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The Digest

Pharma news roundup and Larvol updates

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Month: February 2020

Weekly Top News – IBD – February 17, 2020

February 17, 2020

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 HIBISCUS 2 trial (NCT02171429) for TNF naive ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 GARDENIA trial (NCT02136069) for moderate to severe ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

etrolizumab (RG7413) / Roche
Etrolizumab clinical trial estimate: Data from P3 trials LAUREL (NCT02165215), HICKORY (NCT02100696) and HIBISCUS 1 (NCT02163759) for ulcerative colitis in mid-2020 (J.P. Morgan) – Feb 15, 2020 – A subscription to Thomson ONE is required to gain full access to report 68787838; Page no: 3; REPORT TITLE: – “Roche: Strong year of newsflow offers significant potential for earnings upgrades”; AUTHOR: Vosser, Richard, et al; DATE: 02/03/2020

 

carotegrast methyl (AJM300) / Kissei, Eisai
AJM300 clinical trial estimate: Data from P3 trial (NCT03531892) for ulcerative colitis in H2 2020 (J.P. Morgan) – Feb 17, 2020 – A subscription to Thomson ONE is required to gain full access to report 68874313; Page no: 11; REPORT TITLE: “European Pharma & Biotech: Flushing out the UC opportunity: ROG’s etrolizumab seems well positioned, GLGP’s filgotinib could be less differentiated”; AUTHOR: Vosser, Richard, et al; DATE: 02/13/2020

 

Stelara (ustekinumab) / J&J
New phase 3b interim data from STARDUST study show two-thirds of patients with moderately to severely active Crohn’s disease achieved clinical remission after two doses of Stelara (ustekinumab) (PRNewswire) – Feb 14, 2020 – P3b, N=500; STARDUST (NCT03107793); Sponsor: Janssen-Cilag Ltd.; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical response and 67 percent were in clinical remission…Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as digital oral presentations at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO)….Janssen is presenting a total of 23 abstracts at this year’s ECCO congress.”

 

Entyvio (vedolizumab) / Takeda
Investigational subcutaneous formulation of vedolizumab achieves clinical remission at week 52 in patients with moderately to severely active Crohn’s disease (Businesswire) – Feb 14, 2020 – P3, N=383; VISIBLE 2 (NCT02611830); Sponsor: Takeda; “Takeda Pharmaceutical Company Limited…today announced results from the phase 3 VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the…vedolizumab (Entyvio®) for use during maintenance therapy in adult patients with moderately to severely active Crohn’s disease (CD)….The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008])…These data were announced during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.”

 

Humira (adalimumab) / Eisai, AbbVie
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn’s Disease (clinicaltrials.gov) – Feb 11, 2020 – P3; N=514; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals’ presence at the European Crohn’s and Colitis Organisation (ECCO) Congress further highlights commitment to the GI community (Arena Press Release) – Feb 11, 2020 – P2, N=156; NCT02447302; Sponsor: Arena; “Arena Pharmaceuticals…announced it will present new data from the open-label extension (OLE) of the Phase 2 OASIS trial for its investigative drug candidate etrasimod, a next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, at the 15th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is taking place February 12-15, 2020, in Vienna, Austria….Arena is presenting additional data on etrasimod and the unmet need in IBD, as well as hosting a dinner symposium with focused discussion on the integration of histology into a treat-to-target strategy.”

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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 – Breast Cancer – February 10, 2020

February 10, 2020

Piqray (alpelisib) / Novartis
Qiagen launches new breast cancer test in Europe (SeekingAlpha) – Feb 3, 2020 – “QIAGEN N.V…announces CE Mark certification of its therascreen PIK3CA RGQ PCR kit as an aid in identifying breast cancer patients with a PIK3CA mutation. Market launch is underway….The FDA approved the test last year. It is used as a companion diagnostic for Novartis’ Piqray (alpelisib).”

