Medexus Reports Health Quality Ontario Recommends Gliolan® for Public Reimbursement
MONTREAL, Sept. 12, 2019 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today announced that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan® (5-aminolevulinic acid hydrochloride) for guiding maximal surgical resection of high-grade gliomas in adults, conditional on Health Canada approval. Gliolan® assists neurosurgeons to better visualize and more completely remove malignant brain tumors (gliomas) by causing them to become fluorescent and glow during surgery.
Health Canada previously granted Medexus authorization to distribute Gliolan® in Canada under the Special Access Program, which provides healthcare practitioners with access to non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The Company has long-term exclusive rights to market and distribute Gliolan® in Canada.
Ken d’Entremont, Chief Executive Officer of Medexus, commented, “The response to Gliolan® from the medical community has been extremely positive, as evidenced by strong market uptake, even prior to full registration. The recommendation for public reimbursement from Health Quality Ontario further validates our belief that Gliolan® not only improves outcomes, but is a cost effective solution for high level glioblastoma patients. Furthermore, we expect broader distribution of Gliolan® in Canada, as a fully registered product, which we believe has the potential to improve survival and represents a sizable market opportunity. We have now held a pre-registration meeting with Health Canada for the Gliolan® application. We plan to file for registration of Gliolan® with Health Canada in 2019 and anticipate receiving full registration within 6 to 18 months following application.”
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 is focused on the therapeutic areas of auto-immune disease and pediatrics. The 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; 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.
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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 September 12, 2019