Spectrum Pharmaceuticals Divests Rights to ZEVALIN® (ibritumomab tiuxetan) in Japan & Select Other Ex-US Countries to Mundip...
November 18 2015 - 3:00AM
Business Wire
- Spectrum to receive an up-front
payment of $15 million plus $5 million in profits on initial
ZEVALIN supply
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced today the divestment of ZEVALIN rights in Japan and other
countries in Asia Pacific (excluding China and India), Middle East,
Africa and Latin America, to Mundipharma. Spectrum will receive an
up-front payment of $15 million plus $5 million in profits on
initial ZEVALIN supply. Spectrum will continue to own ZEVALIN
rights for US, Canada, and Europe.
“This divestiture is consistent with Spectrum’s strategy of
focusing on our strong late state pipeline and increasing our
operational effectiveness,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “While providing non-dilutive cash, this deal lets
us concentrate our efforts on developing drugs like SPI-2012 and
poziotinib that have the potential to compete in blockbuster
markets. This deal also helps us lower our cost of operations
related to territories that are not strategic for Spectrum’s
growth. Mundipharma will be able to take over Spectrum’s operations
in Japan, and with reinvigorated efforts be able to better serve
non-Hodgkin lymphoma patients in select ex-US countries.”
About ZEVALIN® and the ZEVALIN Therapeutic
Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is
indicated for the treatment of patients with relapsed or
refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma
(NHL). ZEVALIN is also indicated for the treatment of patients with
previously untreated follicular non-Hodgkin's Lymphoma who achieve
a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The
ZEVALIN therapeutic regimen consists of two components: rituximab,
and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN
builds on the combined effect of a targeted biologic monoclonal
antibody augmented with the therapeutic effects of a beta-emitting
radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an
essential component of the ZEVALIN therapeutic regimen. These
fatalities were associated with hypoxia, pulmonary infiltrates,
acute respiratory distress syndrome, myocardial infarction,
ventricular fibrillation, or cardiogenic shock. Most (80%)
fatalities occurred with the first rituximab infusion. ZEVALIN
administration can result in severe and prolonged cytopenias in
most patients. Severe cutaneous and mucocutaneous reactions, some
fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED
WARNINGS, for ZEVALIN and rituximab. Full prescribing information
for ZEVALIN can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Oncology and Hematology. Spectrum
and its affiliates market five oncology drugs─ FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has
worldwide marketing rights, and BELEODAQ® (belinostat) for
Injection in the U.S. Additionally, Spectrum's pipeline includes
two drugs targeting blockbuster markets in advanced stages of
clinical development. Spectrum's strong track record in-licensing
and acquiring differentiated drugs, and expertise and proven track
record in clinical development have generated a robust,
diversified, and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on
Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including
certain company milestones, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that
our efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of sustained revenue history, our
limited marketing experience, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™, and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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