Spectrum Pharmaceuticals Files a New Drug Application with the FDA for Captisol-Enabled™ (Propylene Glycol-Free) Melphalan
December 26 2014 - 7:00AM
Business Wire
- Approval is being sought for use as a
high-dose conditioning treatment prior to stem cell transplantation
in multiple myeloma and for the palliative treatment of patients
with multiple myeloma for whom oral therapy is not
appropriate.
- The Company expects FDA review to take
approximately 10 months.
- The Company plans to launch this drug
with its existing hematology/oncology sales force next year pending
approval.
- Our formulation is free of propylene
glycol and does not use a custom solvent for its reconstitution; it
is more stable with a longer use time, simplifying clinical
administration logistics.
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology, today
announced the company has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for the approval of
Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection
(propylene glycol-free) for use as a high-dose conditioning
treatment prior to hematopoietic progenitor (stem) cell
transplantation in patients with multiple myeloma. Spectrum is also
seeking approval for the palliative treatment of patients with
multiple myeloma for whom oral therapy is not appropriate.
“We believe the lack of propylene glycol in the preparation of
CE-Melphalan eliminates the risk of the toxicities associated with
that excipient,” said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. “The improved
solubility and stability of this novel melphalan formulation,
CE-Melphalan, will make it an attractive treatment option for both
transplant conditioning, and the palliative treatment of patients
with multiple myeloma who cannot take oral melphalan. The enhanced
stability of this new CE-Melphalan formulation simplifies clinical
administration and is anticipated to allow for longer use and
infusion times. This NDA submission represents another important
step forward in bringing new treatment options to cancer
patients.”
The Phase 2 pivotal trial evaluating CE-Melphalan was a
multi-center trial evaluating safety and efficacy. The primary
objective of the study was to determine the overall safety and
toxicity profile in multiple myeloma patients receiving 200 mg/m2
of CE-Melphalan as myeloablative therapy prior to autologous stem
cell transplantation (ASCT). The secondary objectives evaluated the
efficacy of CE-Melphalan in this patient population as measured by
Multiple Myeloma Response Rate (according to International Myeloma
Working Group [IMWG] criteria), and the rates of myeloablation and
engraftment. The primary as well as secondary endpoints of this
Phase 2 trial were met, and a comprehensive 505(b)(2) NDA was
submitted to the FDA.
In a previous clinical study, CE-Melphalan met the requirements
for establishment of bioequivalence to the currently approved
commercial intravenous formulation of melphalan. When approved,
this demonstrated bioequivalence of CE-Melphalan should facilitate
the use of this new more stable, propylene glycol-free Captisol
formulation of melphalan.
Spectrum Pharmaceuticals gained global development and
commercialization rights to CE-Melphalan from Ligand
Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013.
Spectrum assumed the responsibility for the pivotal clinical trial
and was responsible for filing the NDA. Under the license
agreement, Ligand received a license fee and is eligible to receive
milestone payments, as well as royalties following potential
commercialization.
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 five 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; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has
worldwide marketing rights and BELEODAQ™ (belinostat) for Injection
in the U.S. 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.
About Captisol-Enabled Melphalan
Captisol-Enabled, Propylene Glycol-free Melphalan is a novel
intravenous formulation of melphalan being investigated for the
multiple myeloma transplant setting, for which it has been granted
an Orphan Drug Designation by the FDA. This formulation eliminates
the need to use propylene glycol containing custom diluent, which
has been reported to cause renal and cardiac side effects, which in
turn limit the ability to deliver higher doses of therapeutic
compounds. The use of the Captisol® technology to reformulate
melphalan also improves its stability and is anticipated to allow
for slower infusion rates and longer administration durations,
potentially enabling clinicians to safely achieve a higher dose
intensity for pre-transplant chemotherapy.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin
with a structure designed to optimize the solubility and stability
of drugs. Captisol was invented and initially developed by
scientists in the laboratories of Dr. Valentino Stella at the
University of Kansas’ Higuchi Biosciences Center for specific use
in drug development and formulation. This unique technology has
enabled six FDA-approved products, including Onyx Pharmaceuticals’
Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL
IV. There are also more than 30 Captisol-enabled products currently
in clinical development.
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®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc. and its affiliates. 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
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Sep 2023 to Sep 2024