ROCKVILLE, Md., April 5, 2018 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to bringing high quality, cost-effective pharmaceutical
products and innovative oncology therapeutics to patients,
announces receipt of a letter from the Center for Drug Evaluation
(CDE) (group within the China FDA in charge of technical review)
indicating that EVOMELA® (melphalan) for
injection has been scheduled for review by the Expert Advisory
Anti-Tumor (Oncology) Drugs Committee (the "Advisory Committee"),
which is scheduled to take place between April 25-26, 2018 (the "Advisory Committee
Meeting").
The Advisory Committee Meeting is a closed meeting. No
additional information on the EVOMELA®
application has been requested by the CDE in advance of the
Advisory Committee Meeting, however, CASI will submit a Clinical
Data Briefing Package which will summarize the various components
contained in the previously submitted application.
EVOMELA® was accepted under CFDA's new
guidelines for priority review and the review by the Advisory
Committee was expected as part of the recently implemented CFDA
reforms. CASI anticipates that after the Advisory Committee
Meeting, the Advisory Committee will make a recommendation to CDE,
followed by CDE recommendation to CFDA, and CFDA notification of
review status to CASI.
As reported previously, the September
2017 CFDA letter provided the following reasons for granting
priority review of EVOMELA®:
- EVOMELA® is indicated for the treatment of multiple
myeloma, which is classified as a rare disease in China;
- There is no melphalan in any formulation available in
China to address this unmet
medical need;
- EVOMELA® has clear therapeutic advantage to currently available
therapeutics.
Wei-Wu He, Ph.D., CASI
Pharmaceuticals Executive Chairman, commented, "Receiving notice
from CDE regarding the Advisory Committee Meeting is very exciting
news. This indicates the completion of the CDE's initial
review of the EVOMELA® NDA package and referral
to the panel of independent experts is the next step in the review
process. Multiple myeloma is the second most common
hematological malignancy which often occurs in elderly
patients. The Advisory Committee review of the
EVOMELA® application marks a significant
milestone toward addressing an unmet medical need for patients with
multiple myeloma in China, as
there are no versions of melphalan commercially available.
EVOMELA®'s innovative and proprietary new
formulation of melphalan offers significant advantages in that it
does not contain propylene glycol which causes significant side
effects, has long stability and is the only intravenous melphalan
product approved for use in the high-dose conditioning indication
in pre-transplant therapy".
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based biopharmaceutical company dedicated to
bringing high quality, cost-effective pharmaceutical products and
innovative oncology therapeutics to patients. CASI's product
pipeline features (1) EVOMELA®, MARQIBO®, and
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 abbreviated new drug applications
(ANDAs), one ANDA that was tentatively approved and three ANDAs
that are pending FDA approval, from which CASI will prioritize a
select subset for 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 immuno-oncology
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: 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.
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
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PressComm PR,
LLC
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Lacey-Moreira
410.299.3310
jamielacey@presscommpr.com
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SOURCE CASI Pharmaceuticals, Inc.