Galapagos NV GLPG and its collaboration partner Gilead Sciences, Inc. GILD announced that the European Commission has granted approval to their marketing authorization application (“MAA”) for Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor.
The MAA sought approval for Jyseleca as monotherapy or in combination with methotrexate (MTX) for treating rheumatoid arthritis (“RA”) in patients who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
We note that Jyseleca is the first approved drug in the Galapagos portfolio. The company will receive a milestone payment of $75 million from Gilead related to the approval of the drug in Europe per their collaboration agreement.
The approval in Europe is based on positive results from the phase III, FINCH, and phase II DARWIN studies. Data from the late-stage FINCH studies have shown that patients receiving Jyseleca once daily showed improvements in clinical signs and symptoms, as measured by ACR20/50/70 scales. A significantly higher proportion of patients achieved low disease activity and/or remission following treatment with Jyseleca 200 mg plus MTX or other conventional synthetic DMARDs, compared to placebo or MTX alone at weeks 12 and 24. Patients who had an inadequate response to MTX also achieved statistically significant inhibition of progression of structural joint damage when treated with Jyseleca plus MTX. Moreover, data from the open-label, long-term extension DARWIN 3 study showed that improvement in clinical signs and symptoms were maintained for up to three years in patients who received Jyseleca 200 mg as monotherapy or in combination with MTX.
Please note that the FDA issued a complete response letter for the new drug application seeking approval for Jyseleca in the United States last month. The FDA has requested additional data for reviewing the overall benefit/risk profile of the drug.
Shares of Galapagos were up 5.1% on Sep 25, following Jyseleca’s approval. Galapagos’ shares have lost 32.7% in the year so far against the industry’s increase of 1.5%.
Per the existing collaboration agreement between Galpagos and Gilead for filgotinib, Galapagos will have sole rights to commercialize Jyseleca in Netherlands, Belgium and Luxembourg and may co-commercialize in France, Germany, Italy, Spain and the United Kingdom. The companies will equally share net profit or losses in these countries. Galapagos will receive tiered royalty from net sales of the drug outside these countries.
Meanwhile, Galapagos and Gilead are developing the drug in several other inflammatory indications including ulcerative colitis, Crohn’s disease, psoriatic arthritis and ankylosing spondylitis.
Apart from the collaboration agreement for filgotinib, Galapagos has an option, license and collaboration agreement with Gilead. Per this agreement, Gilead has the option to acquire exclusive commercial licenses in all countries outside of Europe to all current and future clinical programs of Galapagos during the 10-year initial option term of the agreement.
Galapagos has collaborated with several other pharma/biotech companies including AbbVie ABBV, and Servier for developing its pipeline candidates. These deals along with Gilead has been the primary source of revenues for the company through milestone payments. Jyseleca’s approval in Europe will likely generate a steady stream of revenuesfor the company going forward. However, the drug may face competition from approved JAK inhibitors for treating RA in Europe,which includes Eli Lilly’s LLY Olumiant.
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Galapagos currently carries a Zacks Rank #4 (Sell).
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