ROCKVILLE, Md., June 21, 2018 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to the development and delivery of high quality,
cost-effective pharmaceutical products and innovative therapeutics
to patients in the U.S., China and
throughout the world, announces a strategic and long-term
manufacturing agreement with Yiling Wanzhou International
Pharmaceutical Co., Ltd. for the manufacturing of entecavir and
cilostazol. Yiling Wanzhou International Pharmaceutical Co., Ltd.
is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd. The
contracted manufacturing facilities have been inspected by both the
U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and
operate to strict International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH) Good
Manufacturing Practice (GMP) standards, which will enable CASI to
eventually sell both entecavir and cilostazol in the U.S.,
China and worldwide markets.
Entecavir and cilostazol are part of the 29 abbreviated new drug
applications (ANDAs) that CASI acquired from Sandoz in January 2018.
Ken K. Ren, Ph.D., CASI's Chief
Executive Officer stated, "We are very pleased to partner with
Yiling Wanzhou International as our manufacturing site for
entecavir and cilostazol. Through this partnership, we will
leverage Yiling's manufacturing knowledge and capabilities in order
to provide high quality, cost-effective medicines that are
critically needed for patients both in China and the U.S."
Dr. Ren continued, "This partnership further supports the
overarching vision of CASI to bring much needed medicines from the
U.S. into China as well as
cost-effective drugs from China to
the U.S. This would also be the first step for CASI to execute on
our overall development plan for the acquired ANDAs with additional
development activities and partnering discussions
underway."
The FDA approved entecavir in 2005 for the treatment of chronic
hepatitis B viral (HBV) infection.1 Entecavir is an HBV
nucleoside analog reverse transcription inhibitor that interferes
with HBV replication. There are over 100 million HBV carriers in
China with approximately 20
million people with chronic HBV infection. The 2016 estimated sales
in China for entecavir were
approximately $1.5 billion USD, which
accounted for approximately 20-percent of the patients with chronic
HBV receiving entecavir treatment.
The FDA approved cilostazol in 2006 for the reduction of
symptoms of intermittent claudication.2 Cilostazol is a
PDE-III inhibitor. Cilostazol inhibits platelet aggregation,
improves endothelial cell function, and acts as a vasodilator
enabling blood to move more easily through peripheral blood
vessels. The 2016 estimated sales in China for cilostazol were approximately
$65 million USD.
About CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals (NASDAQ: CASI) is a biopharmaceutical
company dedicated to the development and delivery of high quality,
cost-effective pharmaceutical products and innovative therapeutics
to patients in the U.S., China and
throughout the world. CASI's product pipeline features three U.S.
Food and Drug Administration (FDA)-approved drugs in-licensed from
Spectrum Pharmaceuticals, Inc. for China regional rights. These are currently in
various stages in the regulatory process for market approval in
China. The Company also acquired a
portfolio of 25 FDA-approved abbreviated new drug applications
(ANDAs), and four pipeline ANDAs that are pending FDA approval.
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.
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: 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; 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;
the risk that we will not be able to effectively select, register
and commercialize products from our recently acquired portfolio of
ANDAs; 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 and early
clinical models are not necessarily indicative of later 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.
1.
|
See
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206672
for the full U.S. Entecavir prescribing information
|
2.
|
See
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077310
and
https://www.accessdata.fda.gov/Scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077021
for the full U.S. Cilostazol prescribing information
|
COMPANY
CONTACT:
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Solebury
Trout
Jennifer
Porcelli
646.378.2962
jporcelli@troutgroup.com
Brennan
Doyle
617.221.9005
BDoyle@troutgroup.com
|
MEDIA
CONTACT:
PressComm PR,
LLC
Juliette
Bogus
410.980-5687
juliettebogus@presscommpr.com
|
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SOURCE CASI Pharmaceuticals, Inc.