SOUTH SAN FRANCISCO, Calif.,
Nov. 15, 2021 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced plans to exit early-stage research and focus resources on
its mid to late-stage development programs and its commercial
efforts. The strategy will strengthen Rigel's ability to build
value for shareholders by executing on the company's near-term
value drivers: growing ITP sales, expanding the addressable market
for TAVALISSE® (fostamatinib) with warm autoimmune
hemolytic anemia (wAIHA) and COVID-19, advancing its wholly-owned
IRAK1/4 program in hematology and immunology, and exploring other
opportunities that will complement Rigel's
hematology/oncology-focused commercial offerings.
"I want to thank the Rigel research team who discovered the
pipeline of novel molecules, which includes TAVALISSE, the first
and only SYK inhibitor approved for ITP and now in Phase 3
development for patients suffering from warm autoimmune hemolytic
anemia and COVID-19, as well as molecules targeting IRAK1/4 and
RIP1 for heme-onc and immune diseases," said Raul Rodriguez, president and chief executive
officer of Rigel. "We look forward to advancing these programs
through the clinic and delivering these medicines to patients and
the physicians who treat them."
Rigel will reduce its workforce by 16%, resulting in the
elimination of 31 positions, primarily in the research
organization. As a result of the workforce reduction, Rigel expects
that it will recognize in the fourth quarter of 2021 a one-time
severance-related charge, which will consist of cash severance and
non-cash expense related to option modifications. Rigel estimates
that the cash-related charge will be approximately $3.3 million. Rigel also plans to modify
certain equity grants to the affected employees, the cost of which
is still being determined. This measure is expected to provide
reduced operating expenses ranging from $11-$15 million
annually starting in 2022, inclusive of potential future facility
cost savings.
Rigel plans to reallocate savings from these measures to advance
clinical development of its mid to late-stage pipeline programs,
and to drive commercial execution, setting the company up for a
transformative year in 2022.
About Rigel
Rigel Pharmaceuticals, Inc., is a
biotechnology company dedicated to developing and commercializing
novel small molecule drugs that significantly improve the
lives of patients with hematologic disorders, cancer and rare
immune 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 is also commercially available in
Europe, the United Kingdom (TAVLESSE) and Canada (TAVALISSE) for the treatment of
chronic immune thrombocytopenia in adult patients.
Fostamatinib is currently being studied in a Phase 3 clinical
trial (NCT03764618) for the treatment of warm autoimmune hemolytic
anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703)
for the treatment of hospitalized high-risk patients with
COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial
(ACTIV-4 Host Tissue Trial, NCT04924660) for the treatment of
COVID-19 in hospitalized patients, and a Phase 2 clinical trial
(NCT04581954) for the treatment of COVID-19 being conducted by
Imperial College London.
Rigel's other clinical programs include its interleukin
receptor-associated kinase (IRAK) inhibitor program, and a
receptor-interacting serine/threonine-protein kinase (RIP1)
inhibitor program in clinical development with partner Eli Lilly
and Company. In addition, Rigel has product candidates in
development with partners AstraZeneca, BerGenBio ASA, and Daiichi
Sankyo.
For further information, visit www.rigel.com or follow us
on Twitter or LinkedIn.
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, expected cost savings associated with Rigel's
reduction in force and refocus of resources, and the timing of any
such savings, Rigel's commercial plan and execution, and Rigel's
clinical development plans. 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 "potential", "may",
"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 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 quarter ended September 30, 2021 and subsequent filings. 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, except as required by law.
Investor and Media Contact:
Jodi Sievers
Rigel Pharmaceuticals, Inc.
Phone: 650.624.1232
Email: ir@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.