FDA grants Priority Review Designation
FDA decision date based on PDUFA set for August 9, 2014
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations and a
primary focus in Hematology and Oncology, announced today that its New
Drug Application (NDA) for Beleodaq, a novel, pan-histone deacetylase
(HDAC) inhibitor, has been accepted for filing by the U.S. Food and Drug
Administration (FDA). FDA establishes review classification for this
application as Priority Review. The FDA has assigned a Prescription Drug
User Fee Act (PDUFA) action date of August 9, 2014. Spectrum is seeking
FDA approval of Beleodaq for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (R/R PTCL).
"The FDA's acceptance of this NDA submission is another important
milestone in our strategy to bring Beleodaq to market, and one step
closer to the possible availability of more treatment options to address
the unmet medical need for patients with R/R PTCL," said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. "The Priority Review designation for the
Beleodaq NDA acknowledges the potential significant improvement in its
safety or effectiveness for the treatment for patients with the serious
condition of R/R PTCLs when compared to standard applications. Since
approximately 70% of R/R PTCL patients fail the currently approved
treatments in the course of their therapy, Beleodaq could be an
important additional treatment option for these patients. Importantly,
several patients treated with Beleodaq were able to go on to potentially
curative stem cell transplantation. We expect to use our existing sales
force to successfully launch Beleodaq if approved by the FDA."
Beleodaq is differentiated from other HDAC inhibitors that selectively
inhibit a single class of HDAC enzymes by virtue of its inhibition of
all 3 classes of the zinc-dependent HDAC enzymes (Class I, Class II and
Class IV); this leads to different alterations in histone and
non-histone protein acetylation that, in turn, could importantly
influence chromatin accessibility, gene transcription, and the clinical
activity of this drug in different cancer patients, including those who
have developed drug-resistant disease.
About Peripheral T-Cell Lymphoma
According to the Lymphoma Research Foundation (www.lymphoma.org),
lymphoma is the most common blood cancer. Hodgkin's lymphoma and
non-Hodgkin's lymphoma (NHL) are the two main forms of lymphoma.
Lymphoma occurs when lymphocytes, a type of white blood cell, grow
abnormally and accumulate in one or more lymph nodes or lymphoid
tissues. The body has two main types of lymphocytes that can develop
into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells).
PTCL comprises a group of rare and aggressive NHLs that develop from
mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL
cases in the United States.
Beleodaq is a pan-HDAC inhibitor being studied in multiple clinical
trials as a single agent or in combination with chemotherapeutic agents
for the treatment of various hematological and solid cancers. Its
anticancer effect is thought to be mediated through multiple mechanisms
of action, including the inhibition of cell proliferation, induction of
apoptosis (programmed cell death), inhibition of angiogenesis, and the
induction of differentiation. Beleodaq has been shown to have activity
in tumors that had become resistant to anticancer agents such as the
platinums, taxanes and topoisomerase II inhibitors.
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
four oncology drugs — FUSILEV® (levoleucovorin) for
Injection in the U.S.; FOLOTYN® (pralatrexate injection),
also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan)
Injection for intravenous use, for which the Company has worldwide
marketing rights and MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, 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 sales
of Spectrum's drug products, 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
customer concentration, the possibility for fluctuations in customer
orders, evolving market dynamics, our dependence on third parties for
clinical trials, manufacturing, distribution, information 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®, ZEVALIN® and
MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc and
its affiliates. BELEODAQ™, REDEFINING CANCER CARE™ and the
Spectrum Pharmaceuticals logos are trademarks owned by Spectrum
Pharmaceuticals, Inc. Any other trademarks are the property of
their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Vice President, Strategic
Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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