Spectrum Pharmaceuticals, Inc.:
Conference Call:
Monday, March 10, 2008 @ 4:30pm Eastern/1:30pm Pacific
Domestic:
866-510-0710
International:
617-597-5378
Passcode:
52089784
Webcast and replays:
www.spectrumpharm.com
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it
has received marketing approval from the U.S. Food and Drug
Administration (FDA) for Levoleucovorin for Injection. It 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). The Company currently
expects its commercial launch by June 2008.
LEVOleucovorin was reviewed under a full NDA, and included an Oncologic
Drug Advisory Committee (ODAC) review. Spectrum anticipates that the
drug will be listed without any therapeutically equivalent product in
the FDA Orange Book. Drugs without therapeutic equivalents are
considered 'single source drugs' which under section 1847A of the Social
Security Act generally qualify for a separate reimbursement code with
CMS.
"LEVOleucovorin is the first new oncology drug
approved by the FDA in 2008, and is the first of what we hope will be
many approvals from our pipeline,” said Rajesh
C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals. "Only four of the 17
drugs approved by the FDA in 2007 were new oncology drugs. This approval
is the result of dedicated efforts by our experienced team and serves as
a validation of our business model. We are focused on building a
diversified portfolio of promising late stage drugs, and advancing them
through clinical development, regulatory process and commercialization.”
In preparation for the commercial launch, last year the Company
appointed George Uy, an experienced oncology marketing veteran, as its
Vice President of Sales and Marketing. George brings more than 20 years
of hands on experience, including the launches of ABRAXANE®
at Abraxis Bioscience, Inc., and XELODA®
at Hoffmann-La Roche Inc. In addition, the Company recently appointed
Lynne Murphy as Executive Director of Sales. Ms. Murphy has more than 20
years of sales and marketing experience, which include many sales
leadership positions with responsibility for the launch of more than 10
products during her tenure at Bayer Healthcare. Ms. Murphy also led a
specialty sales force for Amgen, Inc., and launched Aranesp®
Singleject. Ms. Murphy will be responsible for building and assembling a
launch team of experienced oncology sales specialists.
"LEVOleucovorin provides physicians and
patients with an important treatment alternative to leucovorin,”
said Richard A. Bender, M.D., F.A.C.P., Chief Medical Officer of
Spectrum Pharmaceuticals. "With this drug,
patients undergoing cytotoxic chemotherapy are spared the administration
of the pharmacologically inactive dextro-isomer. Preclinical studies
have shown that the dextro-isomer may compete with the active
levo-isomer for transport into cells.”
The Company plans to file for a supplemental New Drug Application with
the FDA for use in colorectal cancer in 5-fluorouracil containing
regimens and an NDA amendment for an oral tablet formulation by mid-year
2008.
Levoleucovorin for Injection is currently listed as a replacement for
calcium leucovorin in the NCCN Clinical Practice Guidelines in Oncology.
The NCCN Drugs and Biologics Compendium is an important reference that
has been recognized by United HealthCare as a formal guidance for
approval of coverage policy. Visit www.nccn.org
for more information.
Conference Call
Spectrum Pharmaceuticals will host a conference call to discuss the
approval of Levoleucovorin for Injection and Tentative launch plans on:
Monday, March 10, 2008 @ 4:30pm
Eastern/1:30pm Pacific
Domestic:
866-510-0710
passcode 52089784
International:
617-597-5378
passcode 52089784
Webcast and replays: www.spectrumpharm.com.
Audio replays will be available through March 17, 2008.
Domestic:
888-286-8010, passcode 61786785
International:
617-801-6888, passcode 61786785
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
Spectrum Pharmaceuticals is focused on building a diversified portfolio
of promising late stage drugs, and advancing them through clinical
development, regulatory process and commercialization. The company's
pipeline includes promising early and late-stage drug candidates with
unique formulations and mechanisms of action that address the needs of
seriously ill patients. 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 the Company currently expects the LEVOleucovorin
commercial launch by June 2008, Spectrum anticipates that the drug will
be listed without any therapeutically equivalent product in the FDA
Orange Book, that there could be many approvals from our pipeline, that
the Company plans to file for LEVOleucovorin a supplemental New Drug
Application with the FDA for use in colorectal cancer in 5-fluorouracil
containing regimens and an NDA amendment for an oral tablet formulation
by mid-year 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. ISO-VORIN™, 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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