Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American
(ex-USA) specialty pharmaceutical company, announced today that its
Brazilian affiliate, United Medical Ltd., has submitted a marketing
authorization application for pemigatinib to ANVISA, the Brazilian
health regulatory agency, under the rare diseases approval pathway,
for the treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or rearrangement that have progressed after at least
one prior line of systemic therapy. Marketing authorization
applications for pemigatinib have also been submitted previously in
Colombia, Mexico and Argentina.
“This milestone demonstrates Knight’s commitment
to providing innovative therapies for important unmet healthcare
needs in Latin America,” said Samira Sakhia, President and Chief
Executive Officer of Knight Therapeutics Inc.
Cholangiocarcinoma is the malignant neoplasm of
the primary biliary tract, being the intrahepatic type localized in
the biliary duct ramifications inside the liver. This kind of tumor
is considered rare, and more than 50% of the patients are diagnosed
in advanced disease stages.
In September 2021, Knight entered into a supply
and distribution agreement with Incyte (NASDAQ: INCY), for the
exclusive rights to distribute pemigatinib (Pemazyre®) as well as
tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in
Europe) in Latin America.
In July 2023, ANVISA granted regulatory approval
in Brazil for Minjuvi® in combination with lenalidomide followed by
tafasitamab monotherapy for the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL),
including DLBCL due to low-grade lymphoma, who are not eligible for
autologous stem cell transplantation (ASCT). Upon obtaining the
marketing authorization from ANVISA, Knight submitted an
application for pricing approval to the Drugs Market Regulation
Chamber (“CMED”) which establishes maximum prices allowed for drugs
sold in Brazil. The commercial launch of Minjuvi® is dependent upon
the outcome of the pricing approval process which could take up to
two years. Knight has also submitted marketing authorization
applications for tafasitamab in Colombia, Mexico and Argentina.
About Pemigatinib
(Pemazyre®)
Pemigatinib is a kinase inhibitor indicated
in the United States for the treatment of adults with
previously treated, unresectable locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or other rearrangement as detected by an
FDA-approved test. This indication is approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
The FDA approval in the USA is based on a
multicenter, open-label, single-arm, multicohort, phase 2 study
(FIGHT-202), that evaluated the safety and antitumor activity of
pemigatinib in patients with previously treated, locally advanced
or metastatic intrahepatic cholangiocarcinoma with and without
FGFR2 fusions or rearrangements, in patients aged 18 years or older
with disease progression following at least one previous
treatment.
The overall response rate was 36%, with 2.8% of
patients having a complete response and 34% having a partial
response. Median duration of response was 9.1 months. The most
common adverse reactions occurring in 20% or more of patients who
received pemigatinib are hyperphosphatemia, alopecia, diarrhea,
fatigue, dysgeusia, nausea and stomatitis.
Pemigatinib is also the first targeted treatment
approved for use in the United States for treatment of
adults with relapsed or refractory myeloid/lymphoid neoplasms
(MLNs) with FGFR1 rearrangement.
In Japan, pemigatinib is approved for the
treatment of patients with unresectable biliary tract cancer (BTC)
with a fibroblast growth factor receptor 2 (FGFR2) fusion gene,
worsening after cancer chemotherapy.
In Europe, pemigatinib is approved for the
treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or rearrangement that have progressed after at least
one prior line of systemic therapy.
Pemazyre® is marketed
by Incyte in the United
States, Europe and Japan.
Pemazyre® is a trademark of Incyte
Corporation.
About Tafasitamab
(Minjuvi®)
Tafasitamab is a humanized Fc-modified cytolytic
CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive
worldwide rights to develop and commercialize tafasitamab from
Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc
domain, which mediates B-cell lysis through apoptosis and immune
effector mechanism including Antibody-Dependent Cell-Mediated
Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis
(ADCP).
In the United States,
Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and
Drug Administration in combination with lenalidomide for the
treatment of adult patients with relapsed or refractory DLBCL not
otherwise specified, including DLBCL arising from low grade
lymphoma, and who are not eligible for autologous stem cell
transplantation (ASCT). This indication is approved under
accelerated approval based on overall response rate. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).
Please see the U.S. full Prescribing Information for Monjuvi for
important safety information.
In Europe, Minjuvi® (tafasitamab) received
conditional approval, in combination with lenalidomide, followed by
Minjuvi monotherapy, for the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who
are not eligible for autologous stem cell transplantation
(ASCT).
Tafasitamab is being clinically investigated as
a therapeutic option in B-cell malignancies in several ongoing
combination trials. Its safety and efficacy for these
investigational uses have not been established in pivotal
trials.
Minjuvi® and Monjuvi® are registered
trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte
and MorphoSys under the brand name Monjuvi® in the U.S., and
marketed by Incyte under the brand name Minjuvi® in Region
Europe, the United Kingdom and Canada. As part of its agreement
with MorphoSys, Incyte received exclusive commercialization rights
for tafasitamab outside the United States.
XmAb® is a registered trademark of Xencor,
Inc.
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.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, 2022, 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
K Abou-Alfa et al. (2020). Pemigatinib for
previously treated, locally advanced or metastatic
cholangiocarcinoma: a multicentre, open-label, phase 2 study. The
Lancet Oncology VOLUME 21, ISSUE 5, P671-684, MAY 2020.
DOI:https://doi.org/10.1016/S1470-2045(20)30109-1
Banales, J., Cardinale, V., Carpino, G. et al.
Cholangiocarcinoma: current knowledge and future perspectives
consensus statement from the European Network for the Study of
Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13,
261–280 (2016). https://doi.org/10.1038/nrgastro.2016.51
Investor Contact: |
|
Knight Therapeutics Inc. |
|
Samira Sakhia |
Arvind Utchanah |
President & Chief Executive
Officer |
Chief Financial Officer |
T: 514.484.4483 |
T. +598.2626.2344 |
F: 514.481.4116 |
|
Email: info@knighttx.com |
Email: info@knighttx.com |
Website: www.knighttx.com |
Website: www.knighttx.com |
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