SOUTH SAN FRANCISCO, Calif. and
PETACH TIKVA, Israel, Nov. 23, 2020 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) and Medison Pharma (Medison)
today announced that Health Canada has approved the new drug
submission (NDS) for TAVALISSE® (fostamatinib disodium
hexahydrate) for the treatment of thrombocytopenia in adult
patients with chronic immune thrombocytopenia (ITP) who have had an
insufficient response to other treatments.
"This approval of TAVALISSE provides ITP patients and physicians
in Canada with a new oral
treatment option, the only therapy to address the underlying
platelet destruction that causes ITP," said Raul Rodriguez, Rigel's president and CEO. "With
Medison as our collaborative partner, we believe TAVALISSE is well
positioned for commercial success in the Canadian market."
In October 2019, Rigel entered
into exclusive license agreements with Medison to
commercialize TAVALISSE in Canada
and Israel. With the approval from
Health Canada, Medison intends to launch TAVALISSE in Canada in Q1 2021. In Israel, a decision on the new drug application
(NDA) is anticipated during Q2 2021.
"Our multiregional partnership with Rigel to deliver TAVALISSE
in Canada and Israel is a testament to our ongoing efforts
to extend the reach of highly innovative therapies to patients
across international markets," said Meir Jakobsohn, founder and CEO
of Medison Pharma.
"Given our specialization in delivering cutting-edge
therapeutics, TAVALISSE is a natural fit for Medison's expertise
and will enable us to bring a much-needed treatment option to
Canadian ITP patients," said Joe
O'Neill, GM of Medison Canada.
Fostamatinib is commercially available in the U.S. under the
brand name TAVALISSE® (fostamatinib disodium
hexahydrate) tablets, which is the first and only spleen tyrosine
kinase (SYK) inhibitor indicated for the treatment of
thrombocytopenia in adult patients with chronic ITP who have had an
insufficient response to a previous treatment.
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 include fatigue,
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. In addition
to fostamatinib, 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 Medison Pharma
Medison is one of the world's
largest commercial partners of leading global biotech companies.
Medison is uniquely qualified to provide the complete spectrum of
integrated services for international companies looking to enter or
expand their presence in international markets, focusing on
Canada, Israel, and Central Eastern Europe. Medison
runs a corporate venture arm with a dedicated research and
evaluation team boasting deep scientific and commercial
backgrounds. Medison also operates a scouting program to cater its
partners and is an active investor in life science projects around
drug development and digital health. For more information,
visit www.medison.co.il and follow Medison on LinkedIn.
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) tablets,
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. The
product has been approved by the European Commission for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments and is marketed in Europe under the name TAVLESSE®
(fostamatinib).
Fostamatinib1 is currently being studied in a Phase 3
trial for the treatment of warm autoimmune hemolytic anemia (AIHA);
an NIH/NHLBI-Sponsored Phase 2 trial for the treatment of
hospitalized COVID-19 patients, in collaboration with Inova Health
System; and a Phase 2 trial for the treatment of COVID-19 being
conducted by Imperial College London. Additionally, Rigel plans to
launch a Phase 3 clinical trial of fostamatinib for the treatment
of hospitalized COVID-19 patients in the fourth quarter of
2020.
Rigel's other clinical programs include an ongoing 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 AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
Please see www.TAVALISSE.com for the full Prescribing
Information.
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 potential future commercial success of TAVALISSE in the
Canadian market, Rigel's ability to receive further
payments under the Medison agreement, the timing of a launch of
TAVALISSE in Canada, the timing
for a decision on the NDA in Israel, and the expansion of the global
opportunity for TAVALISSE through more marketing authorizations and
launches. 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 "plans," "may,"
"anticipates," "believe," "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 fostamatinib in the
U.S. and Europe; risks that the
FDA, European Medicines Agency (EMA) or other regulatory
authorities may make adverse decisions regarding fostamatinib or
any of Rigel's product candidates; risks that clinical trials may
not be predictive of real-world results or of results in subsequent
clinical trials; the availability of resources to develop and, if
approved, commercialize fostamatinib or any other of Rigel's
product candidates; the progress of our and our collaborators'
product development programs, including clinical testing, and the
timing of results thereof; our expectations with respect to
regulatory submissions and approvals; our research and development
expenses; protection of our intellectual property; 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 quarter ended
September 30, 2020. In
addition, the ongoing COVID-19 pandemic may result in further
delays in Rigel's studies and trials, or impact Rigel's sales and
ability to obtain supply of fostamatinib. 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.
Medison Contact
Maya Nix
Corporate Communications Lead
Phone: +972.3.925.0260
Email: mayan@medison.co.il
Rigel IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.; Medison Pharma