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Category: Psoriasis

Weekly Top News – Psoriasis – March 30, 2020

March 30, 2020

ANB019 / AnaptysBio
ANB019: “Both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy”; Generalized pustular psoriasis (Cowen & Co. 40th Annual Health Care Conference 2020, AnaptysBio) – Mar 24, 2020 – “Patients demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113” 
[Screenshot]

 

Taltz (ixekizumab) / Eli Lilly
Taltz approved for pediatric patients with moderate to severe plaque psoriasis (eMPR) – Mar 27, 2020 – “The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy….The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (IXORA-Peds) that evaluated the efficacy and safety of ixekizumab in 171 patients aged 6 to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.”

 

AVT02 (adalimumab biosimilar) / Alvotech, Cipla
Alvotech and DKSH partner on adalimumab in Asia (Generics Bulletin – Informa) – Mar 26, 2020 – “Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.”

 

vunakizumab (SHR-1314) / Jiangsu Hengrui Medicine
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults (clinicaltrials.gov) – Mar 23, 2020 – P2; N=120; Suspended; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jun 2021 –> Dec 2020; Not yet recruiting –> Suspended; Trial primary completion date: Mar 2021 –> Jun 2020

 

BMS-986165 / BMS
Epidemic ‘secondary’ impact: Clinical trials and CDMO industry pressing the pause button [Google translation] (Sina Corp) – Mar 26, 2020 – “In the face of the epidemic, clinical trials can also respond in some ways, but the biggest risk may be that patients cannot follow up, and a large number of clinical trials are being threatened by the epidemic, and the delay has become a reality….At least five of these blockbusters were affected, including…Bristol-Myers Squibb’s BMS-986165 (Tyk2)….On March 23, Galapago’s founder and CEO Onno van de Stolpe also said that he would “suspend clinical trials of filgo to protect patient safety.”

 

 Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
IMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) – Mar 27, 2020 – P3; N=444; Active, not recruiting; Sponsor: AbbVie; Trial primary completion date: Jun 2020 –> Jan 2021

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Weekly Top News – Psoriasis – March 23, 2020

March 23, 2020

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) – Mar 19, 2020 – P3; N=200; Not yet recruiting; Sponsor: Sun Pharma Global FZE

 

IMU-935 / Immunic
Immunic, Inc. reports year end 2019 financial results and highlights recent achievements (PRNewswire) – Mar 16, 2020 – “…We completed enrollment for our phase 2 EMPhASIS trial of our lead compound, IMU-838, for patients with relapsing-remitting multiple sclerosis (RRMS), roughly nine months ahead of our initial plan….We anticipate reporting top-line results in the third quarter of this year and believe that positive data could allow us to move quickly into a pivotal phase 3 trial….The current, single ascending dose trial of IMU-935 is planned to be followed by a phase 1 multiple ascending dose trial in healthy volunteers and a phase 1 trial in patients with mild-to-moderate psoriasis; both are expected to start during the first half of this year.”

 

Tremfya (guselkumab) / J&J
MorphoSys presents results for fiscal year 2019 (Yahoo Finance) – Mar 19, 2020 – “Revenues for 2019 include €62.3 million for success-based payments received primarily from Janssen (2018: €19.4 million) including royalties on net sales of Tremfya(R) amounting to €31.8 million for 2019 (2018: €15.4 million)….Janssen is currently conducting a series of clinical studies with Tremfya(R) (guselkumab) in various indications that could generate data during 2020. In 2019, Janssen submitted marketing authorization applications to the U.S. FDA and EMA for Tremfya(R) for the treatment of psoriatic arthritis. Decisions on these applications could potentially be made in 2020.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) (clinicaltrials.gov) – Mar 19, 2020 – P3; N=50; Not yet recruiting; Sponsor: Sun Pharma Global FZE

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Weekly Top News – Psoriasis – March 16, 2020

March 16, 2020

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
EMBRACE 1: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) – Mar 12, 2020 – P3; N=120; Not yet recruiting; Sponsor: LEO Pharma

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s Skyrizi expected to rock local psoriasis treatment market (Korea Biomedical Review) – Mar 11, 2020 – “AbbVie’s Skyrizi (ingredient: risankizumab), an interleukin-23 (IL-23) inhibitor, has passed the local health authorities’ reimbursement review three months after winning the marketing license in Korea….Armed with excellent data, Skyrizi recently passed the review of the Health and Insurance Review and Assessment Service (HIRA)’s Pharmaceutical Reimbursement Evaluation Committee.”

