Athenex, Inc. Receives U.S. FDA Orphan Drug Designation for Oraxol for the Treatment of Angiosarcoma
April 19 2018 - 8:00AM
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 Drug Designation from
the U.S. FDA for Oraxol for the treatment of angiosarcoma. Oraxol,
an innovative development in the treatment of cancer, is a novel
oral formulation of paclitaxel, a very effective and commonly used
chemotherapy treatment for many cancers, combined with HM30181A (a
novel orally non-absorbable gastrointestinal tract P-glycoprotein
pump inhibitor).
Rudolf Kwan, Athenex’s Chief Medical Officer,
commented, “We are pleased to receive Orphan Drug Designation for
Oraxol for the treatment of angiosarcoma, a form of malignant blood
vessel cancer. This designation represents our commitment to expand
the use of Oraxol, in which the active pharmaceutical ingredient is
paclitaxel, to additional clinical indications based on the known
efficacy of paclitaxel and the observed improved pharmacokinetic
profile of Oraxol. This is a parallel development with our clinical
studies in metastatic breast cancer and gastric cancer, in which
Oraxol has already shown promising efficacy and safety profile. We
will be initiating the angiosarcoma clinical study soon.”
The FDA grants Orphan Drug status to support
development of medicines for the treatment of diseases that that
affect fewer than 200,000 people in the United States. Orphan Drug
Designation may provide certain benefits, including a seven-year
period of market exclusivity if the drug is approved, tax credits
for qualified clinical trials and an exemption from FDA application
fees.
Athenex previously announced that it had met its
enrollment target for the second interim analysis for the Oraxol
Phase III clinical trial for metastatic breast cancer and is
scheduled to conduct this interim analysis in the third quarter of
2018. Additionally, the Company announced the receipt of the
Promising Innovative Medicine designation for Oraxol by the United
Kingdom Medicines and Healthcare products Regulatory Agency on
December 27, 2017, qualifying Athenex to apply for Step II of the
Early Access to Medicines Scheme to provide patients early access
to Oraxol prior to receiving marketing authorization. Athenex also
recently announced that the Chinese FDA has allowed the
Investigational New Drug application for Oraxol on January 8, 2018.
Athenex also announced initial results of a clinical study in
Taiwan in patients with metastatic breast cancer, as well as
results of the first cohort of patients in a study in Taiwan on the
combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal
antibody against VEGFR2) in patients with gastric cancer.
Oraxol was initially discovered by Hanmi
Pharmaceuticals and licensed to Athenex, in territories including
North and Latin Americas, Europe, Japan, greater China and
Southeast Asia, Australia and New Zealand. Athenex is leading the
registration effort from IND and clinical studies.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical
stage biopharmaceutical company dedicated to becoming a leader in
the discovery and development 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. Athenex’s Oncology Innovation
Platform generates clinical candidates through an extensive
understanding of kinases, including novel binding sites and human
absorption biology, as well as through the application of Athenex’s
proprietary research and selection processes in the lab. The
Company’s current clinical pipeline is derived from two different
platform technologies Athenex calls Orascovery and Src Kinase
Inhibition. The Orascovery platform is based on the novel oral
P-glycoprotein pump inhibitor molecule HM30181A, through which
Athenex is able to facilitate oral absorption of traditional
cytotoxics, which Athenex believes may offer improved patient
tolerability and efficacy as compared to IV administration of the
same cytotoxics. The Orascovery platform was developed by Hanmi
Pharmaceuticals and licensed exclusively to Athenex for all major
worldwide territories except Korea, which is retained by Hanmi. The
Src Kinase Inhibition platform refers to novel small molecule
compounds that have multiple mechanisms of action, including the
inhibition of the activity of Src Kinase and the inhibition of
tubulin polymerization during cell division. Athenex believes the
combination of these mechanisms of action provides a broader range
of anti-cancer activity as compared to either mechanism of action
alone. 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 and multiple locations in Chongqing, China.
Forward-Looking Statement Disclaimer/Safe
Harbor Statement
Except for historical information, all of the
statements, expectations, and assumptions contained in this press
release are forward-looking statements. 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, including Almirall for success in
certain areas of Athenex’s business; need to raise additional
capital; competition; intellectual property risks; risks relating
to doing business in China; 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. We assume no
obligation and do not intend to update these forward-looking
statements, except as required by law.
CONTACT:Jim PolsonTel: +1-716-427-2952Athenex,
Inc.
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