Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American
(ex-USA) specialty pharmaceutical company, announced today that its
Brazilian affiliate, United Medical Ltd., has received pricing
approval for Minjuvi® (tafasitamab) from the Drugs Market
Regulation Chamber (“CMED”). As a result, Knight expects to launch
Minjuvi® in Brazil in the second quarter of 2024.
In July 2023, ANVISA (Agência Nacional de
Vigilância Sanitária) granted Market Authorization under their rare
disease designation according to Resolution RDC 205/2017 for
Minjuvi® in combination with lenalidomide followed by Minjuvi®
monotherapy for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL
arising from low grade lymphoma, and who are not eligible for
autologous stem cell transplantation (ASCT).
Diffuse large B-cell lymphoma is a type of
aggressive non-Hodgkin lymphoma, with suboptimal efficacy results
with standard available therapies for patients who have failed to
previous treatments and are not candidates for transplant.
“Considering the nature of the disease and the
current unmet medical need, there is still space to improve the
treatment of patients with relapsed or refractory diffuse large
B-cell lymphoma in Brazil,” said Dr. Danielle Leão, Head of the
Hematology Department from Beneficência Portuguesa Hospital in São
Paulo. “Minjuvi® is an innovative therapy with proven efficacy and
safety profile. There is no other effective alternative approved in
the country in the second line of treatment for relapsed or
refractory DLBCL”.
The approval is based on the data from L-MIND,
an open label, multicenter, single arm Phase 2 study, that
evaluated Minjuvi® in combination with lenalidomide for the
treatment of adult patients with relapsed or refractory DLBCL. The
study primary analysis results showed an objective response rate
(ORR, primary endpoint) of 60%, including a complete response rate
(CR) of 43% and a disease control rate (DCR) of 75%.
“We’re excited to continue to advance the
approval of Minjuvi® in Brazil, a new treatment option for a
current unmet need. We look forward to launching Minjuvi® in Brazil
and obtaining approval in other key markets in Latin America,” said
Samira Sakhia, Knight Therapeutics President and CEO.
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.
With the price approval Minjuvi® will be
available for commercialization in the Brazilian market. “Knight’s
team is working diligently with physicians, key institutions and
payors to ensure patients have access to Minjuvi®,” said Cristiane
Coelho, Knight Therapeutics Brazil General Manager.
About Minjuvi®
(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 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 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 because of new
information or future events, except as required by law.
CONTACT INFORMATION:
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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