 

Cosentyx (secukinumab) / Novartis
INVIGORATE 2: Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Mar 12, 2020 – P3; N=380; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting –> Recruiting

 

Tremfya (guselkumab) / J&J
Janssen launched Tremfya, event [Google translation] (Pharmabiz) – Mar 9, 2020 – “Janssen Immuno is putting all his chips to Tremfya, his new product to treat severe psoriasis. It is in this context that last week the company held an event in the Escondida de Dorrego – Palermo – to present the product to the medical community of Argentina and Chile.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight (clinicaltrials.gov) – Mar 12, 2020 – P4; N=384; Not yet recruiting; Sponsor: LEO Pharma
Clinical • New P4 trial

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Plaque psoriasis: Reimbursement for risankizumab [Google translation] (Corriere Nazionale) – Mar 8, 2020 – “The Italian Medicines Agency (Aifa) has approved the reimbursement in Italy of risankizumab for the treatment of moderate to severe plaque psoriasis in adult patients candidates for systemic therapy. Risankizumab can be administered by two subcutaneous injections every 12 weeks, after two starting doses administered at week 0 and week 4.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie announces new formulary listings for Skyrizi in the treatment of moderate to severe plaque psoriasis (Benzinga) – Mar 11, 2020 – “AbbVie…announced today that SKYRIZI® (risankizumab) is now listed on the formularies of the Non-Insured Health Benefits program (NIHB) and the province of Manitoba for the treatment of moderate to severe plaque psoriasis. This announcement comes just three months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA), bringing a much-needed treatment to patients living with psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Public consultation for inclusion of new medication for psoriasis in SUS open on CONITEC website [Google translation] (PRNewswire) – Mar 13, 2020 – “The National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) is open to public consultation to receive contributions from the population to assess the incorporation by SUS of risanquizumab for the treatment of adult patients with moderate to severe plaque psoriasis, candidates for phototherapy or systemic treatment.”

 

JTE-451 / Japan Tobacco, Orphagen
IMPACT-PS: Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Mar 9, 2020 – P2; N=152; Completed; Sponsor: Akros Pharma Inc.; Active, not recruiting –> Completed; Trial completion date: Jul 2020 –> Feb 2020

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Weekly Top News – Psoriasis – March 9, 2020

March 16, 2020

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
EMBRACE 1: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) – Mar 12, 2020 – P3; N=120; Not yet recruiting; Sponsor: LEO Pharma

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s Skyrizi expected to rock local psoriasis treatment market (Korea Biomedical Review) – Mar 11, 2020 – “AbbVie’s Skyrizi (ingredient: risankizumab), an interleukin-23 (IL-23) inhibitor, has passed the local health authorities’ reimbursement review three months after winning the marketing license in Korea….Armed with excellent data, Skyrizi recently passed the review of the Health and Insurance Review and Assessment Service (HIRA)’s Pharmaceutical Reimbursement Evaluation Committee.”

 

Cosentyx (secukinumab) / Novartis
INVIGORATE 2: Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Mar 12, 2020 – P3; N=380; Recruiting; Sponsor: Novartis Pharmaceuticals; Not yet recruiting –> Recruiting

 

Tremfya (guselkumab) / J&J
Janssen launched Tremfya, event [Google translation] (Pharmabiz) – Mar 9, 2020 – “Janssen Immuno is putting all his chips to Tremfya, his new product to treat severe psoriasis. It is in this context that last week the company held an event in the Escondida de Dorrego – Palermo – to present the product to the medical community of Argentina and Chile.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight (clinicaltrials.gov) – Mar 12, 2020 – P4; N=384; Not yet recruiting; Sponsor: LEO Pharma

