AbbVie and Galapagos to co-develop cystic fibrosis therapies

Firms aim to start Phase 1 trials at end of 2014

Just days after signing a worldwide licensing agreement with Belgian firm Ablynx for an autoimmune disorder drug candidate, AbbVie has entered into a deal with Galapagos.

The alliance with Galapagos covers the discovery, development and commercialisation of novel potentiator and combination therapies for cystic fibrosis (CF).

AbbVie and Galapagos will aim to develop and market oral drugs that address the main mutations in CF patients, including F508del and G551D. The firms will identify compounds that correct defects in expression of (corrector) and/or increase the activity (potentiator) of the main mutations in the cystic fibrosis transmembrane regulator (CFTR) protein, including the F508del mutation, which is the most common with 90% prevalence in patients with CF.

In the alliance, AbbVie and Galapagos will develop potentiators and correctors discovered by Galapagos and expand the range of molecules, with the aim to initiate Phase 1 clinical studies at the end of 2014.

Following successful clinical development and regulatory approval, AbbVie will be responsible for commercial activities, with Galapagos retaining exclusive rights in China and South Korea and co-promotion rights in Belgium, the Netherlands, and Luxembourg.

Partnering with AbbVie allows us to ramp up our commitment significantly, share development risk and expertise

Under the terms of the agreement, AbbVie will make an initial upfront payment of US$45m to Galapagos. On the completion of pre-determined success milestones, AbbVie and Galapagos will share responsibility and funding for Phase III clinical development. However, Galapagos is eligible to receive up to $360m in additional payments for developmental, regulatory milestones and sales milestones. Galapagos will also receive double-digit royalty payments on net sales.

'Galapagos is very pleased to join forces with AbbVie in this exciting new area of CF. Our programmes in CF show promise. Partnering with AbbVie allows us to ramp up our commitment significantly, share development risk and expertise, and increase our chances of bringing best-in-class therapies to CF patients,' said Onno van de Stolpe, Chief Executive of Galapagos.

Galapagos initiated its research in CF in 2005 as part of a collaboration with the Cystic Fibrosis Foundation. In 2010, the firm decided to pursue CF as the first orphan disease in which the company is attempting to discover, develop and launch its own medicines. Galapagos has developed small molecule therapies that can restore the function of the defective CF protein (CFTR).

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