SOUTH SAN FRANCISCO, Calif.,
Jan. 7, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
today provided a business update, including the quantity of
TAVALISSE™ bottles sold in 2018 and its cash position as of
December 31, 2018, as well as an
overview of its strategy for 2019. The company's president and CEO,
Raul Rodriguez, will provide a more
detailed company overview during his presentation at the
37th Annual J.P. Morgan Healthcare Conference on
Wednesday, January 9 at 11:00am PT.
"2018 was a monumental year for Rigel, during which we
transitioned into a commercial stage company with the successful
launch of TAVALISSE. The ongoing execution of our TAVALISSE
commercial strategy will be a key focus in 2019," said Mr.
Rodriguez. "We will also be concentrating on the expansion
of fostamatinib into Europe
and further development of its utility in other indications, with
the initiation of a Phase 3 trial in warm autoimmune hemolytic
anemia. Our research team is making great strides identifying
additional molecules that could potentially utilize the immune
system to fight diseases and which we can move into clinical
development or partner with leading pharmaceutical companies."
Commercial Update
TAVALISSE Early Stage of Launch
In April 2018, TAVALISSE was approved
in the U.S. for the treatment of thrombocytopenia in adult patients
with chronic immune thrombocytopenia (ITP) who have had an
insufficient response to a previous treatment. Following the
product launch of TAVALISSE at the end of May 2018, the company has continued to execute on
its commercial strategy.
From May 29, 2018 through
December 31, 2018, Rigel sold 1,794
bottles of TAVALISSE, of which, 1,556 were shipped directly to
patients and clinics. There has been encouraging early demand for
TAVALISSE, including use as the first or second choice after
steroids. Based on experience to date, continuity of TAVALISSE
therapy has been positive as well. The company estimates that over
45% of eligible patients have continued on treatment for the fourth
consecutive month.
Rigel remains on track with the execution of its global
commercial strategy for fostamatinib. In early 2019, Kissei
Pharmaceuticals, Rigel's partner in Asia, plans to meet with Japan's Pharmaceuticals and Medical Devices
Agency. In parallel, the European Medicines Agency is progressing
with its review of the marketing authorization application (MAA)
for fostamatinib for the treatment of adults with chronic ITP in
Europe. The company anticipates a
final decision on the MAA by the end of 2019. Discussions with
potential partners to commercialize the product in Europe are ongoing and an agreement is
expected during 2019.
Portfolio Update
Fostamatinib in Autoimmune Hemolytic Anemia (AIHA)
In the first half of 2018, the company reported data from its Phase
2 clinical trial evaluating the use of fostamatinib to treat warm
AIHA. Additional data were also presented at the 2018 American
Society of Hematology annual meeting in December 2018. These
data enabled meetings with the United States Food and Drug
Administration (FDA) to discuss the planned Phase 3 pivotal trial,
which the company hopes to launch in the first half of 2019.
Clinical trial sites will be located in the U.S., Western Europe, Central Europe, Canada, and Australia.
R8351 (IRAK 1/4 Inhibitor) Program
During 2018, Rigel initiated a Phase 1 clinical trial of R835, an
investigational IRAK 1/4 inhibitor, to assess the safety,
tolerability, and pharmacokinetics in healthy subjects. IRAK 1/4
plays a central role in the innate immune response to tissue
damage. Therefore, it is a potential pathway to target a
variety of immune-mediated diseases, allowing for a broad range of
clinical opportunities. As these and other data mature, the company
will pursue opportunities to optimize the strategic value of this
asset across indications and geographies.
Financial Update
Based upon preliminary estimates, Rigel expects to end 2018 with
approximately $128.5 million in cash,
cash equivalents, and short-term investments, which it believes
will be sufficient to fund its operations into 2020. These
operations include continued expansion of its commercial programs
for TAVALISSE in the U.S., the launch of a Phase 3 clinical
trial for fostamatinib in warm AIHA, and continued support of
on-going research and development programs. In 2019, the company
also expects incremental contribution to its cash position from
revenue generated by its commercial business.
37th Annual J.P. Morgan Webcast Presentation
Details
Rigel's presentation will be webcast and is scheduled to take place
Wednesday, January 9 at 11:00am PT. To access the live audio webcast or
the subsequent archived recording, log on to www.rigel.com. Please
connect to Rigel's website several minutes prior to the start of
the live webcast to ensure adequate time for any software download
that may be necessary.
