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ASLAN gains global rights for ASLAN004
SINGAPORE—ASLAN Pharmaceuticals has announced an amended license agreement with CSL Limited (CSL), in which ASLAN now has full global rights to develop, manufacture and commercialize ASLAN004 in all indications. The amended agreement replaces a licensing agreement between ASLAN and CSL that was signed in May 2014.
Under the terms of the amended agreement, ASLAN will make a first payment of $30 million to CSL, upon commencement of a Phase 3 study of ASLAN004. CSL is also eligible to receive up to $95 million of regulatory milestones, $655 million of sales milestones and tiered royalties on net sales between mid-single digits and 10%. Under the 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 commercialization; CSL was eligible to receive between 40% and 50% of all ASLAN004 revenues, including proceeds from out-licensing agreements.
“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,” said Dr. Carl Firth, chief executive officer of ASLAN Pharmaceuticals. “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.”
ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor α1 subunit (IL-13Rα1). By targeting IL-13Rα1, ASLAN004 potently inhibits signaling of both interleukin 4 (IL-4) and interleukin 13 (IL-13). IL-4 and IL-13 are central to triggering symptoms of allergy in atopic dermatitis such as redness and itching of the skin, as well as asthma symptoms like shortness of breath, exacerbations of disease, wheezing and coughing.
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, which is testing a subcutaneous formulation, shortly. The company intends to initiate a multiple ascending dose study in moderate to severe atopic dermatitis patients in the second half of 2019.