SOUTH SAN FRANCISCO, Calif.,
Sept. 23, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced
that its collaboration partner, Kissei Pharmaceuticals Co., Ltd.
("Kissei"), has initiated a Phase 3 trial in Japan of fostamatinib disodium hexahydrate in
adult patients with chronic immune thrombocytopenia (ITP). The
efficacy and safety of orally administered fostamatinib will be
assessed by comparing it with placebo in a randomized, double-blind
study. Fostamatinib is commercially available in the U.S. under the
brand name TAVALISSE® for the treatment of adult patients with
chronic ITP who have had an insufficient response to a previous
treatment.
Kissei is a Japan-based
pharmaceutical company addressing patients' unmet medical needs
through its research, development and commercialization efforts, as
well as through collaborations with partners. Earlier this year,
Kissei submitted a Phase 3 trial design to Japan's Pharmaceuticals and Medical Devices
Agency (PMDA) and it was recently accepted by the agency. The
results of this trial will be used to support a new drug
application (NDA) that Kissei plans to file in Japan in late 2021 or early 2022. Japan has the third highest prevalence of
chronic ITP in the world behind the U.S. and EU. Currently a
marketing authorization application for fostamatinib in chronic ITP
in adult patients is being reviewed by the European Medicines
Agency for potential approval in Europe.
In October 2018, Rigel and Kissei
entered into an agreement for the development and commercialization
of fostamatinib in all current and potential indications in
Japan, China, Taiwan
and the Republic of Korea. Under the terms of the agreement, Rigel
received an upfront cash payment of $33
million, with the potential for an additional $147 million in development and commercial
milestone payments and will receive product transfer price payments
in the mid to upper twenty percent range based on tiered net
sales.
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 (TPO receptor agonists) and
splenectomy. However, not all patients are adequately treated with
existing therapies. As a result, there remains a significant
medical need for additional treatment options for patients with
ITP.
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 (e.g., rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (e.g., 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 registered 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) tablets, 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 clinical
programs include a Phase 3 study of TAVALISSE in warm autoimmune
hemolytic anemia (AIHA) and a Phase 1 study of R835, a proprietary
molecule from its interleukin receptor associated kinase (IRAK)
program. In addition, Rigel has product candidates in clinical
development with partners BerGenBio ASA, Daiichi
Sankyo, Aclaris Therapeutics, and AstraZeneca.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
payments that will be received by Rigel under the Collaboration and
License Agreement; the potential opportunity for fostamatinib to
obtain approval in the EU; the management and advancement of
Rigel's clinical programs; 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," "expect," "anticipate," 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 quarter 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.
Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.