About ITP
In patients with 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. 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 (TPOs) 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.
About AIHA
AIHA is a rare, serious blood disorder in which the immune system
produces antibodies that result in the destruction of the body's
own red blood cells. AIHA affects approximately 40,000 adult
patients in the U.S. and can be a severe, debilitating disease. To
date, there are no disease-targeted therapies approved for AIHA,
despite the unmet medical need that exists for these patients.
About R8351
The investigational candidate, R835, is an orally available, potent
and selective inhibitor of IRAK1 and IRAK4 that has been shown
preclinically to block inflammatory cytokine production in response
to toll-like receptor (TLR) and the interleukin-1 (IL-1R) family
receptor signaling. TLRs and IL-1Rs play a critical role in the
innate immune response and dysregulation of these pathways can lead
to a variety of inflammatory conditions. R835 is active in multiple
rodent models of inflammatory disease including psoriasis,
arthritis, lupus, multiple sclerosis and gout. The safety and
efficacy of R835 has not been established by the FDA or any
healthcare authority.
About
TAVALISSE
Indication
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.
Important Safety Information
Warnings and Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the
hypertensive effects. Monitor blood pressure every 2 weeks until
stable, then monthly, and adjust or initiate antihypertensive
therapy for blood pressure control maintenance during therapy. If
increased blood pressure persists, TAVALISSE interruption,
reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can
occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to >3 x upper limit of normal, manage
hepatotoxicity using TAVALISSE interruption, reduction, or
discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea
occurred in 1% of patients treated with TAVALISSE. Monitor patients
for the development of diarrhea and manage using supportive care
measures early after the onset of symptoms. If diarrhea becomes
severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE;
febrile neutropenia occurred in 1% of patients. Monitor the ANC
monthly and for infection during treatment. Manage toxicity with
TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant
women. Advise pregnant women the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment and for at least 1 month after the last dose.
Verify pregnancy status prior to initiating TAVALISSE. It is
unknown if TAVALISSE or its metabolite is present in human milk.
Because of the potential for serious adverse reactions in a
breastfed child, advise a lactating woman not to breastfeed during
TAVALISSE treatment and for at least 1 month after the last
dose.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.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 trademark of Rigel Pharmaceuticals,
Inc.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals,
Inc., is a biotechnology company dedicated to discovering,
developing and providing novel small molecule drugs that
significantly improve the lives of patients with immune and
hematologic disorders, cancer and rare diseases. Rigel's pioneering
research focuses on signaling pathways that are critical to disease
mechanisms. The company's first FDA approved product is TAVALISSE™
(fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase
(SYK) inhibitor, for the treatment of adult patients with chronic
immune thrombocytopenia who have had an insufficient response to a
previous treatment. Rigel's current clinical programs include an
upcoming Phase 3 study of fostamatinib in autoimmune hemolytic
anemia and an ongoing Phase 1 study of R835, a proprietary molecule
from its interleukin receptor associated kinase (IRAK) program. In
addition, Rigel has product candidates in development with partners
BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
1The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
commercial success of TAVALISSE in the U.S.; Rigel's ability to
broaden its pipeline of assets targeting immune-mediated diseases;
Rigel's efforts to expand fostamatinib in Europe; the utility of fostamatinib in other
indications, including warm autoimmune hemolytic anemia and other
indications; Rigel's ability to achieve development and commercial
milestones; the sufficiency of Rigel's cash, cash equivalents and
short-term investments and the timing of its current cash runway;
and the design, timing and results of Rigel's clinical
trials. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "planned", "will", "may",
"expects", "anticipates", "estimates", "hopes", "believes"
and similar expressions are intended to identify these
forward-looking statements. These forward-looking statements are
based on Rigel's current expectations and inherently involve
significant risks and uncertainties. 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 TAVALISSE; risks that the FDA, EMA or other regulatory
authorities may make adverse decisions regarding fostamatinib;
risks that TAVALISSE clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that TAVALISSE 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
Quarterly Report on Form 10-Q for the period ended September
30, 2018. Rigel does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.