 

Piqray (alpelisib) / Novartis
EPIK-B3: Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation (clinicaltrials.gov) – Feb 5, 2020 – P3; N=566; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces first patients treated in separate phase 1b and registrational bridging studies (GlobeNewswire, Zai Lab Limited) – Feb 4, 2020 – “Zai Lab Limited…announced that the first patients have been dosed in two separate clinical studies: i) Phase 1b dose escalation and expansion clinical study of niraparib, in combination with MGD013, for the treatment of patients with advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (collectively as gastric cancer) who failed prior treatment, and ii) Registrational bridging study of margetuximab, in combination with chemotherapy, for the treatment of patients with metastatic HER2-positive breast cancer, respectively….Pending acceptance of the BLA, MacroGenics anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Regulatory approval for breast cancer in Q2 2021 (Syndax) – Feb 6, 2020 – Corporate Presentation 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Overall survival with ribociclib plus fulvestrant in advanced breast cancer (NEJM) – Feb 6, 2020 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.00455). The benefit was consistent across most subgroups.”

 

Piqray (alpelisib) / Novartis
QIAGEN launches FFPE and liquid biopsy PIK3CA diagnostics in Europe to enhance precision medicine in advanced breast cancer (Businesswire) – Feb 3, 2020 – “QIAGEN…announced the CE-marking and launch of its therascreen® PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. Last year the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray® (alpelisib) in the US…The therascreen PIK3CA test is a new diagnostic assay for detection of activating mutations in the phosphatidyl 3-kinase catalytic subunit alpha (PIK3CA) gene, and the first to enable testing of both DNA from FFPE tissue or plasma specimens.”

 

Perjeta (pertuzumab) / Roche; Tecentriq (atezolizumab) / Roche
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov) – Feb 5, 2020 – P1; N=98; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed

 

racemetyrosine (SM-88) / Tyme
TYME announces third quarter fiscal 2020 financial and operating results (GlobeNewswire) – Feb 5, 2020 – “Second half of calendar 2020: Publish SM-88 Phase II prostate study; Advance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers; Advance PanCAN’s Precision PromiseSM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane; Present and/or publish final data from Part 1 of TYME-88-Panc study; Complete enrollment in TYME-88-Panc pivotal study; Advance plans for TYME-18 IND program”

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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 
[Screenshot]

 

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 
[Screenshot]

 

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 
[Screenshot]

 

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 
[Screenshot]

 

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 
[Screenshot]

 

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 
[Screenshot]

 

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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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 – Breast Cancer – February 3, 2020

February 3, 2020

Kisqali (ribociclib) / Novartis
Kisqali: OS data from P3 MONALEESA-2 trial (NCT01958021) for postmenopausal women with advanced breast cancer in H2 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results 
[Screenshot]

 

Ibrance (palbociclib) / Pfizer; Erbitux (cetuximab) / Eli Lilly, EMD Serono; Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Pfizer reports fourth-quarter and full-year 2019 results provides 2020 financial guidance (Pfizer Press Release) – Jan 28, 2020 – “‘In the first half of 2020, we expect to report pivotal top-line results…in addition to the potentially registration-enabling Phase 2 ANCHOR study evaluating the combination of Braftovi, Mektovi and cetuximab for the first-line treatment of BRAFV600E-mutant metastatic colorectal cancer…In the second half of 2020, we look forward to top-line results for the Phase 3 PENELOPE-B study of Ibrance in early-stage breast cancer…we now expect the Phase 3 PALLAS study of Ibrance in early-stage breast cancer to complete in early 2021.’… In December 2019, Pfizer announced that the FDA accepted and granted priority review to the company’s supplemental New Drug Application (sNDA) for Braftovi in combination with Erbitux….The sNDA has a Prescription Drug User Fee Act goal date for a decision by the FDA in April 2020.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: Regulatory submission in EU for HER2 positive breast cancer in Q1 FY 2020 (Daiichi Sankyo) – Feb 1, 2020 – Regulatory submission in Japan for HER2 positive gastric cancer in Q1 FY 2020 
[Screenshot]

 

Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Pfizer) – Jan 28, 2020 – Q4 2019 Results 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in US/EU in combination with paclitaxel for 1L TNBC in 2020 (Roche) – Jan 30, 2020 – Regulatory submissions in US/EU in combination with nab-paclitaxel for adjuvant TNBC in 2020 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Kisqali: Interim analysis data from P3 NATALEE trial (NCT03701334) for adjuvant HR+, HER2(-) breast cancer in H1 2021 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Final data from P3 NATALEE trial for adjuvant HR+, HER2(-) breast cancer in 2026 
[Screenshot]

