Abbott buys into Galapagos’ RA candidate
pharmafile | February 29, 2012 | News story | Research and Development, Sales and Marketing | Abbott, Galapagos, Humira, JAK, RA, TNF
Abbott has struck a deal with Galapagos to develop and commercialise a promising oral JAK1 inhibitor to treat multiple autoimmune diseases, including rheumatoid arthritis.
Abbott’s Humira is the world’s leading treatment for rheumatoid arthritis (and several other autoimmune diseases), clocking up $7.93 billion in sales in 2011.
But competition is fierce to find the drug which will represent the ‘next generation’ treatment for RA and other autoimmune diseases.
The Janus kinases (JAK) inhibitor class is tipped as one of the most likely successors, which could match the performance of Humira, but have the convenience of an oral formulation.
Pfizer filed its JAK inhibitor, tofacitinib, with the FDA in December. The drug impressed analysts in September when it matched Humira in a Phase III head-to-head, but concerns were raised when four patients died on a trial, with one death potentially related to use of the drug.
Now Abbott has moved in to claim rights for Galapagos’ own JAK inhibitor, GLPG0634.
While Pfizer’s drug inhibits the JAK3 enzyme, Galapogos’ candidate is a highly selective inhibitor of JAK1, the other key target in this class. Galapagos is developing for RA and other autoimmune diseases, and the compound is currently in Phase II.
A recently reported four-week Phase IIa study found that GLPG0634 demonstrated efficacy measures among the best reported in RA. All patients completed the study, and few experienced any side effects. No anaemia, change in blood pressure or lipids were observed. An additional Phase IIa dose-range finding study with GLPG0634 is expected to begin shortly.
“The addition of this novel, oral compound offers patients the potential for advanced treatment options and an improved patient experience to address RA and other autoimmune diseases,” said John Leonard, senior vice president of R&D, Abbott. “Abbott’s expertise in immunology, combined with a robust portfolio of investigational treatments represents promising innovation across several areas of medical need.”
“We are excited to continue the Phase II trials and expect to deliver to Abbott a complete Phase II package in 2014,” said Onno van de Stolpe, chief executive, Galapagos. “With GLPG0634 we have proven that we can deliver from target to clinical proof of concept, and we aim to do the same on many novel target programmes in our pipeline. This collaboration is transformational for Galapagos, providing the means to progress these innovative products into the clinic.”
Abbott will make an initial upfront payment of $150 million for global rights. Upon successful completion of the RA Phase II studies, Abbott will license the programme for $200 million if the studies meet certain pre-agreed criteria, and then assume sole responsibility for Phase III clinical development and global manufacturing.
Pending achievement of certain milestones, Galapagos would receive extra milestone payments from Abbott up to $1billion, plus tiered double-digit royalties on net sales upon launch. Galapagos retains co-promotion rights in Belgium, the Netherlands and Luxembourg.
Andrew McConaghie
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