The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – IBD – September 2, 2019

September 2, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Credit Suisse) – Aug 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836161; Page no: 1; REPORT TITLE: “VIDEO – US biotech week in review (8/16)”; AUTHOR: Research Department; DATE: 08/16/2019

 

Otezla (apremilast) / Amgen
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq sales projection: $5B (previously $3B) peak (SVB Leerink) – Aug 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838026; Page no: 1; REPORT TITLE: “Upa gets class, but not product thrombosis labelling; P/T $91”; AUTHOR: Porges, Geoffrey, et al; DATE: 08/18/2019

 

Rinvoq (upadacitinib) / AbbVie
Rinvoq US sales projection: $60M in Q3 2019 and $232M in FY2019 (UBS) – Aug 30, 2019 – A subscription to Thomson ONE is required to gain full access to report 67834016; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Weekly Skyrizi tracker” (Neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan sales projection: $1.3B in 2019 (Barclays) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 67590552; Page no: 1; REPORT TITLE: “Bausch Health Companies Inc – Bausch Health Companies: Fundamentals continue to strengthen; Stay OW”; AUTHOR: Prasad, Balaji, et al; DATE: 07/08/2019

 

AEVI-002 / Sanofi, Aevi Genomic, Kyowa Hakko Kirin
AEVI-002: Initial data from P1 trial (NCT03169894) for crohn’s disease in H2 2019 (Aevi Genomic Medicine) – Aug 27, 2019 – Corporate Presentation  
[Screenshot]

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Xifaxan sales projection: $1,338M in 2019 (BTIG) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 66633408; Page no: 1; REPORT TITLE: “Bausch Health Companies – Xifaxan beat offsets more weakness in ortho derm; Will Duobrii be a meaningful contributor in 2H19?”; AUTHOR: Chiang, Timothy, et al; DATE: 08/07/2019

 

Kappaproct (cobitolimod) / InDex
InDex Pharmaceuticals meets primary endpoint in the phase IIb study CONDUCT with cobitolimod in ulcerative colitis (BioSpace) – Aug 27, 2019 – P2, N=213; CONDUCT (NCT03178669); Sponsor: InDex; “The study met the primary endpoint of clinical remission, demonstrating a superior efficacy of 15% (delta) in patients receiving the highest dose of cobitolimod compared to placebo. Cobitolimod was well tolerated at all dose levels and no differences in the safety profile were observed compared to placebo.”

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Weekly Top News – Psoriasis – September 2, 2019

September 2, 2019

Otezla (apremilast) / Amgen
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.2B in FY2020 (CFRA) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873275; Page no: 1; REPORT TITLE: “Amgen Inc- Otezla deal highly accretive – Provides synergy and accelerates rev/EPS growth”; AUTHOR: Werber, Yaron, et al; DATE: 08/26/2019

 

Otezla (apremilast) / Amgen
Otezla patent expiry: February 2028 (CFRA) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67874668; Page no: 5; REPORT TITLE: “Amgen Inc”; AUTHOR: Huang, Kevin, et al; DATE: 08/26/2019

 

Otezla (apremilast) / Amgen
Otezla WW sales projection: $3.1B (US: $2.5B) peak in 2028 (RBC Capital Markets (Canada)) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873985; Page no: 3; REPORT TITLE: “Amgen Inc. – Thesis-changing M&A comes at a high cost: Otezla acquisition adds +$14/sh to PT”; AUTHOR: Mackay, Kennen, et al; DATE: 08/26/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $2.2B in 2020, $3.1B peak and guidance of $1.9B in 2019 (J.P. Morgan) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67885180; Page no: 1; REPORT TITLE: “Amgen Inc- Amgen Inc: Updating model for Otezla acquisition; It helps but additional levers needed to further boost growth outlook”; AUTHOR: Kasimov, Cory, et al; DATE: 08/28/2019

 

Otezla (apremilast) / Amgen
Otezla: Expiry of patent in US in 2028 (Amgen) – Aug 31, 2019 – Amgen to Acquire Otezla  
[Screenshot]

 

Otezla (apremilast) / Amgen
Otezla sales projection: $3.7B in 2026 (Cantor Fitzgerald) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873189; Page no: 1; REPORT TITLE: “Amgen Inc- Post Enbrel, Amgen keeps on trucking with a new I&I add to their portfolio”; AUTHOR: Research Department; DATE: 08/26/2019

 

