- Kissei gains exclusive rights to develop and commercialize
olutasidenib in all current and potential indications in
Japan, the Republic of
Korea and Taiwan
- Rigel will receive an upfront cash payment of
$10.0 million with the potential for
up to $152.5 million in future
development, regulatory, and commercial milestone payments
- Rigel to receive product transfer price payments in the
mid-twenty to lower-thirty percent range based on tiered net sales
for exclusive supply of REZLIDHIA
SOUTH
SAN FRANCISCO, Calif., Sept. 3,
2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc.
(Nasdaq: RIGL), a commercial stage biotechnology company focused on
hematologic disorders and cancer, today announced it has entered
into an exclusive license and supply agreement with Kissei
Pharmaceutical Co., Ltd. ("Kissei") to develop and commercialize
REZLIDHIA® (olutasidenib) in all current and
potential indications in Japan,
the Republic of Korea (Korea) and Taiwan. REZLIDHIA is commercially available to
patients in the U.S. for the treatment of relapsed or refractory
(R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid
leukemia (AML). Rigel has an existing agreement with Kissei to
develop and commercialize TAVALISSE® (fostamatinib
disodium hexahydrate) for the treatment of chronic immune
thrombocytopenia (ITP) and in all other potential indications in
Japan, China, Taiwan
and the Republic of Korea.
"Kissei has an excellent track record of development and
commercial success with in-licensed products for the Asian market,
including with Rigel's TAVALISSE. The approval and launch of
TAVALISSE in Japan, combined with
the strong relationship we have built with Kissei, made expanding
our partnership to include REZLIDHIA a natural next step," said
Raul Rodriguez, Rigel's president
and CEO. "From our experience, we are confident in Kissei's ability
and commitment to bring REZLIDHIA to patients in their
territories."
Under the terms of the agreement, Rigel will receive an upfront
cash payment of $10.0 million from
Kissei, with the potential for up to an additional $152.5 million in development, regulatory and
commercial milestone payments. Rigel will receive product transfer
price payments in the mid-twenty to lower-thirty percent range
based on tiered net sales for the exclusive supply of REZLIDHIA.
Kissei receives exclusive rights to REZLIDHIA in AML and all future
indications in Japan, Korea and
Taiwan. Kissei will initially seek
approval for REZLIDHIA in Japan
for R/R mIDH1 AML and will be responsible for conducting clinical
studies as required by the Japanese regulatory agency,
Pharmaceuticals and Medical Devices Agency (PMDA).
"We are pleased to expand our relationship with Rigel to develop
and commercialize olutasidenib in Japan, Korea and Taiwan, leveraging our extensive
infrastructure and our expertise in the hematology-oncology space,"
said Mutsuo Kanzawa, Chairman and
CEO of Kissei. "In Japan, there are estimated to be 11,000 AML
patients, with a higher incidence than any other subtypes of
leukemia. Despite the current treatment options available, there
are still clear unmet medical needs in the AML treatment
landscape."
Kissei is a Japanese pharmaceutical company with approximately
80 years of history, specialized in the field of urology,
kidney-dialysis and unmet medical needs. Kissei aims to develop
innovative pharmaceutical products that contribute to the
improvement of medicine and the health of people around the world
by aggressive incorporation of leading-edge technology and joint
research and collaborations with its foreign and domestic
partners.
Rigel retains the global rights, excluding these Asian
countries, to develop and commercialize REZLIDHIA for all
indications, and is currently exploring other ex-US partnership
opportunities.
In August 2022, Rigel and Forma
Therapeutics, Inc., now Novo Nordisk (Forma), announced an
exclusive, worldwide license agreement to develop, manufacture and
commercialize REZLIDHIA. Pursuant to the agreement, Forma is
entitled to a certain portion of Rigel's sublicensing revenue from
olutasidenib.
