SOUTH SAN FRANCISCO, Calif.,
Jan. 13, 2020 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
provided a business update, including preliminary product revenue
and total TAVALISSE® (fostamatinib disodium
hexahydrate) bottles for the quarter; the European Commision's (EC)
approval of fostamatinib disodium hexahydrate (fostamatinib) for
adult patients with chronic immune thrombocytopenia (ITP); and
enrollment progress in its Phase 3 pivotal trial for warm
autoimmune hemolytic anemia (AIHA). The company's president and
CEO, Raul Rodriguez, will provide a
more detailed company overview during his presentation taking place
on Thursday, January 16 at
7:30am PT at the 38th Annual J.P.
Morgan Healthcare Conference.
"Rigel has built a solid foundation for continued growth,
anchored by increased revenues from our U.S. commercial business.
With European approval of fostamatinib, we expect to generate
revenue from royalty payments beginning in the second half of the
year, and importantly, we will receive a $20
million milestone from our partner, Grifols, S.A.," stated
Mr. Rodriguez, Rigel's president and CEO. "Enrollment of our Phase
3 clinical trial in warm AIHA is accelerating with the ongoing
activation of trial sites. This is an extremely attractive market
for Rigel given the lack of an FDA-approved therapy and the
synergies with our ITP commercial business. Additionally, we are
making meaningful progress with our novel IRAK 1/4 and RIP1
inhibitor programs and are excited about their potential
value."
Preliminary Financial Update
While Rigel is still in
the process of determining final results for the fourth quarter of
2019, the company expects to report net product sales of
approximately $13.8 million, compared
to $7.3 million in the same period of
2018, an increase of 90%.
Contract revenues from collaborations for the quarter ended
December 31, 2019, are expected to be
approximately $1.6 million, which
consists of a $1.5 million fee earned
pursuant to an amendment in October
2019 of the license and collaboration agreement with Aclaris
dated August 27, 2015, as well as
deferred revenue from its collaboration with Grifols related to the
performance of certain research and development services.
For the fourth quarter 2019, Rigel expects to report total
revenues of approximately $15.4
million.
The company expects to report cash, cash equivalents and
short-term investments as of December 31,
2019 of approximately $98.0
million, compared to $128.5
million as of December 31,
2018.
The above information is preliminary, has not been audited and
is subject to change upon completion of the audit of the company's
financial statements as of and for the year ended December 31, 2019.
Commercial Update
Growing TAVALISSE in the U.S.
Market
During the fourth quarter of 2019, a total of 1,518
bottles of TAVALISSE were sold in the U.S. of which 1,422 were
shipped directly to patients and clinics. The refill rate at month
4 increased to approximately 54%, reflecting the benefit patients
are experiencing as TAVALISSE is used more frequently in earlier
line treatment and physicians become more experienced with its
use.
Heading into 2020, Rigel is poised for further growth with plans
to expand its salesforce by six people in key markets. In addition,
the company intends to continue its ongoing data initiatives and
leverage recently presented post-hoc data showing a 78% response
rate in ITP patients who received TAVALISSE in second line use.
EC Approval of Fostamatinib and Product Launch
Rigel
today announced that it has received EC approval of its marketing
authorization application (MAA) for fostamatinib for the treatment
of chronic immune thrombocytopenia in adult patients who are
refractory to other treatments. With this approval, the company
will receive a milestone payment of $20
million based on terms of its collaboration with Grifols,
S.A. During the regulatory review process, Grifols began preparing
to launch the product in the major European markets and is now able
to begin the regulatory processes for marketing in the individual
countries. The company expects to generate incremental revenue from
European sales of fostamatinib in the second half of this year in
the form of royalty payments.
