AbbVie Takes Sole Control of Potential CF Therapies Developed with Galapagos

Galapagos and AbbVie agreed that AbbVie will now have full control of the cystic fibrosis (CF) drug discovery portfolio the two companies have developed together. This means that the exclusive global rights to the investigational therapeutic candidates for CF will be held by AbbVie alone.

This decision comes after months of discussions between the two companies, which entered the global partnership in 2013.

Their collaborative CF portfolio includes two classes of CF therapeutics that work differently. They are ‘potentiators’ that ease the flow of chloride ions through the cystic fibrosis transmembrane conductance regulator (CFTR) channel (CFTR is the gene defective in CF), and ‘correctors’ that help the CFTR protein to adopt a proper 3D structure, so the channel can be formed correctly and ease the flow of molecules though the cells’ membrane.

According to the agreement, AbbVie will bear the responsibility and costs of all future CF-related activities, and will continue the development of triple combination CF therapies.

“We are very pleased with the outcome of our discussions with AbbVie regarding the future of the CF portfolio. We believe that AbbVie is well-equipped to further develop this CF portfolio and to come up with a competitive triple combination product for CF patients,” Onno van de Stolpe, CEO of Galapagos, said in a press release.

As part of the decision, Galapagos is set to receive $45 million upfront from AbbVie, and is eligible to an additional $200 million as milestone payments as AbbVie reaches certain pre-determined developmental, regulatory, and commercial accomplishments in the CF portfolio.

Galapagos is also eligible to royalty payments if AbbVie is successful in obtaining regulatory approval for any CF indications. Furthermore, if any of these candidate therapies show promise in conditions other than CF and AbbVie obtain global commercial sales rights for them, Galapagos will receive additional adjusted royalties (or tiered royalties).

But Galapagos will hold exclusive worldwide rights over a potential corrector molecule – GLPG2737 – in indications other than CF. In a Phase 2 clinical trial (NCT03474042), the molecule showed promising results in CF patients when combined with Orkambi (lumacaftor/ivacaftor; developed by Vertex Pharmaceuticals).

AbbVie will be eligible to receive milestone payments and adjusted royalties from Galapagos related to commercial sales of GLPG2737 should it be approved to treat non-CF diseases, the release stated.