Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab).

In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology.

Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP).

Sanofi received marketing authorization from the European Commission. Image: iStock/Attribution 2.0 Generic (CC BY 2.0)

“Manufacturing of Cablivi is a complex operation involving several manufacturing facilities in multiple EU countries,” Sanofi spokesperson Anna Robinson told BioProcess Insider.

“The active pharmaceutical ingredient is produced in large fermenters of 1500L after which the active molecule, caplacizumab, is purified out and shipped to a site where it is filled into vials and turned into powder. These vials with powder are then packed together with all components required to prepare and administer a dose of Cablivi.”

According to Robinson, the firm already has the capacity to supply the anticipated product demand for Cablivi commercially and no scaling-up is necessary.

Cablivi is the first therapeutic specifically indicated for the treatment of aTTP, and according to Ablynx/Sanofi it has peak sales potential of around €300 million. In the US, the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for caplacizumab and given it a target action date of February 6, 2019.

Nanobodies

Nanobodies are based on antibodies found in camels and llamas (camelidae), which lack the light chain domains present in traditional molecules. Instead they consist only of the heavy chains and a single variable region. Therefore, Nanobodies can bind multiple therapeutic targets – including those that cannot be accessed by conventional antibodies. Due to their size, they can be delivered by non-conventional administrative routes.

Through the acquisition of Ablynx, Sanofi has a pipeline of around 40 Nanobody programs, with four other products in clinical development.