(News Bulletin 247) – The Burgundian company announced this Thursday that it had signed a licensing agreement with a Japanese company relating to the development and marketing of lanifibranor, its drug candidate against soda sickness, in Japan and South Korea.

In a market overwhelmed by the very firm tone of the American Federal Reserve – the CAC 40 lost 1.2% – Inventiva managed to escape the ambient gloom.

The biotech stock rose 12% around 11 a.m., peaking at 25% early in the morning. This progression is due to the announcement of a licensing agreement for its flagship molecule, lanifibranor, intended to treat non-alcoholic steatohepatitis (Nash), also known as “human fatty liver disease” or “soda” and likely to affect 10% of Americans.

Inventiva has entered into an agreement with the Japanese company Hepalys Pharma, created by the investment company Catalys Pacific and in which Inventiva has taken a 30% stake, to develop and market lanifibranor in Japan and South Korea. Hepalys Pharma will thus have the exclusive license for this molecule for these two countries.

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An upfront payment of $10 million

Under the terms of this agreement, Hepalys Pharma will make an upfront payment of $10 million to Inventiva, followed by up to $231 million in milestone payments, which, as is often the case in the pharmaceutical industry, will depend on the achievement of certain commercial, clinical and regulatory milestones.

Assuming that lanifibranor is approved in Japan, Inventiva will also receive “tiered” royalties based on net sales of lanifibranor in Japan and South Korea, with royalties ranging from the mid-10s to the low end of the range. around twenty percent,” the company explains in a press release.

In addition, Inventiva has an option to acquire all of the shares of Hepalys Pharma.

The Japanese company will soon launch the clinical development of lanifibranor via two Phase 1 studies (first stage of clinical trials) in Japanese patients and healthy volunteers.

“If positive, the results of these studies should allow the start of a dedicated pivotal trial in Japanese and South Korean patients with Nash, as soon as the results of NATiV3, the pivotal Phase III trial (the last step before a potential marketing, Editor’s note) currently carried out by Inventiva, will be available”, explained the biotech in a press release.

Up to $520 million in milestone payments

Inventiva is currently recruiting patients to conduct this phase III study and expects the first visit of the last enrolled patient to take place at the end of this year.

Hepalys Pharma “will be responsible for the conduct and financing of all clinical trials carried out in Japan and South Korea necessary to obtain marketing in these territories”, the company also specifies.

According to Inventiva, up to 2.7% and 5.2% of the population in Japan and South Korea, respectively, suffer from Nash.

Inventiva had already signed, almost a year ago to the day, a licensing agreement in China with the Sino Biopharm group which provided for total payments of up to $290 million.

“With the ongoing partnership in Greater China and this new agreement in Japan and Korea, Inventiva is eligible to receive up to an additional $519 million in clinical, regulatory and commercial milestone payments,” explained Frédéric Cren, CEO of Inventiva in a press release.