Athenex Announces Progress Update from Partner Almirall on Tirbanibulin Ointment
October 28 2019 - 3:30AM
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 a progress update from
partner Almirall on tirbanibulin ointment (also known as ALM14789,
formerly known as KX-01 or KX2-391) for the treatment of actinic
keratosis (AK).
|
ALM14789 for actinic keratosisAs announced in the
2019 American Academy of Dermatology Annual Meeting in Washington,
DC (on March 2, 2019), both Phase III studies, KX01-AK-003 and
KX01-AK-004, achieved their primary endpoint, which was defined as
100% clearance of the AK lesions at Day 57 within the face or scalp
treatment areas: Complete Clearance was observed in 44% and 54% of
the patients for tirbanibulin respectively while it was 5% and 13%
for vehicle treated groups. Only patients showing complete
clearance at the primary evaluation endpoint on day 57 were
followed quarterly in the extension period until recurrence was
observed in the treatment area. Recurrence rates were defined as
proportion of patients in whom at least one treated or new actinic
keratosis lesion was identified in the treated area throughout one
year follow up.The recurrence rates in patients treated with
tirbanibulin 1% ointment were 74% and 72% in the pivotal trials
KX01-AK-003 and KX01-AK-004, respectively. Overall, at the
recurrence follow up study visit when actinic keratosis (maximum
eight initial number of lesions) in the treated area was first
observed, 86% had only one or two lesions and 48% reported at least
one lesion that was not identified at the time of the initial
treatment i.e. newly occurring lesions that were considered as
recurrences.These results represent the last piece of information
to submit the New Drug Application (NDA) in the US and the
Marketing Authorization Application (MAA) in Europe that are
expected to be launched in Q1 2021 and Q2 2021 respectively. |
Dr. Rudolf Kwan, Chief Medical Officer of
Athenex, stated, “We are pleased with the continued progress of the
tirbanibulin ointment program. We recently completed pre-NDA
consultation with the U.S. FDA and our preparations for the NDA
submission in the U.S. are on track. We look forward to working
with our partner, Almirall, towards commercializing this product,
if approved.”
In December 2017, Athenex granted Almirall, S.A., a leading
skin-health focused global pharmaceutical company, an exclusive
license to research, develop and commercialize tirbanibulin in the
U.S. and European countries, including Russia. Athenex is
responsible for the U.S. FDA regulatory for tirbanibulin ointment
in AK. Almirall will employ its expertise to support the
development in Europe and also to commercialize the product in the
defined territories.
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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