Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia

Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven® (eribulin) injection.

Halaven® (eribulin) injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven®(eribulin) injection is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed. It is used in patients who have already been treated with an anthracycline, unless deemed unsuitable.

Halaven® (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment. Halaven® (eribulin) injection indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies ¹ _. Also, Halaven® (eribulin) injection demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine in patients with locally advanced/recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies ² .

Breast cancer is now the most frequently diagnosed cancer in Colombian women. In 2020, an estimated 15,509 patients were diagnosed with breast cancer ³ . Further, approximately 1,500 patients in Colombia are diagnosed with soft tissue sarcoma each year, and liposarcoma, an area with high unmet medical need, represents the most common form of soft tissue sarcoma ⁴ .

"We're pleased to announce the approval of Halaven® (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma," said Samira Sakhia, President & Chief Executive Officer. "Our Colombian team is focused on our oncology launches with the approval of Halaven® (eribulin) injection and Lenvima® (lenvatinib) and will be coordinating launch efforts with our teams throughout the region."

Knight has an exclusive license from Eisai to commercialize Lenvima® (lenvatinib), Halaven® (eribulin) injection, Fycompa® (perampanel), and Inovelon® (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven® (eribulin) injection and Lenvima® (lenvatinib).

About Halaven®   (eribulin)   injection

Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype ^5-6 . Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells ^5-6 .

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. 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.gud-knight.com or www.sedar.com .

Forward-Looking Statement

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, 2020 as filed on www.sedar.com . 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.

References:

1. Cortes J et al., Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study Lancet, 2011; 377, 914-23
2. Schöffski P et al. Randomized, open-label, multicenter, phase 3 study of eribulin versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma (ADI). American Society of Clinical Oncology annual meeting 2015; Abstract #LBA10502
3. Cancer today. Gco.iarc.fr. (2021). Retrieved 2 November 2021, from https://gco.iarc.fr/today/online-analysis table?v=2020&mode=cancer&mode_population=continents&population=900&populations=170&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1
   
4. Ducimetière, F., Lurkin, A., Ranchère-Vince, D., Decouvelaere, A., Péoc'h, M., & Istier, L. et al. (2011). Incidence of Sarcoma Histotypes and Molecular Subtypes in a Prospective Epidemiological Study with Central Pathology Review and Molecular Testing. Plos ONE, 6(8), e20294. https://doi.org/10.1371/journal.pone.0020294
   
5. Funahashi Y et al., Eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. Cancer Sci., 2014; 105, 1334-1342
   
6. Yoshida T et al., Eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (EMT) to mesenchymal-epithelial transition (MET) states. Br J Cancer, 2014; 110, 1497-1505