Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ENTERS INTO EXCLUSIVE LICENSE AGREEMENT WITH AMNEAL PHARMACEUTICALS FOR IPX203

Knight Therapeutics Inc. has entered into an exclusive licence agreement with Amneal Pharmaceuticals Inc., granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America. IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed for the treatment of Parkinson's disease. Financial terms of the agreement were not disclosed.

IPX203 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 slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach.

IPX203 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 met its primary and secondary end points and showed that treatment with IPX203 demonstrated statistically significant improvement in daily "Good On" time with fewer doses of IPX203 compared with immediate-release carbidopa-levodopa (least squares mean, 0.53 hour; 95 per cent CI (confidence interval), 0.09 to 0.97), with IPX203 dosed a mean three times per day versus five times per day for immediate-release carbidopa-levodopa.

"This transaction builds on our strategy of expanding our CNS [central nervous system] portfolio," said Samira Sakhia, president and chief executive officer of Knight. "There is a high unmet medical need in the treatment of Parkinson's disease and we are confident that, with IPX203, we will be bringing a much needed novel treatment option to Parkinson's patients."

"We have found in Knight an equally committed partner who will work with us to advance IPX203 and bring it to patients across Canada and Latin America," said Chirag and Chintu Patel, co-chief executive officers at Amneal. "We see IPX203 as a critical innovation that can meaningfully advance the standard of care for Parkinson's patients."

About Parkinson's disease

Parkinson's disease (PD) has become the fastest growing neurological disorder worldwide, with approximately one million patients diagnosed in the United States. It is a progressive disorder of the central nervous system that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremour and impaired balance. While PD is not considered a fatal disease, it is associated with significant morbidity and disability. The average age at diagnosis for patients with PD is 60; as people live longer, the number of patients living with PD 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.

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