Full Press Release Details
Rigel Announces Settlement Agreement Resolving
TAVALISSE (fostamatinib disodium hexahydrate) Patent Litigation
SOUTH SAN FRANCISCO,
Calif., March 27, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has
entered into a settlement agreement with Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. (collectively "Annora")
resolving patent litigation related to Rigel's product TAVALISSE (fostamatinib disodium hexahydrate). The litigation
resulted from submission by Annora of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking
approval to market a generic version of TAVALISSE in the United States. Under the terms of the settlement agreement, Annora will
have a license to sell its generic product in Q2 2032 or earlier under certain circumstances. In accordance with the agreement, the parties
terminated all ongoing litigation between Rigel and Annora regarding TAVALISSE patents pending in New Jersey.
of this patent litigation underscores the strength of Rigel's intellectual property protecting TAVALISSE, an innovative treatment
for people with immune thrombocytopenia," said Raul Rodriguez, Rigel's president and CEO. "We remain committed to advancing
our portfolio of novel therapies with the potential to improve the lives of patients with hematological disorders and cancer, and to
continue to develop and enhance our intellectual property portfolio."
with immune thrombocytopenia (ITP), 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. Patients 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.
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, www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE is a registered
trademark of Rigel Pharmaceuticals, Inc.
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.
Forward Looking Statements
This press release contains
forward-looking statements relating to, among other things, expected generic product market entry, the strength of our intellectual property
portfolio and our ability to develop and enhance it, TAVALISSE as a treatment for immune thrombocytopenia, and expectations to grow and
advance our commercial portfolio. 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 "anticipates", "plan",
"potential", "may", "look to", "expects", "will", "initial",
"promising", 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 fostamatinib,
olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions
regarding fostamatinib, pralsetinib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of
results in subsequent clinical trials; risks that fostamatinib, pralsetinib or olutasidenib may have unintended side effects, adverse
reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; 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, 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.
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Rigel Pharmaceuticals, Inc.