• Boehringer Ingelheim focuses on the development      of next generation NASH treatments that target all three key drivers of the      disease - steatosis, inflammation and fibrosis

• Collaboration aims to develop first-in-class dual      agonist (GLP1R/FGF21R agonist) for NASH

• Yuhan Corporation to receive up to USD 870      million in upfront and success-based development and commercialization milestones,      excluding royalties

INGELHEIM, Germany & SEOUL, South Korea -- (BUSINESS WIRE) --

Boehringer Ingelheim and Yuhan Corporation today announced a collaboration and license agreement for the development of a first-in-class dual agonist for the treatment of NASH and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. The collaboration brings together Yuhan Corporation’s expertise in FGF21 biology, obesity and NASH with Boehringer Ingelheim’s pharmaceutical expertise and commitment to bringing innovative medicines to patients with cardiometabolic diseases.

NASH often starts with the accumulation of fat in the liver, giving rise to inflammation and finally leading in many patients to liver fibrosis and cirrhosis. It has an especially high prevalence among obese and diabetic patients and is an area of high-unmet medical need with no treatments currently available. Boehringer Ingelheim believes that in many cases approaches targeting one of the features of NASH will not be able to achieve the desired resolution of NASH in patients with advanced stages of the disease. Thus Boehringer Ingelheim has built a comprehensive program to develop next generation therapy approaches targeting all three key drivers of the disease - steatosis, inflammation and fibrosis.

Preclinical evidence suggests high efficacy, when combining the gut-derived hormone GLP-1 with FGF21. The dual agonist (GLP1R/FGF21R agonist) is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis as well as having direct antifibrotic effects and complements Boehringer Ingelheim’s R&D portfolio in NASH adding another potential first-in-class opportunity.

“We are excited about this new opportunity which adds to our longstanding and successful partnership with Yuhan Corporation,” says Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the Innovation Unit. “This partnership brings us closer to next generation treatments for patients with NASH,” adds Pairet.

”We look forward to working jointly with Boehringer Ingelheim, with its strong track record of bringing new treatments to patients with cardiometabolic disease. Boehringer Ingelheim’s clinical expertise will now be applied to the development of this drug which has the potential to make a real difference for patients with NASH,” says Jung Hee Lee, CEO and President at Yuhan Corporation. “This molecule, which is a fusion protein utilizing the long-acting (HyFc) technology of Genexine, has been developed in-house by Yuhan Corporation. Not only is our collaboration with Boehringer Ingelheim on this molecule Yuhan’s first external partnership with biologics, it is also the very first out-licensing of biologics targeting NASH from Korea,” adds Mr. Lee.

Boehringer Ingelheim has a long history of excellence in the discovery and development of medicines for patients with cardiometabolic diseases. It has established a broad portfolio of marketed products for thromboembolic diseases, type 2 diabetes, acute myocardial infarction, hypertension, and cardio-renal risk reduction. The cardiometabolic diseases pipeline extends beyond type 2 diabetes and anticoagulation with a focus on innovative drugs for the treatment of the devastating consequences of diabetes as well as contributing factors like obesity.

Yuhan Corporation has over many years been a commercial partner for selected Boehringer Ingelheim cardiovascular and metabolic products in Korea. Under the terms of the agreement Yuhan Corporation will receive an upfront and near term payments of USD 40 million and is eligible to receive up to USD 830 million in potential milestone payments plus tiered royalties on future net sales.