Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES FILING OF NEW DRUG SUBMISSION FOR CREXONT (CARBIDOPA AND LEVODOPA) EXTENDED-RELEASE CAPSULES IN CANADA

Knight Therapeutics Inc.'s new drug submission (NDS) for Crexont has been accepted for review by Health Canada.

Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson's disease. The innovative design of Crexont allows for rapid onset while leveraging a mucoadhesive polymer for slow LD release, potentially enabling longer LD absorption in the gut. Crexont is expected to compete in a market size of over $50-million in Canada and over $120-million in Brazil. In each of these markets, the controlled release portion of the market was $15-million, during the 12-month period ended on September, 2024, according to IQVIA.

In January, 2024, Knight announced that it had entered into an agreement with Amneal Pharmaceuticals Inc. for the exclusive rights to seek regulatory approval and commercialize Crexont in Canada and Latin America. Knight is also working to submit the marketing authorization application in Mexico and Brazil during 2025.

"The submission of Crexont in Canada highlights Knight's ongoing commitment to enhancing our central nervous system (CNS) portfolio," said Samira Sakhia, president and chief executive officer of Knight. "With a significant unmet medical need in Parkinson's disease treatment, Crexont will offer a valuable new therapeutic option for the patients."

About Crexont

Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) capsule that combines both immediate-release granules and extended-release beads for the treatment of Parkinson's disease.

Crexont contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for gradual drug release, a mucoadhesive polymer designed to prolong adhesion at absorption site and an enteric coating to prevent the granules from disintegrating prematurely in the stomach.

Crexont was studied in the Rise-PD clinical study, which was a 20-week, randomized, double-blind, double-dummy, active-controlled phase 3 clinical trial with 630 patients.

The Rise-PD study successfully met its primary and secondary end points, demonstrating that treatment with Crexont significantly improved daily "good on" time with fewer doses compared with IR CD/LD. Specifically, Crexont showed an improvement of 0.53 hour (least squares mean, 95-per-cent confidence interval, 0.09 to 0.97), with an average dosing frequency of three times per day versus five times per day for IR CD/LD. A posthoc analysis of the primary end point on a per-dose basis showed 1.55 more hours of "good on" time per dose of Crexont, compared with IR CD/LD.

The most common adverse reactions with Crexont (incidence greater than or equal to 3 per cent and greater than IR CD/LD) are nausea and anxiety. Avoid sudden discontinuation or rapid dose reduction with Crexont. If you are discontinuing Crexont, work with your health care provider to taper the dose over time to reduce the risk of fever or confusion.

About Parkinson's disease

Parkinson's disease has become the fastest-growing neurological disorder worldwide, with approximately one million patients diagnosed in the United States. As of 2021, over 100,000 people live with Parkinson's disease in Canada, with an estimated 6,600 new diagnoses occurring annually based on an annual incidence rate of 20 new cases per 100,000 people. It is a progressive disorder of the CNS that affects dopamine-producing neurons in the brain that affect movement. Parkinson's disease is characterized by slowness of movement, stiffness, resting tremor and impaired balance. While Parkinson's disease is not considered a fatal disease, it is associated with significant morbidity and disability. The average age at diagnosis for patients with Parkinson's disease is 60; as people live longer, the number of patients living with Parkinson's disease is predicted to grow significantly over the coming decades.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics' shares trade on the Toronto Stock Exchange under the symbol GUD.

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