Spectrum Pharmaceuticals Presents New Data on EVOMELATM (CE-Melphalan), at the Annual Meeting of the American Pharmacists Ass...
March 30 2015 - 6:00AM
Business Wire
- EVOMELA stability shown to be
significantly longer than current Melphalan HCl for Injection in an
oral presentation at the annual American Pharmacists Association
(APhA) meeting.
- The increased stability of EVOMELA
allows a longer use time, and could importantly simplify clinical
administration logistics.
- EVOMELA is free of propylene glycol, a
diluent which is present in current Melphalan formulations and is
associated with renal and cardiac toxicities.
- PDUFA decision date is October 23,
2015; if approved, the Company plans to launch EVOMELA with its
existing hematology/oncology sales force.
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 results of a clinical study of the
stability of Captisol-enabled Melphalan versus the currently
marketed, propylene glycol-containing melphalan formulation
entitled, Solution Stability of Captisol-enabled Melphalan vs
Marketed Melphalan Products. These results were presented in an
oral presentation at the annual American Pharmacists Association
(APhA) Annual Meeting & Exposition in San Diego, California
(March 27-30).
“The improved stability of EVOMELA may potentially ensure that
cancer patients receive the full, intended therapeutic dose of
intravenous (IV) melphalan, by increasing the use time and infusion
time, and simplifying clinical administration logistics,” said
Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of
Spectrum Pharmaceuticals. “EVOMELA is a new injectable formulation
of melphalan that incorporates the Captisol brand of modified
β-cyclodextrin improving the solubility and stability of melphalan.
It also uses a standard aqueous diluent (normal saline) for
reconstitution, instead of propylene glycol, which is associated
with toxicities including renal dysfunction and arrhythmias. We
look forward to launching EVOMELA with our existing sales force
later this year and providing this new treatment option to cancer
patients.”
The following is the summary of the oral presentation at the
APhA annual meeting in San Diego:
Abstract #377 Solution Stability
Comparison of Capitsol-enabledTM Melphalan HCI vs.
Marketed Melphalan HCI Products
Summary: Over time, the rate of
degradation for reconstituted solutions of marketed IV melphalan
HCl in vials was 17X faster than reconstituted solutions in vials
prepared from EVOMELA. Similarly, melphalan was shown to degrade 5X
faster in infusion bag admixtures prepared from marketed products
compared to admixtures prepared from EVOMELA. EVOMELA for Injection
can be stored up to 1 hour after reconstitution and is stable for
an additional 4 hours after preparation of the infusion
solution.
Conclusions: Data show that EVOMELA
has significantly better stability in solution compared to the
marketed melphalan formulations. Reconstituted solution in vials is
17X more stable, and the admixture solution in bags is 5X more
stable, respectively, than the same solutions prepared using
currently marketed formulations.
In December 2014, Spectrum submitted a NDA to the FDA for the
approval of EVOMELA for use as a high-dose conditioning treatment
prior to AHCT in patients with Multiple Myeloma (MM). Spectrum is
also seeking approval for the palliative treatment of patients with
MM for whom oral therapy is not appropriate. The NDA was accepted
and a PDUFA decision is expected October 23, 2015, 10 months from
NDA filing.
Spectrum Pharmaceuticals gained global development and
commercialization rights to EVOMELA 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 EVOMELATM
EVOMELA 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 a propylene
glycol-containing custom diluent, which has been reported to cause
renal and cardiac side effects, and, in turn, limits 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.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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