AsianScientist (Nov. 12, 2015) – ASLAN Pharmaceuticals (ASLAN) and Hyundai Pharm Co. Ltd. (Hyundai) have entered a collaboration and licencing agreement to develop and commercialize ASLAN001 (varlitinib) for the treatment of cholangiocarcinoma (CCA) in South Korea.
ASLAN001 is a small molecule pan-HER inhibitor targeted for cholangiocarcinoma, an aggressive form of bile duct cancer with no approved therapy and a very poor prognosis. It is also being studied in gastric and breast cancer. Worldwide, South Korea has one of the highest prevalence of cholangiocarcinoma and gastric cancer, with 4,000 and 30,000 new patients diagnosed annually respectively.
Under the terms of agreement, ASLAN and Hyundai will collaborate closely to accelerate the development of ASLAN001 in South Korea and will conduct clinical trials to study the efficacy of the drug in CCA. Together, both parties intend to submit an Investigational New Drug Application to the Korean Ministry of Food and Drug Safety to initiate clinical trials in Korea for CCA before the end of 2015.
Hyundai will pay to ASLAN upfront and development milestones and royalties on sales upon successful commercialization of ASLAN001. Hyundai also retains the first rights of negotiation to develop and commercialize ASLAN001 for gastric and breast cancer in South Korea. ASLAN will retain co-marketing rights to ASLAN001 in South Korea.
ASLAN will continue the development of ASLAN001 in a Phase 2A/B study that commenced in December 2014 in second-line metastatic breast cancer across Asia. ASLAN001 was awarded Orphan Drug Designation by the US FDA in CCA in August 2015.
Carl Firth, Chief Executive Officer and Founder, ASLAN Pharmaceuticals, said, “The prevalence of diseases such as gastric cancer and cholangiocarcinoma is higher in South Korea than many other parts of the world, creating a high unmet need for more effective treatments. We are pleased to collaborate with Hyundai which has a long history in South Korea.”
Young Hak Kim, Hyundai Pharm Group Chief Executive Officer, added: “ASLAN001 has demonstrated promising results in studies in cholangiocarcinoma, gastric and breast cancer, and we look forward to working together with ASLAN to deliver treatments that will improve the lives of patients in South Korea.”
Source: ASLAN Pharmaceuticals; Photo: Ed Uthman/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.