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Weekly Top News – IBD – February 10, 2020

February 10, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Initiation of P3 trial for ulcerative colitis in 2020 (AbbVie) – Feb 8, 2020 – Pipeline Update: Initiation of P3 trial for atopic dermatitis in 2021 
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ravagalimab (ABBV-323) / AbbVie
Ravagalimab: Initiation of P3 trial for ulcerative colitis in 2021 (AbbVie) – Feb 8, 2020 – Pipeline Update: Proof-of-concept data from P2 trial (NCT03695185) for ulcerative colitis in 2020 
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Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Data from P3 trial for Crohn’s disease in 2020 (AbbVie) – Feb 8, 2020 – Pipeline Update: Data from P3 KEEPSAKE2 trial (NCT03671148) for psoriatic arthritis in 2020 
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TD-1473 / J&J
TD-1473: Data from P2 DIONE trial (NCT03635112) for Crohn’s disease in late 2020 (Theravance) – Feb 6, 2020 – Investor Presentation: Data from P2b portion of P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in late 2020 
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PTG-200 / Protagonist Therapeutics, J&J
PTG-200: Data from P2 PRISM trial (NCT04102111) for Crohn’s disease in H1 2021 (Protagonist Therapeutics) – Feb 6, 2020 – Corporate Presentation 
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Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Rinvoq (upadacitinib) / AbbVie
AbbVie reports full-year and fourth-quarter 2019 financial results (PRNewswire) – Feb 7, 2020 – “‘The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter.’…Global SKYRIZI net revenues were $216 million and global RINVOQ net revenues were $33 million….Detailed data from both pivotal studies will be presented at an upcoming medical meeting and AbbVie expects to submit our regulatory applications for RINVOQ in PsA in the second quarter of this year.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Regulatory submissions for Crohn’s disease and psoriatic arthritis in 2021 (AbbVie) – Feb 8, 2020 – Pipeline Update 
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Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Amgen launches biosimilar for the treatment of inflammatory diseases [Google translation] (PRNewswire) – Feb 3, 2020 – “Amgen…announces the launch and commercialization of the first biosimilar medicine of the molecule adalimumab available in Brazil. AMGEVITA® was approved by the National Health Surveillance Agency (ANVISA), with indication for the treatment of several inflammatory diseases, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis or ulcerative colitis, plaque psoriasis, uveitis and hydradenitis suppurative.”

 

Humira (adalimumab) / Eisai, AbbVie
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis (clinicaltrials.gov) – Feb 5, 2020 – P3; N=59; Active, not recruiting; Sponsor: AbbVie; Enrolling by invitation –> Active, not recruiting; N=93 –> 59; Trial completion date: Mar 2026 –> May 2025; Trial primary completion date: May 2023 –> Mar 2025

 

Humira (adalimumab) / Eisai, AbbVie
AbbVie reports full-year and fourth-quarter 2019 financial results (PRNewswire) – Feb 7, 2020 – “Fourth-Quarter Results: Worldwide net revenues were $8.704 billion, an increase of 4.8 percent…Excluding the unfavorable impact of international HUMIRA net revenues due to biosimilar competition, fourth-quarter net revenues grew 11.0 percent operationally. U.S. HUMIRA net revenues were $3.969 billion, an increase of 9.8 percent. Internationally, HUMIRA net revenues were $948 million, a decrease of 27.3 percent…due to biosimilar competition.”

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