Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in oncology and hematology, announced today the launch of
the Company’s re-positioning campaign for ZEVALIN®
(ibritumomab tiuxetan) at the 2011 Annual Meeting of the American
Society of Hematology being held December 10-13.
"For many years, there has been a large disconnect between ZEVALIN’s
impressive safety and efficacy data and its awareness and utilization in
the non-Hodgkin lymphoma community. We hope to change that in the years
to come, in part with this initiative. Following recent approval by the
FDA to remove bioscan requirement, the goal of the re-positioning
campaign is to not only re-engage physicians with the new and simplified
ZEVALIN administration, but also expand our messaging to patients and
payers,” said Rajesh C. Shrotriya, MD., Chairman, Chief Executive
Officer and President of Spectrum Pharmaceuticals, Inc. "Patients today
are more empowered to take an active role in decisions regarding their
treatment options. Patients who received a single course of treatment
with ZEVALIN in the FIT Study experienced a median
time-to-next-treatment of more than eight years. So for patients, one
therapeutic dose of ZEVALIN represents freedom to enjoy life without
being burdened with continuous therapies, such as 16 doses of
rituximab-maintenance over two years while reducing costs to the
healthcare system.”
The repositioning campaign will continue to focus on the therapeutic
profile of ZEVALIN. ZEVALIN was initially approved in February 2002 for
the treatment of follicular NHL patients who had recurred or progressed
after other systemic therapies. In September 2009, ZEVALIN was approved
as part of the first-line setting based on results from a 414-patient
study (the "FIT” Study) that showed a 54% decreased risk of progression
with ZEVALIN. A 130-patient multicenter, randomized, open-label clinical
study comparing the efficacy of the ZEVALIN therapeutic regimen versus
rituximab in patients with relapsed or refractory low-grade or
follicular NHL showed that ZEVALIN therapeutic regimen produced an
overall response rate of 83% compared to 55% with rituximab.
To raise awareness about ZEVALIN among patients, physicians and payers,
the campaign will focus on key messages such as "It’s About Time,”
and "ZEVALIN Simplified.” In the past two years, Spectrum has
taken several initiatives to ensure that ZEVALIN’s benefits can be
experienced by more patients: receiving FDA approval for ZEVALIN in the
front-line setting; working with the Centers for Medicare and Medicaid
Services for reimbursement uniformity; collecting and presenting data at
key medical conferences; streamlining the distribution of ZEVALIN;
assembling a dedicated and highly trained oncology sales force; and
getting FDA approval on the removal of the bioscan requirement. ZEVALIN,
now without the bioscan requirement, will be re-introduced to physicians
as "RRZ" — rituximab, rituximab,
ZEVALIN
While the campaign will continue to focus on physicians, a new emphasis
will be placed on targeting patients and payers. The repositioning
campaign includes redesigned and rebranded websites, revamped sales
materials, patient-to-patient grassroots campaigns, e-mobile
initiatives, and online media and print advertising. In addition, a
greater emphasis will be placed on the pharmacoeconomic value of ZEVALIN
to the payers that highlights the physical and psychological burden of
additional and more expensive therapies after induction chemotherapy
such as a two-year course of rituximab-maintenance.
About Non-Hodgkin Lymphoma
According to the National Cancer Institute (www.cancer.gov),
there are expected to be 66,360 new cases of non-Hodgkin lymphoma
diagnosed and approximately 19,320 deaths in the United States in 2011.
Non-Hodgkin lymphoma is defined as any of a large group of cancers of
lymphocytes (white blood cells). Non-Hodgkin lymphomas 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 types of non-Hodgkin
lymphoma. These types can be divided into aggressive (fast-growing) and
indolent or low grade (slow-growing) types, and they can be formed from
either B-cells or T-cells. Prognosis and treatment depend on the stage
and type of disease.
About ZEVALIN® and the
ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is
indicated for the treatment of patients with previously untreated
follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or
complete response to first-line chemotherapy. ZEVALIN is also indicated
for the treatment of patients with relapsed or refractory, low-grade or
follicular B-cell non-Hodgkin's lymphoma.
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. The ZEVALIN
therapeutic regimen is a form of cancer therapy called
radioimmunotherapy. 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 can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully
integrated commercial and drug development operations with a primary
focus in hematology and oncology. The Company’s strategy is comprised of
acquiring, developing and commercializing a broad and diverse pipeline
of late-stage clinical and commercial products. The Company markets two
oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and
belinostat, in late stage development along with a diversified pipeline
of novel drug candidates. The Company has assembled an integrated
in-house scientific team, including clinical development, medical and
regulatory affairs, biostatistics and data management, formulation
development, and has established a commercial infrastructure for the
marketing of its drug products. 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.
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 drug
candidates may not receive approval from the FDA, and other regulatory
agencies 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. ®, ZEVALIN®, and FUSILEV® are
registered trademarks of Spectrum Pharmaceuticals, Inc.
REDEFINING
CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned
by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights
Reserved.
