SOUTH SAN FRANCISCO, Calif.,
Jan. 4, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that Raul Rodriguez, the company's president and
chief executive officer, will present an update on its product
pipeline and a financial overview at the upcoming
36th Annual J.P. Morgan Healthcare
Conference in San Francisco,
California on January 10, 2018, at 1:30pm PST (see
webcast details below).
Rigel's presentation will include a review of the company's New
Drug Application (NDA) for fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, in adult patients with immune
thrombocytopenia (ITP). The FDA has confirmed that it does not plan
to convene an Oncology Drugs Advisory Committee (ODAC)
meeting to discuss the NDA. The action date for
the FDA to complete its review is April 17, 2018 under the Prescription Drug User
Fee Act (PDUFA).
"In 2017, we achieved the critical milestones necessary to
transition Rigel into a fully integrated research, development and
commercial company prepared to launch its first product into the US
market," said Mr. Rodriguez. "2018 will be an exciting year.
Fostamatinib, if approved by the FDA, could become an
important alternative treatment option for patients with chronic
ITP. Additionally, we have now shown in preliminary results
that 47% of the patients treated with fostamatinib in our
autoimmune hemolytic anemia study had a clinical response as
measured by a defined increase in hemoglobin. There are
currently no approved therapies for this indication."
Portfolio Update
Fostamatinib in ITP
In June, Rigel announced that
the FDA had accepted for filing its NDA for fostamatinib
for the treatment of adult patients with ITP. The NDA is supported
by data from the FIT clinical program, which included three Phase 3
studies, two randomized placebo-controlled studies (Studies 047 and
048) and an open-label extension study (Study 049). Since the
NDA filing, Rigel has worked closely with the FDA to address any
questions and will continue to do so in 2018. Rigel has undergone
two routine FDA inspections at its headquarters (BIMO and PAI)
which did not result in any FDA Form 483 observations.
In addition, the FDA has inspected the two highest enrolling FIT
clinical sites, both without 483 observations.
The organization is ramping up for a potential product launch,
anticipated in the second quarter of 2018. In addition to hiring
key personnel, Rigel is developing relationships with external
partners to establish distribution channels and the systems needed
to provide medication access.
Fostamatinib in Autoimmune Hemolytic Anemia (AIHA)
The
Phase 2, open-label, multi-center, Simon two-stage study of
fostamatinib for the treatment of warm AIHA completed enrollment of
Stage 1. The study is evaluating the safety and efficacy of
fostamatinib, at 150mg BID (twice daily), in patients with warm
AIHA who have previously received at least one treatment for this
disease, but did not have a meaningful benefit and are still
anemic.
Stage 1 of the study enrolled 17 evaluable patients. 47% of
these patients (8 patients out of 17) have responded to
fostamatinib treatment as of December 2017. Six
patients, including the last two patients enrolled, responded
during the 12-week evaluation period and an additional two patients
met the response criteria in the extension study after 12 weeks of
dosing. A response was defined as achieving a hemoglobin
level of greater than 10 g/dl and at least a 2 g/dl increase from
baseline. The safety profile was consistent with the existing
fostamatinib safety database. Stage 2 enrollment commenced in late
2017. Stage 2 follows the same protocol as Stage 1 and will include
20 patients.
These data are planned to be presented at a future medical
meeting. Rigel plans to meet with the FDA in the first half of 2018
to determine the regulatory path for approval of fostamatinib in
AIHA.
Additional Product Development
- Rigel has completed enrollment of the second cohort in its
blinded Phase 2 study of fostamatinib in IgA Nephropathy (IgAN).
The study is evaluating the efficacy, safety, and tolerability of
fostamatinib as measured by change in proteinuria, renal function,
and histology (comparing the pre- and post-study renal biopsies).
The second cohort evaluates a higher dose of fostamatinib, 150mg
BID, while the first cohort evaluated 100mg BID. The primary
efficacy endpoint is the mean change of proteinuria from baseline
at 24 weeks. Rigel expects the study to be complete at the end of
the first quarter of 2018.
- During 2017, Rigel selected a molecule from its IRAK program
for preclinical development. The molecule is differentiated in that
it inhibits both the IRAK 1 and IRAK 4 signaling pathways, with
potential to treat autoimmune and inflammatory diseases such as
psoriasis, lupus, gout, psoriatic arthritis and multiple sclerosis.
The company expects to initiate clinical trials in 2018.
Financial Update
Based upon preliminary estimates,
Rigel expects to end 2017 with approximately $115.6 million in
cash, cash equivalents, and short-term investments, which it
believes will be sufficient to fund its operations into 2019. These
operations include the potential commercial launch of fostamatinib
in the U.S. in 2018 including hiring the sales force associated
with the launch, the fostamatinib clinical trials described above
for AIHA and IgAN, and continuing to advance the research
pipeline.
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 increased risk of severe
bleeding events that can result in serious medical complication, or
even death. Current therapies for ITP include steroids, blood
platelet production boosters (TPOs) 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 AIHA
Autoimmune hemolytic anemia (AIHA) is a
rare, serious blood disorder where 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 US and can be a severe, debilitating anemia. To date, there are
no approved therapies disease-targeted therapies for AIHA, despite
the tremendous medical need that exists for these patients.
Webcast Details
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 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
hematological disorders, cancer and rare diseases. Rigel's
pioneering research focuses on signaling pathways that are critical
to disease mechanisms. The company's current clinical programs
include clinical trials of fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, in a number of indications. Rigel has
submitted and the FDA has accepted for review, an NDA for
fostamatinib in patients with chronic or persistent immune
thrombocytopenia (ITP). In addition, Rigel has product candidates
in development with partners BerGenBio AS, Daiichi
Sankyo and Aclaris Therapeutics.
Forward Looking Statements
This
release contains forward-looking statements relating to, among
other things, the timing of enrollment and results of on-going
clinical trials and the results of the FDA's review of
Rigel's NDA for fostamatinib in patients with chronic or persistent
ITP; Rigel's ability to transition to an organization prepared to
launch its first commercial product; Rigel's belief that
fostamatinib may be an important alternative for patients with ITP
or AIHA; the management and advancement of Rigel's clinical
programs; and the 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,"
"should," "expect," 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,
the FDA may interpret Rigel's findings differently, which
could result in the FDA not approving the NDA; 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, 2017. 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: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com
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SOURCE Rigel Pharmaceuticals, Inc.