SOUTH SAN FRANCISCO, Calif.,
Oct. 23, 2019 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today provided a business
update that will be discussed in more detail on the company's
investor and analyst call to be held today at 10am Eastern Time / 7am
Pacific Time.
"This is an exciting time for Rigel with significant
advancements in all segments of our business," said Raul Rodriguez, Rigel's president and CEO. "We
continue to grow sales of TAVALISSE in the U.S. and are making
substantial strides in expanding our pipeline. Our clinical
development efforts will be led by our newly appointed chief
medical officer, Dr. Wolfgang
Dummer. We are excited to leverage his experience and
depth of knowledge as we continue to pursue our clinical
development goals."
Business Update Highlights
TAVALISSE Revenues Increase
Preliminary estimates
indicate that TAVALISSE (fostamatinib disodium hexahydrate) net
product sales continued to achieve double digit quarter over
quarter growth, increasing 15% to $11.7
million from $10.2 million in
the second quarter of 2019. This information is preliminary, has
not been audited and is subject to change upon completion of
Rigel's closing procedures.
IRAK1/4 Program Shows Proof-of-Mechanism in
Humans
Rigel completed a Phase 1 clinical trial of R835, an
interleukin-1 receptor-associated kinase 1/4 (IRAK 1/4) inhibitor.
In addition to positive tolerability and pharmacokinetic data, R835
showed consistent inhibition of cytokine production in an LPS
(lipopolysaccharide) challenge which was designed to gauge the
molecule's impact on inflammatory stimulation.
New RIP1 Inhibitor Program
For the first time today,
Rigel announced its new receptor-interacting protein kinase (RIP1)
inhibitor program. The lead molecule, R552, has initiated a
Phase 1 clinical trial. RIP1 is believed to be a key driver of
necroptosis which is implicated in a broad range of key
inflammatory cellular processes including cell death and cytokine
production.
Appointment of Wolfgang
Dummer, MD, PhD as CMO
The Company is pleased to
announce the appointment of Wolfgang
Dummer, MD, PhD to the role of Chief Medical Officer.
Dr. Dummer has more than 20 years of clinical and drug development
experience at world class institutions, as well as an extensive
academic history. Most recently, he served as Chief Medical Officer
at Aridis Pharmaceuticals, Inc. where he was responsible for
overseeing all aspects of drug development in the field of
antimicrobial immunotherapy. Prior to that, he served as Vice
President of Clinical Development at BioMarin Pharmaceutical Inc.,
where he led the development of a deep rare disease pipeline,
including the company's leading marketed product, Vimizim
(elosulfase alpha). Prior to Biomarin, Dr. Dummer served for 11
years in capacities of increasing importance in Clinical Research
and Development at Genentech, Inc. (now part of Roche), overseeing
numerous programs, including Rituximab. Dr. Dummer is a
board-certified clinical dermatologist and allergist/immunologist.
Over the course of his career, he has published more than 50 peer
reviewed journal articles and has more than 40 abstracts,
presentations, and book contributions.
Business Update Conference Call
As previously
announced, Rigel will host a conference call today to provide a
business update. Participants can access the live conference call
by dialing (877) 407-3088 (domestic) or (201) 389-0927
(international). The conference call and accompanying slides
will also be webcast live and can be accessed from Rigel's website
at www.rigel.com. The webcast will be archived and available for
replay for 90 days after the call via the Rigel website.
About ITP
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.
About R8351
R835 is an oral
investigational candidate that is a potent and selective inhibitor
of IRAK1 and IRAK4 shown preclinically to block inflammatory
cytokine production in response to toll-like receptor (TLR) and the
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 a variety of
inflammatory conditions. Dysregulation of the TLR and IL-1R
pathways may be associated with a variety of inflammatory
conditions including psoriasis, rheumatoid arthritis, lupus and
gout (among others).
About R5521
R552 is an
investigational candidate that is a receptor-interacting protein
kinase (RIP1) inhibitor. RIP1 is believed to play a critical role
in necroptosis, a type of regulated cell death. In necroptosis,
cells rupture leading to the dispersion of cell contents, which
signals an immune response and enhances inflammation. It is
implicated in a broad range of key inflammatory cellular processes
including cell death and cytokine production. In preclinical
studies, R552 showed prevention of joint and skin inflammation in a
RIP1-mediated murine model of inflammation and tissue
damage.
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), the only 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
a Phase 3 study of fostamatinib in autoimmune hemolytic anemia
(AIHA) 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 ASA, Daiichi Sankyo, Aclaris Therapeutics, and
AstraZeneca.
1The product candidate is investigational and has not
been established safe or effective by the U.S. Food and Drug
Administration (FDA) or any regulatory authority.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
continued growth of commercial sales of TAVALISSE in the U.S.;
Rigel's third quarter net product sales results; the potential
expansion of fostamatinib into other countries; expected pipeline
expansion and related commercial growth from product sales;
preliminary estimates of TAVALISSE sales for Q3; 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; changes or
revisions as a result of Rigel's quarterly closing procedures;
risks that the FDA, European Medicines Agency (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 June 30, 2019. 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
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SOURCE Rigel Pharmaceuticals, Inc.