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Plaque psoriasis: Reimbursement for risankizumab [Google translation] (Corriere Nazionale) – Mar 8, 2020 – “The Italian Medicines Agency (Aifa) has approved the reimbursement in Italy of risankizumab for the treatment of moderate to severe plaque psoriasis in adult patients candidates for systemic therapy. Risankizumab can be administered by two subcutaneous injections every 12 weeks, after two starting doses administered at week 0 and week 4.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie announces new formulary listings for Skyrizi in the treatment of moderate to severe plaque psoriasis (Benzinga) – Mar 11, 2020 – “AbbVie…announced today that SKYRIZI® (risankizumab) is now listed on the formularies of the Non-Insured Health Benefits program (NIHB) and the province of Manitoba for the treatment of moderate to severe plaque psoriasis. This announcement comes just three months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA), bringing a much-needed treatment to patients living with psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Public consultation for inclusion of new medication for psoriasis in SUS open on CONITEC website [Google translation] (PRNewswire) – Mar 13, 2020 – “The National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) is open to public consultation to receive contributions from the population to assess the incorporation by SUS of risanquizumab for the treatment of adult patients with moderate to severe plaque psoriasis, candidates for phototherapy or systemic treatment.”

 

JTE-451 / Japan Tobacco, Orphagen
IMPACT-PS: Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Mar 9, 2020 – P2; N=152; Completed; Sponsor: Akros Pharma Inc.; Active, not recruiting –> Completed; Trial completion date: Jul 2020 –> Feb 2020

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Weekly Top News – Psoriasis – March 9, 2020

March 9, 2020

Stelara (ustekinumab) / J&J
Stelara: “The Committee confirmed that all issues previously identified in this application had been addressed [Moderate to severe psoriasis]” (EMEA) – Mar 3, 2020 – CHMP Final Minutes of the meeting on 9-12 December 2019: “The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Plaque psoriasis: Reimbursement for risankizumab [Google translation] (Corriere Nazionale) – Mar 8, 2020 – “The Italian Medicines Agency (Aifa) has approved the reimbursement in Italy of risankizumab for the treatment of moderate to severe plaque psoriasis in adult patients candidates for systemic therapy. Risankizumab can be administered by two subcutaneous injections every 12 weeks, after two starting doses administered at week 0 and week 4.”

 

BMS-986165 / BMS
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) – Mar 4, 2020 – P3; N=80; Active, not recruiting; Sponsor: Bristol-Myers Squibb; Recruiting –> Active, not recruiting

 

KD025  / Kadmon, Romeck Pharma
KD025: Expiry of patents related to composition-of-matter and method of use for fibrosis in US in 2029 and Canada, China, Eurasia, Europe, and Japan in 2026. (Kadmon) – Mar 6, 2020 – Annual Report 2019: Expiry of patents related to method of use for cGVHD in US in 2035 and for immune diseases including GVHD in US, Japan, Canada, China, Eurasia, and Europe in 2033 
[Screenshot]

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite is filing drug safety update report showing positive safety results from phase II and phase III studies of namodenoson and piclidenoson (Businesswire) – Mar 3, 2020 – “Can-Fite is filing drug safety update report showing positive safety results from phase-Can-Fite BioPharma Ltd….today announced it is submitting its annual Drug Safety Update Reports (DSUR) for both Piclidenoson and Namodenoson to the governing health regulatory agencies where its drug candidates are currently treating patients….Can-Fite’s reports being filed this year extend the growing body of documentation showing both Piclidenoson and Namodenoson have favorable safety profiles and risk-benefit ratios in more than 1,500 patients.”

 

RTA 1701 / Reata
RTA 1701: Expiry of patents related to composition-of-matter and method of use claims in US/ex-US between 2031- 2037 (Reata) – Mar 5, 2020 – Annual Report 2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
The Interministerial Commission modifies the price of 50 medicines (Acta Sanitaria) – Mar 6, 2020 – “The Interministerial Commission for the Prices of Medicines (CIPM), at its meeting held on February 4, approved three new drugs and decided to review the price of 50…as stated in the information provided by the Ministry of Health….According to the minutes of the CIPM meeting, the Commission approved three new medicines (Skyrizi, from Abbvie…The price set for this drug is € 3,833.49.”

