Singapore, 9 NOVEMBER 2015 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, and Hyundai Pharm Co. Ltd. (Hyundai), a leading Korean pharmaceutical company, have entered a collaboration and licence agreement to develop and commercialise ASLAN001 (varlitinib) for the treatment of cholangiocarcinoma (CCA) in South Korea.
ASLAN001 is a potentially best-in-class small molecule pan-HER inhibitor targeted for cholangiocarcinoma, an aggressive form of bile duct cancer with no approved therapy and a very poor prognosis, and is also being studied in gastric and breast cancer. Worldwide, South Korea has one of the highest prevalence rates of cholangiocarcinoma and gastric cancer, with 4,000 and 30,000 new patients diagnosed annually respectively[1],[2].
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 commercialisation of ASLAN001. Hyundai also retains the first rights of negotiation to develop and commercialise 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: “This agreement underscores our focus and commitment to transforming the treatment of Asia prevalent cancers. 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. The Group’s wide access to patients and healthcare professionals, expertise and innovative strategy make Hyundai a strong commercial partner for ASLAN in South Korea. Together, we look forward to expediting the development of ASLAN001 in this important market.”
Young Hak Kim, Hyundai Pharm Group Chief Executive Officer, added: “We are excited to add ASLAN001 to our growing portfolio of innovative therapeutic agents. This enhances our oncology pipeline and aligns with our long-term research and development strategy.
“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.”
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 9107 5559
Email: ASLAN@spurwingcomms.com
Yang-Kyu, Kim
Hyundai Pharm Co., Ltd.
Tel: +82 (2) 2600 3824
Email: 20060016@hdpharm.co.kr
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals is an oncology focused biotechnology company developing a portfolio of immunotherapies and targeted drugs, focusing on Asia prevalent tumour types. Led by a highly experienced management team with global pharmaceutical expertise, ASLAN is headquartered in Singapore with a platform which reaches across the region via its offices in Taiwan and China, enabling the Company to conduct and support regional clinical development programmes. The Company’s proprietary pipeline of 4 development-stage candidates addresses multiple indications including gastric and breast cancers and inflammatory diseases. ASLAN’s most advanced compounds are in phase 2: ASLAN001, a pan-HER inhibitor with phase 2 data in gastric cancer, being developed in cholangiocarcinoma, breast cancer and gastric cancer; and ASLAN002, which targets RON, an immune checkpoint inhibitor, and cMET. www.aslanpharma.com
About Hyundai Pharm Co., Ltd.
Founded in 1965 HYUNDAI Pharm Co. Ltd., with its base in Seoul, Korea, is a pharmaceutical company specialized in modern medicine. Establishing a corporate philosophy to “Contribute to the improvement of human health”, which aims to capture an idea of respect for human life and the spirit of the CEO’s transparent philosophy, the Company’s vision is to achieve novel transformations through changes and innovation in order to proactively respond to the rapidly changing domestic and international environment.
HYUNDAI is a leading expert in various therapeutic categories, including CV and respiratory system, and the Company is expanding into additional areas including women’s health, CNS, and oncology. HYUNDAI engages in manufacturing and sales of more than 200 products in prescription medications, OTC medications, FDA-approved hair loss treatments, and health functional beverages. Concurrently, HYUNDAI is investing in pharmaceutical product development, most recently in the in-house development of novel Type II diabetes molecules, as well as co-development agreements with foreign biotech companies and universities. http://www.hyundaipharm.co.kr/english/index.jsp
About ASLAN001
ASLAN001 is a potent small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The type I RTK family consists of four distinct but closely related receptors: epidermal growth factor receptor (EGFR, ErbB1, HER1), epidermal growth factor receptor 2 (HER2, ErbB2), epidermal growth factor receptor 3 (HER3, ErbB3), and epidermal growth factor receptor 4 (HER4, ErbB4). ASLAN001 is a potent, reversible inhibitor of EGFR, HER2 and HER4. In a large variety of cancers, the overexpression and/or constitutive activation of EGFR and HER2 are often observed and frequently correlate with poor clinical prognosis. Therefore, by inhibiting the activation of the HER receptors via ASLAN001, effects such as shrinkage of the tumor and longer survival can be anticipated. ASLAN001 is currently being studied in breast cancer and studies in gastric cancer and cholangiocarcinoma are underway.
About Cholangiocarcinoma
Cholangiocarcinoma is cancer of the biliary tract and is currently classified into two subtypes - intrahepatic or extrahepatic. Globally, cholangiocarcinoma is the second most common form of liver cancer. Cholangiocarcinoma is a very heterogeneous and poorly understood disease for which there are currently no approved targeted therapies. There is strong scientific rationale for HER cMET and RON inhibitors in cholangiocarcinoma, demonstrating aberrant pathway activity with disease progression. ASLAN is currently planning further clinical trials of ASLAN001 in cholangiocarcinoma, targeting the HER, cMET and RON pathways.
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