ROCKVILLE, Md., Jan. 26, 2018 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to bringing quality pharmaceutical products to the
Chinese and U.S. markets announced today that it has acquired a
portfolio of 25 U.S. FDA-approved abbreviated new drug applications
(ANDAs), one ANDA that FDA tentatively approved, and three ANDAs
that are pending FDA approval. CASI intends to select and
commercialize certain products from the portfolio that have unique
market opportunity and cost-effective manufacturing in China and/or in the U.S.
Ken Ren, Ph.D., CASI's Chief
Executive Officer commented, "The acquisition of the Sandoz ANDAs
enhances our strategic focus to build a robust pipeline and
commercialize quality drug candidates in China, including entecavir, an antiviral
medication used in the treatment of hepatitis B viral infection
("HBV"), which unfortunately in China accounts for more than half of the
estimated 700,000 HBV-related deaths worldwide each year.
With FDA-approved ANDA status and the high-quality standards of
Sandoz, we anticipate leveraging the Chinese FDA's (CFDA) more
recent regulations to accept western pharmaceutical and clinical
data for rapid entry into China's
market while being competitive in the marketplace."
Dr. Ren continued, "This is an exciting and unprecedented time
in the CFDA regulatory landscape, against a backdrop of soaring
demand in China for high quality
import pharmaceuticals. We are confident in our ability to
launch certain products that we acquired from the Sandoz portfolio
in China, along with our launch of
EVOMELA®, MARQIBO® and ZEVALIN®
all of which are in various stages of CFDA review. We look forward
to completing our Company's transition from research and
development to commercial."
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, commercial stage biopharmaceutical company
focused on the acquisition, development and commercialization of
therapeutics addressing cancer and other unmet medical needs for
the global market with a focus on commercialization in China. CASI's product pipeline features (1)
EVOMELA®, MARQIBO®, ZEVALIN®, all
U.S. Food and Drug Administration (FDA) approved drugs in-licensed
from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in
various stages in the regulatory process for market approval in
China, (2) an acquired portfolio
of 25 FDA-approved ANDAs, 4 ANDAs that are pending FDA approval,
from which CASI will prioritize a select subset of product
registration and commercialization in China, (3) our proprietary drug candidate,
ENMD-2076, currently in Phase 2 clinical development, and (4)
proprietary early-stage candidates in preclinical
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.
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.
EVOMELA®, MARQIBO®,
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
jm@sdthc.com
|
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SOURCE CASI Pharmaceuticals, Inc.