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Weekly Top News – Psoriasis – March 2, 2020

March 2, 2020

topical roflumilast cream (ARQ-151) / Arcutis
DERMIS-OLE: Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (clinicaltrials.gov) – Feb 27, 2020 – P3; N=250; Enrolling by invitation; Sponsor: Arcutis Biotherapeutics, Inc.

 

Cosentyx (secukinumab) / Novartis
Study to demonstrate the efficacy, safety and tolerability of intravenous secukinumab up to 52 weeks in subjects with active Psoriatic Arthritis (clinicaltrialsregister.eu) – Feb 29, 2020 – P3; N=380; Ongoing; Sponsor: Novartis Pharma AG

 

Taltz (ixekizumab) / Eli Lilly
IXORA-R: A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) – Feb 27, 2020 – P4; N=1028; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

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Weekly Top News – Psoriasis – February 24, 2020

February 24, 2020

bimekizumab (UCB4940) / UCB
Bimekizumab: Topline data from P3 BE COMPLETE trial (NCT03896581) for psoriatic arthritis in H2 2021 (UCB) – Feb 21, 2020 – FY 2019 Results
[Screenshot]

 

bimekizumab (UCB4940) / UCB
Bimekizumab: Topline data from P3b BE RADIANT trial (NCT03536884) for psoriasis in Q2 2020 (UCB) – Feb 21, 2020 – FY 2019 Results
[Screenshot]

 

bimekizumab (UCB4940) / UCB
Bimekizumab: Topline data from P3 BE OPTIMAL trial (NCT03895203) for psoriatic arthritis in H2 2021 (UCB) – Feb 21, 2020 – FY 2019 Results
[Screenshot]

 

Tremfya (guselkumab) / J&J
They launch a new medicine for the treatment of psoriasis [Google Translation] (Diario Panorama) – Feb 22, 2020 – “Janssen…announced that a new psoriasis drug is available in the local market . This is Guselkumab aimed at treating adult patients with moderate to severe plaque disease who are also candidates for systemic therapy. The drug was approved by the National Administration of Medicines, Food and Medical Technology (Anmat) in July last year.”

 

Taltz (ixekizumab) / Eli Lilly
Taltz: Protection of compound patent in US until 2026, EU until 2031 and Japan until 2030 (Eli Lilly) – Feb 20, 2020 – Annual Report 2019: Biologic data package protection in US until 2028

 

Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly; bimekizumab (UCB4940) / UCB
UCB full year report 2019 (PRNewswire.co.uk) – Feb 20, 2020 – “R&D update: UCB plans to submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in mid-2020; Net sales break-down by core product: Cimzia® (certolizumab pegol)…net sales increased to more than € 1.7 billion, driven by continued, sustainable growth in all regions. Growth is also driven by new patient populations like women of childbearing age and people living with non-radio-graphic axial spondyloarthritis and with psoriasis.”

 

Stelara (ustekinumab) / J&J
Stelara: Expiry of patents ex-US in 2021 (J&J) – Feb 19, 2020 – Annual Report 2019

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Weekly Top News – Psoriasis – February 17, 2020

February 17, 2020

Otezla (apremilast) / Amgen
Amgen Canada receives approval of marketing authorization transfer of Otezla for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis (Canada Newswire) – Feb 12, 2020 – “Today, Amgen Canada Inc…announced Health Canada’s approval of the Marketing Authorization transfer of OTEZLA…from Celgene Corporation to Amgen Canada. This transfer is in line with Amgen Inc.’s previously announced acquisition of the worldwide rights to OTEZLA completed in November 2019. OTEZLA is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and…for the treatment of active psoriatic arthritis…”

 

Fumaderm (dimethyl fumarate) / Biogen; Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall; Skilarence (dimethyl fumarate) / Almirall
TRANSITION: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (clinicaltrials.gov) – Feb 11, 2020 – P4; N=250; Recruiting; Sponsor: Almirall, S.A.

