Gilead Sciences Enters $785M Collaboration with Yuhan to Advance Novel NASH Therapies for Advanced Fibrosis

On January 6, Gilead Sciences and Yuhan Co., Ltd. announced that the two companies had entered into a licensing and collaboration agreement to jointly develop novel therapeutic regimens for the treatment of advanced fibrosis caused by non-alcoholic steatohepatitis (NASH).

Under this agreement, Gilead will obtain the rights to globally develop and commercialize novel small molecules with undisclosed targets, while Yuhan will retain commercialization rights for certain specific products in South Korea. Yuhan and Gilead will jointly conduct preclinical studies, and Gilead will be responsible for global clinical development. Under the terms of this agreement, Yuhan will receive a $15 million upfront payment and will be eligible for up to $770 million in potential milestone payments upon achieving certain development and commercial milestones, as well as royalties on future net sales. This agreement builds upon the existing commercial collaboration between the two companies to promote Gilead’s products in South Korea.

Yuhan Co., Ltd. is a healthcare company headquartered in South Korea, established in 1926. The company has positioned itself as the largest in South KoreaPharmaceuticalsOne of the company’s core businesses includes specialized care, dietary supplements, home and animal health, and contract manufacturing of active pharmaceutical ingredients (APIs). The company has multiple subsidiaries and conducts business globally through joint ventures with The Clorox Company and Kimberly-Clark Corporation in the United States. Currently, the company’s primary areas of focus include cardiovascular and metabolic diseases, inflammatory and immune disorders, and cancer. The pipeline of investigational products related to cardiovascular and metabolic diseases disclosed on the company’s official website is as follows:

NASH is a chronic, progressive liver disease characterized by hepatic fat accumulation and inflammation, which can lead to liver scarring or fibrosis, thereby impairing liver function. Patients with advanced fibrosis caused by NASH, defined as bridging fibrosis (F3) or cirrhosis (F4), face severe outcomes, including end-stage liver disease, hepatocellular carcinoma, and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. Currently, treatment options for patients with NASH are limited.

John McHutchison, Chief Scientific Officer of Gilead Sciences, stated: “This collaboration builds on our long-standing partnership with YUHAN, with the new focus on researching novel approaches to treat advanced fibrosis caused by NASH, complementing our ongoing research programs. We look forward to working with the YUHAN team to advance our efforts in this area, where there is a significant unmet need for patients.”

Jung Hee Lee, President of Yuhan, stated, “I am delighted with this collaboration, which significantly expands and deepens our long-standing, trusted partnership with Gilead. We believe that Gilead’s expertise in liver diseases will accelerate the development of our novel drugs. As a company, we are committed to researching new therapies to improve the lives of patients with NASH.”

In late December 2018, Gilead Sciences secured an exclusive right of first refusal for the global rights to three TGF-beta antibodies from Scholar Rock, with an upfront payment of $80 million ($50 million in cash and $30 million in equity) and a near-term milestone payment of $25 million. Various milestone payments could bring the total value of the deal to up to $1.4 billion. The three programs acquired by Gilead include two TGF-beta complex activation inhibitors and another TGF-beta inhibitor with an undisclosed mechanism of action. All these products are intended for the treatment of fibrosis, thereby strengthening Gilead’s NASH pipeline.(Compiled by David, Sina Medicine; Edited by Kerr)

Source: Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis

Source: Sina Medical News