Otezla (apremilast) / Amgen
Otezla sales projection: $1.9B in 2019 and $2.2B in 2020 (Jefferies) – Sep 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67873157; Page no: 1, 3; REPORT TITLE: “Amgen Inc- Smart deal and very accretive…we’d buy the dip today; Reiterate BUY”; AUTHOR: Yee, Michael, et al; DATE: 08/26/2019

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Weekly Top News – Breast Cancer – August 26, 2019

August 26, 2019

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-756 trial (NCT03725059) for ER+/HER2- breast cancer in 2031 (Credit Suisse) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 18; REPORT TITLE: “Adjuvant Immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Verzenio (abemaciclib) / Eli Lilly; Imfinzi (durvalumab) / AstraZeneca, Celgene
More cancer meds added to Dutch basic health insurance package (NL Times) – Aug 20, 2019 – “From September 1st the medicines durvalumab and abemaciclib will be covered by the basic health insurance package, Minister Bruno Bruins of Medical Care announced. Durvalumab is used to treat a specific form of lung cancer, abemaciclib is an approved treatment for certain forms of breast cancer.”

 

Perjeta (pertuzumab) / Roche
Roche’s Perjeta nails new indication approval in China (GBI Health) – Aug 21, 2019 – “Switzerland-based giant Roche announced a new indication approval from China’s National Medical Products Administration (NMPA) in relation to Perjeta (pertuzumab). The drug will be used in combination with sister product Herceptin (trastuzumab) and chemotherapy as an adjuvant therapy for the treatment of patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (>2 cm in diameter or positive for lymph nodes).”

 

Trazimera (trastuzumab biosimilar) / Pfizer
Pfizer launches Herceptin biosimilar in Japan (Pharma Japan) – Aug 23, 2019 – “Pfizer Japan said…that its biosimilar version of the major cancer drug Herceptin (trastuzumab) is now available with the exact same indications and dosing schedules as Chugai Pharmaceutical’s originator product.”

 

Versavo (bevacizumab biosimilar) / Dr. Reddy’s
Dr. Reddy’s Laboratories announces the launch of Versavo (bevacizumab biosimilar) in India(Businesswire) – Aug 19, 2019 – “Dr. Reddy’s Laboratories Ltd…announced…that it has launched Versavo® (bevacizumab), a biosimilar of Roche’s Avastin® in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer).”

 

Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
Japan gives further nod to Celltrion’s breast cancer biosimilar (Korea Biomedical Review) – Aug 22, 2019 – “Celltrion Healthcare said that Japan’s Ministry of Health, Labour and Welfare has approved a three-week cycle method for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast cancer.”

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Weekly Top News – IBD – August 26, 2019

August 26, 2019

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in H2 2021 (Wells Fargo) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67741783; Page no: 2; REPORT TITLE: “Update from San Francisco biotech access day”; AUTHOR: Research Department; DATE: 08/02/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 clinical trial estimate: Initiation of P3 trial for Crohn’s disease in Q1 2020(Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67673924; Page no: 1; REPORT TITLE: “Redhill Biopharma Ltd 2Q19 results; Talica PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/24/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NICE’s fast-track catapults Skyrizi into market (PMLive) – Aug 21, 2019 – “NICE has published a final recommendation for AbbVie and Boehringer Ingelheim’s Skyrizi today, completing a fast-track process which will see the new psoriasis treatment gain market access in record time….Accelerates the review process and also cuts the standard 90 day implementation period down to 30 days. This means the NHS across England has a month from today to make preparations for prescribing of Skyrizi to begin….SVB Leerink analyst Geoffrey Porges predicts $3bn in peak sales for AbbVie’s Skyrizi, with its success dependent on how it will fare not just in psoriasis but the other hotly-contested inflammation and immunology indications as well, such as Crohn’s and ulcerative colitis.”

 

Otezla (apremilast) / Celgene
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Humira (adalimumab) / Eisai, AbbVie
Humira pricing: Wholesale acquisition cost of $57,000/year (UBS) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836265; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Upadacitinib approval mostly in-line w/ expectations””; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira patent expiry: 2022 (NH Inv.) – Aug 22, 2019 – A subscription to Thomson ONE is required to gain full access to report 67851543; Page no: 21; REPORT TITLE: “Medy Tox Inc – Initiating coverage – Medytox-Ready to cross the great wall-08/21/2019”; AUTHOR: Ra, Ryan, et al; DATE: 08/21/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 patent expiry: 2019-2038 (Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67570515; Page no: 8; REPORT TITLE: “Redhill Biopharma Ltd Priority review for Talicia (RHB-105); PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/03/2019

