Weekly Top News – Psoriasis – November 18, 2019

November 18, 2019

bimekizumab (UCB4940) / UCB
Bimekizumab positive results confirmed in second phase 3 psoriasis study (PRNewswire) – Nov 15, 2019 – P3, N=435; BE READY (NCT03410992); Sponsor: UCB Biopharma; “UCB…announced positive results from BE READY, the second of three Phase 3 studies this year to report findings on the investigational treatment bimekizumab…This randomized withdrawal study met its co-primary endpoints….The full BE READY results will be presented at a scientific congress in 2020…UCB is now preparing for a bimekizumab submission to regulatory authorities in mid-2020 to bring this promising treatment option to people living with psoriasis.”


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi with ok in Argentina [Google Translation] (Pharmabiz) – Nov 12, 2019 – “The ANMAT given the nod to Skyrizi to be marketed in the Argentine market….He obtained approval in Argentina from ANMAT during this November. It was only seven months after it was approved by the United States FDA.”


Tremfya (guselkumab) / J&J
Tremfya (guselkumab), a first-in-class il-23 p19 subunit inhibitor, meets primary endpoints of superior ACR20 responses versus placebo at week 24 in phase 3 psoriatic arthritis studies (PRNewswire) – Nov 11, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 24-week Phase 3 data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with TREMFYA® (guselkumab)…These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies…These data were presented…at the American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) 2019 Annual Meeting taking place November 8-13 in Atlanta.”


Humira (adalimumab) / Eisai, AbbVie; Taltz (ixekizumab) / Eli Lilly
ACR 2019: Lilly presents 52-week head-to-head (SPIRIT-H2H) data from Taltz (ixekizumab) versus Humira (adalimumab) trial in psoriatic arthritis (Eli Lilly Press Release) – Nov 12, 2019 – P3b/4, N=566; SPIRIT-H2H (NCT03151551); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today the 52-week results from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study of Taltz® (ixekizumab) versus Humira® (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). The results are being presented as a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta. Taltz met the primary and all major secondary endpoints of the study.”


Otezla (apremilast) / Amgen
Bristol-Myers Squibb receives clearance from U.S. Federal Trade Commission for Celgene acquisition (Bristol-Myers Squibb Press Release) – Nov 15, 2019 – “Bristol-Myers Squibb Company…announced today that the U.S. Federal Trade Commission (FTC) has accepted the proposed consent order in connection with the pending merger of Bristol-Myers Squibb and Celgene Corporation…thereby permitting the parties to close the transaction. As announced on August 26, 2019, Celgene entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast)….Bristol-Myers Squibb also expects the OTEZLA divestiture to be completed promptly following the closing of the merger.”


Otezla (apremilast) / Amgen
Zydus Cadila gets tentative USFDA approval to market arthritis drug (Business Standard) – Nov 16, 2019 – “Drug firm Zydus Cadila on Saturday said it has received a tentative approval from the US health regulator to market generic Apremilast tablets….used to treat psoriatic arthritis and moderate to severe plaque psoriasis.”


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $167M (consensus: $98M) in Q4 2019 (UBS) – Nov 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 68304392; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 11/08/2019


Skilarence (dimethyl fumarate) / Almirall; Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Almirall 9M 2019 business results: Continued good business momentum driven by positive uptake of recent launches (Almirall Press Release) – Nov 11, 2019 – “Skilarence® sales were of €24 MM….Ilumetri…for the treatment of adult patients with moderate-to-severe plaque psoriasis, continues the rollout. It has achieved €13 MM of net sales during the first nine months of 2019 and, in the third quarter, the product was launched in Austria, Switzerland, the Netherlands and Spain. The rollout continues in Italy, Belgium, Czech Republic and France.”


Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $300M peak (Jefferies) – Nov 16, 2019 – A subscription to Thomson ONE is required to gain full access to report 68296514; Page no: 1; REPORT TITLE: “Sun Pharmaceutical Industries Ltd – 2Q20: In- line quarter as strong India offset US weakness”; AUTHOR: Nahar, Piyush, et al; DATE: 11/07/2019


Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $4.1B in 2022 and $4.6B peak (Barclays) – Nov 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68241420; Page no: 1; REPORT TITLE: “NOVN/UCB: Cosentyx data takes: still struggling to EXCEED”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 11/01/2019

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