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,
announced today that its partner, Almirall (Almirall, S.A., BME:
ALM), has launched Klisyri® (tirbanibulin) in Germany and the UK.
Klisyri received approval by the European Commission and the UK
Medicines & Healthcare products Regulatory Agency (MHRA) in
July and August of 2021, respectively, for the topical treatment of
actinic keratosis (AK) of the face and scalp in adults.
Tirbanibulin is a novel, topical first-in-class
microtubule inhibitor with a selective antiproliferative mechanism
of action that we believe represents a significant step forward in
the treatment of AK due to its short treatment protocol (one
application daily for 5 days), proven efficacy, and safety
profile.
“We are extremely pleased to see Klisyri
launching in these two major European markets by our partner
Almirall,” said Dr. Johnson Lau, Chief Executive Officer of
Athenex. “The launch of Klisyri represents an option with
acceptable tolerability and shorter duration of treatment for
dermatologists to provide their patients. Athenex is also working
with our commercial partners in other geographies on either
clinical studies or regulatory filings and expect to launch in more
geographic areas in 2022, making this important treatment available
to more AK patients.”
Under the terms of the license agreement with
Almirall, Athenex is eligible to receive up to $45M in milestone
payments associated with launch and expansion into additional
indications. The Company is also eligible to receive additional
sales-related milestone payments. The terms of agreement included
tiered royalties payable to Athenex starting at 15%, based on
annual net sales.
Athenex also has strategic partnerships for
tirbanibulin with Seqirus Pty Ltd, a subsidiary of CSL Limited in
Australia and New Zealand, PharmaEssentia for Japan and Taiwan, and
Xiangxue Pharmaceuticals in China.
About Klisyri®
(tirbanibulin)
Klisyri® (tirbanibulin) is a microtubule
inhibitor indicated for the topical treatment of actinic keratosis
(AK) of the face or scalp. Two phase III studies (KX01-AK-003 and
KX01-AK-004) evaluated the efficacy and safety of tirbanibulin
ointment 1% (10 mg/g) in adults with AK on the face or scalp. The
studies achieved their primary endpoint, which was defined as 100%
clearance of the AK lesions at Day 57 within the face or scalp
treatment areas, each study achieving statistical significance
(p<0.0001) on this endpoint[1].
About Actinic Keratosis
Actinic keratosis (AK) or solar keratosis is a
chronic and precancerous skin disease that occurs primarily in
areas that have been exposed to ultraviolet radiation for a long
period of time. It is usually found on the face, ears, lips, bald
scalp, forearms, the posterior part of the hands, and lower legs.
It is not possible to predict which AK lesions will develop into
squamous cell carcinoma. AK is the most common pre-cancerous
dermatological condition[2].
Athenex and Almirall
Partnership
Athenex, Inc. (NASDAQ: ATNX) and Almirall
entered into a strategic partnership in December 2017 to develop
and market tirbanibulin for the treatment of actinic keratosis and
other skin conditions in the United States and Europe, including
Russia. Athenex has been responsible for conducting all preclinical
and clinical studies in order to gain FDA approval of tirbanibulin.
Almirall will leverage its expertise to support development in
Europe and to market the product in all licensed 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 technologies: (1)
Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase
inhibition, (3) Cell therapy, 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. 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,” “expect,” “foresee,”
“goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,”
“predict,” “preliminary,” “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, uncertainties around
regulatory reviews and approvals; our ability to agree with the FDA
on a new clinical study for oral paclitaxel that is capital and
time efficient; our ability to scale our manufacturing and
commercial supply operations for current and future approved
products, and ability to commercialize our products, once approved;
ability to successfully demonstrate the safety and efficacy of its
drug candidates and gain approval of its drug candidates on a
timely basis, if at all; the preclinical and clinical results for
Athenex’s drug candidates, which may not support further
development of such drug candidates; risks related to our ability
to successfully integrate the business of Kuur into our existing
businesses, including uncertainties associated with maintaining
relationships with customers, vendors and employees, as well as
differences in operations, cultures, and management philosophies
that may delay successful integration and our ability to support
the added cost burden of Kuur’s business; risks related to
counterparty performance, including our reliance on third parties
for success in certain areas of Athenex’s business; our history of
operating losses and our need and ability to raise additional
capital; uncertainties around our ability to meet funding
conditions under our financing agreements and access to capital
thereunder; risks and uncertainties inherent in litigation,
including purported stockholder class actions; risks and
uncertainties related to the COVID-19 pandemic and its ongoing
impact on our operations, supply chain, cash flow and financial
condition; competition; intellectual property risks; uncertainties
around our ability to successfully integrate acquired and merged
businesses in a timely and cost-effective manner and to achieve
synergies; risks relating to doing business internationally and in
China; the risk of development, operational delays, production
slowdowns or stoppages or other interruptions at our manufacturing
facilities as well as our ability to find alternative sources of
supply to meet our obligations and requirements; 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.
Athenex Contacts
Investors
Daniel Lang, MDAthenex, Inc.Email: danlang@athenex.com
Caileigh DoughertyAthenex, Inc.Email:
cdougherty@athenex.com
References
- Blauvelt A, Kempers S, Lain E, et
al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.
New England Journal of Medicine. 2021 Feb 11;384(6):512-520.
- Skin Cancer Foundation. Actinic
Keratosis Overview. Available at:
https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation
January 2021.
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