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
HENDERSON, Nev. & ROCKVILLE, Md.--(BUSINESS WIRE)--
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
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
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
Please see full Prescribing Information, including BOXED WARNINGS, for
ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be
found at www.ZEVALIN.com.
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
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.
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
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®,
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
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.
Shiv Kapoor, 702-835-6300
Vice President, Strategic
Planning & Investor Relations
CASI Pharmaceuticals, Inc.
Sutton Golodetz, 212-838-3777
Source: Spectrum Pharmaceuticals, Inc.
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