05.06.2008 11:00:00
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New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) today announced that it
has completed its filing with the U.S. Food and Drug Administration
(FDA) with the filing of an amendment to the New Drug Application (NDA)
for Levoleucovorin Tablets. Levoleucovorin for Injection is indicated
after high-dose methotrexate therapy in patients with osteosarcoma, and
to diminish the toxicity and counteract the effects of impaired
methotrexate elimination or inadvertent overdose of folic acid
antagonists. LEVOleucovorin is a novel folate analog formulation and the
pharmacologically active isomer of calcium leucovorin. Levoleucovorin
for Injection is the only commercially available formulation comprised
only of the pharmacologically active enantiomer of leucovorin
(Levoleucovorin or (6S)-leucovorin).
The Oncology Drug Advisory Committee (ODAC) has already voted
affirmatively that the oral formulation is safe and effective when used
in the rescue of high dose methotrexate.
"Levoleucovorin Tablets is the natural product line expansion for our
recently FDA approved Levoleucovorin for Injection," said Rajesh C.
Shrotriya, M.D., Chairman, President, and Chief Executive Officer of
Spectrum Pharmaceuticals. "If approved, the tablets will provide
physicians with a new, more convenient treatment option. Furthermore, we
continue to work on filing the supplemental NDA with the FDA for
Levoleucovorin for Injection’s use in
colorectal cancer with 5-fluorouracil containing regimens."
The FDA approved the NDA for Levoleucovorin for Injection on March 7,
2008. The amendment to the NDA filed provides manufacturing information
and six months stability data on commercial batches, required by the FDA
to complete its review of Levoleucovorin Tablets.
About Levoleucovorin for Injection
LEVOleucovorin is a novel folate analog formulation and the
pharmacologically active isomer of calcium leucovorin. LEVOleucovorin is
indicated after high-dose methotrexate therapy in patients with
osteosarcoma, and to diminish the toxicity and counteract the effects of
impaired methotrexate elimination or inadvertent overdose of folic acid
antagonists. LEVOleucovorin is the only commercially available
formulation comprised only of the pharmacologically active enantiomer of
leucovorin (levoleucovorin or (6S)-leucovorin). Upon market launch,
LEVOleucovorin will be supplied in 50mg vials of freeze-dried powder.
Ex-U.S. sales of LEVOleucovorin by Wyeth, Sanofi-Aventis, and others,
are approximately $200 million annually.
Important Levoleucovorin for Injection™
Safety Considerations
LEVOleucovorin is contraindicated for patients who have had previous
allergic reactions attributed to folic acid or folinic acid. Due to
calcium content, no more than 16mL (160mg) of Levoleucovorin for
Injection solution should be injected intravenously per minute.
Levoleucovorin for Injection 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
placebo-controlled study. Allergic reactions were reported in patients
receiving Levoleucovorin for Injection. Vomiting (38%), stomatitis (38%)
and nausea (19%) were reported in patients receiving Levoleucovorin for
Injection as rescue after high dose methotrexate therapy. Levoleucovorin
for Injection may counteract the antiepileptic effect of phenobarbital,
phenytoin and primidone, and increase the frequency of seizures in
susceptible patients.
About Spectrum Pharmaceuticals
We are a biopharmaceutical company that acquires, develops and
commercializes a diversified portfolio of drug products, with a focus
mainly on oncology and urology. Our strategy is comprised of acquiring
and developing a broad and diverse pipeline of late-stage clinical and
commercial products; establishing a commercial organization for our
approved drugs; continuing to build a team with people who have
demonstrated skills, passion, commitment and have a track record of
success in developing drugs and commercialization in our areas of focus,
and; leveraging the expertise of partners around the world to assist us
in the execution of our strategy. For more information, please visit our
website at www.spectrumpharm.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 include but are not limited to statements
that relate to our business and its future, Spectrum's ability to
identify, acquire, develop and commercialize its portfolio of drug
candidates, that if approved, the tablets will provide physicians with a
new, more convenient treatment option, that we plan to launch
Levoleucovorin for Injection in the third quarter 2008, the safety and
efficacy of LEVOleucovorin, the Company's promising pipeline, 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. Levoleucovorin for Injection™, SPECTRUM
PHARMACEUTICALS, INC.™, TURNING INSIGHTS INTO
HOPE™ and the Spectrum Pharmaceutical logos
are trademarks owned by Spectrum Pharmaceuticals, Inc. All other
trademarks and trade names are the property of their respective owners. © 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
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