 

Cosentyx (secukinumab) / Novartis
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More wt Group With Moderate/Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Feb 13, 2020 – P3; N=331; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting –> Active, not recruiting; Trial primary completion date: Feb 2020 –> Sep 2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis (clinicaltrials.gov) – Feb 13, 2020 – P2/3; N=120; Recruiting; Sponsor: Sun Pharma Global FZE; Not yet recruiting –> Recruiting

 

ANB019 / AnaptysBio
ANB019 sales potential: $250M peak (Infinata) – Feb 14, 2020 – A subscription to Thomson ONE is required to gain full access to report 68635796; Page no: 8; REPORT TITLE: “Boehringer Ingelheim Pharma GmbH & Co. KG – Company report”; AUTHOR: Infinata, et al; DATE: 02/10/2020

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s Skyrizi now listed on the Nova Scotia formulary for the treatment of moderate to severe plaque psoriasis (Canada Newswire) – Feb 13, 2020 – “AbbVie…announced today that Nova Scotia has listed SKYRIZI™ (risankizumab) on its provincial formulary for the treatment of moderate to severe plaque psoriasis. This announcement comes just two months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA). Nova Scotia joins Ontario, Alberta, Saskatchewan and Quebec in bringing a much-needed treatment to patients living with psoriasis.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (clinicaltrials.gov) – Feb 12, 2020 – P3; N=146; Not yet recruiting; Sponsor: Sun Pharma Global FZE; Trial completion date: Sep 2022 –> Apr 2024; Initiation date: Mar 2020 –> Sep 2020; Trial primary completion date: Sep 2021 –> May 2023

 

Otezla (apremilast) / Amgen
APOLO: A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium (clinicaltrials.gov) – Feb 10, 2020 – P=N/A; N=106; Completed; Sponsor: Celgene; Active, not recruiting –> Completed

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Weekly Top News – Psoriasis – February 10, 2020

February 10, 2020

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Brodalumab: Regulatory decision in Asia for psoriasis in 2020 (Kyowa Hakko Kirin Pharma) – Feb 6, 2020 – FY 2019 Results
Non-US regulatory
[Screenshot]

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Data from P3 trial (NCT03478787) for psoriasis in 2020 (AbbVie) – Feb 8, 2020 – Pipeline Update 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
OASIS-1: A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) – Feb 5, 2020 – P3; N=530; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
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.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of patents on method of use for psoriasis in US in 2032 and EU/Japan in 2031 with patent term extension in Japan in 2032-2033 (Novartis) – Feb 2, 2020 – Annual Report 2019: Expiry of patent on method of use for AS in US in 2033 and psoriatic arthritis in Japan in 2031; Pediatric exclusivity in EU until 2030

 

PF-06763809 / Pfizer
Termination of Karo agreement with Pfizer (PRNewswire.co.uk) – Feb 4, 2020 – “Karo Pharma AB…has been informed by Pfizer Inc….about its decision to terminate the Research Collaboration and License Agreement, which the two companies entered in December 2011. Following the wind-down of this agreement, there will be no active collaboration agreements between the two companies. This information follows Pfizer’s decision to terminate a specific development project, PF-06763809, which Karo informed about in press releases issued on November 5th and November 20th, 2019.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of SUNPG1623 (clinicaltrials.gov) – Feb 6, 2020 – P2b; N=391; Completed; Sponsor: Sun Pharma Global FZE; Active, not recruiting –> Completed

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of composition-of-matter patent in EU/Japan in 2025 and US in 2026 with patent term extensions in US until 2029 and Japan between 2026-2028-2029 (Novartis) – Feb 2, 2020 – Annual Report 2019: Regulatory data protection in US until 2027, EU until 2026 and Japan until 2022; SPC in EU until 2030

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie’s Skyrizi now publicly reimbursed in Ontario, Alberta, Saskatchewan and Quebec for the treatment of moderate to severe plaque psoriasis (Canada Newswire) – Feb 6, 2020 – “AbbVie…announced today that Ontario, Alberta, Saskatchewan and Quebec have listed SKYRIZI™ (risankizumab) on their respective provincial formularies for the treatment of moderate to severe plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi US sales projection: $246M (consensus: $133M) in Q1 2020 (UBS) – Feb 3, 2020 – A subscription to Thomson ONE is required to gain full access to report 68727877; Page no: 1; REPORT TITLE: “US Pharmaceuticals “Drug launches – weekly tracker” Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 01/27/2020

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Weekly Top News – Psoriasis – February 3, 2020

February 3, 2020

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission in US/EU for juvenile PsA in H2 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission in US for pediatric psoriasis in 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Regulatory submission for psoriatic arthritis (head to head) in 2020; Regulatory submission for ankylosing spondylitis in 2024 or later 
[Screenshot]

 

Otezla (apremilast) / Amgen
Otezla: PDUFA action date for scalp psoriasis in April 2020 (Amgen) – Jan 31, 2020 – Q4 2019 Results 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory decision in China for ankylosing spondylitis in H1 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Regulatory decision in EU for pediatric psoriasis in H2 2020 
[Screenshot]

 

ANB019 / AnaptysBio
ANB019: Top-line data from P2 POPLAR trial (NCT03633396) for palmoplantar pustulosis in H2 2020 (38th Annual J.P. Morgan Healthcare Conference, AnaptysBio) – Jan 28, 2020 
[Screenshot]

 

Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Cimzia (certolizumab pegol) now available for patients in Japan living with multiple psoriatic diseases (UCB Press Release) – Jan 28, 2020 – “UCB announced today that it received approval from Japanese health authorities for CIMZIA® (certolizumab pegol) to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective. The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF treatment option now available for these patients in Japan….For the newly approved indication of CIMZIA for psoriasis, UCB Japan will be conducting all promotional activities, thus expanding its dermatology footprint to Japan.”

 

Xeljanz (tofacitinib) / Pfizer; abrocitinib (PF-04965842) / Pfizer; PF-06700841 / Pfizer; PF-06826647 / Pfizer
Pfizer reports fourth-quarter and full-year 2019 results (Businesswire) – Jan 28, 2020 – “In the first half of 2020, we expect to report pivotal top-line results for the JADE Compare study for abrocitinib (PF-04965842), our Janus kinase-1 (JAK1) inhibitor for moderate-to-severe atopic dermatitis…for Xeljanz in ankylosing spondylitis….We also expect data in the first half of 2020 for promising earlier-stage opportunities, including proof-of-concept readouts for PF-06939926…for Duchenne muscular dystrophy…and for PF-06700841, an investigational topical TYK2/ JAK1 dual inhibitor for psoriasis and AD….In the second half of 2020, we look forward to top-line results for…PF-06700841 for potential treatment of psoriatic arthritis (PsA), and for PF-06826647, our investigational TYK2 inhibitor for psoriasis.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of composition-of-matter patent in EU/Japan in 2025 and US in 2026 with patent term extensions in US until 2029 and Japan between 2026-2028-2029 (Novartis) – Feb 2, 2020 – Annual Report 2019: Regulatory data protection in US until 2027, EU until 2026 and Japan until 2022; SPC in EU until 2030

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of patents on method of use for psoriasis in US in 2032 and EU/Japan in 2031 with patent term extension in Japan in 2032-2033 (Novartis) – Feb 2, 2020 – Annual Report 2019: Expiry of patent on method of use for AS in US in 2033 and psoriatic arthritis in Japan in 2031; Pediatric exclusivity in EU until 2030

 

Stelara (ustekinumab) / J&J
Anvisa approves new indication for ustequinumab, from Janssen, for the treatment of psoriasis in children and adolescents [Google Translation] (PRNewswire) – Jan 27, 2020 – “Janssen…announces that Anvisa has approved, in fast track – accelerated drug registration, STELARA® (ustequinumab) for the treatment of psoriasis in moderate to severe plaque in pediatric patients aged 6 to 17 years. Brazil was the first country to register the approval of ustequinumab for the age group of 6 to 11 years – a population in need of safe and effective treatment options….Janssen announced that it made the same submission to the US Food and Drug Administration (FDA) in October 2019, and the regulatory review is in process.”

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