Ligand Partner Spectrum Pharmaceuticals Receives FDA Approval of EVOMELA™ (melphalan) for Injection
Ligand to receive $6 million milestone related to EVOMELA’s approval
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that
Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), a biotechnology
company with fully integrated commercial and drug development operations
with a primary focus in hematology and oncology, received approval from
the U.S. Food and Drug Administration (FDA) of EVOMELA™ (melphalan) for
use in two indications: 1) as a high-dose conditioning treatment prior
to hematopoietic progenitor (stem) cell transplantation (ASCT) in
patients with MM, and 2) for the palliative treatment of patients with
MM for whom oral therapy is not appropriate. This is the first product
to be FDA approved for the high-dose conditioning indication in MM.
Spectrum plans to launch EVOMELA with its existing sales force.
“We extend congratulations to our partner Spectrum Pharmaceuticals on
achieving FDA approval for EVOMELA in these two indications and look
forward to the commercial launch of this product,” said John Higgins,
Chief Executive Officer of Ligand. “Through partnerships such as this
one, Ligand is able to share in the economic success of important,
innovative new drugs across a range of indications and patient
populations.”
Spectrum Pharmaceuticals licensed global development and
commercialization rights to EVOMELA from Ligand Pharmaceuticals in March
2013. Spectrum assumed responsibility for completing the pivotal Phase 2
clinical trial, and was responsible for filing the New Drug Application
(NDA). Under the license agreement, Ligand received an upfront fee and
earned a $6 million milestone payment on EVOMELA approval, as well as
royalties on net sales.
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 U.S. in 2016 and more than
11,000 deaths annually (American Cancer Society Stats, 2016). The rate
of 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 the 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 new 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 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
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WARNING: SEVERE BONE MARROW SUPPRESSION,
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HYPERSENSITIVITY, and LEUKEMOGENICITY
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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.
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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.
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Melphalan produces chromosomal aberrations in vitro and in
vivo. EVOMELA should be considered potentially leukemogenic in
humans.
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Contraindications
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History of serious allergic reaction to melphalan.
Warnings and Precautions
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Nausea, vomiting, diarrhea, or oral mucositis may occur. Provide
supportive care using antiemetic and antidiarrheal medications as
needed.
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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.
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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.
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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
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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%).
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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.
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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
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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
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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.
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Advise females of reproductive potential to avoid pregnancy, which may
include the use of effective contraception methods, during and after
treatment with EVOMELA.
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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 eight FDA-approved
products, including Amgen’s Kyprolis®, Baxter International’s
Nexterone®, Spectrum Pharmaceuticals’ EVOMELA™, and Merck’s NOXAFIL IV.
There are more than 30 Captisol-enabled products currently in clinical
development.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring
technologies that help pharmaceutical companies discover and develop
medicines. Our business model creates value for stockholders by
providing a diversified portfolio of biotech and pharmaceutical product
revenue streams that are supported by an efficient and low corporate
cost structure. Our goal is to offer investors an opportunity to
participate in the promise of the biotech industry in a profitable,
diversified, and lower-risk business than a typical biotech company. Our
business model is based on doing what we do best: drug discovery,
early-stage drug development, product reformulation, and partnering. We
partner with other pharmaceutical companies to leverage what they do
best (late-stage development, regulatory management, and
commercialization) to ultimately generate our revenue. Ligand’s
Captisol® platform technology is a patent-protected, chemically modified
cyclodextrin with a structure designed to optimize the solubility and
stability of drugs. OmniAb® is a patent-protected transgenic animal
platform used in the discovery of fully human mono- and bispecific
therapeutic antibodies. Ligand has established multiple alliances,
licenses, and other business relationships with the world's leading
pharmaceutical companies, including Novartis, Amgen, Merck, Pfizer,
Celgene, Gilead, Janssen, Baxter International, and Eli Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that
involve risks and uncertainties and reflect Ligand's judgment as of the
date of this release. These include statements regarding the timing of
the commercial launch of EVOMELA, the size and growth of the patient
population for MM, the size of the potential market for IV melphalan
products, and Ligand's potential revenue under its license agreement
with Spectrum Pharmaceuticals. Actual events or results may differ from
our expectations. For example, there can be no assurances that Spectrum
Pharmaceuticals will successfully launch EVOMELA and the patient
population may be smaller than anticipated. The failure to meet
expectations with respect to any of the foregoing matters may reduce
Ligand's stock price. Additional information concerning these and other
important risk factors affecting Ligand (including Ligand’s current
reliance on revenues based on sales of Promacta® and Kyprolis®, and
various risks to which Ligand’s Captisol® cyclodextrin operations are
subject) can be found in Ligand's prior press releases available at www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release, except
as required by law. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160315005683/en/
Ligand Pharmaceuticals Incorporated
Todd Pettingill
investors@ligand.com
(858)
550-7500
or
LHA
Bruce Voss
bvoss@lhai.com
(310)
691-7100
Source: Ligand Pharmaceuticals Incorporated
Released March 15, 2016