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Pharma news roundup and Larvol updates

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Month: September 2019

Tiger Day 2019

September 13, 2019

By Sam SzDigital Media Specialist


Tiger Day 2019

 

Here at Larvol, we refer to our team members as tigers.  This year, we celebrated our 4th annual Tiger Day where we come together on one big Zoom meeting and watch a variety of submitted videos from team members performing a talent.  People can also opt to film their children, or junior tigers, performing or showcasing a talent.  This years video capped off at 35 minutes of submissions filled with the talent of our team and their families.

 

 

 

We witnessed beautifully choreographed dances, singing, photography, paintings, art, and even baking!  As a fully remote team, we don’t always have the opportunity to come together and Tiger Day gives us the chance to “meet”. This meeting takes our long distance work relationships and shrinks them in a way that truly makes it feel like we are all in the room together.

 

 

 

Larvol turned 15 this year and this company is filled with outstanding people and it was an absolute pleasure to watch everyone in their video submissions.  We laughed, cried, and were mesmerized by what our team can do!  It was nice to have a meeting with the full team that was mainly focused on getting to know each other.  Tiger Day is very special to us and we look forward to what 2020 will bring!

 

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Weekly Top News – Breast Cancer – September 9, 2019

September 9, 2019

Kisqali (ribociclib) / Novartis
Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results (ESMO 2019) – Sep 3, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
Daiichi Sankyo advances [fam-] trastuzumab deruxtecan (DS-8201) in Japan with regulatory submission in HER2 positive metastatic breast cancer (Daiichi Sankyo Press Release) – Sep 9, 2019 – “Daiichi Sankyo Company…today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer…’We are proud to initiate this critical next step in the regulatory process in Japan and look forward to the presentation of the phase 2 DESTINY-Breast01 study of [fam-] trastuzumab deruxtecan to the scientific community,’ said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.”

 

margetuximab (MGAH 22) / MacroGenics
Zai Lab announces financial results and corporate update for the six months ended June 30, 2019 (GlobeNewswire) – Sep 3, 2019 – “Anticipated Upcoming Milestones…Margetuximab….Initiate bridging trial of heavily pretreated HER2-positive metastatic breast cancer patients in China; MacroGenics to present the results from a pre-specified interim overall survival (OS) analysis and submit a Biologics License Application (BLA) to the U.S. FDA in the fourth quarter of 2019; Potential China CTA approval for the planned global gastric cancer and join MacroGenics to initiate the global registrational trial in combination with checkpoint inhibitor molecules, including INCMGA 0012 and MGD013, for patients with gastric or gastroesophageal junction cancer in 2019”

 

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals announces the initiation of two clinical trials evaluating IPI-549 in novel triple combination therapies for the treatment of solid tumors (PRNewswire) – Sep 4, 2019 – “Infinity Pharmaceuticals, Inc….announced the initiation of two clinical trials for IPI-549…Infinity initiated MARIO-3, a Phase 2 multi-arm study in collaboration with Roche/Genentech evaluating IPI-549 in combination with Tecentriq® and Abraxane® (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq….Additionally, Arcus Biosciences initiated a Phase 1/1b study, in collaboration with Infinity, evaluating IPI-549 in a novel combination regimen with AB298, Arcus’s dual adenosine receptor antagonist, and Doxil®, a chemotherapy, in patients with advanced TNBC.”

 

Nerlynx (neratinib) / Puma
FDA grants Orphan Drug Designation to Puma Biotechnology’s Nerlynx for the treatment of breast cancer patients with brain metastases (Puma Biotech Press Release) – Sep 3, 2019 – “Puma Biotechnology…announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)
Pivotal new data from Merck’s broad oncology portfolio at ESMO 2019 Congress (Merck (MSD) Press Release) – Sep 9, 2019 – “Merck…announced new data from its broadoncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions.”

