Sanofi divests Zentiva as part of a restructuring strategy. Credit: Sanofi de.

Sanofi has closed the divestiture of its European generics business Zentiva to private equity firm Advent International for a total consideration of €1.9bn ($2.2bn).

The sale is in line with Sanofi’s restructuring strategy. Advent plans to support the Zentiva management team for investment in operations, production facilities, and research and development (R&D) pipeline.

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Sanofi and Advent signed a share purchase agreement for Zentiva in June this year, following exclusive discussions that were initiated in April.

Zentiva head Patrick Aghanian said: “We are confident that with the support of Advent we can realise our ambition to maximise our competitive advantage, expand our market footprint and upgrade our manufacturing network and capabilities.”

Meanwhile, Sanofi has secured the US Food and Drug Administration (FDA) approval for Libtayo (cemiplimab-rwlc) to treat metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC.

The indication covers intravenous infusion of 350mg Libtayo in patients who are not candidates for curative surgery or radiation.

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“We are confident that with the support of Advent we can realise our ambition to maximise our competitive advantage, expand our market footprint and upgrade our manufacturing network and capabilities.”

Libtayo is a fully human monoclonal antibody designed to target the PD-1 immune checkpoint receptor. It is said to be the first and only specific treatment approved for advanced CSCC in the US.

Sanofi is co-developing the drug in collaboration with Regeneron Pharmaceuticals.

The FDA decision comes after a review of results from the EMPOWER-CSCC-1 Phase II trial (Study 1540) and two advanced CSCC expansion cohorts in a Phase I trial (Study 1423).

For the integrated analysis of this trial data, the major efficacy outcome measures were confirmed as objective response rate (ORR) and ICR-assessed duration of response (DOR).

Libtayo obtained FDA breakthrough therapy designation last year.

In April this year, the European Medicines Agency (EMA) agreed to review the drug’s marketing authorisation application seeking approval for the treatment of metastatic or locally advanced CSCC.

Sanofi’s specialist care global business unit Sanofi Genzyme and Regeneron will jointly market Libtayo in the US.