Palm Beach, FL –– February 24, 2022  – FinancialNewsMedia.com News Commentary – The prevalence of mental health disorders has risen exponentially but the development of novel medications has not kept pace, precipitating a crisis in psychiatric medicine. A novel innovation is psychedelic drug-assisted psychotherapy – the medically approved use of MDMA, psilocybin, and LSD as a component of elevated psychotherapy programs. A report from ResearchAndMarkets said that mental disorders are an urgent health crisis worldwide, especially exacerbated by COVID-19. As per a study by Harvard, the medical cost of mental health conditions is estimated to rise to $6 trillion by 2030. According to the publisher, the psychedelic drugs market is expected to grow at a robust rate of 14.5% CAGR during the forecast period and reach a value of $6330 Mn in 2026 from $3210 in 2021 as there is a large unmet need for treatment driving the adoption of psychedelic drugs.  The report pointed out key insights such as: Ketamine eyes CAGR of 16.0% amongst all products in terms of value as it has a robust clinical trials portfolio in multiple diseases viz. depression (MDD, TRD), bi-polar disorder, suicidal ideation, drug and alcohol dependence, and social anxiety; Products with natural origin are anticipated to gain 90 BPS in terms of value market share by the end of the forecast period. However, synthetic products will maintain their dominant market position with an 85% market share in 2026; Depression is estimated to hold the largest chunk of the disease indication segment with more than 40% market share in 2021; and Oral drugs are estimated to contribute more than 55% to the global psychedelic drugs market…”  Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), Atara Biotherapeutics,Inc. (NASDAQ: ATRA), Biogen Inc. (NASDAQ: BIIB), Teva Pharmaceutical Industries Limited (NYSE: TEVA), Relmada Therapeutics, Inc. (NASDAQ: RLMD).

ResearchAndMarkets continued: “The prevalence of mental health disorders has risen exponentially but the development of novel medications has not kept pace, precipitating a crisis in psychiatric medicine. A novel innovation is psychedelic drug-assisted psychotherapy – the medically approved use of MDMA, psilocybin, and LSD as a component of elevated psychotherapy programs.  North America is predicted to remain the largest region in the psychedelic drugs market due to a surge of clinical trials, massive investments, regulatory support, and widespread public awareness. The continent accounts for half of the revenue in the global psychedelic drugs market and should be worth $3184.0 Mn by the end of the forecast period. The strong presence of companies and ongoing clinical trials are also expected to bode well for the regional market.”

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Announces Plans to Open Three New Clinics in the UK by Mid-2022–  Pasithea erapeutics Corp. (Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, has expanded its treatment offer and is planning to open three new clinics in London to treat patients suffering from mental health issues. The Company already has locations in Marylebone and Knightsbridge.

“With these new clinics, we will broaden our London footprint and start offering pharmacy services and new treatment options, bringing important and novel mental health therapies to an ever-growing number of people. In addition to pharmacy services, our London clinics will offer other psychiatric treatment therapies, including repeated transcranial magnetic stimulation in addition to intravenous (“IV”) ketamine” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics. “With our strong cash position and our continued expansion in London, we believe we are well positioned to bring value to our shareholders,” concluded Dr. Marques.

“We are excited to [partner/expand our partnership] with ZEN Healthcare, who has been providing pioneering IV therapies in London for six years. By offering more locations, and a greater number of treatment options, we continue to work toward closing the treatment gap and getting millions of people the help they need,” said Dr. Yassine Bendiabdallah, Managing Director of Pasithea Clinics in the U.K.

The clinics, which will be operated by Pasithea, with management support from ZEN Healthcare, are expected to open by mid-2022. Each clinic will contribute an estimated USD$5 million annually in revenue.

Repeated transcranial magnetic stimulation (“rTMS”) is a therapeutic brain-stimulation technique based on the principle of electromagnetic induction. First developed in 1985, rTMS has been studied as a treatment for depression, psychosis, anxiety, and other mental health conditions, and has shown particular efficacy with drug-resistant depressive disorders. In 2008, rTMS was approved for use by the FDA as a treatment for major depression for patients who do not respond to at least one antidepressant medication. A typical plan consists of five treatments per week over the course of four to six weeks.  CONTINUED…  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

Atara Biotherapeutics,Inc. (NASDAQ: ATRA) recently reported Memorial Sloan Kettering Cancer Center’s (MSK) notification to the U.S. Food and Drug Administration (FDA) of a fatal serious adverse event (SAE) associated with a patient treated in the ongoing Phase 1, MSK-conducted dose-escalation clinical study of autologous mesothelin CAR T, ATA2271. MSK has voluntarily paused enrollment of new patients in the study on a temporary basis while additional information regarding the case is gathered and reviewed. The FDA has notified MSK of its agreement with this approach.

ATA2271 is a next-generation, autologous chimeric antigen receptor (CAR) T-cell therapy targeting mesothelin currently under clinical investigation in patients with malignant pleural mesothelioma. The single case involved a patient with a history of multiple malignancies and other comorbidities undergoing treatment for advanced recurrent mesothelioma. MSK is in the process of further evaluating the occurrence, including the extent of the relationship of the event to ATA2271.

Biogen Inc. (NASDAQ: BIIB) and Xbrane Biopharma AB (XBRANE) recently announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA^® (certolizumab pegol).

CIMZIA^®’s primary indication is for rheumatoid arthritis in adults as well as axial spondylarthrosis, psoriasis and Crohn’s disease. In 2020 global sales of CIMZIA^®were 1.8 billion Euro. Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and will be the Marketing Authorization Holder.

Teva Pharmaceutical Industries Limited (NYSE: TEVA) and Teva Pharmaceuticals Europe BV recently confirmed that the SmPC for COPAXONE^® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated. The product is now approved by EU health authorities for use in breastfeeding. The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.

COBRA, the largest standardized analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life. The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.

Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), recently  announced top-line results of the human abuse potential (HAP) study with REL-1017, a novel NMDA receptor (NMDAR) channel blocker and the company’s lead candidate in Phase 3 development for the treatment major depressive disorder (MDD).

Top-line results showed that all three doses of REL-1017 (25 mg, 75 mg, and 150 mg, the therapeutic, supratherapeutic and maximum tolerated doses, respectively) tested in recreational drug users, demonstrated a substantial (30+ points) and statistically significant difference vs. the active control drug, intravenous ketamine 0.5 mg/kg over 40 minutes, and were statistically equivalent to placebo. The study’s primary endpoint was a measure of “likability” with the subjects rating the maximum effect (or Emax) for Drug Liking “at this moment”, using a 1-100 bipolar rating scale (known as a visual analog scale or VAS), with 100 as the highest likability, 50 as neutral (placebo-like), and 0 the highest dislike. Consistent results are seen for the secondary endpoints.

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