Athenex Announces Licensing Agreement with PharmaEssentia for Rights to Oradoxel (Oral Docetaxel) in Certain Asian Territorie...
November 29 2018 - 7:07AM
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 entered into an agreement with
PharmaEssentia Corporation (Taipei Exchange:6446) to license the
rights to develop and commercialize Athenex’s Oradoxel in Taiwan,
Singapore and Vietnam. The existing licensing agreement for Oraxol
(oral paclitaxel) and Oratecan (oral irinotecan) with
PharmaEssentia is being expanded to account for additional
considerations, including milestone payments, for Oradoxel
(oral docetaxel). In December 2013, Athenex and PharmaEssentia
entered into a license agreement, pursuant to which PharmaEssentia
was granted a license to develop and commercialize Oraxol and
Oratecan in Taiwan and Singapore. The agreement was amended in
December 2016 to also include Vietnam in the territories covered by
the license.
Under the terms of the expanded agreement, which includes
Oradoxel, Athenex will receive a cash payment as well as the
potential to receive additional milestone payments for certain
development and regulatory milestones of Oradoxel in the
territories. PharmaEssentia will be responsible for all activities
and expenses relating to clinical development, regulatory approval,
and commercialization of Oradoxel in the territories.
Docetaxel is an anti-cancer chemotherapeutic agent that is used
widely in the treatment of breast, prostate, gastric, head and
neck, and lung cancers. Oradoxel is an oral formulation of
Docetaxel combined with HM30181A, a novel gastrointestinal tract
specific P-glycoprotein pump inhibitor. Oradoxel is currently in
Phase I clinical studies in the U.S. and New Zealand, and is ready
to advance to Phase II with studies expected to begin in the first
half of 2019.
Dr. Kochung Lin, Chief Executive Officer of PharmaEssentia,
commented, “We are excited with the encouraging results so far from
clinical trials of Athenex’s Orascovery drug candidates,
particularly Oraxol. The potential of oral chemotherapy drugs to
improve efficacy and safety, and improve patients’ quality of life,
cannot be overstated. Athenex has generated promising Phase I data
with both Oratecan and Oradoxel, and we are pleased to participate
in the development of these exciting products in Taiwan, Singapore
and Vietnam to help realize the full potential of this platform. We
have been impressed by the Athenex team in their execution and are
delighted to continue and expand our excellent partnership with the
addition of
Oradoxel.”
Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex,
stated, “This agreement builds on our longstanding relationship
with PharmaEssentia. PharmaEssentia has demonstrated strong
commitment to cancer drug research and development, and we are
confident they have the capabilities for successfully delivering
Oradoxel to patients in the licensed territories.”
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 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. 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; and multiple locations
in Chongqing, China. For more information, please visit
www.athenex.com.
About PharmaEssentia CorporationPharmaEssentia
Corporation (Taipei Exchange:6446) is a fully integrated global
biopharmaceutical company delivering efficacious, safe and
cost-effective therapeutic products for the treatment of human
diseases while aiming to bring long lasting value to stakeholders.
PharmaEssentia was founded in 2003 by a group of Taiwanese-American
executives and high-ranking scientists from leading U.S.
biotechnology and pharmaceutical companies in order to develop
treatments for myeloproliferative neoplasms, hepatitis and other
diseases. The company is committed to the improvement of health and
quality of life for patients suffering from these diseases. The
company’s world-class cGMP biologics facility in Taichung is
certified by the Taiwan Food and Drug Administration (TFDA) and is
designed and operated to be compliant with all U.S. FDA and EMA
requirements.
Forward-Looking Statement 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,”
“expect,” “foresee,” “guidance,” “intend,” “likely,” “may,” “plan,”
“potential,” “predict,” “probable,” “project,” “seek,” “should,”
“will,” 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; 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 SzeChief Financial
OfficerEmail: randollsze@athenex.com Jacqueline
LiCorporate Development and Investor
RelationsEmail: jacquelineli@athenex.com
PharmaEssentia Corporation:
Dr. Shan-Chi KuEmail:
ShanChi_Ku@pharmaessentia.com
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