filgotinib reumamiddel in onderzoeks fase

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filgotinib reumamiddel in onderzoeks fase

Berichtdoor gijsbrecht » wo mei 25, 2016 11:17 am

AMSTERDAM (AFN) - Het onderzoek van Galapagos naar de werking van het middel filgotinib tegen reuma gaat een nieuwe fase in. Dat zal sommige van de laatste twijfels wegnemen die nog leven in de markt over het medicijn, verwachten analisten van KBC.

Galapagos liet dinsdagavond weten dat het besprekingen over zijn reumaprogramma met Europese en Amerikaanse toezichthouders succesvol heeft afgerond. In het derde kwartaal wordt een nieuwe fase van het onderzoek naar een middel tegen reuma opgestart.

Filgotinib

Filgotinib is a highly selective JAK1 inhibitor discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 700 patient years of rheumatoid arthritis (RA) clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and to be safe and well tolerated in these so called DARWIN studies. A Phase 3 program with filgotinib in rheumatoid arthritis will be initiated mid-2016.

Filgotinib has also shown to be effective and safe as once-daily, oral induction treatment in moderate to severe Crohn’s disease, based on the FITZROY phase 2 study at 10- and 20-week analysis. The study achieved the primary endpoint of clinical remission at 10 weeks: the percentage of patients achieving a CDAI score lower than 150 was significantly higher in patients treated with filgotinib versus patients receiving placebo. Filgotinib was shown to be well tolerated throughout the FITZROY study, strengthening its favorable safety profile.

"We are pleased by the outcome of the FITZROY study, positioning filgotinib as a potential oral treatment for patients with Crohn’s disease. We are proud to be advancing what could become the first new oral treatment for Crohn’s disease in decades," said Piet Wigerinck, CSO of Galapagos. “These findings complement the excellent DARWIN data in rheumatoid arthritis and open up new opportunities in a broader range of inflammatory diseases for filgotinib."

In December 2015, Galapagos and Gilead signed a global partnership for the global development and commercialization of filgotinib in inflammatory diseases. Under the terms of the agreement, the companies will collaborate jointly on the global development of filgotinib starting with the initiation of Phase 3 trials in RA and Crohn's disease. Galapagos will co-fund 20 percent of global development activities and Gilead will be responsible for manufacturing and worldwide marketing and sales activities. Galapagos has the option to co-promote filgotinib in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg, in which case the companies will share profits equally. If Galapagos exercises its option to co-promote in Belgium, the Netherlands or Luxembourg, it will also book sales in these countries. Galapagos will receive an upfront license fee of $300 million and Gilead will make a $425 million equity investment in Galapagos. Galapagos is eligible to receive further development, regulatory and commercial milestone payments up to $1.35 billion, plus tiered royalties on global sales starting at 20%, with the exception of the co-promotion territories where profits will be shared equally.
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