ASLAN Pharmaceuticals Enters Into a Strategic Licensing Deal With Zenyaku
Kogyo for the Development and Commercialization of Eblasakimab in Japan
o ASLAN will receive up to $15 million in upfront and near-term payments and
up to an additional $123.5 million based on development and commercial
milestones plus tiered royalties on sales in percentages ranging up to low
twenties
o Zenyaku Kogyo, a leading Japanese pharmaceutical company specializing in
dermatology and oncology, plans to initiate a Phase 1 study of eblasakimab
in Japan in the first half of 2024
o Topline data from ASLAN’s global TREK-AD Phase 2b study of eblasakimab in
moderate-to-severe AD patients is expected in early July 2023
SAN MATEO, Calif. and SINGAPORE and TOKYO, June 22, 2023 (GLOBE NEWSWIRE) --
ASLAN Pharmaceuticals (“ASLAN”, Nasdaq: ASLN), a clinical-stage,
immunology-focused biopharmaceutical company developing innovative treatments
to transform the lives of patients, and a leading Japanese pharmaceutical
company Zenyaku Kogyo Co., Ltd. (“Zenyaku”), a subsidiary of privately held
Zenyaku Holdings Co., Ltd. (“Zenyaku Holdings”), today announced a strategic
licensing agreement granting Zenyaku exclusive rights to develop and
commercialize eblasakimab in atopic dermatitis (AD) and all other indications
in Japan.
ASLAN will receive an upfront payment of $12 million and is eligible to
receive an additional $3 million from Zenyaku upon achieving certain
pre-agreed conditions for the TREK-AD Phase 2b trial data readout and delivery
of the clinical study report, up to $29.5 million in development milestones
and up to $94 million in commercial milestones. Zenyaku will make double digit
royalty payments to ASLAN on net sales of eblasakimab in percentages ranging
up to low twenties. Under the terms of the licensing agreement, Zenyaku will
be responsible for all development and commercialization activities for
eblasakimab in Japan. Zenyaku plans to initiate a Phase 1 study of eblasakimab
in Japan in the first half of 2024. ASLAN retains an option that can be
exercised at any time to reacquire the rights to eblasakimab in Japan in the
future.
Zenyaku has extensive product development, regulatory and marketing expertise
in dermatology and immunology indications in Japan. A long-term partner of
leading global pharmaceutical companies, Zenyaku markets Rituxan^® (rituximab)
in the Japanese market, and conducts all clinical development in Japan.
Zenyaku has successfully obtained regulatory approvals in Japan for Rituxan^®
in 11 additional indications, including several oncology and dermatology
indications, 7 of which are unique to the Japanese market.
“We are extremely pleased to partner with Zenyaku, a leading Japanese
pharmaceutical company with exceptional clinical and life cycle management
expertise. Zenyaku has established a successful track record in developing
novel biologics and gaining regulatory approvals, as well as successfully
commercializing dermatology therapies in Japan,” said Dr Carl Firth, CEO,
ASLAN Pharmaceuticals. “The burden of AD is significant and growing in Japan –
there are 5 million people living with the disease^1 and millions more who
live with other Type 2 driven diseases. As we approach late-stage development
of eblasakimab globally, it was important for us to identify a partner like
Zenyaku who can apply its experience to accelerate the development of
eblasakimab in Japan.”
“As the burden of living with moderate-to-severe AD continues to grow in
Japan, there is an increasing demand for more innovative, effective and
convenient treatments from physicians and patients,” said Koichi Hashimoto,
President and Chief Executive Officer of Zenyaku Kogyo. “We are very pleased
to partner with ASLAN as we expand our dermatology portfolio, and
eblasakimab’s unique mechanism of action and the potential for a safe,
efficacious, and convenient treatment for moderate-to-severe AD, represents an
important and strategic addition to our pipeline. Based on the positive data
generated to date, we believe that eblasakimab has the potential to be a
first-in-class differentiated therapy for AD in Japan.”
