ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology-focused biopharmaceutical company developing novel
therapeutics for global markets, and BioGenetics Co Ltd, a leading
South Korean healthcare company, have entered into an agreement
whereby both parties will collaborate to commercialise varlitinib
in all indications in South Korea.
ASLAN will grant BioGenetics exclusive rights to commercialise
varlitinib in South Korea in exchange for an upfront payment of
US$2 million and up to US$11 million in sales and development
milestones. ASLAN is also eligible to receive tiered double digit
royalties on net sales up to the mid-twenties. ASLAN will continue
to fund all clinical development of varlitinib, BioGenetics will be
responsible for obtaining initial and all subsequent regulatory
approvals of varlitinib in South Korea.
ASLAN is currently conducting a global pivotal trial (TreeTopp)
in second-line biliary tract cancer (BTC), with topline data
expected in the second half of 2019. At the recent ASCO GI
conference, ASLAN presented positive data from an ongoing
multicentre phase 1b/2 clinical trial of varlitinib plus
gemcitabine and cisplatin in first-line BTC. Varlitinib has been
awarded orphan drug designation for the treatment of BTC by the
Ministry of Food and Drug Safety in South Korea, which provides
certain benefits for the development and commercialisation of
varlitinib in South Korea including an extension of the marketing
exclusivity period and exemption of certain local clinical trial
requirements.
Dr Carl Firth, Chief Executive Officer of ASLAN
Pharmaceuticals, commented: “We are delighted to partner
with a team that brings strong knowledge of the South Korean
regulatory and commercial environment. We believe BioGenetics is
well placed to maximise the value of varlitinib in BTC and
potentially other tumour types in the future.”
JooHoon Ahn, Chief Executive Officer of Biopharma,
BioGenetics, commented: “We are excited by the clinical
data in BTC that ASLAN has generated to date. The unmet need for
effective treatments for BTC, one of the ten most prevalent cancers
in South Korea, is high. Our partnership with ASLAN is in-line with
our strategy to identify high-quality, late stage development
assets that have the potential to transform treatment paradigms and
address pressing needs in oncology. We have attracted a team of
experienced pharmaceutical executives to build our pharmaceutical
division and we look forward to working closely with ASLAN to
realise the potential of varlitinib in South Korea.”
In 2015, ASLAN entered a collaboration and license agreement
with Hyundai Pharm to develop and commercialise varlitinib for the
treatment of cholangiocarcinoma (CCA) in South Korea. Prior to
executing a broader agreement with BioGenetics, ASLAN exercised its
right to buy back the rights to varlitinib in CCA, making a payment
of $0.3M to Hyundai Pharm.
Ends
Media and IR contacts
Emma
ThompsonSpurwing CommunicationsTel: +65 6340 7287Email:
ASLAN@spurwingcomms.com |
Robert
UhlWestwicke PartnersTel: +1 858 356 5932Email:
robert.uhl@westwicke.com |
About Varlitinib
Varlitinib (ASLAN001) is a highly potent, oral, reversible,
small molecule pan-HER inhibitor that targets the human epidermal
growth factor receptors HER1, HER2 and HER4. These receptors can be
mutated or overexpressed in many tumors, which can cause excessive
proliferative activity and uncontrolled growth. Therefore, by
inhibiting the activation of the HER receptors, varlitinib could
inhibit proliferation and control tumor growth. Varlitinib is
currently being studied in a global pivotal study (TreeTopp) for
2nd line biliary tract cancer. Varlitinib has been granted orphan
drug designation in the United States for cholangiocarcinoma, a
sub-type of biliary tract cancer, and was awarded orphan drug
designation for the treatment of biliary tract cancer by the
Ministry of Food and Drug Safety in South Korea.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a
clinical-stage oncology-focused biopharmaceutical company
developing novel therapeutics for global markets. ASLAN targets
diseases that are both highly prevalent in Asia and orphan
indications in the United States and Europe. Led by a senior
management team with extensive experience in global and regional
development and commercialisation, ASLAN is headquartered in
Singapore and has offices in Taiwan and China. ASLAN’s portfolio is
comprised of three product candidates which target validated growth
pathways applied to new patient segments, novel immune checkpoints
and novel cancer metabolic pathways. ASLAN’s partners include Array
BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional
information please visit www.aslanpharma.com.
About BioGenetics
BioGenetics, formerly Unidus Corporation, is a Korea-based
company established in 1973 engaged in the manufacturing of medical
products. As part of the company’s diversification strategy,
BioGenetics established its biopharmaceutical division in April
2018 and appointed Mr Joohoon Ahn, as CEO of the newly established
division. Mr Ahn was most recently Senior Managing Director at
Kwangdong Pharmaceuticals, one of the top 3 domestic pharmaceutical
companies in Korea, and has 28 years of experience in the Korean
pharma industry in regulatory affairs, commercialisation, and
business development. Biogenetics is co-developing WM-S1-001
for Erbitux®-resistant colon cancer with WellMarkerBio, a spin-off
company from Asan Medical Center, one of the largest private
hospitals in Korea.
Forward looking statementsThis release and the
accompanying financial information, if any, 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, the
Company’s plans to develop and commercialise its product
candidates, the safety and efficacy of the Company’s product
candidates, the Company’s plans and expected timing with respect to
regulatory filings and approvals, and the size and growth potential
of the markets for the Company’s product candidates. 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 these risks and uncertainties, which
include, without limitation the risk factors described in the
Company’s US Securities and Exchange Commission filings and reports
(Commission File No. 001-38475), including the Company’s prospectus
dated May 8, 2018 filed with the US Securities and Exchange
Commission on such date.
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.
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