Galapagos Shares Drop 19% After Gilead Won't Seek FDA Approval for Jyseleca

By Chris Wack

Gilead Sciences Inc. and Galapagos NV said they are amending their commercialization and development arrangement for Jyseleca, or filgotinib, while Gilead said it won't pursue U.S. Food and Drug Administration approval of the medication in the treatment of rheumatoid arthritis.

Galapagos shares were down 19% to $97.11 in heavier-than-usual volume of 1.3 million shares at 12:45 p.m. ET. The stock hit its 52-week low of $96.26 earlier inthe session.

The companies said Wednesday that Gilead made that decision based on the feedback received from the FDA in a Type A meeting and during the new-drug-application review process. The Type A meeting was held to discuss points raised in a complete response letter related to the NDA for filgotinib in the treatment of RA.

While both Gilead and Galapagos said they continue to believe in the clinical profile of the 200-milligram dose, Gilead has concluded that this dose is required to be competitive in RA in the U.S. and that it is unlikely to achieve approval for RA in the country without conducting substantial additional clinical studies.

Under the amended arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications, the companies said.

Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe, and Gilead will receive royalties from European sales of the medication, the companies said.

This new deal is an acceleration of the commercial strategy in place for products under the separate 10-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialization, the companies said. The majority of activities in Europe supporting filgotinib are expected to be assumed by Galapagos by the end of 2021, the companies said.

The companies said Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside Europe, including in Japan where the medication has recently been approved and is co-marketed with Eisai Co.

All commercial economics on filgotinib in Europe will transfer to Galapagos as of Jan. 1, 2022, subject to payment of tiered royalties of 8% to 15% of net sales in Europe to Gilead, starting in 2024, the companies said.

In connection with the amended arrangement, Gilead has agreed to irrevocably pay Galapagos 160 million euros ($195 million), which will be split between a EUR110 million payment in 2021 and a EUR50 million payment in 2022, the companies said. Gilead expects to recognize the full amount of these payments in its research-and-development expenses in the fourth quarter of 2020.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

December 16, 2020 13:06 ET (18:06 GMT)

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