AbbVie said that it will return all rights to the compound to Galapagos, citing promising results in a pair of Phase II studies of ABT-494.
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The second, BALANCE-2, assessed five doses of ABT-494 in 300 patients with the same RA profile as BALANCE-1 but who had an inadequate response to methotrexate.
Because of Humira’s efficacy and the fact that it’s a complex biologic, AbbVie charges as much as $60,000 per year for it, depending on patient weight and dosing frequency.
“The levels of ACR response across the ABT-494 studies are impressive and warrant further investigation, particularly in treatment-refractory patients with the highest unmet need”, said Joel Kremer, M.D., director of research, The Center for Rheumatology in Albany, New York and a clinical investigator on BALANCE-I.
ABT-494 belongs to class of drugs known as JAK1 inhibitors that block the action of enzymes responsible for the inflammatory process of rheumatoid arthritis.
In its Balance 1 trial, which evaluated patients that inadequately responded to TNF-inhibitors like Humira, 71% of patients taking 18 mg twice a day achieved ACR20 and 40% achieved ACR50.
“Anything we can do to better help these patients would represent an important advancement to the field”, Genovese said in a press release.
Rheumatoid arthritis occurs when the immune system attacks the body’s tissues, causing joint pain, swelling and stiffness. According to its makers, the drug could potentially offer significant benefits to Humira that could allow it to become a top seller only if phase 3 results back up phase 2 performance.
“Galapagos management can negotiate another deal with a key rheumatoid arthritis player and advance filgotinim quickly”, Morgan Stanley analyst Matthew Harrison said in a note. These experimental programs have made Galapagos an interesting takeover target for drug makers such as Johnson & Johnson (NYSE:JNJ) and AbbVie which are planning to expand into the said treatment markets. However, it is a highly unlikely scenario, given that Galapagos has over half a dozen potential partners with whom the drug maker is already negotiating.
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Galapagos had entered into two development partnerships with AbbVie, one on rheumatoid arthritis and one on cystic fibrosis. The partnership included development of GLPG1690 for the treatment of idiopathic pulmonary fibrosis (IPF), a risky lung-scarring condition.
