- Global Pharma News & Resources


Singapore, 31 May 2019 – ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, today announced that it has amended its license agreement with CSL Limited (CSL) so that ASLAN has full global rights to develop, manufacture and commercialise ASLAN004 in all indications. The amended agreement replaces the licensing agreement ASLAN and CSL signed in May 2014.

Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: “We are very excited by the recent data we have generated on ASLAN004 and we believe that it has the potential to be a best-in-class treatment for atopic dermatitis and other inflammatory indications with a differentiated profile. The amendment of our agreement with CSL is an important achievement in our strategy to gain greater commercial control and retain more value from our pipeline programs. We look forward to reporting further data on ASLAN004 in atopic dermatitis and investigating its potential in other inflammatory indications.”

Under the terms of the amended agreement, ASLAN will make a first payment of US$30 million to CSL upon commencement of a phase 3 study of ASLAN004. CSL is also eligible to receive up to US$95 million of regulatory milestones, US$655 million of sales milestones and tiered royalties on net sales between mid-single digits and 10%. Under the terms of the original agreement, ASLAN was responsible for the development of ASLAN004 through to proof-of-concept and the identification of a partner to complete phase 3 development and commercialisation. CSL was eligible to receive between 40% and 50% of all ASLAN004 revenues, including proceeds from out-licensing agreements.

ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor α1 subunit, or IL-13Rα1. By targeting IL-13Rα1, ASLAN004 potently inhibits signalling of both interleukin 4 (IL-4) and interleukin 13 (IL-13), which are central to triggering symptoms of allergy in atopic dermatitis. ASLAN is currently conducting a phase 1 clinical trial in healthy volunteers investigating ASLAN004 as a treatment for atopic dermatitis. Recently announced data from the first part of the study demonstrated that ASLAN004 was safe and well tolerated at all doses when administered intravenously. Analysis of downstream mediators including phosphorylation of STAT6, a critical mediator of allergic inflammation, demonstrated complete inhibition within one hour of dosing, which was then maintained for more than 29 days. ASLAN expects to report data from the second part of the study, testing a subcutaneous formulation, shortly and intends to initiate a multiple ascending dose study in moderate to severe atopic dermatitis patients in the second half of 2019. 

Atopic dermatitis is the most common dermatological disease, affecting over 200 million patients worldwide[1], characterized by red inflamed skin and severe daytime and night-time itching, which can severely impact patients’ quality of life. Up to one-third of adult atopic dermatitis patients are considered moderate-to-severe, for which currently available therapeutics are limited and management is challenging in the majority of cases.

[1] Nutten, S. 2015. Atopic dermatitis: global epidemiology and risk factors