Wall Street Trader schreef op 17 november 2020 13:27:
FDA is requesting data from the safety studies MANTA and MANTA-RAy studies before completing its review of the NDA while raising concerns regarding the overall benefit/risk profile of the filgotinib 200mg dose. There are no plans to only resubmit the 100mg prior to the MANTA data.•
Gilead management is conducting a Type A meeting with FDA and has indicated that if it believes approval of the 200mg dose is unlikely to have a path forward after that meeting, it may adjust its commercial stance in the US related to the marketing of filgotinib.
Such actions could include a full return of US commercial rights, a decision to not pursue the RA indication, but continue to pursue the IBD indications or a decision to move ahead based on a positive outcome related to 200mg.• Galapagos and Gilead expect the MANTA data in the first half of 2021 and expect a 2 to 6 month assessment period after the filgotinib re-submission of the market application. The final decision of the FDA should then follow at the end of next year (if there is no AdCom).
So possibly a little longer if there is an AdCom of which Management said that they would like to be able to use such an AdCom to clearly defend the "best in class" profile of Filgotinib. All test persons were recruited for the MANTA and MANTA RAy studies; Galapagos is on track to release the results in the first half of 2021
Gilead Management acknowledged that the 200mg dose is important to the commercial profile of filgotinib in a very crowded class and that it may have to re-evaluate its filgotinib strategy if it cannot receive approval for the 200mg dose in RA.Filgotinib UC:
Filing in EU in 2H20 and Japan early 2021.
US filing on hold until the MANTA results come in. Ulcerative Colitis was positive in the 200mg dose only,
meaning that potential sales will not only be delayed until at least 2022, but FDA concerns will need to be alleviated to allow success in this indication.
• Results of the Phase II PINTA study with GLPG1205 as treatment for idiopathic pulmonary fibrosis (IPF) are expected before the end of the year.
Galapagos also announced a partnership with Polish listed biotech company OncoArendi. Galapagos obtains worldwide R&D and commercial rights to OATD-01, the first compound resulting from OncoArendi's portfolio of chitinase inhibitors. Upon completion of a Phase I study in healthy volunteers, Galapagos aims to bring OATD-01 to a Phase II study for IPF and potentially other fibrotic diseases.
Galapagos will pay OncoArendi an advance of € 25 million and the partner is eligible for € 320 million in milestone payments and low double-digit royalties. In addition, Galapagos will pay EUR 2 million for the right of first negotiation for all assets coming from OncoArendi's chitinase platform.
• Bart Filius, COO & CFO, will participate in a fireside chat
with analyst Peter Welford at the Jefferies 2020 Virtual London Healthcare Conference on Thursday, 19 November at 14:30 CET (8:30am ET)
. The discussion will be webcast live and can be accessed on the day via the following link:wsw.com/webcast/jeff141/register.aspx...
A replay of the webcast will be available on the Galapagos website, for 90 days following the presentation. To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast.