September 25, 2015
By Mark Terry, BioSpace.com Breaking News Staff
North Chicago, Ill.-based AbbVie announced today that it has declined its in-license deal with Mechelen, Belgium-based Galapagos for its selective JAK1 inhibitor, filgotinib.
Galapagos was founded in 1999 as a joint venture between Crucell and Tibotec. The company raised 23.4 million euros in 2002 through private placement and went public in May 2005, raising 22.4 million euros. It then raised another 144 million euros in private placements in 2006, 2009, 2010 and 2013, with an additional 4.4 million euro equity investment by GlaxoSmithKline in 2007. It sold its BioFocus and Argenta divisions to Charles River Laboratories International in 2014. It was listed on the U.S. NASDAQ under the symbol GLPL in May 2015, which raised an additional 279 million euros.
The company’s fligotinib (GLPG0634) is an oral, selective inhibitor of JAK1 (Janus kinase 1) for the treatment of rheumatoid arthritis and possibly for other inflammatory diseases. The company started its Phase IIb clinical trials in June 2013 in rheumatoid arthritis. It started a Phase II study with the same drug in January 2014 in Crohn’s disease, an inflammatory bowel disease.
AbbVie and Galapagos signed a global deal on Feb. 29, 2012 to develop and commercialize filgotinib. AbbVie made an initial upfront payment of $150 million. Once the RA Phase II studies were completed, AbbVie would license the program for a $200 million one-time fee if the studies met specific criteria. AbbVie would then take on responsibility for Phase III clinical development and global manufacturing. Milestones payments could have hit $1 billion, as well as tiered double-digit royalties.
On Aug. 10, 2015, Galapagos announced the results of its RA trials, which set the clock ticking for 24 weeks for AbbVie to decide if it was going to continue with the deal. The drug showed improvements in symptoms of moderately to severe, active RA and was well tolerated.
“The DARWIN 2 24-week data clearly show the efficacy of this compound in rheumatoid arthritis,” said Arthur Kavanaugh, professor of medicine at the University of California, San Diego (UCSD) School of Medicine and principal investigator for DARWIN 2, in a statement. “In addition, the safety profile is quite notable. The increase in hemoglobin and lack of lymphocyte reduction suggest that there can be differentiation of various safety signals among different JAK inhibitors.”
AbbVie, however, has decided to advance its own JAK1 inhibitor, ABT-494, to Phase III studies in RA.
“We believe ABT-494 has the potential to become a best-in-class therapy for patients,” said Michael Severino, executive vice president, research and development and chief scientific officer of AbbVie in a statement. “In our view, ABT-494 also offers a faster path to Phase III development with less uncertainty.”
All rights to filgotinib will revert to Galapagos.
AbbVie simultaneously announced that ABT-494 clinical trial data in patients did not respond adequately to either methotrexate or TNF inhibitors. The two trials were BALANCE-I and BALANCE-II, and looked at patients with modreate to severe RA.
“These were well-designed studies across a broad dose range that allow us to understand the full potential of inhibiting this pathway,” said Mark Genovese, professor of medicine, Stanford University Medical Center, Division of Immunology and Rheumatology, in a statement. “The consistency of response and the overall safety profile of ABT494 in these two patient populations offer the potential for significant benefit and support advancing this compound into Phase III studies. In particular, the TNF-IR population is increasing and represents those failing current standard of care. Anything we can do to better help these patients would represent an important advancement to the field.”
Galapagos stock, not surprisingly, did not take the news well. Shares traded on Sept. 21 for $63.73, but dropped at the news to $47.89 currently. Most of this year, shares had been on a pretty steady increase, trading for $35 on April 24 and $58.33 on June 1.
