FSD Pharma Enters into License Agreement to Develop FDA approved Veterinary Drugs for the Treatment of Gastro-Intestinal Diseases in Dogs and Cats
FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE) (“FSD Pharma” or the “Company”) today announces that it has entered into a license agreement (the “License Agreement”) with Innovet Italia S.R.L. (“Innovet”), under which Innovet granted the Company a license to use ultramicronized-palmitoylethanolamide (or ultramicronized PEA) (“ultra-micro PEA”) to develop U.S. Food and Drug Administration (“FDA”) approved veterinary drugs for the treatment of gastro-intestinal diseases in Canine and Feline (Dogs and Cats). In addition, the Company today announces the filing of its year-end results and provides corporate updates.
“The licensing agreement with Innovet Italia S.R.I, to evaluate the use of ultra- micro PEA as a veterinary anti-inflammatory prescription drug, is an exciting opportunity for the company to enter into a new and untapped market,” said Dr. Raza Bokhari, Executive Chairman & CEO. “With a balance sheet that is stronger today than it was when we began our journey nearly three years ago, we are actively exploring other M&A and licensing opportunities to expand our drug development pipeline.”
The License Agreement grants the Company an exclusive, worldwide license (excluding Italy, and subject to a first refusal right maintained by Innovet, any other country in Europe) to research, manufacture and commercialize products using certain proprietary formulations of ultra-micro PEA (the “Licensed Products”) to treat gastro-intestinal diseases in canines and felines. The License Agreement provides that the Company shall develop the Licensed Products with a view to submitting an Investigational Animal Drug Application with the FDA within thirty-six (36) months of the date of the agreement and shall submit a New Animal Drug Application within sixty (60) months of the effective date of the agreement.
Under the terms of the License Agreement, the Company is required to make payments to Innovet upon the achievement of specified milestones. An initial non-refundable sum of US$500,000 is due and payable to Innovet on the effective date of the License Agreement and a second non-refundable sum of US$250,000 will be due and payable to Innovet on the first anniversary of the effective date of the License Agreement. Within thirty business days of the first notification of approval of a New Animal Drug Application by the FDA of the first Licensed Product to receive such approval in the United States, the Company is required to pay an additional non-refundable sum of US$750,000 to Innovet.
|Diskussion: FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19|