AbbVie and Galapagos said today they will develop and commercialize new oral therapies for cystic fibrosis (CF) in a deal that could net Galapagos as much as $405 million.
The companies will develop potentiators to increase the activity of the main mutations in the CF transmembrane regulator (CFTR) protein, as well as correctors designed to correct defects in CFTR protein expression. Mutations targeted by the collaboration include F508del, which is 90% prevalent in people with the disease, and G551D.
AbbVie and Galapagos said they aim to initiate Phase I clinical studies at the end of 2014. Upon successful clinical development and regulatory approval, AbbVie will oversee commercial activities, with Galapagos retaining exclusive rights in China and South Korea, and co-promotion rights in its home country of Belgium, as well as the Netherlands and Luxembourg.
The collaboration marks AbbVie’s second with Galapagos. The first partnership focuses on developing GLPG0634, a selective JAK1 inhibitor, against rheumatoid arthritis (RA). It was expanded in May to include Crohn’s disease. AbbVie agreed to pay Galapagos $50 million upon successful completion of a Phase IIa/b study, set to launch early next year and generate topline results in Q2 2015, the companies said at the time. Galapagos acquired rights to GLPG0634 from GlaxoSmithKline after an arthritis alliance with that company ended.
Also, just yesterday, AbbVie inked an up-to-$840 million collaboration with another Belgian drug developer, Ablynx, to further develop and commercialize the latter’s ALX-0061 nanobody®, which targets the interleukin-6 (IL-6) pathway, as a therapy for inflammatory diseases. AbbVie is seeking successors to its blockbuster Humira (adalimumab), which was last year’s top best-selling drug [See “Top 20 Best-Selling Drugs of 2012,” published in GEN on March 1].
In the latest collaboration, AbbVie will pay Galapagos $45 million up front, while the companies will share responsibility and funding for Phase III clinical development upon successful completion of undisclosed milestones. Galapagos is eligible to receive up to $360 million in total additional payments for undisclosed developmental and regulatory milestones, as well as milestone payments for minimum annual net sales thresholds, and additional double-digit royalty payments on net sales.
“Our programs in CF show promise,” Galapagos CEO Onno van de Stolpe said in a statement. “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.”
Galapagos launched its CF research in 2005 with the Cystic Fibrosis Foundation, which resulted in 19 novel disease-modifying targets validated in the standard preclinical model for the disease. Galapagos secured all rights to these targets and has started to develop small molecule therapies against a select group of these targets. Five years later, the company opted to discover, develop, and launch its own medicines for CF and other orphan diseases.
With upfront AbbVie cash in hand, Galapagos said it will raise its guidance to investors on its projected year-end cash balance from €100 million ($134.7 million) to €125 million ($168.4 million). The company’s guidance for projected 2013 group revenues will stay unchanged at €160 million ($215.5 million).