Medexus Enters into Exclusive License to Register and Commercialize Triamcinolone Hexacetonide (TH) in the United States with Ethypharm

IndustryPRwire -- Medexus Pharmaceuticals announces it has entered into an exclusive license agreement with Ethypharm (“Ethypharm”) to register and commercialize Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (“TH”) in the United States.

TH is indicated for intra-articular, intrasynovial, or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases, including: rheumatoid arthritis, juvenile idiopathic arthritis (JIA), osteoarthritis and post-traumatic arthritis, synovitis, tendinitis, bursitis and epicondylitis. It is the longest-acting corticosteroid for intra articular injection, often lasting twice as long as competitive products.

The companies have agreed to a small upfront fee, which will be funded by Medexus with available liquidity, along with milestone payments at the time of FDA approval, at commercial product launch, and upon certain sales milestones. Medexus will also pay a double-digit royalty to Ethypharm on net sales of TH in the United States. TH has the potential to become the standard of care by offering a longer duration of action along with fewer injections (and by extension, fewer hospital visits and general anesthetics), as well as a safer and more cost-effective solution than competitive products. The Company expects to file for FDA approval of TH within 12-24 months.

Ken d’Entremont, Chief Executive Officer of Medexus, commented, “There has been a long-standing drug shortage of Triamcinolone Hexacetonide in North America due to previous manufacturing issues. Through the commercialization of Trispan, our Canadian product for the same indication, we have witnessed the urgency of providing patients with a solution firsthand. Our work with Health Canada prompted the FDA to reach out to us and inquire about the possibility of Medexus providing a similar solution in the United States. While we are committed to pursuing FDA approval for a commercial product launch, in the near term, we are engaged with the FDA’s CDER Drug Shortage Staff in an effort to facilitate the import of finished drug product to address the ongoing drug shortage.”

Ken d’Entremont continued, “This exclusivity agreement is a major step towards offering a critical solution for patients suffering from debilitating forms of joint disease in the United States. The transaction is indicative of our continued efforts to bring in additional products and grow the Company both organically and inorganically. We will continue to look for additional opportunities to bring important specialty treatments to physicians and patients across North America.”

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