On March 11, 2019 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, reported that they have expanded their strategic collaboration by entering into a new commercialisation agreement whereby both parties will partner to commercialise ASLAN003 in all indications in South Korea (Press release, ASLAN Pharmaceuticals, MAR 11, 2019, View Source [SID1234534264]).
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ASLAN will grant BioGenetics exclusive rights to commercialise ASLAN003 in South Korea in exchange for an upfront payment of US$1 million and up to US$8 million in sales and development milestones. ASLAN is also eligible to receive tiered double digit royalties on net sales from the high-teens to the mid-twenties range. BioGenetics will contribute to the global R&D costs incurred by ASLAN in the clinical development of ASLAN003 in acute myeloid leukaemia (AML) and will be responsible for obtaining initial and all subsequent regulatory approvals of ASLAN003 in South Korea.
ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be first-in-class in AML. ASLAN is currently conducting a phase 2a dose optimisation study of ASLAN003 in AML and expects to complete the study in the first half of 2019. ASLAN recently presented preliminary data from the study at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in which ASLAN003 showed early signs of safety and efficacy in relapsed and refractory AML patients. In previous clinical studies, ASLAN003 has demonstrated potent inhibition of DHODH, a lack of toxicities associated with first generation inhibitors and other novel AML therapies, and the potential to induce differentiation in blast cells and applicability in a broad range of AML patients. ASLAN003 has been awarded orphan drug designation from the US Food and Drug Administration.
In 2018, the estimated five-year prevalence of leukaemia in South Korea was 10,9481. AML has previously been reported to be the most frequent subtype among all myeloid malignancies2 in South Korea.
Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, commented: "We believe that ASLAN003 has the potential to be a first-in-class therapy for AML and are pleased that BioGenetics has chosen to partner with us as we continue the phase 2 development of this important asset. We have already seen early signs of clinical activity and look forward to the read out from the first part of the ongoing study later this year."
JooHoon Ahn, Chief Executive Officer of Biopharma, BioGenetics, commented: "We are delighted to be partnering with ASLAN for the second time as we build a pipeline of innovative drugs that we believe have the potential to address significant unmet needs for Korean patients. We are excited by the data that ASLAN003 has generated to date and its potential in a broad range of AML patients."
The agreement for ASLAN003 is ASLAN’s second commercialisation agreement with BioGenetics. In February 2019, ASLAN signed an agreement with BioGenetics whereby both parties will collaborate to commercialise ASLAN’s lead asset, varlitinib, in all indications in South Korea.
ASLAN acquired the global rights to develop and commercialise ASLAN003 in May 2012 from Almirall. Under the terms of the agreement, ASLAN is required to pay Almirall a low double-digit percentage of all licensing revenues received.