 

Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in early 2021 (Pfizer) – Jan 28, 2020 – Q4 2019 Results 
[Screenshot]

 

tucatinib (ARRY-380) / Seattle Genetics
EMA validates Seattle Genetics’ Marketing Authorization Application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer (Seattle Genetics Press Release) – Jan 31, 2020 – “Seattle Genetics, Inc…announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens. The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process…The MAA is based on data from the pivotal HER2CLIMB clinical trial…”

 

Keytruda (pembrolizumab) / Merck (MSD); Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201 + Keytruda: Initiation of P1b trial (NCT04042701) for breast cancer in Q4 FY 2019 (Daiichi Sankyo) – Feb 1, 2020 – Q3 FY 2019 Results
Trial initiation date

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Weekly Top News – IBD – February 3, 2020

February 3, 2020

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission in US for ulcerative colitis in 2020 (Roche) – Jan 30, 2020 – FY 2019 Results: Regulatory submission in EU for ulcerative colitis in 2020 
[Screenshot]

 

Stelara (ustekinumab) / J&J
REScUE: Loss of RESponse to Ustekinumab Treated by Dose Escalation (clinicaltrials.gov) – Jan 28, 2020 – P3; N=108; Not yet recruiting; Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz: “The CHMP adopted an opinion by consensus based on the PRAC recommendation [Ulcerative colitis]” (EMEA) – Jan 28, 2020 – CHMP Final Minutes for the meeting on 11-14 November 2019: “The Committee recommended that the marketing authorisations for Xeljanz should be varied. It was recommended that Xeljanz should be used with caution in all patients at high risk of blood clots”

 

Stelara (ustekinumab) / J&J
Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (Canada Newswire) – Jan 27, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial…”

 

brazikumab (AMG 139) / Allergan
Abbvie and Allergan announce agreements to divest brazikumab and Zenpep (Allergan Press Release) – Jan 27, 2020 – “AbbVie…today announced that Allergan has entered into definitive agreements to divest brazikumab (IL-23 inhibitor)…AstraZeneca…will acquire brazikumab…in Phase 2b/3 development for Crohn’s Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights….AbbVie and Allergan continue to expect a first-quarter 2020 close of their pending transaction, subject to receipt of required regulatory approvals and other closing conditions.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: $20B peak (Credit Suisse) – Jan 29, 2020 – A subscription to Thomson ONE is required to gain full access to report 68679165; Page no: 22; REPORT TITLE: – “First edition summary Europe: Monday, 20 January, 2020”; AUTHOR: Product Marketing, Credit Suisse E, et al; DATE: 01/20/2020

 

filgotinib (GLPG0634) / Gilead
Filgotinib sales projection: $517M for Crohn’s disease by 2030 (Morgan Stanley) – Jan 30, 2020 – A subscription to Thomson ONE is required to gain full access to report 68667865; Page no: 129; REPORT TITLE: – “Biotechnology: Quick 4Q19 preview”; AUTHOR: Harrison, Matthew, et al; DATE: 01/17/2020

 

Alofisel (darvadstrocel) / Takeda
Alofisel sales projection: $250M in 2024 (Bank Vontobel) – Jan 28, 2020 – A subscription to Thomson ONE is required to gain full access to report 68642122; Page no: 15; REPORT TITLE: – “Lonza (BUY, PT CHF 390) – An in-depth look into Lonza’s biologics businesses – the pearl and main growth driver of Lonza going forward”; AUTHOR: Buchta, Daniel, et al; DATE: 01/14/2020

 

phosphatidylcholine CR (LT‑02) / Lipid Therap, Nestle, Dr Falk
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) (clinicaltrials.gov) – Jan 27, 2020 – P3; N=150; Completed; Sponsor: Dr. Falk Pharma GmbH; Active, not recruiting –> Completed

 

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata (clinicaltrials.gov) – Jan 27, 2020 – P; N=4000; Not yet recruiting; Sponsor: Momentum Data

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