Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia
06 Januar 2022 - 2:00PM
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 therapies1. 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 cancer3. 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 sarcoma4.
“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
phenotype5-6. Eribulin has also been shown to decrease the
migration and invasiveness of human breast cancer cells5-6.
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.
Investor Contact: |
|
Knight Therapeutics Inc. |
|
Samira Sakhia |
Arvind Utchanah |
President & Chief Executive
Officer |
Chief Financial Officer |
T: 514.484.4483 |
T. 514.484.4483 |
F: 514.481.4116 |
F. 514.481.4116 |
Email: info@knighttx.com |
Email: info@knighttx.com |
Website: www.gud-knight.com |
Website: www.gud-knight.com |
References:
- 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
- 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
- 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
- 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
- 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
- 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
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