Spectrum Pharmaceuticals Has Ample Supplies of FUSILEV® to Meet the Growing Demand of Colorectal Cancer Patients in the U.S.
FUSILEV Was Approved by the FDA for Use In Colorectal Cancer On
April 29, 2011
Working Closely With the FDA, Spectrum Has Secured Multiple
Sources of Manufacturing FUSILEV
Spectrum Expects to Report Record Revenues for the Second
Quarter and Full Year 2011
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in oncology, announced today that during the second
quarter the Company has worked closely with the U.S. Food & Drug
Administration (FDA) on securing multiple sources of U.S. manufacturing
for the Company's anti-cancer drug, FUSILEV, approved on April 29, 2011
for use in the palliative treatment of patients with advanced metastatic
colorectal cancer. Spectrum believes it has secured ample FUSILEV
manufacturing capacity to meet the current and anticipated demand in
patients undergoing treatment for colorectal cancer.
According to the American Cancer Society, colorectal cancer is the third
most commonly diagnosed cancer and the third leading cause of cancer
death in both men and women in the U.S., with approximately 141,210 new
cases and 49,380 deaths expected in 2011.
"Colorectal cancer is without a doubt a terrible disease, with roughly
400 patients newly diagnosed every single day. As a result, we are
pleased to announce that beginning with the second quarter we have
secured ample supplies of FUSILEV and manufacturing capacity to meet
both current and anticipated demand for patients with colorectal
cancer," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive
Officer, and President of Spectrum Pharmaceuticals. "We would like to
thank the FDA for its efforts in quickly reviewing and approving FUSILEV
manufacturing sites. We are now able to meet the growing needs of the
tens of thousands of patients who depend upon FUSILEV's availability.
Having multiple U.S. suppliers also reduces the risk of supply
interruptions, so physicians who prefer to use FUSILEV in their
treatment regimens do not have to seek alternative treatment options."
FUSILEV is sold under various trade names in Europe and Japan by Pfizer,
Sanofi-Aventis, and Takeda Pharmaceuticals. Ex-U.S. sales are reported
to be in excess of $180 million annually, despite the availability of
alternate generic treatments that are sold by many suppliers.
"We expect record second quarter and full-year 2011 revenues," concluded
FUSILEV, a novel folate analog, is now approved as a ready-to-use
(FUSILEV Injection) solution in 175 mg and 250 mg vials, and as
freeze-dried powder (FUSILEV for Injection) in 50 mg vials. FUSILEV is
indicated for use in combination with 5-fluorouracil in the palliative
treatment of patients with advanced metastatic colorectal cancer.
FUSILEV is also indicated for rescue after high-dose methotrexate
therapy in osteosarcoma. FUSILEV is also indicated to diminish the
toxicity and counteract the effects of impaired methotrexate elimination
and of inadvertent overdosage of folic acid antagonists. FUSILEV, under
various trade names, is marketed outside the United States by Wyeth,
Sanofi-Aventis, and Takeda.
(levoleucovorin) Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic
reactions attributed to folic acid or folinic acid. Due to calcium
content, no more than 16-mL (160-mg) of levoleucovorin solution should
be injected intravenously per minute. FUSILEV enhances the cyto-toxicity
of fluorouracil. Concomitant use of d,l-leucovorin with
trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV
patients was associated with increased rates of treatment failure in a
placebo-controlled study. Allergic reactions were reported in patients
receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%)
were reported in patients receiving FUSILEV as rescue after high dose
methotrexate therapy. The most common adverse reactions (>50%) in
patients with advanced colorectal cancer receiving FUSILEV in
combination with 5-fluorouracil were diarrhea, nausea and stomatitis.
FUSILEV may counteract the antiepileptic effect of phenobarbital,
phenytoin and primidone, and increase the frequency of seizures in
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully
integrated commercial and drug development operations with a primary
focus in 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
research, 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 revenues, 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
Spectrum Pharmaceuticals, Inc.
Source: Spectrum Pharmaceuticals, Inc.
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