Athenex Announces European Commission Grants Orphan Designations for Paclitaxel and Encequidar for the Treatment of Soft Tiss...
October 30 2019 - 7:00AM
Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical
company dedicated to the discovery, development and
commercialization of novel therapies for the treatment of cancer
and related conditions, today announced that it has received Orphan
Designations from the European Commission (EC) for paclitaxel
and encequidar (“Oral Paclitaxel”) for the treatment of soft tissue
sarcoma, following a positive opinion from the European Medicines
Agency (EMA).
Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented,
“We are very pleased to receive Orphan Designations from the
European Commission, as this further recognizes the potential
benefits of Oral Paclitaxel. Earlier this year, we shared
encouraging early results from a clinical study in angiosarcoma, a
form of soft tissue sarcoma, that showed rapid responses in a
difficult to treat patient population. We will soon be extending
this study to include sites in Europe.”
The EC grants Orphan Designation status to support
development of medicines for the treatment of diseases that affect
fewer than 5 in 10,000 people in the European Union and
provide a significant benefit to those affected by the condition.
Orphan Designation may provide certain benefits, including protocol
assistance, fee reductions, and a ten-year period of market
exclusivity if the drug is approved.
The U.S. FDA has granted oral paclitaxel and encequidar an
Orphan Drug Designation in the treatment of angiosarcoma.
The Orascovery platform was initially developed by Hanmi
Pharmaceuticals and licensed exclusively
to Athenex for all major worldwide territories
except Korea, which is retained by Hanmi.
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization of next generation
drugs for the treatment of cancer. Athenex is organized
around three platforms, including an Oncology Innovation Platform,
a Commercial Platform and a Global Supply Chain Platform. The
Company’s current clinical pipeline is derived from four different
platform technologies: (1) Orascovery, based on non-absorbed
P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell
receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation
therapy. Athenex’s employees worldwide are dedicated to improving
the lives of cancer patients by creating more active and tolerable
treatments. Athenex has offices
in Buffalo and Clarence, New York; Cranford,
New Jersey; Houston, Texas; Chicago, Illinois; Hong
Kong; Taipei, Taiwan; multiple locations
in Chongqing, China; and Manchester, UK. For
more information, please visit www.athenex.com.
Forward-Looking Statements Except for
historical information, all of the statements, expectations, and
assumptions contained in this press release are forward-looking
statements. These forward-looking statements are typically
identified by terms such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “evaluate,” “expect,” “foresee,” “guidance,”
“intend,” “investigate,” “likely,” “may,” “plan,” “potential,”
“predict,” “preliminary,” “prepare,” “potential,” “probable,”
“project,” “promising,” “seek,” “should,” “will,” “would,” and
similar expressions. Actual results might differ materially
from those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: the development stage of our primary clinical
candidates and related risks involved in drug development, clinical
trials, regulation, manufacturing and commercialization; our
reliance on third parties for success in certain areas of
Athenex’s business; our history of operating losses and need to
raise additional capital to continue as a going concern;
competition; intellectual property risks; risks relating to doing
business in China; the uncertainty of when, if at all, we will
be able to resume producing API in our Chongqing plant;
and the other risk factors set forth from time to time in
our SEC filings, copies of which are available for free
in the Investor Relations section of our website
at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or
upon request from our Investor Relations Department. All
information provided in this release is as of the date hereof and
we assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
CONTACTS Investor
Relations: Tim McCarthy Managing Director, LifeSci Advisors,
LLC Tel: +1 716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll Sze Chief Financial Officer
Email: randollsze@athenex.com
Jacqueline Li Corporate Development and Investor Relations
Email: jacquelineli@athenex.com
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