Knight Therapeutics Enters into Exclusive License and Supply Agreements with Rigel Pharmaceuticals to Commercialize Fostamatinib in Latin America
24 Mai 2022 - 01:30PM
Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA)
specialty pharmaceutical company, today announced that it has
entered into exclusive license and supply agreements with Rigel
Pharmaceuticals granting Knight the rights to commercialize
fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in
Latin America.
Fostamatinib is commercially available in the
United States under the brand name TAVALISSE® (fostamatinib
disodium hexahydrate) and in Europe under the brand name TAVLESSE®
for the treatment of chronic immune thrombocytopenia (ITP).
Fostamatinib is also currently being studied in a Phase 3 clinical
trial for the treatment of warm autoimmune hemolytic anemia
(wAIHA)1 and in two Phase 3 clinical trials for the treatment of
hospitalized patients with COVID-19.2,3
Under the terms of the agreement, Rigel will
receive an upfront cash payment, with the potential for additional
regulatory and commercial milestones, and stepped-up royalties
based on tiered net sales. In return, Knight receives exclusive
rights to fostamatinib in all potential indications, including
chronic ITP, wAIHA, and COVID-19 in Latin America.
“This partnership represents the continued
execution of our strategy of leveraging our solid platform and
expertise to bring innovative medicines to our markets,” said
Samira Sakhia, President and CEO of Knight. “We are excited to be
working with Rigel to provide access to an innovative,
first-in-class treatment option to patients across Latin America
with chronic ITP.”
“We consider Knight to be the partner of choice
in Latin America and look forward to a productive collaboration
that further expands TAVALISSE’s global reach to patients in need,”
said Raul Rodriguez, President and CEO of Rigel. “TAVALISSE is
already available in several countries around the world for the
treatment of chronic ITP, and we look forward to pivotal readouts
from our Phase 3 clinical trials with fostamatinib in wAIHA and
COVID-19.”
About ITP
In patients with ITP (immune thrombocytopenia),
the immune system attacks and destroys the body's own blood
platelets, which play an active role in blood clotting and healing.
Common symptoms of ITP are excessive bruising and bleeding. People
suffering with chronic ITP may live with an increased risk of
severe bleeding events that can result in serious medical
complications or even death. Current therapies for ITP include
steroids, blood platelet production boosters (TPO-RAs), and
splenectomy. However, not all patients respond to existing
therapies. As a result, there remains a significant medical need
for additional treatment options for patients with ITP.
About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare,
serious blood disorder in which the immune system produces
antibodies that lead to the destruction of the body's own red blood
cells. Warm antibody AIHA (wAIHA), which is the most common form of
AIHA, is characterized by the presence of antibodies that react
with the red blood cell surface at body temperature. To date, there
are no disease-targeted therapies approved for wAIHA, despite the
unmet medical need that exists for these patients.
About COVID-19 & SYK
Inhibition
COVID-19 is the infectious disease caused by
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).
SARS-CoV-2 primarily infects the upper and lower respiratory tract
and can lead to acute respiratory distress syndrome (ARDS).
Additionally, some patients develop other organ dysfunction
including myocardial injury, acute kidney injury, shock resulting
in endothelial dysfunction and subsequently micro and macrovascular
thrombosis.4 Much of the underlying pathology of SARS-CoV-2 is
thought to be secondary to a hyperinflammatory immune response
associated with increased risk of thrombosis.5
SYK is involved in the intracellular signaling
pathways of many different immune cells. Therefore, SYK inhibition
may improve outcomes in patients with COVID-19 via inhibition of
key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR)
mediated drivers of pathology such as pro-inflammatory cytokine
release by monocytes and macrophages, production of neutrophil
extracellular traps (NETs) by neutrophils, and platelet
aggregation.6,7,8,9 Furthermore, SYK inhibition in neutrophils and
platelets may lead to decreased thrombo-inflammation, alleviating
organ dysfunction in critically ill patients with COVID-19.
About Knight
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 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 Statements for
Knight
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.
Please
see www.TAVALISSE.com for
full Prescribing Information.
TAVALISSE and TAVLESSE are registered trademarks of Rigel
Pharmaceuticals, Inc.
Investor Contact for Knight Therapeutics
Inc.:
Knight Therapeutics Inc.
Samira SakhiaPresident & Chief Executive OfficerT:
514.484.4483F: 514.481.4116Email: info@knighttx.comWebsite:
www.gud-knight.com |
Arvind UtchanahChief Financial OfficerT. 598.2626.2344Email:
info@knighttx.comWebsite: www.gud-knight.com |
References:
- Clinicaltrials.gov: NCT03764618
- Clinicaltrials.gov: NCT04629703
- Clinicaltrials.gov: NCT04924660
- Berlin DA, Gulick RM, and Martinez FJ. Severe Covid-19. N
Engl J Med 2020.
DOI: https://doi.org/10.1056/NEJMcp2009575
- Becker RC. COVID-19 Update: COVID-19 associated
coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020.
DOI: https://doi.org/10.1007/s11239-020-02134-3
- Hoepel W et al. High titers and
low fucosylation of early human anti–SARS-CoV-2 IgG
promote inflammation by alveolar macrophages. Science Translational
Medicine 02 Jun 2021.
DOI: https://www.doi.org/10.1126/scitranslmed.abf8654
- Sung P-S and Hsieh S-L. CLEC2 and CLEC5A: Pathogenic Host
Factors in Acute Viral Infections. Frontiers in Immunology December
6, 2019. DOI: https://doi.org/10.3389/fimmu.2019.02867
- Strich J et al. Fostamatinib Inhibits Neutrophils
Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential
Therapeutic. Journal of Infectious Disease March 15, 2021.
DOI: https://doi.org/10.1093/infdis/jiaa789
- Bye AP et al. Aberrant glycosylation of anti-SARS-CoV-2
IgG is a pro-thrombotic stimulus for
platelets. BioRxiv March 26, 2021.
DOI: https://doi.org/10.1101/2021.03.26.437014
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