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Boehringer bolsters NASH pipeline with $870m Yuhan deal

Strengthens existing relationship

Boehringer

Boehringer Ingelheim has added to its non-alcoholic steatohepatitis (NASH) pipeline once again via a licence deal with South Korean biotech Yuhan.

The German drugmaker has pledged up to $870m in upfront and milestone payments to the alliance, which will draw on Yuhan’s expertise in fibroblast growth factor 21 (FGF21) – a drug target for NASH and other liver diseases.  Around $40m of the total is in upfront or near-term payments.

The partners want to develop a first-in-class dual agonist that will target both FGF21 and glucagon-like peptide-1 (GLP-1), a well-characterised target for diabetes and obesity therapies. Boehringer is a diabetes specialist and already has a dual GLP-1 and glucagon agonist, partnered with Zealand Pharma, in phase 1b testing.

The two partners think the first-in-class dual agonist will help tackle liver cell injury by hitting all three key drivers of the NASH disease process, reducing liver cell inflammation by resolving steatohepatitis and cutting fibrosis.

NASH is characterised by a build-up of fat that can lead to fibrosis, cirrhosis and - in some patients - the need for a liver transplant. Rates of NASH are on the increase thanks to an epidemic of obesity and diabetes, which increase the risk of developing the disease.

The liver disease is already firmly in Boehringer’s sights, as the company has a Pharmaxis-sourced AOC3 inhibitor called BI 1467335 in a phase 2 trial due to read out later this year, as well as a drug candidates for the disease covered by its recently expanded $201m collaboration with Dicerna Pharma.

Boehringer already has an existing relationship with Yuhan, which acts as the South Korean marketer for three of the German firm’s Eli Lilly-partnered diabetes therapies, Tradjenta (linagliptin), Trajenta Duo (linagliptin/metformin) and Jardiance (empagliflozin).  Yuhan has retained rights to the dual agonist in its home market.

Yuhan said that the combined molecule will be developed using technology licenced from fellow South Korean biotech Genexine, which will be eligible for a 5% of the out-licencing deal in royalties.

NASH is a red hot target in pharma development at the moment, with a host of companies vying to bring forward new treatments for the disease although so far none has made it successfully through to regulatory approval.

Among the big players is Gilead, which recently reported two failed phase 3 trials for ASK1 inhibitor selonsertib and has previously had to abandon two other candidates (simtuzumab and Px-102).

It’s now hoping for better results from a combination approach that will see selonsertib given alongside an FXR agonist (GS-9674) and an ACC inhibitor (GS-0976).

Article by
Phil Taylor

3rd July 2019

From: Research

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