Spectrum Pharmaceuticals to Acquire Worldwide Rights to Market ZEVALIN®
Spectrum's Commercial Footprint Expands Beyond the U.S.;
Irrevocable License From Bayer Healthcare Leverages Spectrum's
Existing Clinical, Regulatory and Marketing Investments;
Spectrum Will Continue To Advance ZEVALIN's Clinical Development
Program And Will Now Be Better Positioned To Grow ZEVALIN Sales
Globally In The Long-Term.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS:SPPI) announced that it has entered
into an agreement to acquire licensing rights to market ZEVALIN
(ibritumomab tiuxetan) injection for intravenous use outside of the
United States of America from Bayer Healthcare. ZEVALIN is currently
approved in more than 40 countries outside the U.S. for the treatment of
follicular B-cell non-Hodgkin's lymphoma, including countries in Europe,
Latin America and Asia. Under the agreement, Spectrum will have all
rights related to marketing, sales, and patents, and access to existing
inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of
company resources and partnerships to support the product outside the
"We are excited to expand our commercial footprint globally with an
approved, state-of-the-art drug that we know very well," said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and
the impressive and broadening clinical outcome data from ZEVALIN, as
presented at major international scientific conferences over the past
two years, has increased our confidence in the long-term potential of
ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we
will be able to further leverage our existing clinical, regulatory and
marketing investments. Working closely with European investigators who
have spearheaded exciting new data with ZEVALIN in recent years,
Spectrum will continue to advance its clinical development program and
will now be better positioned to grow ZEVALIN sales globally in the
long-term. Our access to the worldwide market will help patients with
follicular lymphoma who can benefit from ZEVALIN."
"The global market for ZEVALIN is several times larger than the US, with
more than 350,000 cases of non-Hodgkin's lymphoma diagnosed every year.
Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully
reversed the declining sales trajectory and nearly tripled 2008 sales.
We hope to achieve similar milestones outside the U.S. with our focused
sales and marketing efforts. This licensing transaction demonstrates our
commitment to being focused on our strategy of bringing novel cancer
treatments to patients while at the same time delivering value to our
shareholders," concluded Dr. Shrotriya.
The closing of the agreement is subject to customary closing conditions.
The Merchant Banking Group of Burrill & Company acted as advisor to
Spectrum Pharmaceuticals in this transaction.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus
in oncology and hematology, currently markets two oncology drugs, FUSILEV®
and ZEVALIN®. In addition, Spectrum has two drugs, apaziquone
and belinostat, in late stage development with a goal of filing New Drug
Applications (NDAs) with the U.S. Food & Drug Administration in 2012.
The Company also has a diversified pipeline of novel drug candidates.
The Company's strategy is comprised of acquiring, developing and
commercializing a broad and diverse pipeline of late-stage clinical and
commercial drug products. The Company has aggressive business
development and commercial operation teams that support a robust drug
development program encompassing clinical development, medical research,
regulatory affairs, biostatistics and data management. The Company also
leverages the expertise of its worldwide partners to assist in the
execution of its strategy. For more information, please visit the
Company's website at www.sppirx.com.
Important ZEVALIN® Safety
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
Please see full Prescribing Information, including Boxed WARNINGS, for
ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma is defined as any of a large group of cancers of
lymphocytes (a type of white blood cell). Non-Hodgkin's lymphoma can
occur at any age and are often marked by lymph nodes that are larger
than normal, fever, and weight loss. There are many different categories
of non-Hodgkin's lymphoma. These categories can be divided into
aggressive (fast-growing) and indolent or low grade (slow-growing), and
they can be formed from either B-cells or T-cells. Prognosis and
treatment depend on the stage and type of disease.
According to GLOBOCON 2008 estimates, there were approximately 355,900
new cases of non-Hodgkin's lymphoma diagnosed and approximately 191,400
deaths globally in 2008. Over 3.5 million people worldwide are alive
with a diagnosis of NHL, at various stages of disease progression and
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 the closing of the transaction with Bayer
Healthcare, 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 may not receive approval, and other regulatory
agencies in a timely manner or at all, the possibility that the
transaction with Bayer Healthcare may not timely close, if at all, 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.®, ZEVALIN®,
and FUSILEV® are registered trademarks of
Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
© 2012 Spectrum Pharmaceuticals, Inc. All Rights
Vice President, Strategic
Planning & Investor Relations
Senior Manager, Investor Relations
Source: Spectrum Pharmaceuticals
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