Galapagos NV and AbbVie have entered into a global alliance to discover, develop and commercialize combination therapies in cystic fibrosis (CF). AbbVie and Galapagos will contribute technologies and resources to identify oral compounds that correct the main mutations in CF patients, including F508del and G551D, and/or increase the activity of the cystic fibrosis transmembrane regulator (CFTR) protein. The companies aim to begin Phase I studies at the end of 2014. Following successful clinical development and regulatory approval, AbbVie will be responsible for commercial activities. Galapagos will retain exclusive rights in China and South Korea and co-promotion rights in Belgium, the Netherlands, and Luxembourg.
AbbVie will make an initial upfront payment of $45 million for rights related to the global alliance. AbbVie and Galapagos will share responsibility and funding for Phase III development. Galapagos is eligible to receive as much as $360 million in total additional payments for development and regulatory milestones, sales milestones and royalty payments.
"Galapagos is very pleased to join forces with AbbVie in this exciting new area of CF. Our programs 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 officer, Galapagos.
"We're pleased to enhance our partnership with Galapagos to include research in cystic fibrosis, a debilitating disease with significant unmet medical need. Our knowledge of the patient experience, combined with innovative advances in the understanding of disease etiology, offers the potential for new transformational treatments," said Jim Sullivan, Ph.D., vice president, pharmaceutical discovery, AbbVie.