Portfolio Update
Phase 3 Trial in Warm
AIHA
Since the launch of FORWARD (Fostamatinib Research in
Warm Antibody AIHA Disease), Rigel's Phase 3 pivotal trial in warm
AIHA, the company has been working with clinics and regulatory
authorities and has established a vast majority of the more than
100 clinical trial sites planned across 22 countries. With the
number of opened sites growing rapidly, over 45 in the last three
months, enrollment of the trial has accelerated as planned with 15
of 20 total patients enrolled in the last two months. The trial
remains on track to complete enrollment in mid-2020.
Clinical Development Pipeline
In the fourth quarter of
2019, Rigel announced results from its Phase 1 clinical trial of
R8351, its interleukin-1 receptor-associated kinase 1/4
(IRAK1/4) inhibitor. This novel molecule is the only asset in
clinical development that is a dual inhibitor of IRAK1 and IRAK4
and has been shown preclinically to block inflammatory cytokine
production in response to toll-like receptor (TLR) and the
interleukin-1 receptor (IL-1R) family signaling. The Phase 1 trial
established proof-of-mechanism by demonstrating the inhibition of
inflammatory cytokine production in an LPS (lipopolysaccharide)
challenge.
In addition, Rigel recently initiated a Phase 1 trial of its
receptor-interacting protein kinase (RIP1) inhibitor,
R5521. RIP1 is believed to play a critical role in
necroptosis, a form of regulated cell death implicated in
inflammatory and neurodegenerative diseases. Initial data from
Rigel's ongoing Phase 1 suggests R552 has an attractive
pharmacokinetic (PK) and safety profile with a half-life of
approximately 15 hours. In earlier preclinical studies, the
molecule was shown to prevent joint and skin inflammation in a RIP1
kinase-mediated murine model.
Both assets target pathways that are of high interest in the
biopharma industry and are widely thought to have significant
potential in the treatment of inflammatory and immune-mediated
diseases.
38th Annual J.P. Morgan Webcast Presentation
Details
Rigel's presentation will be webcast and is
scheduled to take place Thursday, January
16 at 7:30am PT. To access the
live and subsequently archived webcast, go to the Investor
Relations section of the company's website at www.rigel.com. Please
connect to the 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 (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 AIHA
Autoimmune hemolytic anemia (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 45,000 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. Warm
antibody AIHA (wAIHA), the most common form of AIHA, is
characterized by the presence of antibodies that react with the red
blood cell surface at body temperature.
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 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 pathological conditions. R835 treatment demonstrates
amelioration of clinical symptoms 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 R5521
The investigational candidate,
R552, is an orally available, potent and selective inhibitor of
receptor-interacting protein kinase (RIP1). RIP1 is believed to
play a critical role in necroptosis. Necroptosis is a form of
regulated cell death where the rupturing of cells leads to the
dispersion of their inner contents, which induces immune responses
and enhances inflammation. In preclinical studies, R552 prevented
joint and skin inflammation in a RIP1-mediated murine model of
inflammation and tissue damage. The safety and efficacy of R552 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), 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 fostamatinib in warm autoimmune
hemolytic anemia (AIHA); a recently completed Phase 1 study of
R8351, a proprietary molecule from its interleukin
receptor associated kinase (IRAK) inhibitor program; and an ongoing
Phase 1 study of R5521, a proprietary molecule from its
receptor-interacting protein kinase (RIP) inhibitor program. In
addition, Rigel has product candidates in clinical development with
partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and
Daiichi Sankyo.
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 and to expand its salesforce in key
markets; Rigel's regulatory and collaborative efforts in
Europe to make fostamatinib
available to ITP patients more globally; the utility of
fostamatinib in other indications, including warm autoimmune
hemolytic anemia; Rigel's ability to achieve development and
commercial milestones; Rigel's expected operating results for the
quarter ending and as of December 31,
2019, including net sales and cash, cash equivalents and
short-term investments; expectations related to the market
opportunity for ITP in the European market, and the design, timing,
enrollment 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 "goals", "potential", "preliminary", "may",
"expects", 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, 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.