFE), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Aphria Inc. (NYSE: APHA) (TSX: APHA).

These gradual legalization victories are of course resembling the achievements of cannabis over the last decade. Following the passage of numerous legislations in recent years, the North American cannabis industry is positioned to continue to witness growth in its consumers. In particular, the U.S. is anticipated to dominate the global cannabis market because of its early adoption while Canada is expected to trail behind, even though it is the second nation to ever completely legalize cannabis. Both psychedelics and the cannabis segments are becoming actual components of the biotech/pharmaceutical markets, as more and more studies are indicating such products have legitime medical applications. The biotech market is constantly expanding, even as a 2017 report from the Institute for Health Metrics and Evaluation (IHME) showed that a total of 359 diseases and injuries were added to the fatal and non-fatal list of conditions since 1950. According to data by the Global Burden of Diseases, the most common causes of fatalities are heart conditions, stroke, respiratory infections, lung diseases, Alzheimer’s, diabetes, and kidney diseases. Overall, the global biotechnology market size is expected to reach USD 727.1 Billion by 2025 while expanding at a CAGR of 7.4%, according to a new report by Grand View Research, Inc.

Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO) announced earlier last week that, “it has added world renowned drug discovery expert Dr. Denton Hoyer to its Scientific Advisory Board.

Dr. Hoyer has been involved in drug discovery at leading pharmaceutical companies and research institutions for the last 30 years. He holds numerous patents and has been published extensively in the field of medicinal chemistry and drug research. Dr. Hoyer has unparalleled expertise in computational chemistry enabled probe molecule design, drug design and optimization, synthetic planning and execution, evaluation of chemical novelty and intellectual property assessment and strategies.

As part of his role with the company, Dr. Hoyer will directly work with Mydecine CSO Rob Roscow in developing research strategies, computational assessment of drug properties, formulation and pharmacokinetic studies as well as synthetic chemistry of drug substances.

“Dr. Hoyer’s decades of experience in drug discovery, genetics, pharmacology and intellectual property are going to be instrumental to our long term success,” expressed Rob Roscow.

Most recently, Dr. Hoyer served as the Director of Chemistry for the Yale Center for Molecular Discovery, where he led a team of scientists collaborating with Yale investigators to translate academic research into novel therapies for diseases across multiple therapeutic areas.

During his time at Pfizer, Dr. Hoyer held a joint appointment to both medicinal and computational groups developing a unique perspective and approach to lead finding and optimization. His deep knowledge of ADME and in-silico filtering provided Pfizer with novel properties screens and improved the quality of their screening collections. While at Novartis, Dr. Hoyer worked on compounding physical properties and ADME and created a novel approach to solubility determinations, later dubbed “kinetic” solubility.

Dr. Hoyer TSX obtained his Ph.D. with A. I. Meyers at Colorado State University developing new synthetic methodology followed by post-doctoral studies in Chemical Biology with Peter G. Schultz at the University of California, Berkeley.

“Dr. Hoyer will provide Mydecine strategic support with the entire process of drug discovery from target conception, through drug design and selection of clinical candidates. He will be instrumental to our R&D efforts at our Innovation center in Denver as well as the University of Alberta,” added Mydecine CEO Josh Bartch.”

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Novartis AG (NYSE: NVS) announced last year results from two analyses of real-world experience with Kymriah® (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications. These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with evidence of the Kymriah real-world experience in expanded groups of patients. When Kymriah was used in the real-world setting, efficacy and safety were consistent when compared to the pivotal trials, including the 24-month analysis of JULIET in adults with r/r diffuse large B cell lymphoma (DLBCL) and ELIANA in children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL). The real-world experience data were presented at the 61st American Society of Hematology (ASH) annual meeting.

Pfizer Inc. (NYSE: PFE) announced earlier in June that the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim). NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. “The FDA approval of NYVEPRIA is a positive step that could both enable cost savings and increase access to an important treatment option,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to add this new, long-acting supportive care option to our robust portfolio, now with six FDA-approved oncology biosimilars including three specifically approved for supportive care for patients with cancer. We look forward to making NYVEPRIA available to U.S. patients and physicians later this year.”

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, presented data in March further describing the baseline characteristics of the pediatric and adolescent patients in the fully-enrolled Phase 2 BRIGHT trial of Zygel™ (CBD transdermal gel; ZYN002) in children and adolescents with autism spectrum disorder (ASD), indicating that the trial enrolled a broad population of patients with moderate-to-severe ASD.  “ASD is a complex neurodevelopmental disorder characterized by difficulties with behaviors, communication, and social interaction,” said Zynerba’s Chief Medical Officer, Joseph M. Palumbo. “Pediatric and adolescent patients with ASD may also present with profound clinical anxiety, above the rate seen in neurotypical children, further complicating their condition and treatment regimen. Unfortunately, current ASD management options are restricted to cognitive behavioral therapy and a small number of approved pharmacologic treatments, highlighting the substantial unmet need for novel therapies in this population. We believe that we have enrolled an appropriate population of patients into our well-designed exploratory BRIGHT trial to enable a robust analysis of outcomes to help inform the design of future double-blind, placebo-controlled studies.”

Aphria Inc. (NYSE: APHA) (TSX: APHA) announced last year that it had received a cultivation license from Health Canada for Aphria Diamond, the Company’s second Leamington, Ontario cannabis greenhouse facility, bringing an additional 1,300,000 sq. ft. of production space with an annual growing capacity of 140,000 kg. Combined with the Company’s Aphria One facility and its subsidiary Broken Coast Cannabis, the Company now has more than 2,400,000 sq. ft. of cultivation space capable of reaching a total annualized production capacity of 255,000kg.  “We are extremely pleased to receive the licence for our long-awaited Aphria Diamond facility, which more than doubles our Canadian production capacity,” said Irwin D. Simon. “Reaching industry-leading production levels coinciding with the expansion into new categories and new opportunities for cannabis in Canada and around the world is a transformative moment for Aphria Inc.”