SOUTH SAN FRANCISCO, Calif.,
Jan. 23, 2019 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)
today announced that it has entered into an exclusive license
and supply agreement with Spain-based Grifols, S.A (MCE: GRF, MCE:
GRF.P, NASDAQ: GRFS) to commercialize fostamatinib disodium
hexahydrate in all potential indications in Europe and Turkey. Grifols is a global healthcare company
and a leading producer of plasma-derived medicines for the
treatment of rare and chronic diseases, including intravenous
immunoglobulin (IVIG) which is used in the treatment of ITP and
AIHA. Fostamatinib is commercially available in the U.S. under the
brand name TAVALISSE® (fostamatinib disodium
hexahydrate) and is the first and only SYK inhibitor indicated for
the treatment of thrombocytopenia in adult patients with chronic
immune thrombocytopenia who have had an insufficient response to a
previous treatment.
"Grifols has a broad presence in Europe and an established position in the
hematology commercial landscape, which supports our goal of
bringing fostamatinib to patients in these countries," said
Raul Rodriguez, President and CEO of
Rigel. "Our marketing authorization application for fostamatinib in
chronic ITP is currently under review by the European Medicines
Agency, and we anticipate a decision by the end of 2019. This
provides a potential opportunity for fostamatinib to begin
generating revenue in the European market in 2020."
Under terms of the agreement, Rigel will receive a $30 million upfront cash payment, with the
potential for $297.5 million in
payments related to regulatory and commercial milestones, which
includes a $20 million payment for
EMA approval of fostamatinib for the treatment of chronic ITP.
Rigel will receive significant stepped double-digit royalty
payments based on tiered net sales which may reach 30% of net
sales. In return, Grifols receives exclusive rights to fostamatinib
in human diseases, including chronic ITP, autoimmune hemolytic
anemia (AIHA), and IgA nephropathy (IgAN), in Europe and Turkey. In the event that, in 2021, after the
second anniversary of the agreement, fostamatinib has not been
approved by the EMA for the treatment of ITP in Europe, Grifols will have the option during a
six-month time-frame to terminate the entire agreement which would
terminate all their rights to ITP, AIHA, and all other
indications. In this limited circumstance, Rigel will pay
Grifols $25 million and regain all
rights to fostamatinib in Europe
and other territories. Rigel retains the remaining global
rights to fostamatinib outside the Grifols territories and those
rights previously granted to Kissei Pharmaceuticals (in
Japan, China, Taiwan
and the Republic of Korea).
"Given our global leadership position as a manufacturer of
plasma medicines and our in-depth knowledge and expertise in blood
disorders, adding fostamatinib to our portfolio is a natural fit
for Grifols," said Joel Abelson,
President, Bioscience Commercial Division of Grifols. "Its
potential in multiple indications, including ITP, may provide
significant benefit for patients and is a valuable addition to our
portfolio."
On October 4, 2018, the EMA
validated the marketing authorization application for
fostamatinib in adult chronic ITP, which was submitted by Rigel.
The company anticipates a decision from the EMA's Committee on
Human Medicinal Products by the fourth quarter of 2019 and
potential European approval by the end of 2019.
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 respond to existing
therapies. As a result, there remains a significant medical need
for additional treatment options for patients with ITP.
About
TAVALISSE
Indication
TAVALISSE® (fostamatinib
disodium hexahydrate) tablets is indicated in the US 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 the FIT-1 and FIT-2 phase 3 clinical trials 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 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), 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 an
upcoming Phase 3 study of fostamatinib in autoimmune hemolytic
anemia 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 AS, Daiichi Sankyo, and Aclaris
Therapeutics.
About Grifols
Grifols is a global healthcare company
with more than 75 years of legacy dedicated to improving the health
and well-being of people around the world. Grifols produces
essential plasma-derived medicines for patients, and provides
hospitals and healthcare professionals with the tools, information
and services they need to help them deliver expert medical
care.
Grifols' three main divisions – Bioscience, Diagnostic and
Hospital – develop, produce and market innovative products and
services that are available in more than 100 countries.
With a network of 250 plasma donation centers, Grifols is a
leading producer of plasma-derived medicines used to treat rare,
chronic and, at times, life-threatening conditions. As a recognized
leader in transfusion medicine, Grifols offers a comprehensive
portfolio of diagnostic products designed to support safety from
donation through transfusion. The Hospital Division provides
intravenous (IV) therapies, clinical nutrition products and
hospital pharmacy systems, including systems that automate drug
compounding and control drug inventory.
Grifols is headquartered in Barcelona,
Spain, and has 20,000 employees in 30 countries. In 2017,
sales exceeded 4,300 million euros.
Grifols demonstrates its strong commitment to advancing healthcare
by allocating a significant portion of its annual income to
research, development and innovation.
The company's class A shares are listed on the Spanish Stock
Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols
non-voting class B shares are listed on the Mercado Continuo
(MCE:GRF.P) and on the US NASDAQ via ADRs (NASDAQ:GRFS).
For more information, visit www.grifols.com
Forward Looking Statements
This release
contains forward-looking statements relating to, among other
things, Rigel's partnership with Grifols; Rigel's partnership with
Kissei; Rigel's ability to achieve regulatory and commercial
milestone payments under its agreement with Grifols; the potential
opportunity for fostamatinib to begin generating revenue in the
European market in 2020; Rigel's interactions with the EMA; and
the timing of the EMA's MAA review process and when Rigel
expects a decision. 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
Quarterly Report on Form 10-Q for the period ended September
30, 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
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SOURCE Rigel Pharmaceuticals, Inc.