SOUTH SAN FRANCISCO, Calif.,
Aug. 8, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today
reported financial results for the second quarter of 2018 and
provided an update on the commercial launch of TAVALISSE™ and the
clinical development pipeline.
Recent Highlights:
- On May 29, Rigel launched
TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of
thrombocytopenia in adult patients with chronic immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment.
- The TAVALISSE commercial team, at over 50 employees strong, is
fully deployed and supporting ITP-prescribing physicians across
the United States.
- RIGEL ONECARE™, Rigel's comprehensive physician and patient
support center, is assisting patients with access to TAVALISSE
through insurance coverage and other patient support programs.
"The second quarter of 2018 marked Rigel's pivotal transition to
a commercial stage company with the successful launch of TAVALISSE.
We are truly excited to be communicating TAVALISSE's attractive
value proposition to patients, physicians and payers: namely, its
unique mechanism of action that targets an underlying cause of the
disease, efficacy, oral dosing, safety profile, and comprehensive
patient support and access programs", stated Raul Rodriguez, president and CEO of Rigel.
"Beyond executing on our goal of making TAVALISSE a commercial
success in chronic ITP following steroid treatment, the company
continues to make exciting pipeline progress that we expect will
fully leverage the commercial capabilities we now have in place. We
look forward to providing a comprehensive corporate and pipeline
update at our upcoming Investor and Analyst Day, which will be held
in New York City this fall."
Financial Update
For the second quarter of 2018,
Rigel reported a net loss of $25.6
million, or $0.16 per share,
compared to a net loss of $19.1
million, or $0.16 per share,
in the same period of 2017.
For the second quarter of 2018, Rigel reported net product sales
from TAVALISSE of $1.8 million. The
Company recognizes revenue using the sell-in methodology when
products are delivered to its distributors. TAVALISSE was made
available by prescription for the treatment of chronic ITP on
May 29, 2018. There were no
product sales or contract revenues from collaborations in the
second quarter of 2017.
Rigel reported total costs and expenses of $27.9 million in the second quarter of 2018,
compared to $19.3 million for the
same period in 2017. The increase in costs and expenses was
primarily due to the increases in personnel costs for Rigel's
customer-facing team, as well as third party costs related to
Rigel's commercial launch of TAVALISSE in chronic ITP.
For the six months ended June 30,
2018, Rigel reported a net loss of $49.9 million, or $0.32 per share, compared to a net loss of
$34.5 million, or $0.29 per share, for the same period of 2017.
As of June 30, 2018, Rigel had
cash, cash equivalents and short-term investments of $135.0 million, compared to $115.8 million as of December 31, 2017. Rigel expects that its cash,
cash equivalents and short-term investments will be sufficient to
support its current and projected funding requirements, including
the on-going commercial launch of TAVALISSE for chronic ITP in the
U.S., into the fourth quarter of 2019.
Development Pipeline Update
In the second quarter,
Rigel continued to support the investigation of fostamatinib for
other serious, autoimmune conditions including autoimmune hemolytic
anemia (AIHA) and IgA nephropathy (IgAN). Updates regarding pivotal
programs in both indications are expected by the fall of 2018.
In June, Rigel announced the initiation of a Phase 1 study in
healthy subjects to assess safety, tolerability, pharmacokinetics
and pharmacodynamics of R835, a proprietary molecule from its
interleukin receptor associated kinase (IRAK) program. Preclinical
studies show that R835 inhibits both the IRAK1 and IRAK4 signaling
pathways, which play a key role in inflammation and immune
responses to tissue damage. Dual inhibition of IRAK1 and IRAK4
allows for more complete suppression of pro-inflammatory cytokine
release. The Phase 1 study is a randomized, placebo-controlled,
double-blind trial in up to 91 healthy subjects, ages 18 to 55. The
study design will assess the tolerability and safety of R835 in
both single ascending and multiple ascending doses.
