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Rigel Pharma Says TAVALISSE Preliminary 2020 Net Product Sales Up 41% - Quick Facts

Rigel Pharmaceuticals, Inc. (RIGL) on Monday provided a business update, including preliminary total revenue and TAVALISSE (fostamatinib disodium hexahydrate) bottles sold for the fourth quarter, Fast Track designation granted for warm autoimmune hemolytic anemia (wAIHA), and the company's COVID-19 program.

For the fourth quarter, Rigel expects to report total revenue of about $18.4 million. The company also said that TAVALISSE preliminary net product sales in full year 2020 were $61.7 million, a year-over-year increase of 41 percent.

Rigel Pharma said its President and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 14, 2020 at the 39th Annual J.P. Morgan Virtual Healthcare Conference.

"Annual sales of TAVALISSE grew by 41% compared to 2019, and its use as an earlier line treatment option for ITP is resonating with both patients and physicians. We are continuing to enroll our Phase 3 trial in wAIHA and we have received Fast Track designation from the FDA which is intended to expedite the review of a potential regulatory filing," said Rodriguez.

TAVALISSE 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.

Rigel Pharma said that in the fourth quarter of 2020, a total of 1,899 bottles of TAVALISSE were sold in the U.S., of which 1,725 were shipped directly to patients and clinics.

While Rigel has not yet determined the final results for the fourth quarter of 2020, it expects to report net product sales of about $17.7 million, an increase of 28 percent $13.8 million in the year-ago quarter.

The company expects contract revenues from collaborations for the fourth quarter to be about $697,000. This consists of $500,000 from Grifols related to an option for commercialization in additional territories, and $197,000 in revenues earned from the performance of certain research and development services from Rigel's collaboration agreement with Grifols.

Further, Rigel noted that the Phase 2 clinical trial sponsored by NIH/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib for the treatment of COVID-19 has enrolled 44 of the 60 patients planned for enrollment.

Rigel has also launched its Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors.

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