Gilead Sciences, Inc. GILD announced that it has entered into an agreement with Eisai Co., Ltd for the distribution and co-promotion of its investigational, oral, selective JAK1 inhibitor, filgotinib, in Japan. The deal is pending approval.
The candidate is being evaluated for the treatment of rheumatoid arthritis (RA).
Per the terms of the deal, Gilead Japan will retain the responsibility of manufacturing and marketing approval of filgotinib, while Eisai will be in charge of product distribution in Japan in RA and other potential future indications. Both the companies will jointly commercialize the drug, if approved.
We note that filgotinib demonstrated durable efficacy and safety results across multiple RA patient populations. This includes patients with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve in phase III FINCH studies.
Per estimates, approximately 600,000 to 1 million patients are living with RA across Japan.
Earlier in the month, Gilead submitted a New Drug Application (NDA) for filgotinib to the FDA. A priority review voucher was submitted with the NDA, which will shorten the anticipated time for review.
Gilead and partner Galapagos NV GLPG already have a global collaboration for the development and commercialization of filgotinib in inflammatory indications.
Global studies investigating filgotinib in additional indications are also underway, including the phase III SELECTION study in ulcerative colitis, the DIVERSITY phase III study in Crohn’s disease, the phase III PENGUIN studies in psoriatic arthritis and phase II studies in uveitis and in small bowel and fistulizing Crohn’s disease.
The European Medicines Agency has also accepted the marketing authorization application for filgotinib as a treatment for RA.
Gilead’s stock has gained 6.6% in the year so far compared with the industry's growth of 10.3%.
The massive decline in sales of the HCV franchise has propelled the company to focus on its HIV franchise, Yescarta, and in other newer avenues. The rapid adoption of Biktarvy continues in the HIV space amid stiff competition from the likes of GlaxoSmithKline GSK. Gilead’s intent to foray into the inflammation market to diversify the revenue base is encouraging as well.
Zacks Rank & A Stock to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Alexion Pharmaceuticals ALXN, which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for 2019 have increased by 40 cents for Alexion in the past 90 days.
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