ROCKVILLE, Md., Oct. 23, 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 China and
throughout the world, announces that it has acquired a U.S.
FDA-approved abbreviated new drug application (ANDA) from Laurus
Labs Limited. The drug, tenofovir disoproxil fumarate (TDF),
is indicated for the treatment of hepatitis B virus (HBV). As part
of the transaction, CASI will make certain upfront and milestone
payments in different phases. There are more than 90 million
chronic carriers of hepatitis B in China which accounts for roughly one-third of
all HBV chronic carriers in the world, with TDF currently as the
first line therapy.
Wei-Wu He, Ph.D., CASI's
Executive Chairman commented, "The acquisition of this ANDA from
Laurus enhances our robust and emergent pipeline and is consistent
with our broader mission to commercialize U.S. FDA approved drugs
in China. The regulatory landscape
in China is rapidly evolving to
provide patients with quicker and more affordable access to
high-quality medicines and we believe CASI is well positioned with
infrastructure and leadership to launch products from our ANDA
portfolio rapidly and efficiently."
Dr. Satyanarayana Chava, Founder
and CEO, Laurus Labs, commented, "The transfer of TDF ANDA for its
use in China enhances our
strategic focus to leverage our development and manufacturing
capabilities in the markets where we have little presence.
Partnering with CASI, in particular, would enable Laurus Labs to
monetize its asset in China while
building a robust pipeline and commercialize quality drugs
in other markets. Laurus Labs is looking forward to
venture into the new geographies where it has no footprint and
would offer its manufacturing capabilities through strategic
ventures and partnerships."
About CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals (NASDAQ: CASI) is a U.S.-based
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.
About Laurus Labs Limited.
Laurus Labs (Laurus BSE: 540222, NSE: Lauruslabs, ISIN:
INE947Q01010) is a leading research & development
driven and fully integrated pharmaceutical company in India. The Company has grown consistently to
become one of the leading manufacturers of Active Pharmaceutical
Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C.
Laurus also manufactures APIs in oncology and other therapeutic
areas. Its strategic and early investments in R&D and
manufacturing infrastructure have enabled it to become one of the
leading suppliers of APIs in the ARV therapeutic area. The company
has also ventured into to develop a Finished Dosages Forms on the
back of existing strengths in APIs with a current capacity of 5
billion units per year, expandable up to 8 billion million units
per year. The company is also driving growth opportunities in the
synthesis and ingredients businesses. www.lauruslabs.com. Corporate
Identification No: L24239AP2005PLC047518.
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: risks relating to interests of our
largest stockholders that differ from our other stockholders; 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 abbreviated new drug applications
(ANDAs); our lack of experience in manufacturing products and
uncertainty about our resources and capabilities to do so on a
clinical or commercial scale; risks relating to the
commercialization, if any, of our products and proposed products
(such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks); our inability to predict when
or if our product candidates will be approved for marketing by the
China Food and Drug Administration authorities; our inability to
enter into strategic partnerships for the development,
commercialization, manufacturing and distribution of our proposed
product candidates or future candidates; the volatility in the
market price of our common stock; 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; 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; and our
dependence on third parties. 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.
CASI
CONTACT:
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
LAURUS LABS
CONTACT:
+91 40 3980
4333
info@lauruslabs.com
|
INVESTOR CONTACT FOR
CASI:
Solebury
Trout
Jennifer
Porcelli
646.378.2962
jporcelli@troutgroup.com
INVESTOR CONTACT FOR
LAURUS LABS :
Monish
Shah
+91 40 3980
4366
investorsrelations@lauruslabs.com
|
MEDIA CONTACT FOR
CASI:
PressComm PR,
LLC
Juliette
Bogus
410.980.5687
juliettebogus@presscommpr.com
MEDIA CONTACT FOR
LAURUS LABS
Pavan
Kumar
+91 40 3980
4380
mediarelations@lauruslabs.com
pavankumar.n@lauruslabs.com
|
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SOURCE CASI Pharmaceuticals, Inc.