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Genix Pharmaceuticals Corporation Enters into Exclusive License and Supply Agreement for Canada's First Generic Thyroid Medication
Vancouver, British Columbia,--(Newsfile Corp. - April 1, 2021) - Genix Pharmaceuticals Corpor...
About this update from Genix Pharmaceuticals Corporation
[{"type":"text","content":"Genix Pharmaceuticals Corporation Enters into Exclusive License and Supply Agreement for Canada's First Generic Thyroid MedicationVancouver, British Columbia,--(Newsfile Corp. - April 1, 2021) - Genix Pharmaceuticals Corporation (TSXV: GENX) (\"GENIX\" or the \"Company\") is pleased to announce that it has entered into an exclusive Canadian licensing and supply agreement (the \"Agreement\") with Acme Generics LLP (\"ACME\") for the manufacture, sale, marketing and distribution of Canada's first available generic version of Synthroid® (Levothyroxine sodium), a widely prescribed treatment for hypothyroidism. Currently sold by Mylan Pharmaceuticals, Synthroid® is the largest volume prescription drug sold in Canada with nearly 20 million prescriptions written in 2019 (www.IQVIA.com). Estimated 2020 sales in Canada is over $200 million. Hypothyroidism (low thyroid hormone), or thyroid dysfunction, affects around 10% of Canadians aged 45 years or older. Levothyroxine is a thyroid medicine that replaces a hormone (T4) normally produced by your thyroid gland to regulate the body's energy and metabolism and is used to treat hypothyroidism. GENIX will pay ACME a total licensing fee of US $350,000 (the \"Transaction\") for the exclusive Canadian rights which includes eleven dosages of Levothyroxine sodium. ACME will assist GENIX and its regulatory consultants to file Abbreviated New Drug Submissions (ANDS) with Health Canada to obtain regulatory approvals for legal sale of the drugs in Canada. The Agreement is subject to TSX-V approval.The terms of the Agreement are as follows: First payment of US $87,500 upon signing the Agreement;Second payment of US $87,500 payable upon completion of the satisfactory review and GAP analysis of the drug dossier by GENIX's regulatory consultants and the consultants' written positive opinion of the dossier being acceptable by Health Canada; andThird payment of US $175,000 upon Health Canada's approval and issuance of the Notice of Compliance (NOC), Marketing Authorization for Canada and Health Canada's issuance of Drug Identification Numbers (DINs) for the products.The initial term of the Agreement is for an eight year period from the date of product approval by Health Canada, which is expected to take between 18-24 months, and will renew automatically for two year terms thereafter. The Company's...