NEW YORK, April 16, 2020 /PRNewswire/ -- The fast pace of technological change in the biotechnology industry and the shifting market demands require continuous innovation. This, in turn, puts pressure on companies to invest in Research and Development. As such, organizations such as the DBT (Department of Biotechnology), together with government-funded institutions and other autonomous organizations, represent the biotechnology sector and promote funding to support R&D and various new product development endeavors. The rise in demand for these therapeutics and diagnostic solutions on principles of red biotechnology, DNA sequencing, and recombinant technology is anticipated to help the industry grow even further. And, the increasing occurrence of diseases such as hepatitis B, cancer, as well as viral infections such as the current pandemic, push biopharmaceutical innovators to lead the charge in the fight against these ailments. In fact, several biotechs over the last month have made announcements that vaccines or possible treatments for the pandemic are being developed. Furthermore, the global biotechnology market size is expected to reach USD 727.1 Billion by 2025 while at a CAGR of 7.4%, according to a new report by Grand View Research, Inc. Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Johnson & Johnson (NYSE: JNJ), OraSure Technologies, Inc. (NASDAQ: OSUR), Voyager Therapeutics, Inc. (NASDAQ: VYGR).
There are several incredible and innovative achievements scientists and researchers have made in biotechnology in recent years. Among the fields of study are gene editing, tissue engineering and regeneration, nanobiotechnology and others. In addition, new segments under the biotech umbrella are constantly being created. For example, the medical cannabis segments that emerged in recent years, or the growing acceptance of psychedelic drugs being used as a treatment for various health conditions including depression, panic disorders, post-traumatic stress disorder (PTSD), and opiate addiction. Overall, in recent years, several psychedelic drug product launches and developments were announced and initiated by companies worldwide, including established pharmaceuticals like Johnson & Johnson.
Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM) is also listed on the Canadian Securities Exchange under the ticker (CSE: SHRM). Earlier this week the Company announced breaking news that, "it has entered into a definitive agreement (the "Agreement") to acquire 100% of AltMed Capital Corp. ("AltMed").
AltMed's chief executive officer, Dr. Roger McIntyre, is a professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. Dr. McIntyre is also executive director of the Brain and Cognition Discovery Foundation in Toronto; director, co-chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance (DBSA) in Chicago, Illinois; professor and Nanshan Scholar at Guangzhou Medical University; and adjunct professor at the College of Medicine at Korea University. Furthermore, Dr. McIntyre is a clinical professor at the State University of New York (SUNY) Upstate Medical University, Syracuse, New York, and a clinical professor, Department of Psychiatry and Neurosciences, University of California School of Medicine, Riverside, California.
Clarivate Analytics has named Dr. McIntyre one of 'The World's Most Influential Scientific Minds' each year from 2014-2019. Dr. McIntyre is widely regarded as the world's most recognized psychiatrist in relation to mood disorders. He has extensive experience collaborating with private-sector partners, including but not limited to entities within the pharmaceutical industry, the insurance industry and the health care industry in Canada, the United States and globally.
AltMed is a Canadian ketamine clinic operator, psychedelic medicine IP aggregator and novel drug discoverer. AltMed has a suite of assets that will accelerate Champignon's multi-pronged business strategy, enabling Champignon to reach the consumer directly via rapid onset medical treatments, with an anticipated rollout of new clinical entities (NCEs) already identified and to be opened across the United States and Canada. Five new clinics in key markets, including New York, Florida and California, are anticipated to be fully operational by Q4 2020.
AltMed's asset portfolio is comprised of the following:
CRTCE & ASSOCIATED SOPs FOR SIGNIFICANT CLINIC ROLLOUT
AltMed owns 75% of the CRTCE, a fully operational ketamine clinic located in Mississauga, Ontario, with over 18 months of operating history. The CRTCE is licensed (2018) by the College of Physicians and Surgeons Ontario (CPSO) under OHPP (Out of Hospital Premise Program) to administer ketamine treatments for indications including but not limited to depression, bipolar disorder, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD).
CRTCE is the only vertically integrated rapid onset treatment centre operating from proof-of-concept to human clinical trials and publication, with study results in peer-reviewed journals by the world's leading experts in psychopharmacology. The CRTCE also serves as a rapid onset treatment training and education center for medical professionals and is equipped with a co-located pharmacy.
