Full Press Release Details
Rigel Pharmaceuticals Provides Business Update
SOUTH SAN FRANCISCO,
Calif., January 8, 2024 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today provided a business update including preliminary
total revenue for the fourth quarter of 2023, ongoing activity from the commercial portfolio, including TAVALISSE (fostamatinib
disodium hexahydrate) tablets and REZLIDHIA (olutasidenib) capsules, and upcoming catalysts for 2024.
was a year of significant growth across our commercial hematology-oncology portfolio. We grew TAVALISSE net product sales nearly
24% over 2022 and successfully achieved more than $10 million of REZLIDHIA revenue during
its first full year of launch. This enabled us to generate more than $104 million of total
net product sales this year," said Raul Rodriguez, Rigel's president and CEO. "Also,
our recent collaborations with MD Anderson and CONNECT will allow us to evaluate the potential of REZLIDHIA as a possible therapy in
a broad range of IDH1-mutant cancers. As we head into the future, we are focused on commercial execution, the advancement of our hematology-oncology
pipeline, and our plan to reach financial breakeven."
Preliminary Financial Update
In the fourth quarter
of 2023, a total of 2,671 bottles of TAVALISSE were sold in the U.S., of which, 2,463 bottles were shipped directly to patients and clinics,
representing the highest daily bottles shipped to patients and clinics in a quarter since launch. While Rigel is still determining final
results for the fourth quarter of 2023, it expects to report net product sales of TAVALISSE of $25.7 million for the fourth quarter compared
to $21.9 million for the same period of 2022.
In the fourth quarter
of 2023, a total of 308 bottles of REZLIDHIA were sold in the U.S., of which, 278 bottles were shipped directly to patients and clinics.
While Rigel is still determining final results for the fourth quarter of 2023, it expects to report net product sales of REZLIDHIA of
$3.9 million for the fourth quarter compared to $0.9 million for the same period of 2022.
Overall, Rigel expects
to report net product sales of $104.3 million in 2023, representing 36% growth over 2022.
Contract revenues for
the fourth quarter of 2023 are expected to be approximately $6.1 million, consisting of $6.0 million in contract revenue from collaborations
and $0.1 million in government contract revenue. Contract revenue from collaborations is expected to include $3.7 million of revenue
from Grifols S.A., related to delivery of drug supplies and earned royalties, as well as $2.2 million of revenue from Kissei Pharmaceutical
Co., Ltd. and $0.1 million of revenue from Medison Pharma Trading AG, related to delivery of drug supplies.
For the fourth quarter
of 2023, Rigel expects to report total revenue of approximately $35.7 million.
Rigel expects to report
cash, cash equivalents, and short-term investments of approximately $56.9 million as of December 31, 2023, compared to $58.2 million
as of December 31, 2022.
The above information
is preliminary, has not been audited, and is subject to change upon the audit of Rigel's financial statements for the year ended
December 31, 2023. Rigel expects to provide complete fourth quarter and full year 2023 financial results in March 2024.
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.
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 in the United States alone, there were about 20,380 new cases, most in adults, in 2023.2
Relapsed AML affects
about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 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.4 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.
is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production
in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in
the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both
these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias
in lower-risk MDS patients.5
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.
Warnings and Precautions
Please see www.TAVALISSEUSPI.com for
Full Prescribing Information.
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 is a registered
trademark of Rigel Pharmaceuticals, Inc.
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.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, can occur with REZLIDHIA
treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight
gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring
until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome.
In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients,
with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome
is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation
syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney
injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after
treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA
initiation and has been observed with or without concomitant leukocytosis.
If differentiation syndrome is suspected, temporarily
withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until
resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated.
Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation
of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold
dose of REZLIDHIA and consider dose reduction based on recurrence.
hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline
phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred
in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in
the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median
time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5
months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities
were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.