Rigel Pharma (RIGL) Announces Settlement Agreement Resolving TAVALISSE Patent Litigation

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.

"The resolution 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."

About ITP
In patients 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.

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