About AML
Acute myeloid leukemia (AML) is a rapidly
progressing cancer of the blood and bone marrow that affects
myeloid cells, which normally develop into various types of mature
blood cells. AML occurs primarily in adults and accounts for about
1 percent of all adult cancers. The American Cancer Society
estimates that there will be about 20,800 new cases in the United States, most in adults, in
2024.1
Relapsed AML affects about half of all patients who, following
treatment and remission, experience a return of leukemia cells in
the bone marrow.2 Refractory AML, which affects between
10 and 40 percent of newly diagnosed patients, occurs when a
patient fails to achieve remission even after intensive
treatment.3 Quality of life declines for patients with
each successive line of treatment for AML, and well-tolerated
treatments in relapsed or refractory disease remain an unmet
need.
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 REZLIDHIA®
REZLIDHIA is indicated for the treatment of adult patients with
relapsed or refractory acute myeloid leukemia (AML) with a
susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected
by an FDA-approved test.
Please click here for Important Safety Information and
Full Prescribing Information, including Boxed WARNING, for
REZLIDHIA.
About TAVALISSE®
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated
for the treatment of thrombocytopenia in adult patients with
chronic immune thrombocytopenia (ITP) who have had an insufficient
response to a previous treatment.
Please click here for Important Safety
Information and Full Prescribing Information for TAVALISSE.
To report side effects of prescription drugs to the FDA,
visit www.fda.gov/medwatch or call 1-800-FDA-1088
(800-332-1088).
TAVALISSE and REZLIDHIA are registered trademarks of Rigel
Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
is a biotechnology company dedicated to discovering, developing and
providing novel therapies that significantly improve the lives of
patients with hematologic disorders and cancer. Founded in 1996,
Rigel is based in South San Francisco,
California. For more information on Rigel, the Company's
marketed products and pipeline of potential products,
visit www.rigel.com.
- The American Cancer Society. Key Statistics for Acute Myeloid
Leukemia (AML). Revised June 5, 2024.
Accessed June 30,
2024: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
- Leukaemia Care. Relapse in Acute Myeloid Leukaemia (AML).
Version 3. Reviewed October 2021.
Accessed June 30,
2024: https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf
- Thol F, Schlenk RF, Heuser M, Ganser A. How I treat
refractory and early relapsed acute myeloid leukemia. Blood
(2015) 126 (3): 319-27. Accessed June 30,
2024.
doi: https://doi.org/10.1182/blood-2014-10-551911
Forward-Looking Statements
This press release
contains forward-looking statements relating to, among other
things, Rigel's receipt of payments from Kissei
under the License Agreement and the Supply Agreement, and the
success of Rigel's collaboration with Kissei. Any statements
contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements.
Forward-looking statements can be identified by words such as
"plan", "potential", "may", "look to", "expects", "will", "intends"
and similar expressions in reference to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on
Rigel's current beliefs, expectations, and assumptions and hence
they inherently involve significant risks, uncertainties and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Therefore, you should not
rely on any of these forward-looking statements. Actual results and
the timing of events could differ materially from those anticipated
in such forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the commercialization and marketing
of olutasidenib; risks that the FDA, European Medicines Agency,
PMDA or other regulatory authorities may make adverse decisions
regarding olutasidenib; risks that clinical trials may not be
predictive of real-world results or of results in subsequent
clinical trials; risks that olutasidenib may have unintended side
effects, adverse reactions or incidents of misuses; market
competition; as well as other risks detailed from time to time in
Rigel's reports filed with the Securities and Exchange Commission,
including its Annual Report on Form 10-K for the year ended
December 31, 2023
and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2024 and subsequent filings.
Any forward-looking statement made by us in this press
release is based only on information currently available to us
and speaks only as of the date on which it is made. Rigel does not
undertake any obligation to update forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise, and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein, except as required by law.
Contact for Investors & Media:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David
Rosen
Argot
Partners
212.600.1902
david.rosen@argotpartners.com
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SOURCE Rigel Pharmaceuticals, Inc.
