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AbbVie, Galapagos Partner on Cystic Fibrosis Therapies

Illustration of lungs (Mikael Häggström/Wikimedia Commons)

(Mikael Häggström/Wikimedia Commons)

The pharmaceutical companies AbbVie in North Chicago, Illinois and Galapagos NV in Mechelen, Belgium are collaborating on development and marketing of treatments for the inherited disease cystic fibrosis. The deal, with a total potential value of at least $405 million, covers discovery, development, and commercialization of compounds addressing defective genetic mutations associated with the disease.

Cystic fibrosis is a chronic disease affectng the lungs and digestive systems caused by defective genes that produce a thick mucus that clogs the lungs and obstructs the pancreas. The build-up of mucus can lead to lung infections and digestive disorders caused by the body’s inability to produce enzymes that help break down and digest food. The Cystic Fibrosis Foundation estimates the disease affects 70,000 people worldwide, including 30,000 in the U.S., both children and adults.

The two companies plan to develop oral drug therapies that correct the defect in the main genetic mutations found in cystic fibrosis patients or increase the activity of the cystic fibrosis transmembrane regulator (CFTR) protein that makes the thinner, more flowing mucus normally produced. Galapagos started its research into cystic fibrosis in 2005, in collaboration with the Cystic Fibrosis Foundation. Since then, the company developed small molecule therapies aimed at restoring normal functioning of the defective CFTR protein.

In the deal, AbbVie and Galapagos will jointly develop therapies based initially on discoveries by Galapagos, but also expanding the molecules during the preclinical phase. The companies aim to have early-stage clinical trials started by the end of next year. Following clinical trials and regulatory approvals, AbbVie will have responsibility for commercializing the compounds, with Galapagos retaining exclusive rights in China and South Korea, while sharing responsibilities with AbbVie in Belgium, Netherlands, and Luxembourg.

AbbVie will pay Galapagos an upfront fee of $45 million, with the companies sharing responsibility and costs for late-stage clinical trials. Galapagos will be elgible for subsequent payments of $360 million based on developmental and regulatory milestones, as well as future royalties on sales.

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Hat tip: FirstWord Pharma

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