Medexus Reports Triamcinolone Hexacetonide Injectable Suspension Approved for Public Reimbursement in Canada
MONTREAL, April 08, 2020 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) is pleased to announce that the pan-Canadian Pharmaceutical Alliance (pCPA) price negotiations for Triamcinolone Hexacetonide Injectable Suspension 20mg/mL (TH) in Canada are completed with expected public reimbursement to roll out in the respective provinces over the coming months.
TH is the longest acting corticosteroid for intra articular injection, often lasting twice as long as competitive products. Health Canada previously approved TH in December 2017 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, post-traumatic arthritis, synovitis, tendinitis, bursitis and epicondylitis.
As previously reported, there has been a long-standing drug shortage of Triamcinolone Hexacetonide in Canada. In October 2018, with the support of the Canadian Rheumatology Association (CRA), the Company launched its own TH product to help fill a care gap by bringing TH back to the market. Since that time, the Company has provided TH to children with JIA through the Special Access Program of Health Canada, providing these children a reliable source for this product, which is a key component for the management of their disease. Medexus’ commercial launch of TH also allows the Company to promote its TH product for use in adults for indications such as osteoarthritis, rheumatoid arthritis and other forms of joint disease.
Ken d’Entremont, Chief Executive Officer of Medexus, commented, “Public reimbursement marks an important milestone for the Company, as it dramatically increases the sales potential and market access to our TH product. Moreover, children and adult patients suffering from debilitating forms of joint disease now have a reliable source and greater access to TH. Importantly, TH transforms the treatment of many severe joint diseases as it provides a longer duration of action, with fewer injections, compared to other corticosteroid injections and intra-articular steroids. By reducing the number of injections, we believe TH offers a safer and more cost-effective solution for the healthcare system, by reducing the number of hospital visits and need to put pediatric patients under general anesthetic for these injections. Reducing the number of injections also helps alleviate the time and stress burden on both parents and children. Public reimbursement for TH is particularly important in the current COVID-19 healthcare environment where patient visits to hospitals should be reduced and focused on urgent patient needs. We agree with the Canadian Rheumatology Association (CRA) in their assessment that TH should be considered the standard of care, and not only for younger patients with JIA, but for all appropriate adult patients with subacute and chronic inflammatory joint disease. Overall, we are quite encouraged by the response to TH from the Canadian medical community and believe TH represents an important market opportunity for Medexus going forward.”
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals is focused on the therapeutic areas of auto-immune disease, hematology and allergy. The Company’s leading products are: Rasuvo™ and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY®, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding; and Rupall®, an innovative allergy medication with a unique mode of action.
For more information, please contact:
Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-762-2626 ext. 202
Investor Relations (U.S.):
Crescendo Communications, LLC
Investor Relations (Canada):
Direct Financial Strategies and Communication Inc.
Neither the 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.
Forward Looking Statements
Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates”, “believes”, “expects”, “will”, “plans” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements with respect to future business operations, the timing of regulatory applications and approvals and the efficacy and success of certain drug therapies. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company's most recent MD&A; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; the Company’s ability to implement its business plan; the Company’s ability to leverage its United States and Canadian infrastructure to promote additional growth, including with respect to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and the potential benefits the Company expects to derive therefrom;, regulatory approval by the Canadian health authorities; product reimbursement by third party payers; patent litigation or patent expiry; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.
Released April 8, 2020