SINGAPORE—ASLAN Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, and BioGenetics, a leading South Korean healthcare company, have expanded their strategic collaboration by entering into a new commercialization agreement whereby both companies will partner to commercialize ASLAN003 in all indications in South Korea. The commercialization agreement is ASLAN’s second with BioGenetics — in February, ASLAN signed an agreement with BioGenetics to commercialize ASLAN’s lead asset, varlitinib, in South Korea.
ASLAN will grant BioGenetics exclusive rights to commercialize 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 in the clinical development of ASLAN003 in acute myeloid leukemia (AML), and will be responsible for obtaining initial and all subsequent regulatory approvals of ASLAN003 in South Korea.
ASLAN003 is a potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which, according to ASLAN, has the potential to be first-in-class in AML. AML is a cancer of the myeloid line of blood cells, characterized primarily by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. ASLAN is currently conducting a Phase 2a dose optimization study of ASLAN003 in AML and expects to complete the study in the first half of 2019. Preliminary data from the study was presented at the 60th American Society of Hematology Annual Meeting, in which ASLAN003 showed early signs of safety and efficacy in relapsed and refractory AML patients.
“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,” said Dr. Carl Firth, chief executive officer of ASLAN Pharmaceuticals. “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.”
In previous clinical studies ASLAN003 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 U.S. Food and Drug Administration.
“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,” added JooHoon Ahn, chief executive officer of biopharma, BioGenetics.
ASLAN acquired the global rights to develop and commercialize ASLAN003 in 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.