Knight Therapeutics Announces Regulatory Submission for Tafasitamab in Brazil
October 06 2022 - 6:12PM
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 tafasitamab in combination with
lenalidomide to ANVISA, the Brazilian health regulatory agency, 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).
In September 2021, Knight entered into an
exclusive supply and distribution agreement with Incyte
(NASDAQ:INCY), for the exclusive rights to distribute tafasitamab
(sold as Monjuvi® in the United States and Minjuvi® in
Europe), as well as pemigatinib (Pemazyre®), in Latin America.
“We are delighted to reach this key milestone
for tafasitamab in Brazil,” said Samira Sakhia, President and Chief
Executive Officer of Knight Therapeutics. “Upon approval,
combination therapy with tafasitamab and lenalidomide will be an
important new therapeutic option for eligible patients with
relapsed or refractory DLBCL in Brazil. We look forward to
continuing to work with the support of our partner, Incyte, as we
work towards regulatory submissions in additional countries in
Latin America over the next year.”
About Tafasitamab
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).
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.
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.gud-knight.com or www.sedar.com.
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, 2021 as filed on www.sedar.com. Knight
Therapeutics Inc. disclaims any intention or obligation to update
or revise any forward-looking statements whether because of new
information or future events, except as required by law.
Investor Contact: |
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Knight Therapeutics Inc. |
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Samira Sakhia |
|
Arvind Utchanah |
President & Chief Executive
Officer |
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Chief Financial Officer |
T: 514.484.4483 |
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T. +598.2626.2344 |
F: 514.481.4116 |
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Email: info@knighttx.com |
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Email: info@knighttx.com |
Website: www.gud-knight.com |
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Website: www.gud-knight.com |
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