HENDERSON, Nev. and
ROCKVILLE, Md., Sept. 18, 2014 /PRNewswire/ -- 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-EnabledTM
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 INVESTOR CONTACT:
|
CASI INVESTOR CONTACTS:
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Spectrum
Pharmaceuticals, Inc.
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CASI Pharmaceuticals,
Inc.
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Shiv Kapoor
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240.864.2643
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Vice President, Strategic Planning & Investor
Relations
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ir@casipharmaceuticals.com
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702-835-6300
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LHA
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InvestorRelations@sppirx.com
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Kim Sutton Golodetz
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212.838.3777
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kgolodetz@lhai.com
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SOURCE CASI Pharmaceuticals, Inc.