- Spectrum receives a 19.99% stake
(pre-transaction) in CASI, a NASDAQ-listed, oncology-focused
Company with expertise and focus on markets in China and a $1.5
million promissory note
Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology, and
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical
company dedicated to the acquisition, development and
commercialization of innovative therapeutics addressing cancer and
other unmet medical needs for the global market with a primary
focus on China, announce the signing of license agreements whereby
CASI has been granted exclusive rights to two of Spectrum
Pharmaceuticals’ commercial oncology drugs, Zevalin® (ibritumomab
tiuxetan) Injection for intravenous use and Marqibo® (vinCRIStine
sulfate LIPOSOME injection) for intravenous infusion, and a Phase 3
drug candidate, Captisol-Enabled™ Melphalan (CE melphalan), for
development and commercialization in China, including Taiwan, Hong
Kong and Macau.
ZEVALIN is used in the treatment of non-Hodgkin’s lymphoma (NHL)
and MARQIBO is used in the treatment of acute lymphoblastic
leukemia (ALL). CE melphalan has met the endpoints in a pivotal
trial for use as a conditioning treatment prior to autologous stem
cell transplant for patients with multiple myeloma. Spectrum plans
to file a New Drug Application with the U.S. Food and Drug
Administration (FDA) for CE melphalan in the second half of
2014.
CASI will be responsible for the development and
commercialization of the three drugs, including the submission of
import drug registration applications to regulatory authorities and
conducting any confirmatory clinical studies in greater China, if
and as required.
“We are delighted to see our anticancer drugs to be developed
and marketed in greater China through CASI, a NASDAQ-listed Company
focused on China,” said Rajesh C. Shrotriya, MD, Chairman and Chief
Executive Officer of Spectrum Pharmaceuticals. “The management of
CASI has a track record of successfully developing anticancer drugs
in China. We are pleased to be a shareholder of CASI at this early
stage of their development and look forward to CASI creating value
for our shareholders as they grow. China’s pharmaceutical market is
growing at a rapid pace and is already approaching second place to
only the United States in the world. The greater China drug market
for anticancer drugs is projected to become the world’s largest in
the next decade and CASI has the opportunity to take a leading
position to address these significant unmet medical needs. We are
impressed with the management team at CASI and their expertise in
China, and look forward to sharing in the success of our drugs in
this important market.”
Commenting on the transaction, Ken K. Ren, Ph.D., CASI’s Chief
Executive Officer, said, “We are very excited to have entered into
this transaction with Spectrum, a Company with a successful track
record of developing and commercializing drugs expeditiously in the
U.S. The addition of these three drugs transforms our pipeline and
significantly expands our market share potential in China. Our
transaction is structured rather uniquely in that the shares and
note represent the purchase price to Spectrum and is in lieu of
royalties and milestones normally associated with traditional
licenses, thereby aligning Spectrum’s interest with our
shareholders. We look forward to a productive relationship with
Spectrum.”
Dr. Ren added, “These drug products come with strong
intellectual property protection and significant technology
barriers. We are currently preparing the import drug registration
applications in greater China, initially for ZEVALIN and MARQIBO,
and since both drugs are approved for sale in the U.S., we
anticipate that confirmatory clinical trials will be required for
marketing approval in our territory. The submission of the import
drug registration for CE melphalan will follow immediately after
its approval by the U.S. FDA. The annual incidence in China for
NHL, ALL and multiple myeloma is increasing each year with high
mortality rates, it is our goal to have these innovative products
available to patients in greater China as soon as possible to
address these unmet medical needs, and as Spectrum expands these
drugs into additional indications in the U.S., we too will apply
for expanded labels in our territory.”
In addition to its initial stake in CASI, Spectrum
Pharmaceuticals will have certain rights to maintain its
post-transaction ownership position. Spectrum Pharmaceuticals also
will have the opportunity to designate a member to CASI’s board of
directors. Detailed information on the transaction can be
found in CASI’s Report on Form 8-K, which will be filed with the
Securities and Exchange Commission.
H.C. Wainwright & Co., LLC acted as Spectrum's advisor.
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; FOLOTYN® (pralatrexate injection);
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use;
MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous
infusion; and BELEODAQ™ (belinostat) for Injection. 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 CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the
acquisition, development and commercialization of innovative
therapeutics addressing cancer and other unmet medical needs for
the global market with a primary focus on China. CASI’s product
pipeline includes exclusive regional rights to ZEVALIN (ibritumomab
tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection) and
Captisol-Enabled (propylene glycol-free) melphalan (CE melphalan)
in greater China (including Taiwan, Hong Kong and Macau). CASI’s
development pipeline also includes its proprietary drug candidate
ENMD-2076, a selective angiogenic kinase inhibitor currently in
multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial)
currently under reformulation development. CASI is headquartered in
Rockville, Maryland and has a wholly owned subsidiary and R&D
operations in Beijing, China. More information on CASI is available
at www.casipharmaceuticals.com and in the Company’s filings with
the U.S. Securities and Exchange Commission.
