- SPRAVATO® (esketamine) nasal spray uses the first new mechanism of action in decades to treat treatment resistant depression disorder
- Aleafia Health medical clinics along with select physicians and nurses now approved to administer and prescribe, following completion of Janssen Journey certification
- Offering expands Aleafia’s health and wellness solutions to existing and prospective patients across Canada
- SPRAVATO® approved by the U.S. Food and Drug Administration and Health Canada
TORONTO, July 24, 2020 (GLOBE NEWSWIRE) — Aleafia Health Inc. (TSX: AH, OTC: ALEAF) (“Aleafia Health” or the “Company”) today announced that Janssen Pharmaceuticals, Inc. (“Janssen”), has approved its wholly owned subsidiary, Canabo Medical Inc. (“Canabo”) as an administrator and prescriber of antidepressant SPRAVATO® (esketamine) nasal spray. Three Canabo clinics, including the Company’s flagship Toronto location, along with a growing number of clinic network physicians and nurses, are now approved to administer and prescribe SPRAVATO® following the Janssen Journey training program’s completion. The Company intends to further expand this offering at its nationwide network of clinics and education centres which are staffed by physicians and nurse practitioners and have served over 70,000 unique patients to date.
Janssen, a division of Johnson & Johnson (NYSE: JNJ), received U.S. Food and Drug Administration approval for SPRAVATO® for use with an oral antidepressant in adults with treatment-resistant depressive disorder (TRD), followed by the drug being made available in Canada on July 22, 2020.
According to Janssen, “Health Canada’s approval was based [on] two pivotal Phase 3 clinical trials; a short-term induction study and a long-term maintenance study. In the induction study, those who took SPRAVATO® and an oral antidepressant experienced a statistically significant improvement in depression symptoms at four weeks compared to those who received a placebo and an oral antidepressant.”
“The expansion of Aleafia Health’s services to our existing and prospective patients speaks to our commitment to improving the lives of Canadians through innovative, evidence-based medicine,” said Aleafia Health CEO Geoffrey Benic. “We believe the skill sets and training of our physicians, the existing infrastructure of our national clinic network and our passion for patient access and best-in-class medicine make Aleafia Health particularly well situated to administer SPRAVATO®.”
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About Aleafia Health
Aleafia Health is a vertically integrated and federally licensed Canadian cannabis company offering cannabis health and wellness services and products in Canada and in international markets. The Company operates medical clinics, education centres and production facilities for the production and sale of cannabis.
Aleafia Health owns three significant licensed cannabis production facilities, including the first large-scale, legal outdoor cultivation facility in Canadian history. The Company produces a diverse portfolio of commercially proven, high-margin derivative products including oils, capsules and sprays. Aleafia Health operates the largest national network of medical cannabis clinics and education centres staffed by MDs, nurse practitioners and educators and operates internationally in three continents.
Innovation, the heart of Aleafia Health’s competitive advantage, has led to the Company maintaining a medical cannabis dataset with over 10 million data points to inform proprietary illness-specific product development and its highly differentiated education platform FoliEdge Academy. The Company is committed to creating sustainable shareholder value; the TSX Venture Exchange named Aleafia the 2019 top performing company prior to its graduation to the TSX.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Forward Looking Information
This news release contains forward-looking information within the meaning of applicable Canadian and United States securities laws and are expressly qualified by this cautionary statement. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes” or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include, but are not limited to, statements with respect to injection of value this settlement brings to the Company’s business. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including risks contained in the Company’s annual information form dated March 18, 2020 which is available on the Company’s SEDAR profile at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.