About eblasakimab
Eblasakimab is a potential first-in-class monoclonal antibody targeting the
IL-13 receptor subunit of the Type 2 receptor, a key pathway driving several
allergic inflammatory diseases. Eblasakimab’s unique mechanism of action
enables specific blockade of the Type 2 receptor and has the potential to
improve upon current biologics used to treat allergic disease. By blocking the
Type 2 receptor, eblasakimab prevents signaling through both interleukin 4
(IL-4) and interleukin 13 (IL-13) – the key drivers of inflammation in atopic
dermatitis (AD). Positive results from a Phase 1b multiple-ascending-dose
study established proof-of-concept for eblasakimab and supported its potential
as a novel, differentiated treatment for AD. ASLAN is currently conducting
TREK-AD, a Phase 2b trial to evaluate eblasakimab in biologic naïve
moderate-to-severe AD patients, with topline readout expected in early July
2023. ASLAN is also investigating eblasakimab in dupilumab experienced,
moderate-to-severe AD patients in the Phase 2 trial TREK-DX, with data
expected in the first quarter of 2024.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused
biopharmaceutical company developing innovative treatments to transform the
lives of patients. ASLAN is developing eblasakimab, a potential first-in-class
antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis
(AD) with the potential to improve upon current biologics used to treat
allergic disease. Eblasakimab is being investigated in a global Phase 2b trial
of moderate-to-severe AD patients with topline readout expected in early July
2023. ASLAN is also developing farudodstat, a potent oral inhibitor of the
enzyme dihydroorotate dehydrogenase (DHODH) as a potential first-in-class
treatment for alopecia areata (AA) in a Phase 2a proof-of-concept trial with
an interim readout expected in 1Q 2024. ASLAN has teams in San Mateo,
California, and in Singapore. For additional information please visit the
website or follow ASLAN on LinkedIn.
About Zenyaku Kogyo
Zenyaku Kogyo, a subsidiary of Zenyaku Holdings, is a privately held Japanese
pharmaceutical company, established in 1950 and headquartered in Tokyo, Japan.
The company develops dermatological and anti-cancer drugs in Japan including
Rituxan^®, an anti-CD20 antibody for the treatment of B-cell Non-Hodgkin's
Lymphoma. The Zenyaku Holdings group of companies, with over 600 employees,
co-markets Rituxan^® with Chugai Pharmaceutical Co., Ltd., and other
prescription drugs including Perazolin for oncology indications and Zefnart, a
topical antifungal preparation and has an OTC consumer healthcare portfolio in
dermatology. Zenyaku Kogyo's ongoing research interests are focused on
dermatology, cancer, autoimmune diseases, and antibody therapeutics. For
additional information in Japanese, please visit www.zenyaku.co.jp.
Forward-looking statements
This release contains forward-looking statements. These statements are based
on the current beliefs and expectations of the management of ASLAN
Pharmaceuticals Limited and/or its affiliates (the “Company”). These
forward-looking statements may include, but are not limited to statements
regarding the Company’s business strategy and clinical development plans; the
Company’s plans to develop and commercialize eblasakimab; the safety and
efficacy of eblasakimab; the Company’s plans and expected timing with respect
to clinical trials, clinical trial enrolment and clinical trial results for
eblasakimab; the potential of eblasakimab as a first-in-class treatment for
atopic dermatitis; and the Company’s cash runway. The Company’s estimates,
projections and other forward-looking statements are based on management’s
current assumptions and expectations of future events and trends, which affect
or may affect the Company’s business, strategy, operations, or financial
performance, and inherently involve significant known and unknown risks and
uncertainties. Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a result of many
risks and uncertainties, which include, unexpected safety or efficacy data
observed during preclinical or clinical studies; clinical site activation
rates or clinical trial enrolment rates that are lower than expected; the
impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and
Russia and bank failures on the Company’s business and the global economy;
general market conditions; changes in the competitive landscape; and the
Company’s ability to obtain sufficient financing to fund its strategic and
clinical development plans. Other factors that may cause actual results to
differ from those expressed or implied in such forward-looking statements are
described in the Company’s US Securities and Exchange Commission filings and
reports (Commission File No. 001- 38475), including the Company’s Annual
Report on Form 20-F filed with the US Securities and Exchange Commission on
March 24, 2023. All statements other than statements of historical fact are
forward-looking statements. The words “believe,” “may,” “might,” “could,”
“will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
“plan,” or the negative of those terms, and similar expressions that convey
uncertainty of future events or outcomes are intended to identify estimates,
projections, and other forward-looking statements. Estimates, projections, and
other forward-looking statements speak only as of the date they were made,
and, except to the extent required by law, the Company undertakes no
obligation to update or review any estimate, projection, or forward-looking
statement.
Notes
1. Decision Resources Group, Atopic Dermatitis Disease Landscape and Forecast
report 2022
ASLAN Media and IR contacts
Emma Thompson Ashley R. Robinson
Spurwing Communications LifeSci Advisors, LLC
Tel: +65 6206 7350 Tel: +1 (617) 430-7577
Email: ASLAN@spurwingcomms.com Email: arr@lifesciadvisors.com
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