Medexus Secures Public Reimbursement for Cuvposa® in Quebec

TORONTO and CHICAGO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) wishes to inform investors that the company has reached an agreement with the provincial government of Quebec for government-sponsored coverage of Cuvposa (glycopyrrolate oral solution 1mg/5mL). Cuvposa will be listed for public reimbursement on the Public Prescription Drug Insurance Plan of the Régime de l’Assurance Maladie du Québec, or RAMQ, starting February 1, 2023.

Cuvposa is indicated in Canada to reduce chronic severe drooling in pediatric patients 3 to 18 years of age with neurologic conditions associated with problem drooling, such as cerebral palsy. Listing Cuvposa fills a health need recognized as being moderate to high in vulnerable and underserved pediatric populations in Canada who are affected by this condition.

Dr Pierre Marois, Pediatric Physiatrist at Montreal’s Ste-Justine Hospital, commented: “Chronic severe drooling, or sialorrhea, is an often-underestimated condition in pediatric patients who are also managing significant neurologic conditions. It can result in dysphagia and impact respiratory health – but can also affect the social and emotional development of these children and the wellbeing of their caregivers and families, contributing to the substantial burden of the underlying conditions.”

“The limited number of available treatment options means that chronic severe drooling is often poorly managed,” added Jean-Claude Beaudoin, Vice President—Sales & Marketing at Medexus. “We are therefore proud to make Cuvposa available to more patients in Quebec through this new partnership with the Quebec government. We believe greater access to Cuvposa will help more people seeking to manage the ancillary effects of neurologic conditions, which can have a significant impact on their wellbeing.”

About Cuvposa

Cuvposa (glycopyrrolate oral solution 1mg/5mL) is indicated to reduce chronic severe drooling in patients 3 to18 years of age with neurologic conditions associated with problem drooling, such as cerebral palsy. Chronic severe drooling may also be diagnosed in patients with other neurological disorders, such as severe developmental delay, autism spectrum disorders, sensory impairments, traumatic brain injuries, or neurogenetic and metabolic disorders.

The rate of cerebral palsy incidence in Canada is estimated at around 0.3 per 1,000 for children less than 20 years old, with newly diagnosed cases expected to increase to nearly 2,200 in 2031 and the number of people living with cerebral palsy increasing to more than 94,000. Over this period, Canadians with cerebral palsy are expected to continue to experience, among other things, a reduced quality of life and a rising need for supportive services including informal care. (Source: , Health Promotion and Chronic Disease Prevention in Canada, Vol 40, No 2, February 2020.)

Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of acetylcholine muscarinic receptors located on peripheral tissues such as salivary glands. Dry mouth, vomiting, constipation, flushing of the face or skin, headache, problems urinating, and rapid heartbeat are the most commonly reported side effects of Cuvposa. For more information about Cuvposa, including important safety information, see the . Medexus holds exclusive distribution rights to Cuvposa in Canada.

Cuvposa is approved by Health Canada for sale and use in Canada only and is not intended for export outside Canada. Medexus makes no representation that Cuvposa is appropriate for, or authorized for sale to or use by, individuals who are not located in Canada.

CUVPOSA® is a registered trademark of Merz Pharmaceuticals, LLC.

About Medexus

Medexus is a leader in innovative and rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products. Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy. We continue to build a highly differentiated company with a growing portfolio of innovative and high-value orphan and rare disease products that will underpin our growth for the next decade.

Our current leading products are 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); Rasuvo® and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; Rupall®, an innovative prescription allergy medication with a unique mode of action; and Gleolan® (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent currently indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

We have also licensed treosulfan, part of a preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv™. Treosulfan is currently the subject of a regulatory review process with the US Food and Drug Administration.

Our mission is to provide the best healthcare products to healthcare professionals and patients. We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.

Contacts

For more information, please contact any of the following:

Medexus

Ken d’Entremont, Chief Executive Officer

Medexus Pharmaceuticals

Tel: 905-676-0003

Email:

Marcel Konrad, Chief Financial Officer

Medexus Pharmaceuticals

Tel: 312-548-3139

Email:

Investor Relations

Victoria Rutherford

Adelaide Capital

Tel: 480-625-5772

Email:

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”, “potential”, and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, statements regarding the present and future status of Cuvposa as listed for public reimbursement on the Public Prescription Drug Insurance Plan (including related expectations regarding financial or operational performance) and regarding conditions associated with the conditions Cuvposa is indicated to treat (including current and future incidence in Canada). 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. Medexus 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, but are not limited to, those set out in Medexus’s materials filed with the Canadian securities regulatory authorities from time to time, including Medexus’s most recent annual information form and management’s discussion and analysis. Given these risks, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Additional note

The information in this press release is provided for informational purposes to investors in Medexus securities only, and is not intended to constitute promotion of any product nor any other activity that would violate any applicable law.