About ZEVALIN and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use, is
indicated for the treatment of patients with relapsed or
refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma
(NHL). ZEVALIN is also indicated for the treatment of patients with
previously untreated follicular non-Hodgkin's Lymphoma who achieve
a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The
ZEVALIN therapeutic regimen consists of two components: rituximab,
and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN
builds on the combined effect of a targeted biologic monoclonal
antibody augmented with the therapeutic effects of a beta-emitting
radioisotope.
Important ZEVALIN Safety
Information
Deaths have occurred within 24 hours of
rituximab infusion, an essential component of the ZEVALIN
therapeutic regimen. These fatalities were associated with hypoxia,
pulmonary infiltrates, acute respiratory distress syndrome,
myocardial infarction, ventricular fibrillation, or cardiogenic
shock. Most (80%) fatalities occurred with the first rituximab
infusion. ZEVALIN administration can result in severe and prolonged
cytopenias in most patients. Severe cutaneous and mucocutaneous
reactions, some fatal, can occur with the ZEVALIN therapeutic
regimen.
Please see full Prescribing Information,
including BOXED WARNINGS, for ZEVALIN and rituximab. Full
prescribing information for ZEVALIN can be found at
www.ZEVALIN.com.
About MARQIBO
MARQIBO is a novel, sphingomyelin/cholesterol
liposome-encapsulated, formulation of vincristine sulfate.
Vincristine, a microtubule inhibitor, is FDA-approved for the
treatment of adult patients with Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has progressed following two or more
anti-leukemia therapies. (The encapsulation technology, utilized in
this formulation, has been shown to provide prolonged circulation
of vincristine in the blood).
Please see important safety information below and the full
prescribing information for MARQIBO at
www.marqibo.com.
Indication and usage
MARQIBO is a liposomal vinca alkaloid
indicated for the treatment of adult patients with Philadelphia
chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in
second or greater relapse or whose disease has progressed following
two or more anti-leukemia therapies. This indication is based on
overall response rate. Clinical benefit such as improvement in
overall survival has not been verified.
Important safety information
CONTRAINDICATIONS
- MARQIBO is contraindicated in patients
with demyelinating conditions including Charcot-Marie-Tooth
syndrome
- MARQIBO is contraindicated in patients
with hypersensitivity to vincristine sulfate or any of the other
components of MARQIBO (vinCRIStine sulfate LIPOSOME injection
- MARQIBO is contraindicated for
intrathecal administration
About Captisol-Enabled Melphalan
Captisol-enabled, PG-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 use of
propylene glycol, which has been reported to cause renal and
cardiac side effects that 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 seven 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 Statements – Spectrum Pharmaceuticals,
Inc.
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.
Forward-Looking Statements – CASI Pharmaceuticals,
Inc.
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act with
respect to the outlook for expectations for future financial or
business performance, strategies, expectations and goals.
Forward-looking statements are subject to numerous assumptions,
risks and uncertainties, which change over time. Forward-looking
statements speak only as of the date they are made, and no duty to
update forward-looking statements is assumed.
Actual results could differ materially from those currently
anticipated due to a number of factors, including: the risk that we
may be unable to continue as a going concern as a result of our
inability to raise sufficient capital for our operational needs;
the possibility that we may be delisted from trading on the Nasdaq
Capital Market; the volatility in the market price of our common
stock; the difficulty of executing our business strategy in China;
our inability to enter into strategic partnerships for the
development, commercialization, manufacturing and distribution of
our proposed product candidate or future candidates; risks relating
to the need for additional capital and the uncertainty of securing
additional funding on favorable terms; risks associated with our
product candidates; risks associated with any early-stage products
under development; the risk that results in preclinical models are
not necessarily indicative of clinical results; uncertainties
relating to preclinical and clinical trials, including delays to
the commencement of such trials; the lack of success in the
clinical development of any of our products; dependence on third
parties; and risks relating to the commercialization, if any, of
our proposed products (such as marketing, safety, regulatory,
patent, product liability, supply, competition and other risks).
Such factors, among others, could have a material adverse effect
upon our business, results of operations and financial condition.
We caution readers not to place undue reliance on any
forward-looking statements, which only speak as of the date made.
Additional information about the factors and risks that could
affect our business, financial condition and results of operations,
are contained in our filings with the U.S. Securities and Exchange
Commission, which are available at www.sec.gov.
SPECTRUM INVESTORS:Spectrum Pharmaceuticals,
Inc.Shiv Kapoor, 702-835-6300Vice President, Strategic Planning
& Investor RelationsInvestorRelations@sppirx.comorCASI
INVESTORS:CASI Pharmaceuticals,
Inc.240-864-2643ir@casipharmaceuticals.comorLHAKim
Sutton Golodetz, 212-838-3777kgolodetz@lhai.com
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