Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced today that the U.S. Food and Drug Administration (FDA)
Office of Orphan Products Development (OOPD) has granted 7 years of
Orphan Drug Exclusivity for EVOMELA for use as a high-dose
conditioning treatment prior to hematopoietic progenitor (stem)
cell transplantation in patients with multiple myeloma. EVOMELA has
also been recently listed in the Orange Book, including two
composition of matter patents that do not expire until March
2029.
“We are pleased to receive FDA Orphan Drug Exclusivity for
EVOMELA, another important regulatory milestone for Spectrum,”
said Rajesh C. Shrotriya, MD, Chairman and Chief Executive
Officer of Spectrum Pharmaceuticals. “EVOMELA is reconstituted
with normal saline and does not contain propylene glycol. EVOMELA’s
formulation is based on Captisol® technology and is stable at room
temperature for 1 hour following reconstitution and for an
additional 4 hours after further dilution. We believe EVOMELA has
the potential to become an important therapy for multiple myeloma
patients undergoing high-dose conditioning treatment prior to
hematopoietic stem cell transplantation and fits very well with our
existing Hematology/Oncology infrastructure. Revenues from our
niche products like EVOMELA help us develop our late-stage drugs
that target blockbuster markets.”
The FDA Orphan Drug Designation program provides a special
status to drugs and biologics intended to treat, diagnose or
prevent so-called orphan diseases and disorders that affect fewer
than 200,000 people in the U.S. Orphan Drug Designation provides
the sponsor certain benefits and incentives, including a period of
marketing exclusivity if regulatory approval is ultimately received
for the designated indication, potential tax credits for certain
activities, eligibility for orphan drug grants, and the waiver of
certain administrative fees.
Spectrum Pharmaceuticals gained global development and
commercialization rights to EVOMELA from Ligand
Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013.
Spectrum assumed responsibility for completing the pivotal Phase 2
clinical trial, and was responsible for filing the NDA. Under the
license agreement, Ligand received a license fee, and NDA approval
milestone, and is eligible to receive further potential milestones
and royalties in connection with commercialization.
About Multiple Myeloma
Multiple Myeloma is a systemic malignancy of plasma cells that
accumulate in the bone marrow, usually associated with monoclonal
antibody secretion, and results in bone marrow failure and bone
destruction. It is the second most common hematologic disease with
nearly 30,000 new cases projected in the US in 2016 and over 11,000
deaths annually (American Cancer Society Stats, 2016). The rate of
autologous stem cell transplantation (ASCT) for patients with MM is
growing by approximately 3.3% annually.
Melphalan is the most commonly used IV agent for high-dose
conditioning for patients undergoing ASCT for MM. The current IV
melphalan market is approximately $100 million annually, with
predominant use in ASCT; EVOMELA is the only intravenous melphalan
product that is approved for use in the high-dose conditioning
indication.
About EVOMELA™
EVOMELA was approved by FDA based on its bioequivalence to the
standard melphalan formulation (Alkeran) in a Phase 2 clinical
study (Aljitawi et al, Bone Marrow Transplant, 2014) via the
505(b)(2) regulatory pathway. EVOMELA has been granted Orphan Drug
Designation by the FDA for its use as a high-dose conditioning
regimen for patients with MM undergoing ASCT.
EVOMELA’s melphalan formulation does not contain propylene
glycol. The use of the Captisol® technology to reformulate also
contributes to the 4-hour admixture stability of EVOMELA at room
temperature. This is in addition to the 1 hour stability of
reconstituted EVOMELA drug product at room temperature and 24 hour
stability at refrigerated temperature (5°C).
Please see the Important Safety Information below and the full
prescribing information, including BOXED WARNINGS, for EVOMELA at
www.evomela.com.
Important Safety Information
WARNING: SEVERE BONE MARROW
SUPPRESSION,
HYPERSENSITIVITY, and
LEUKEMOGENICITY
- Severe bone marrow suppression with resulting infection or
bleeding may occur. Controlled trials comparing intravenous (IV)
melphalan to oral melphalan have shown more myelosuppression with
the IV formulation. Monitor hematologic laboratory
parameters.
- Hypersensitivity reactions, including anaphylaxis, have
occurred in approximately 2% of patients who received the IV
formulation of melphalan. Discontinue treatment with EVOMELA for
serious hypersensitivity reactions.
- Melphalan produces chromosomal aberrations in vitro and in
vivo. EVOMELA should be considered potentially leukemogenic in
humans.
Contraindications
- History of serious allergic reaction to
melphalan.
Warnings and Precautions
- Nausea, vomiting, diarrhea or oral
mucositis may occur. Provide supportive care using antiemetic and
antidiarrheal medications as needed.
- Hepatic disorders ranging from abnormal
liver function tests to clinical manifestations such as hepatitis
and jaundice have been reported after treatment with melphalan.
Hepatic veno-occlusive disease has also been reported. Monitor
liver chemistries.
- EVOMELA can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to avoid pregnancy during and after treatment with
EVOMELA. If this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, advise the patient of
potential risk to the fetus.
- Melphalan-based chemotherapy regimens
have been reported to cause suppression of ovarian function in
premenopausal women, resulting in persistent amenorrhea in
approximately 9% of patients. Reversible or irreversible testicular
suppression has also been reported.
Adverse Reactions
- The most common adverse reactions
observed in at least 50% of patients with multiple myeloma treated
with EVOMELA were neutrophil count decreased (100%), white blood
cell count decreased (100%), lymphocyte count decreased (98%),
platelet count decreased (98%), diarrhea (93%), nausea (90%),
fatigue (77%), hypokalemia (74%), anemia (66%), and vomiting
(64%).
- In a single-arm clinical study, twelve
(20%) patients with multiple myeloma who received EVOMELA
conditioning for ASCT experienced a treatment emergent serious
adverse reaction. The most common serious adverse reactions (>1
patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and
renal failure.
- In a randomized clinical trial studying
the palliative treatment of patients with multiple myeloma, severe
myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common
in the IV melphalan arm (28%) than in the oral melphalan arm
(11%).
Drug Interactions
- No formal drug interaction studies have
been conducted. When nalidixic acid and IV melphalan are given
simultaneously, the incidence of severe hemorrhagic necrotic
enterocolitis has been reported to increase in pediatric
patients.
Use in Specific Populations
- It is not known whether melphalan is
present in human milk. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in
nursing infants from melphalan, breastfeeding is not recommended
during treatment with EVOMELA.
- Advise females of reproductive
potential to avoid pregnancy, which may include the use of
effective contraception methods, during and after treatment with
EVOMELA.
- For Palliative Treatment, consider dose
reduction for patients with renal impairment receiving
EVOMELA.
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.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets six hematology/oncology drugs, and expects
an FDA decision on another drug in the second half of
2016. Additionally, Spectrum's pipeline includes two drugs
targeting blockbuster markets in advanced stages of clinical
development. Spectrum's strong track record for 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.® is a registered trademark of
Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER
CARE™, EVOMELA™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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