Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a pan-American
(ex-USA) specialty pharmaceutical company, today announced that it
has entered into a definitive agreement with Incyte Biosciences
International Sàrl, the Swiss-based affiliate of Incyte
(NASDAQ:INCY), for the exclusive rights to distribute tafasitamab
(sold as Monjuvi® in the United States and Minjuvi® in Europe) and
pemigatinib (Pemazyre®) in Latin America. Under the terms of the
agreement, Incyte will be responsible for the development,
manufacture and supply to Knight of tafasitamab and pemigatinib,
and Knight will be responsible for seeking the necessary regulatory
approvals and distributing both medicines in Latin America.
Tafasitamab in combination with lenalidomide is
approved in the United States and Europe for the treatment of adult
patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL) who are not eligible for autologous stem cell transplant
(ASCT). DLBCL is the most common type of non-Hodgkin lymphoma, and
there are approximately 12,000 – 16,000 new cases of DLBCL each
year in Latin America1,2.
Pemigatinib is approved in the United States,
Europe and Japan for the treatment of adult patients 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.
Cholangiocarcinoma is the most common cancer of the bile duct.
FGFR2 fusions or rearrangements have been observed in 10-16%3 of
patients with intrahepatic cholangiocarcinoma, whereas the
incidence in patients with extrahepatic cholangiocarcinoma is rare.
There are approximately 4,000 – 6,000 new cases of intrahepatic
cholangiocarcinoma each year in Latin America1,4.
“We are delighted to partner with Incyte, a
leading global biopharmaceutical company, to bring tafasitamab and
pemigatinib to patients in Latin America upon approval,” said
Samira Sakhia, President and Chief Executive Officer of Knight.
“Both products will strengthen and complement our oncology
portfolio and will play a key role in the management of diseases
with high unmet need.”
“In Knight, we have found a partner with an
extensive track record of successful partnerships and strong
distribution capabilities,” said Hervé Hoppenot, Chief Executive
Officer of Incyte. “We are eager to work together to expand access
to tafasitamab and pemigatinib so that eligible patients in Latin
America have access to these innovative medicines.”
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic
CD19 targeting monoclonal antibody. 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 January 2020, MorphoSys and Incyte entered
into a collaboration and licensing agreement to further develop and
commercialize tafasitamab globally. Monjuvi® is being
co-commercialized by Incyte and MorphoSys in the United States.
Incyte has exclusive commercialization rights outside the United
States.
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 transplant (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 transplant (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 the
EU.
XmAb® is a registered trademark of Xencor,
Inc.
About Pemigatinib
Pemigatinib (Pemazyre®) 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 test5. 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).
In Japan, Pemazyre® 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, Pemazyre® 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 a potent, selective, oral inhibitor
of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has
demonstrated selective pharmacologic activity against cancer cells
with FGFR alterations.
Pemazyre® is marketed by Incyte in the United
States, Europe and Japan. Incyte has granted Innovent Biologics,
Inc. rights to develop and commercialize pemigatinib in hematology
and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte
has retained all other rights to develop and commercialize
pemigatinib outside of the United States.
Pemazyre® is a trademark of Incyte.
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 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 for Knight
Therapeutics Inc.
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 because of new
information or future events, except as required by law.
Investor Contact:
Knight Therapeutics Inc.
Samira SakhiaPresident and Chief
Executive OfficerT: 514.484.4483F: 514.481.4116Email:
info@knighttx.comWebsite: www.gud-knight.com |
Arvind UtchanahChief Financial
OfficerT. 514.484.4483F. 514.481.4116Email:
info@knighttx.comWebsite: www.gud-knight.com |
References
- Globocan 2020
- Li S et al. Pathology. 2018
Jan;50(1):74-87.
- Jain A et al. JCO Precision Oncology
2018 :2, 1-12
- Lafaro KJ et al. Gastroenterol Res
Pract. 2015;2015:860861.
- Pemazyre® (pemigatinib) [Package
Insert]. Wilmington, DE: Incyte; 2020.
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