SOUTH SAN FRANCISCO, Calif.,
April 27, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that the U.S. Food and Drug Administration (FDA) has
conditionally accepted the proprietary name Tavalisse™ for the
company's investigational product candidate, fostamatinib disodium,
an oral spleen tyrosine kinase (SYK) inhibitor. In addition, Rigel
has applied to the U.S. Patent and Trademark Office to obtain
federal registration of the Tavalisse mark.
The name Tavalisse (pronounced - ta vah lees') was developed
based on the FDA's Guidance for Industry, Contents of a Complete
Submission for the Evaluation of Proprietary Names. Created
with the help of experts in this field, the proprietary name
development included input from prescribers, pharmacists, linguists
and employees to create a unique and approachable name.
Earlier this month, the company announced that it submitted a
New Drug Application (NDA) to the FDA for Tavalisse in patients
with chronic and persistent immune thrombocytopenia (ITP).
The FDA previously granted Orphan Drug designation to
Tavalisse for the treatment of patients with ITP.
The NDA is supported by data from the Phase 3 clinical program
for Tavalisse in ITP, which was comprised of three studies, two
randomized placebo-controlled studies (Studies 047 and 048) and an
open-label extension study (Study 049). In total, 163 ITP patients
have been treated with Tavalisse and included in the NDA
submission. Across all indications, Tavalisse has been
evaluated in over 4,600 subjects.
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, a
portion of patients do not derive a benefit from existing
therapies. As a result, there remains a significant medical need
for additional treatment options for patients with ITP.
About Tavalisse
Tavalisse is an oral investigational
drug candidate with a unique mechanism of action designed to
inhibit SYK kinase, a key player in the immune process that
leads to platelet destruction in ITP. Unlike other therapies
that modulate the immune system in different ways or stimulate
platelet production, Tavalisse may address the underlying
autoimmune cause of ITP by impeding platelet destruction.
About Rigel (www.rigel.com)
Rigel
Pharmaceuticals, Inc. is a clinical-stage biotechnology
company dedicated to the discovery and development of novel,
targeted drugs in the therapeutic areas of immunology, oncology and
immuno-oncology. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. The company's
current clinical programs include clinical studies of Tavalisse, an
oral spleen tyrosine kinase (SYK) inhibitor, in a number of
indications. The company submitted a NDA to the FDA for Tavalisse
in patients with chronic and persistent immune thrombocytopenia
(ITP) in April 2017. Rigel is also
conducting Phase 2 clinical studies with Tavalisse in autoimmune
hemolytic anemia (AIHA) and IgA nephropathy (IgAN). In addition,
Rigel has two oncology product candidates in development with
partners BerGenBio AS and Daiichi Sankyo.
Forward Looking Statements
This release contains
forward-looking statements. 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," "potential," 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 not accept the NDA;
the FDA may interpret Rigel's findings differently, which could
result in the FDA not approving any submitted NDA; risks
related to changes in estimated cash position based on the
completion of financial closing procedures and the audit of Rigel's
financial statements; 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, 2016. 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.