Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today. The second milestone marks the completion of the transfer of the fostamatinib long-term open label extension study from Rigel to AstraZeneca.
"We are proud of our team's ability to successfully and smoothly transition both aspects of the fostamatinib program to AstraZeneca in just six months time, and are pleased to know that fostamatinib will be the focus of one of the largest phase 3 studies in RA patients conducted to date," said James M. Gower, chairman and chief executive officer of Rigel.
In February 2010, Rigel granted AstraZeneca exclusive rights to the future development and commercialization of fostamatinib. AstraZeneca announced that the initial primary focus of their phase 3 clinical development program for fostamatinib, called OSKIRA (Oral Syk Inhibition in Rheumatoid Arthritis), would be in patients with RA, with an inadequate response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate.
In today's announcement, AstraZeneca outlined the scope of their global clinical trial program, which will include three pivotal phase 3 studies assessing the efficacy and tolerability of fostamatinib. Results are expected to allow for the filing of new drug applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) in 2013.
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