Knight Therapeutics Enters into Exclusive License Agreement with Amneal Pharmaceuticals for IPX203

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive license agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal"), granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America. IPX203 is a novel, oral formulation of carbidopalevodopa (CDLD) 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 endpoints 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 hours; 95% CI, 0.09-0.97), with IPX203 dosed a mean three times per day vs 5 times per day for immediate-release carbidopa-levodopa ¹ .

"This transaction builds on our strategy of expanding our CNS portfolio," said Samira Sakhia, President and CEO 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 1 million patients diagnosed in the U.S. ^2,3 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement.

PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance. ⁴ While PD is not considered a fatal disease, it is associated with significant morbidity and disability. ⁵ 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. ^{2 , 6}

  About Knight Therapeutics Inc.  

Knight Therapeutics Inc., 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 Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .

  Forward-Looking Statements  

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2022, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

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  References:  

1. Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069.
 
2. Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
 
3. Marras et al. NPJ Parkinsons Dis. 2018;4:21.
 
4. NINDS. Parkinson's disease: challenges, progress, and promise. Reviewed August 2019. Accessed April 16, 2021.
 
5. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
 
6. John Hopkins Medicine. Young-Onset Parkinson's disease. Accessed August 17, 2021.