Genix Pharmaceuticals Corporation Enters into Exclusive License and Supply Agreement for Canada’s First Generic Thyroid Medication
Vancouver, British Columbia, April 1, 2021 - Genix Pharmaceuticals Corporation (TSX-V: 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:
1. First payment of US $87,500 upon signing the Agreement;
2. 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; and
3. Third 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 CEO, Sina Pirooz, states, “We are excited to secure this exclusive licensing agreement with ACME for Canada’s first generic version of Synthroid®. As the number one prescribed drug in Canada, our generic will provide patients across Canada with a less expensive alternative. Also, since there are no generic competitors suppling Levothyroxine sodium tablets in Canada, we anticipate that GENIX, as the only Canadian generic version of the Synthroid® brand, will have a strong ability to capture market share and generate significant sales for the Company.”
Acme Generics LLC is part of India’s large ACME GROUP, which was established in 2005 and is now one of India’s largest providers of contract manufacturing (CMO) and R&D services to the top 25 Indian pharmaceutical companies and 5 global multinational pharmaceuticals companies. With over 500,000 sq ft of manufacturing space in India, it is also one of the largest producers of Levothyroxine sodium in the world, for the multinational pharmaceutical companies, and possesses global accreditations from various international pharmaceuticals regulatory agencies, including UK-MHRA, US-FDA, EU-GMP, ANVISA, PICS, INVIMA, WHO-Geneva.
Genix Pharmaceuticals Corporation is a highly innovative, Canadian life-sciences company focused on the acquisition, research, development, manufacturing, sales and distribution of innovative, novel and generic prescription and OTC pharmaceuticals for the ophthalmological and COPD markets and to satisfy unmet needs.
Our mission is to provide Canadians access to affordable, highest quality, evidence-based, novel and generic prescription drugs and OTC medicines and nutraceutical products to improve their health and quality of life. All Genix products are developed and supported by evidence-based science and clinical studies and manufactured under the strictest Good Manufacturing Practices (GMP) protocols. We intend to sell these products through traditional retail outlets as well as direct to consumer and e-commerce platforms.
On behalf of the Board,
Sina Pirooz, CEO, Director
Genix Pharmaceuticals Corporation
For more information regarding GENIX, please contact:
Kevin Bottomley, Director
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Statements included in this announcement, including statements concerning our plans, intentions and expectations, which are not historical in nature are intended to be, and are hereby identified as, "forward‐looking statements". Forward‐looking statements may be identified by words including "anticipates", "believes", "intends", "estimates", "expects" and similar expressions. The Company cautions readers that forward‐looking statements, including without limitation those relating to the Company's future operations and business prospects, are subject to certain risks and uncertainties that could cause actual results to differ materially from those indicated in the forward‐looking stat