The clinic has been licensed by Health Canada to dose eligible patients with psilocybin and is the only clinic in Canada to perform psilocybin doses under Health Canada approval.
Champignon and AltMed will begin to roll out a network of subspecialty therapeutic clinics as a complementary, follow-on service for individuals and families who are suffering from the effects of addiction, depression, PTSD and anxiety disorders. Through continued R&D initiatives, the CRTCE plans to expand its clinical footprint via the establishment of NCEs for ketamine, psilocybin and MDMA, as well as pursue partnerships with the broader pharmaceutical industry.
PSYCHEDELIC MEDICINE, NOVEL DRUG DISCOVERY & TRIALS
With this acquisition, Champignon will now have three trials in the Phase I stage and three trials in the preclinical stage during 2020. The Company will also have seven IP patents for its ketamine/psilocybin delivery platforms and formulations.
AltMed maintains a preferred commercial relationship with Canada's largest neuroscience-focused preclinical contract research organization (CRO), InterVivo Solutions. The entities are collaborating to expedite Phase I testing and novel drug development of psychedelic molecules and proprietary delivery systems.
Champignon and AltMed plan to advance psychedelic-derived treatments and establish, via human clinical trials, the most compelling IP portfolio, clinical pipeline and drug development platform in the psychedelic medicine space. In H2 2020, AltMed will commence both comprehensive R&D campaigns as well as clinical trials, to be led and administered by leading M.D.s, clinicians and researchers targeting the following indications:
- Treatment-Resistant Depression (Dr. Roger McIntyre)
- Addiction (Dr. Peggi Shepherd DeGroote)
- PTSD/Traumatic Brian Injury (Dr. David Greenberg and Dr. Michel Rathbone)
- Aging/Dementia (Dr. DW Molloy)
- Anxiety/Obsessive-Compulsive Disorder (Dr. Michael Van Amerigan)"
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Seelos Therapeutics, Inc. (NASDAQ: SEEL) a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced last month additional interim data from its Phase I studies of Intranasal Racemic Ketamine (SLS-002). Seelos also announced that it completed its Type C meeting with the U.S. Food and Drug Administration (FDA) as scheduled to discuss the protocol design for a study of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD). Interim data disclosed includes the hemodynamic (vital signs) side effect profile to address the known and expected side effects of ketamine, which are increases in blood pressure and heart rate.
Johnson & Johnson (NYSE: JNJ) announced earlier this year the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO®▼ (esketamine) nasal spray. The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-tosevere depressive episode of major depressive disorder (MDD) who have current suicidal ideation with intent. "Janssen is committed to reducing the devastating burden caused by serious mental health disorders," said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "There is a need to provide treatments that can rapidly reduce depressive symptoms of individuals living with MDD who are in need of urgent relief. We therefore look forward to working with the EMA to provide a new targeted treatment that could potentially deliver meaningful results for these patients."
OraSure Technologies, Inc. (NASDAQ: OSUR) announced recently that it has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples. This support from BARDA will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market. Built on OraSure's OraQuick® platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. OraSure's portable rapid test platform uses an oral fluid sample and provides results in 20 minutes. No instrumentation or trained personnel would be needed to administer the test or to read the results. OraSure has a well-documented history of success with in-home infectious disease testing; the Company's oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.
Voyager Therapeutics, Inc. (NASDAQ: VYGR) a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases, provided an update earlier this month on the RESTORE-1 clinical trial of VY-AADC (NBIb-1817) for Parkinson's disease. Voyager and its collaborator Neurocrine Biosciences have temporarily paused screening of new patients in the RESTORE-1 trial to allow clinical trial sites to assess the impact of the COVID-19 pandemic on both the implementation of previously disclosed protocol amendments and on the safety of study participants. The companies plan to resume patient screening and enrollment as soon as the assessment is completed and Neurocrine, as the study sponsor, and Voyager, in consultation with clinical sites, determine that screening can safely and effectively resume. Voyager and Neurocrine Biosciences continue preparations for the initiation of the RESTORE-2 registrational study in Parkinson's disease planned for the second half of 2020.
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