Nov 13, 2023 in Press Releases
BIONXT SIGNS DEFINITIVE AGREEMENT FOR 100% ACQUISITION OF IP AND CO-DEVELOPMENT OF CLADRIBINE ODF DRUG REFORMULATION FOR THE TREATMENT OF MULTIPLE SCLEROSIS
VANCOUVER, BC – November 13, 2023 ‐ BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE: BNXT / OTCQB: BNXTF / FSE: BXT) is pleased to report that it has signed a definitive agreement (the “Agreement”) with a German-based pharmaceutical developer for the acquisition of 100% of the intellectual property rights and joint development of an oral dissolvable (“ODF”) drug reformulation using the active pharmaceutical ingredient Cladribine.
Cladribine is approved for use in over 75 countries, including by the United States Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”), for several indications, namely highly active forms of relapsing-remitting Multiple Sclerosis (“MS”) and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe. The global Multiple Sclerosis drug market is expected to top US$ 41 Billion by 2033 according to Market.us.
“The treatment of certain forms of MS with Cladribine is already a blockbuster drug market with over one billion USD in annual sales,” said Hugh Rogers, CEO & Director of BioNxt. “This is an incredible opportunity for BioNxt to participate in a massive and growing drug development market with a proprietary dosage form based on the BioNxt drug delivery platform. We are currently focused on drug delivery systems with our Cladribine ODF and Rotigotine TDS development programs as the Company’s priority initiatives.”
The Company has filed several Cladribine-related preliminary patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
The parties have initiated joint development work including parallel preclinical and clinical activities related to the Cladribine ODF product in accordance with mutually agreed upon development plans. As consideration for the intellectual property rights and development contributions, the Company has agreed to pay the following consideration: (a) a cash fee of €150,000, payable in two equal installments; (b) a monthly management fee of €15,000, which will be increased to €20,000 upon completion of the pilot study related to the Cladribine ODF; (c) license fees in the event the Company grants licenses to any product using the Cladribine ODF or other film developed in performance of the joint development activities; and (d) (i) 100,000 common shares in the capital of the Company (“Shares”) at a deemed price of $0.50 per Share, and (ii) up to 2,500,000 additional Shares upon the occurrence of certain specified milestones.
All Shares issued in connection with the Agreement will be subject to a statutory hold period of four months and one day following the date of issuance in accordance with applicable Canadian securities laws.