SOUTH SAN FRANCISCO, Calif.,
May 30, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that it has appointed Dean
Schorno, CPA as Executive Vice President and Chief Financial
Officer (CFO). Formerly the CFO and Head of Operations at 23andMe,
Inc., Mr. Schorno brings to Rigel over fifteen years of experience
leading finance functions at innovative commercial-stage
biotechnology companies.
"Dean joins the Rigel management team at an important crossroad
as we transition to commercialization with the FDA approval and
recent launch of TAVALISSE™ (fostamatinib disodium
hexahydrate), an important new treatment option for adults with
chronic immune thrombocytopenia (ITP) who have had an insufficient
response to a previous treatment," said Raul Rodriguez, president and CEO of Rigel. "We
will rely on Dean's leadership to guide our corporate finance
function as well as related strategic and operational
implementations as we launch our new product. I'm very confident
that Dean will make important contributions to Rigel's success from
day one."
Mr. Schorno joins Rigel from 23andMe, Inc., the leading consumer
genetics and research company, where he has been CFO since 2015.
Before joining 23andMe, Mr. Schorno was CFO of Adaptive
Biotechnologies (Seattle, WA) and
Genomic Health (Redwood City, CA).
During this time, Mr. Schorno led financial operations through
periods of significant business and commercial growth which
included significant financing and commercial transaction activity.
Mr. Schorno began his career in finance at an international
accounting firm in San Francisco,
CA before starting his own consultancy in 1991. A certified
public accountant, Mr. Schorno is a graduate of the University of California, Berkeley (BS, Business
Administration) and Golden Gate
University (MS, Taxation).
"It's an exciting time to join Rigel and support its growth,"
said Mr. Schorno. "I look forward to working with Rigel's dynamic
leadership team and diving right into the day-to-day operations to
ensure the successful launch of TAVALISSE, while providing
oversight regarding the ongoing study of fostamatinib for other
rare diseases and the continued development of our other
proprietary molecules."
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).
Trademarks for TAVALISSE are owned by or licensed by Rigel.
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, Rigel's ability to transition to an
organization executing the launch of its first commercial
product. 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," "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, 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: Raul Rodriguez
Phone: 650.624.1302
Email: ir@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.