 

etrasimod (APD334) / Arena
Etrasimod share value projection: $56/share to Arena Pharmaceutical (RBC Capital Markets (Canada)) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67780220; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals, Inc. – Q2:19 post-call: ARNA clinical execution continues with trials fully funded”; AUTHOR: Mackay, Kenen, et al; DATE: 08/07/2019

 

PTG-200 / Protagonist Therapeutics, J&J
PTG-200 share value projection: $4.50/share to Protagonist Therapeutics (H.C. Wainwright & Co) – Aug 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67785243; Page no: 2; REPORT TITLE: “Protagonist Therapeutics Inc – PTG-300 broadens its horizons; Reiterate Buy”; AUTHOR: Research Department; DATE: 08/08/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 share value projection: $9/share to RedHill (Roth Capital) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67668922; Page no: 2; REPORT TITLE: “Redhill Biopharma Ltd RDHL: 2Q19 Recap – Focus on Talicia (PDUFA Nov 2)”; AUTHOR: Henry, Scott, et al; DATE: 07/23/2019

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Weekly Top News – Psoriasis – August 26, 2019

August 26, 2019

Cosentyx (secukinumab) / Novartis
Cosentyx clinical trial estimate: Data from P3 BE RADIANT trial (NCT03536884) for psoriasis in Q2 2020 (Barclays) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67816038; Page no: 1; REPORT TITLE: “NOVN/UCB: One back for the IL-17s? Kind of…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 08/13/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NICE’s fast-track catapults Skyrizi into market (PMLive) – Aug 21, 2019 – “NICE has published a final recommendation for AbbVie and Boehringer Ingelheim’s Skyrizi today, completing a fast-track process which will see the new psoriasis treatment gain market access in record time….Accelerates the review process and also cuts the standard 90 day implementation period down to 30 days. This means the NHS across England has a month from today to make preparations for prescribing of Skyrizi to begin….SVB Leerink analyst Geoffrey Porges predicts $3bn in peak sales for AbbVie’s Skyrizi, with its success dependent on how it will fare not just in psoriasis but the other hotly-contested inflammation and immunology indications as well, such as Crohn’s and ulcerative colitis.”

 

Otezla (apremilast) / Celgene
Bristol-Myers Squibb announces agreement between Celgene and Amgen to divest Otezla for $13.4 billion (Businesswire) – Aug 26, 2019 – “Bristol-Myers Squibb Company…announced today that Celgene Corporation…has entered into an agreement with Amgen…under which Amgen would acquire the global rights to OTEZLA® (apremilast) for $13.4 billion in cash….The closing of the acquisition covered by the agreement with Amgen is contingent on Bristol-Myers Squibb and Celgene entering into a consent decree with the Federal Trade Commission (FTC)…’establishing OTEZLA as an important medicine for patients with psoriasis, psoriatic arthritis and Behçet’s Disease’…Bristol-Myers Squibb now expects the pending merger with Celgene to close by the end of 2019.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesale acquisition cost of $59,000/year for maintenance dosing (UBS) – Aug 24, 2019 – A subscription to Thomson ONE is required to gain full access to report 67836265; Page no: 1; REPORT TITLE: “AbbVie Inc- First read: AbbVie “Upadacitinib approval mostly in-line w/ expectations””; AUTHOR: Jacob, Navin, et al; DATE: 08/16/2019

 

Taltz (ixekizumab) / Eli Lilly
Taltz sales projection: $1.4B in 2019 (Cantor Fitzgerald) – Aug 23, 2019 – A subscription to Thomson ONE is required to gain full access to report 67814539; Page no: 1; REPORT TITLE: “Eli Lilly & Co Lly Standing “Taltz” This morning with positive head to head data”; AUTHOR: Research Department, et al; DATE: 08/13/2019

 

Otezla (apremilast) / Celgene
Otezla TRx: 13,093 in second week of August 2019; Otezla NRx: 4,528 in second week of August 2019 (RBC Capital Markets (Canada)) – Aug 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67794724; Page no: 3; REPORT TITLE: “Noteworthy wkly script trends (HIV, HCV, MS, CGRP, TKI, PCSK9, Otezla): RBC Coverage W/E 8/2 – Wk 5 of 3Q”; AUTHOR: Abrahams, Brian, et al; DATE: 08/09/2019

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