Regeneron hands off certain Libtayo rights in Europe to Medison Pharma

After Regeneron took over full Libtayo rights from former partner Sanofi, Medison is now set to commercialize the oncology med in certain European and international markets.

Medison boasts an international commercialization platform and focuses on broadening the reach of therapies such as Libtayo, the company said in a release. Thanks to the Regeneron deal, the company can now commercialize the oncology med in “select European markets” and additional markets around the world, it noted in a press release.

The companies will work together to ensure a “seamless transition” of commercialization activities to Medison over the first half of this year, Medison added.

The PD-1 drug is indicated to treat certain patients with advanced basal cell carcinoma (BCC), cutaneous squamous cell carcinoma (CSCC) and non-small cell lung cancer (NSCLC), plus for advanced cervical cancer in Europe, Canada and Brazil.

Regeneron and Sanofi were originally partnered on the drug until Regeneron took over exclusive worldwide rights in 2022 for $900 million plus royalties and milestone payments.

The deal gave Regeneron “the freedom to explore combination opportunities” and “a greater share” of the potential upside from the drug, CEO Len Schleifer, M.D., Ph.D., said at the time. Sanofi had previously been in charge of ex-U.S. marketing, while the two had split commercialization duties in the U.S.  

Libtayo is slated to exceed $1 billion in global net product sales over 2024, according to a Regeneron update at the J.P. Morgan Healthcare Conference. The drugmaker looks to expand the med’s reach with combination products.

So far, one of those combination efforts hasn’t panned out as hoped, despite turning in positive data. When added to Bristol Myers Squibb’s Yervoy and chemotherapy, Libtayo reduced the risk of death by 38.5%—compared with chemo alone—when used as a first-line treatment in patients with advanced NSCLC.

But because the company ended the combo arm early to focus on the Libyato and chemo regimen that enabled the NSCLC nod from the FDA, the results were merely “descriptive” as opposed to bearing any statistical weight.