Spectrum Pharmaceuticals Announces the USPTO Has Granted Five-Year Extension for FOLOTYN® Patent
FOLOTYN® (pralatrexate injection) is the
first therapeutic to have been approved for peripheral T-cell lymphoma
(PTCL), in September 2009
FOLOTYN net sales were approximately $50 million in 2011
Spectrum acquired FOLOTYN through acquisition of Allos Therapeutics
on September 5, 2012
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced that the
United States Patent and Trademark Office (USPTO) has extended by five
years the U.S. Patent No. 6,028,071, which covers FOLOTYN®
(pralatrexate injection). The extension was granted through the
Hatch-Waxman Act and postpones the original July 16, 2017 expiration
date to July 16, 2022.
"The extension of the FOLOTYN patent provides Spectrum with an
additional five years of exclusive commercial rights to the product. We
believe the drug is an important treatment option in relapsed or
refractory PTCL and look forward to reaching a greater physician and
patient base in the upcoming year," stated Rajesh C. Shrotriya, M.D.,
Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. "In addition, the patent extension confirms
substantial expected revenue growth for the Company in the near- and
FOLOTYN, a folate analogue metabolic inhibitor, was discovered by
Memorial Sloan-Kettering Cancer Center, SRI International and Southern
Research Institute and developed by Allos Therapeutics. In September
2009, the U.S. Food and Drug Administration (FDA) granted accelerated
approval for FOLOTYN for use as a single agent for the treatment of
patients with relapsed or refractory PTCL. This indication is based on
overall response rate. Clinical benefit such as improvement in
progression-free survival or overall survival has not been demonstrated.
FOLOTYN has been available to patients in the U.S. since October 2009.
An updated analysis of data from PROPEL, the pivotal study of FOLOTYN in
patients with relapsed or refractory PTCL, was published in the March
20, 2011 issue of the Journal of Clinical Oncology. FOLOTYN has patent
protection through July 2022. Please see full Prescribing Information
for FOLOTYN at www.FOLOTYN.com.
Important FOLOTYN® Safety Information
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit
or modify dose for hematologic toxicities.
Mucositis may occur. If greater-than or equal to Grade 2 mucositis is
observed, omit or modify dose. Patients should be instructed to take
folic acid and receive vitamin B12 to potentially reduce
treatment-related hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions may be
progressive and increase in severity with further treatment. Patients
with dermatologic reactions should be monitored closely, and if severe,
FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may
occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while
being treated with FOLOTYN and pregnant women should be informed of the
potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients
with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are greater-than or
equal to Grade 3, omit or modify dose.
The most common adverse reactions were mucositis (70%), thrombocytopenia
(41%), nausea (40%), and fatigue (36%). The most common serious adverse
events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration,
dyspnea, and thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the drug,
taking into consideration the importance of the drug to the mother.
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
Please see FOLOTYN® Full Prescribing Information at www.FOLOTYN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in oncology and hematology. Spectrum and its affiliates market
three oncology drugs ─ FUSILEV® (levoleucovorin) for
Injection in the U.S.; FOLOTYN® (pralatrexate injection),
also marketed in the U.S.; and ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights. Spectrum's strong track record in
in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available 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 and other regulatory agencies may not receive approval 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.®, FUSILEV®,
FOLOTYN® and ZEVALIN®,
are registered trademarks of Spectrum Pharmaceuticals, Inc and
its affiliates. REDEFINING CANCER CARE™ and the Spectrum
Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals,
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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