SOUTH SAN FRANCISCO, Calif.,
May 7, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today reported
financial results for the first quarter ended March 31, 2019, including sales of TAVALISSE®
(fostamatinib disodium hexahydrate), for the treatment of
thrombocytopenia in adults with chronic immune thrombocytopenia
(ITP) who have had an insufficient response to a previous
treatment.
"Since the U.S. launch of TAVALISSE one year ago, a growing
number of physicians are utilizing our product in earlier lines of
therapy and with an increasing number of their chronic ITP
patients," stated Raul Rodriguez,
president and CEO. "Internationally, the recent collaboration with
Grifols in Europe enhances our
potential access to a majority of the ex-U.S. ITP market.
Meanwhile, our pipeline is expanding with the initiation of our
Phase 3 trial in warm autoimmune hemolytic anemia and additional
ongoing clinical and research projects."
Financial Update
For the first quarter of 2019, Rigel reported a net loss of
$17.6 million, or $0.11 per share, compared to a net loss of
$24.4 million, or $0.17 per share, in the same period of 2018.
For the first quarter of 2019, Rigel reported total revenues of
$12.6 million, consisting of
$8.1 million in net product sales of
TAVALISSE and $4.6 million in
contract revenues from collaborations. The increase in net product
sales of TAVALISSE reflects the continuing growth of its business
since commercial launch in May 2018.
There were no net product sales nor contract revenues from
collaborations in the first quarter of 2018.
Contract revenues from collaborations of $4.6 million during the three months ended
March 31, 2019 primarily related to a
portion of the $30.0 million upfront
fee recognized as revenue upon delivery of license rights to
Grifols, S.A. and Rigel's performance of certain research and
development services. There were no contract revenues from
collaborations during the three months ended March 31, 2018.
Rigel reported total costs and expenses of $31.0
million in the first quarter of 2019, compared
to $24.7 million for the same period in 2018. The
increase in costs and expense was primarily due to the increases in
personnel costs, including its customer-facing and medical affairs
teams, and third-party costs to support Rigel's commercialization
of TAVALISSE.
As of March 31, 2019, Rigel had cash, cash equivalents and
short-term investments of $127.9
million, compared to $128.5 million as
of December 31, 2018.
Business Update
- Rigel's launch of TAVALISSE in the U.S. continued to build upon
its early success with growth driven by expansion of the prescriber
base, steady use of the product as an early treatment option in
steroid refractory patients, physicians prescribing to an increased
number of patients, and strong reimbursement from the payer
community.
- Rigel advanced the regulatory review of fostamatinib in chronic
ITP by responding to day-120 questions from the European Medicines
Agency (EMA) and remains on track for potential approval in the EU
by the end of 2019.
- In January, Rigel entered into a collaboration with Grifols,
S.A. for the rights to fostamatinib in all indications in
Europe and Turkey enabling a commercial launch
preparation well ahead of the anticipated approval date.
- Kissei Pharmaceuticals, Rigel's collaborator in Japan, has initiated discussions with the
Pharmaceuticals and Medical Devices Agency (PMDA) to define a path
towards fostamatinib approval in Japan.
- In warm AIHA, Rigel opened clinical trial sites for its pivotal
Phase 3 clinical study of fostamatinib. The clinical trial protocol
calls for approximately 80 patients in a 24-week study with
enrollment of the first patient expected this month. Topline trial
results are projected in early 2021, positioning fostamatinib to
potentially be the first FDA-approved treatment for this
indication.
- The company's research and development team continues to
investigate potential molecules that modulate the immune system,
including R835, Rigel's IRAK 1/4 inhibitor currently in Phase 1
development. In addition, Rigel has four partnered programs that
are in Phase 1 and 2 of their clinical development and continue to
advance.
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 AIHA
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 40,000 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.
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 (IL-1R) family receptor 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. The safety and efficacy of R835 has
not been established by the FDA or any healthcare authority.
Conference Call and Webcast with Slides Today at 4:30PM
Eastern Time
Rigel will hold a live conference call and webcast today
at 4:30pm Eastern Time (1:30pm
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 3999559. 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 (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), 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 clinical
development with partners BerGenBio ASA, Daiichi Sankyo, Aclaris
Therapeutics, and AstraZeneca.
1 The 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, Rigel's partnership with Grifols, Kissei and
other partnering opportunities across its pipeline; the utility of
fostamatinib in other indications, including warm autoimmune
hemolytic anemia and other indications; expectations related to the
market opportunity for ITP; Rigel's ability to broaden its
pipeline; the potential opportunity for fostamatinib to obtain
approval in the EU by the end of 2019; 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 Annual Report on Form 10-K for
the year ended December 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: David Burke
Phone: 650.624.1232
Email: dburke@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
March 31,
|
|
|
2019
|
2018
|
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
Product sales,
net
|
$
8,054
|
—
|
|
Contract revenues
from collaborations
|
4,570
|
—
|
|
Total
revenues
|
12,624
|
—
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Cost of product
sales
|
107
|
—
|
|
Research and
development (see Note A)
|
10,949
|
11,242
|
|
Selling, general and
administrative (see Note A)
|
19,946
|
13,492
|
|
Total costs and
expenses
|
31,002
|
24,734
|
Loss from
operations
|
(18,378)
|
(24,734)
|
Interest
income
|
780
|
349
|
Net loss
|
$
(17,598)
|
$
(24,385)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.11)
|
$
(0.17)
|
|
|
|
|
Weighted-average
shares used in computing net loss
per share, basic and diluted
|
|
|
167,173
|
147,114
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
Selling, general and
administrative
|
$
2,166
|
$
940
|
|
Research and
development
|
787
|
600
|
|
|
$
2,953
|
$
1,540
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
(in
thousands)
|
|
|
|
|
|
|
March
31,
|
December
31,
|
|
|
2019
|
2018
(1)
|
|
|
(unaudited)
|
|
|
Cash, cash
equivalents and short-term investments
|
$
127,923
|
$
128,537
|
|
Total
assets
|
172,784
|
139,109
|
|
Stockholders'
equity
|
95,315
|
109,877
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/rigel-announces-first-quarter-2019-financial-results-and-provides-company-update-300845567.html
SOURCE Rigel Pharmaceuticals, Inc.