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Details:
Alfasigma completed acquisition of Jyseleca (filgotinib), which provides European and UK Marketing Authorizations. It is used for the treatment of moderate to severe rheumatoid arthritis.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $184.9 million Upfront Cash: $54.3 million
Deal Type: Acquisition January 31, 2024
Details:
The agreement aims to transfer Galapagos’ Jyseleca (filgotinib maleate) business to Alfasigma, marking a significant milestone in its transformation into an innovative biotechnology company with a pipeline aimed for immunology and oncology.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $229.7 million Upfront Cash: $54.7 million
Deal Type: Agreement January 02, 2024
Details:
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of active axial spondyloarthritis and some other conditions.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and some other conditions.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Details:
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and some other conditions.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
Details:
Jyseleca (filgotinib) is the only 2nd generation JAK inhibitor with JAK1 preferential inhibition of both approved doses, as well as the possibility of treating with the lowest effective dose in both RA and UC.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2022
Details:
Filgotinib is marketed as Jyseleca (200mg and 100mg tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2022
Details:
Type II variation application was supported by interim data on demonstrated a prespecified sperm decrease at the timepoints from ongoing MANTA and MANTA-RAy, investigating effect of Jyseleca (filgotinib) use on semen parameters and sex hormones in adult patients.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2022
Details:
The study showed that Jyseleca 200mg was well-tolerated and efficacious as induction and maintenance therapy with no new safety findings reported. The approval of Jyseleca in Japan is based on data from phase 2b/3 SELECTION study in patients with ulcerative colitis.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Jyseleca is a new oral JAK inhibitor (administered once daily). Jyseleca has been approved in Japan for the treatment of rheumatoid arthritis (including prevention of structural damage) who have responded inadequately to conventional therapies.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Filgotinib is licensed and marketed as Jyseleca (200mg and 100mg tablets) in Great Britain, the European Union and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately or are intolerant.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
The European Commission approved an additional indication for Jyseleca, an oral, once-daily, JAK1 preferential inhibitor, for adult patients with moderately to severely active UC based on data from the Phase 2b/3 SELECTION program.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2021
Details:
Filgotinib, an orally administered, preferential JAK1 inhibitor, used in the induction and maintenance of remission in patients with Crohn’s disease (CD).
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
Filgotinib, an orally administered, preferential JAK1 inhibitor, used in the induction and maintenance of remission in patients with Crohn’s disease (CD).
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
New data analyses on the safety profile of filgotinib, an oral, once-daily, JAK1 preferential inhibitor for the treatment of moderately to severely active RA, are presented from seven trials.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
This latest regulatory submission is based on data from the randomized, double-blind, placebo-controlled Phase 2b/3 SELECTION study, This study showed the efficacy and tolerability of filgotinib 200 mg once daily, and no new safety risks were identified.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: GS-6034
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
Of the 240 participants who were able to be evaluated after 13 weeks of treatment, sperm concentration fell by 50% or more in eight out of 120 in the filgotinib group and 10 out of 120 in the placebo group.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2021
Details:
Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead will not advance Jyseleca for the treatment of Rheumatoid Arthritis (RA) in the U.S. following FDA Type A Meeting.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: $193.8 million Upfront Cash: Undisclosed
Deal Type: Collaboration December 15, 2020
Details:
The EMA application is supported by data from the Phase 2b/3 SELECTION study, which showed a statistically significantly higher proportion of patients treated with once-daily filgotinib 200 mg achieved clinical remission at week 10 and maintained remission at week 58.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile.
Lead Product(s): Filgotinib
Therapeutic Area: Gastroenterology Product Name: Jyseleca
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX.
Lead Product(s): Filgotinib,Methotrexate
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: GS-6034
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2020
Details:
The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Galapagos
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
Phase 2 EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
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