Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, affirmed today that the U.S.
Food & Drug Administration (FDA) has granted FUSILEV®
(levoleucovorin) "Orphan Drug” exclusivity for use in combination
chemotherapy with 5-fluorouracil in the palliative treatment of patients
with advanced metastatic colorectal cancer. In addition, FUSILEV
therapeutic compositions are protected under a US Patent which expires
at the end of December 2019. This is a composition of matter patent
claiming a therapeutically effective amount of purified levoleucovorin.
The Company has already filed a patent extension application.
"We are aware that a company has filed an Abbreviated New Drug
Application for the generic version of FUSILEV,” said Rajesh C.
Shrotriya, MD., Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. "While we recognize that such filings are not
unusual given that FUSILEV has reached significant revenue milestones,
we are confident that our exclusivity position is strong. Our Orphan
Drug exclusivity protects FUSILEV from generic levoleucovorin
competition for the next seven years. In addition, we believe our
intellectual property protecting FUSILEV is strong and we plan to
vigorously defend it to the full extent of the law.”
About FUSILEV®
(levoleucovorin)
FUSILEV, a novel folate analog, is 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 chemotherapy 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.
Important FUSILEV®
(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 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
susceptible patients.
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 and hematology. 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
applications to the FDA may not receive approval, 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.
