AbbVie will assume full development and commercialization responsibilities for all cystic fibrosis (CF) programs partnered with Galapagos, under a restructuring of the companies’ five-year-old collaboration that could generate more than $245 million for the Belgian biotech.

Under the restructuring, AbbVie will continue development of a CF therapy combining three Galapagos candidates—as well as oversee several clinical and preclinical compounds originally discovered and developed jointly by AbbVie and Galapagos.

The triple combination—Galapagos’ C2 corrector GLPG2737, C1 corrector GLPG2222, and potentiator GLPG2451— are intended to collectively increase the activity of the mutated copies of the cystic fibrosis transmembrane conductance regulator (CFTR) protein that causes CF.

The triple combination showed no additional enhancement of CFTR activity over a dual combination of GLPG2222 and GLPG2451 following two weeks of treatment, according to topline interim results of Part 1 of the Phase I FALCON trial (NCT03540524) announced by Galapagos.

And after a previous two-week period, treatment with the dual combination resulted in a mean increase in percent predicted FEV1 of just approximately 3%, and mean decrease from baseline in sweat chloride concentration of approximately 25 mmol/L.

The triple combination candidates are three of five clinical-phase CFTR modulators identified by Galapagos in a June 7 investor presentation; the other two were potentiator GLPG3067, and C1 corrector GLPG2851. Also identified was a preclinical candidate, the C2 corrector GLPG3748.

‘Promising Candidates’

“Our previous work with Galapagos has identified a number of promising candidates and we thank them for their contribution to our partnership,” Michael Severino, M.D., AbbVie EVP of R&D and CSO, said yesterday in a company statement. “We have a proven track record working with challenging molecular targets across a wide range of life-threatening illnesses and will harness this expertise to progress the next-generation of CF treatment.”

AbbVie agreed to pay Galapagos $45 million upfront, and up to $200 million tied to achieving development, regulatory, and commercial milestones. Upon receiving regulatory approval and attaining commercial sales in CF, AbbVie has agreed to pay Galapagos royalties ranging from the single digit to low teen percentages.

Galapagos said it retains exclusive global commercial rights to develop GLPG2737 in all indications outside of CF. Should GLPG2737 or other candidates be approved for indications other than CF, Galapagos has agreed to pay AbbVie future milestone payments and tiered single digit royalties on future global commercial sales.

“We are very pleased with the outcome of our discussions with AbbVie regarding the future of the CF portfolio,” stated Galapagos CEO Onno van de Stolpe. “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.”

Galapagos and AbbVie launched their collaboration in September 2013, focused on treating CF by discovering, developing, and commercializing potentiator and corrector molecules. At the time, AbbVie paid Galapagos $45 million upfront and agreed to pay up to $405 million.

In April 2016, citing expansion of their CF portfolio, the companies expanded their CF collaboration by nearly doubling the size of AbbVie’s total potential payments to Galapagos tied to achieving Phase I and Phase II milestones.

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