Rigel reported that its clinical stage partnerships
continue to make progress. BerGenBio (with bemcentinib) and
Daiichi-Sankyo (with DS-30232) continue to enroll patients in
numerous clinical trials in various solid tumors and
AML. In June, Aclaris Therapeutics announced positive
interim data from their Phase 2 study of the licensed topical JAK
inhibitor, ATI-502, in patients with alopecia areata. Bristol
Myers Squibb has informed Rigel that they will be
terminating their preclinical collaboration.
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 are adequately treated with existing therapies. As a
result, there remains a significant medical need for additional
treatment options for patients with ITP.
About R835
The investigational candidate, R835, is an
orally available, potent and selective inhibitor of IRAK1 and IRAK4
that blocks inflammatory cytokine production in response to
toll-like receptor (TLR) and the interleukin-1 family receptor
(IL-1R) 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.
Conference Call and Webcast With Slides Today at 5:00PM Eastern Time
Rigel will hold a live
conference call and webcast today at 5:00pm
Eastern Time (2:00pm Pacific
Time).
Participants can access the live conference call by dialing
855-892-1489 (domestic) or 720-634-2939 (international) and using
the Conference ID number 8192317. The webcast, with slide
presentation, can be accessed from Rigel's website at
www.rigel.com. The webcast will be archived and available for
replay after the call via the Rigel website.
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 and RIGEL ONECARE are trademarks of Rigel
Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by 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 Phase 2 studies of fostamatinib in
autoimmune hemolytic anemia and IgA nephropathy. 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
potential success of the U.S. commercial launch of TAVALISSE; the
availability of TAVALISSE to patients; the benefits and value to
patients of TAVALISSE; Rigel's ability to identify partners for
commercialization of fostamatinib in ex-U.S. territories; the
sufficiency of Rigel's cash, cash equivalents and short-term
investments and the timing of its current cash runway; Rigel's
interactions with the FDA; 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," "goal," 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 of TAVALISSE; risks that
the FDA or other regulatory authorities may make adverse
decisions regarding TAVALISSE; 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 March 31,
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.
Contact: Dean Schorno
Phone: 650.624.1284
Email: ir@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2018
|
2017
|
|
2018
|
2017
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Product sales,
net
|
$
1,787
|
$
-
|
|
$
1,787
|
$
-
|
|
Contract revenues
from collaborations
|
—
|
—
|
|
—
|
3,584
|
|
Total
revenues
|
1,787
|
—
|
|
1,787
|
3,584
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Cost of product
sales
|
30
|
—
|
|
30
|
—
|
|
Research and
development (see Note A)
|
10,797
|
11,524
|
|
22,039
|
23,900
|
|
Selling, general and
administrative (see Note A)
|
17,071
|
7,820
|
|
30,563
|
15,230
|
|
Total costs and
expenses
|
27,898
|
19,344
|
|
52,632
|
39,130
|
|
|
|
|
|
|
|
Loss from
operations
|
(26,111)
|
(19,344)
|
|
(50,845)
|
(35,546)
|
Interest
income
|
554
|
197
|
|
903
|
353
|
Gain on disposal of
assets
|
—
|
—
|
|
—
|
732
|
Net loss
|
$
(25,557)
|
$
(19,147)
|
|
$ (49,942)
|
$ (34,461)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.16)
|
$
(0.16)
|
|
$
(0.32)
|
$
(0.29)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing
|
|
|
|
|
|
net loss per share, basic and diluted
|
161,577
|
122,500
|
|
154,385
|
118,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
779
|
$
764
|
|
$
1,719
|
$
1,359
|
|
Research and
development
|
333
|
336
|
|
933
|
696
|
|
|
$
1,112
|
$
1,100
|
|
$
2,652
|
$
2,055
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
December
31,
|
|
|
|
|
|
2018
|
2017
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
134,992
|
$
115,751
|
|
|
|
|
Total
assets
|
141,219
|
119,111
|
|
|
|
|
Stockholders'
equity
|
123,567
|
100,646
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.