Galapagos Shares Drop 19% After Gilead Won't Seek FDA Approval for Jyseleca
December 16 2020 - 1:21PM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
December 16, 2020 13:06 ET (18:06 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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