ROCKVILLE, Md., Dec. 5, 2016 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to innovative therapeutics addressing cancer and other
unmet medical needs, announced today that China's Food and Drug Administration (CFDA)
has accepted for review the Company's import drug registration
application for EVOMELA® (melphalan) for Injection.
CASI's China rights to EVOMELA
(melphalan) for Injection was previously licensed from its partner
Spectrum Pharmaceuticals, Inc. along with two other
commercial-stage Spectrum drugs, MARQIBO® and
ZEVALIN®. EVOMELA received U.S. FDA approval
earlier this year for multiple myeloma patients as a high-dose
conditioning treatment prior to autologous stem cell
transplantation (ASCT) and as palliative treatment for patients who
are not candidates for oral therapy. It was launched in the
U.S. this year by Spectrum.
Ken Ren, Ph.D, CASI's Chief
Executive Officer, commented, "Multiple myeloma is the second most
common malignancy in blood cancers, often occurring in elderly
patients. There were more than 12,000 new cases and more than
9,000 deaths from multiple myeloma in China in 2015. With the aging of
China's population, the number of
new cases is rapidly rising. Melphalan is extensively used
worldwide in the treatment of multiple myeloma and is the main drug
in pre-transplant conditioning therapy. Melphalan, however,
is not currently commercially available in China. EVOMELA, an innovative and proprietary
new formulation of melphalan, offers significant advantage in that
it (i) does not contain propylene glycol which causes significant
side effects; (ii) has longer stability; and (iii) is the only
intravenous melphalan product approved for use in the high-dose
conditioning indication. We look forward to working with the
CFDA to advance EVOMELA towards market approval."
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 commercial focus on China. CASI's product pipeline includes
exclusive rights to MARQIBO® (vinCRIStine sulfate
LIPOSOME injection), EVOMELA® (melphalan) for Injection
and ZEVALIN® (ibritumomab tiuxetan) for the greater
China market (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 EVOMELA®
EVOMELA was approved by FDA based on its bioequivalence to the
standard melphalan formulation (Alkeran) in a Phase 2 clinical
study 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 multiple myeloma
undergoing autologous stem cell transplantation (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
(5ºC).
Please see the Important Safety information available at
www.evomela.com. EVOMELA is not yet available in China; more information on EVOMELA for
countries outside the greater China region is available at
www.sppirx.com.
Forward Looking Statements
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: 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 volatility in the market
price of our common stock; risks relating to interests of our
largest stockholders that differ from our other stockholders; the
risk of substantial dilution of existing stockholders in future
stock issuances, the difficulty of executing our business strategy
in China; our inability to predict
when or if our product candidates will be approved for marketing by
CFDA authorities; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates 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.
MARQIBO®, EVOMELA® and
ZEVALIN® are proprietary to Spectrum
Pharmaceuticals, Inc. and its affiliates.
COMPANY
CONTACT:
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Torrey Hills
Capital
Jim
Macdonald
858.456.7300
jmacdonald@torreyhillscapital.com
|
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SOURCE CASI Pharmaceuticals, Inc.