 

Verzenio (abemaciclib) / Eli Lilly
Argentina is second market to wave through Eli Lilly’s Verzenio (GBI Health) – Sep 5, 2019 – “Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) this week cleared Eli Lilly’s breast cancer treatment Verzenio (abemaciclib) for marketing, as GBI analysis reveals. The orally administered therapy is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”

 

Ibrance (palbociclib) / Pfizer
Ibrance exclusivity expiry: 2023 (Trefis) – Sep 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67885259; Page no: 1; REPORT TITLE: “Roche Holding Ltd – Can Roche’s blockbuster drug Herceptin’s Sales Grow?”; AUTHOR: Research Department, et al; DATE: 08/29/2019

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Weekly Top News – IBD – September 9, 2019

September 9, 2019

Stelara (ustekinumab) / J&J
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union (Businesswire) – Sep 4, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis (UC), who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies….The EC approval is based on data from the pivotal Phase 3 UNIFI trial programme…”

 

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

 

Entyvio SC (vedolizumab SC) / Takeda; Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer; Entyvio (vedolizumab) / Takeda; Humira (adalimumab) / Eisai, AbbVie; Stelara (ustekinumab) / J&J; Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J; Xeljanz (tofacitinib) / Pfizer; Remicade (infliximab) / Mitsubishi Tanabe, J&J
ICER to assess treatments for ulcerative colitis (Institute for Clinical and Economic Review) – Sep 6, 2019 – “The Institute for Clinical and Economic Review (ICER) announced today that it plans to assess the comparative clinical effectiveness and value of therapies for ulcerative colitis (UC), including: Vedolizumab (Entyvio®, Takeda), subcutaneous and IV formulations, Infliximab (Remicade®, Janssen), Infliximab-dyyb (Inflectra®, Pfizer), Adalimumab (Humira®, AbbVie), Golimumab (Simponi®, Janssen), Tofacitinib (Xeljanz®, Ustekinumab (Stelara®, Janssen)….A draft scoping document, which will provide more detail on ICER’s planned analysis, will be available on September 27, 2019. That document will be open to public comment for three weeks.”

 

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

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi WW sales projection: $300M in FY2019 and $800M in FY2020 (Piper Jaffray) – Sep 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67909429; Page no: 1; REPORT TITLE: “Abbvie Inc – Skyrizi En Fuego – New derm survey indicates Q219 was no fluke”; AUTHOR: Raymond, Christopher, et al; DATE: 09/04/2019

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Weekly Top News – Psoriasis – September 9, 2019

September 9, 2019

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi for the treatment of moderate to severe plaque psoriasis in adults is included in the high-cost protection and is available in Sweden [Google Translation] (Mynewsdesk) – Sep 6, 2019 – “Skyrizi (risankizumab) is part of the drug subsidy in Sweden from June 14, 2019 and is now available at Swedish pharmacies….According to a decision from the Dental Care and Medicines Benefit Agency (TLV), Skyrizi (risankizumab) is included in the Swedish drug benefit. Skyrizi has already been approved in Europe for the treatment of moderate to severe plaque psoriasis in adults who need systemic treatment.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Almirall launches ‘Ilumetri’ in Spain for moderate to severe plaque psoriasis in adults [Google Translation] (Infosalus.com) – Sep 2, 2019 – “The pharmaceutical company Almirall has started the commercialization in Spain of ‘Ilumetri’ (tildrakizumab) for the treatment of moderate to severe plaque psoriasis in adults, after receiving the marketing authorization from the European Commission in September 2018 and the decision of the Ministry of Health to include it in the pharmaceutical benefit of the National Health System (SNS) last July.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx regulatory estimate: Approval in axial spondyloarthritis in H2 2020 (Jefferies) – Sep 7, 2019 – A subscription to Thomson ONE is required to gain full access to report 67891655; Page no: 4; REPORT TITLE: “Novartis AG: Wave of new launches underappreciated driving confidence in ongoing upgrades”; AUTHOR: Welford, Peter, et al; DATE: 08/30/2019

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Weekly Top News – Breast Cancer – September 2, 2019

September 2, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion030 trial (NCT03498716) for TNBC in 2022 (Credit Suisse) – Aug 29, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 11; REPORT TITLE: “Adjuvant immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in December 2019 (Credit Suisse) – Aug 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 11; REPORT TITLE: “Adjuvant immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma Team, European, et al; DATE: 08/19/2019

 

Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka; Tecentriq (atezolizumab) / Roche
European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer (Roche Press Release) – Aug 29, 2019 – “Roche…announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease….Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people with PD-L1-positive metastatic triple-negative breast cancer.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Chugai files for additional indication for anti-HER2 antibody drug conjugate Kadcyla for adjuvant therapy of HER2-positive early breast cancer (Chugai Press Release) – Aug 30, 2019 – “Chugai Pharmaceutical Co., Ltd…announced…that it has filed an application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for an additional indication for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla® (generic name: trastuzumab emtansine), as adjuvant therapy in patients with HER2-positive early breast cancer….This application is based on results from an open-label, randomized, global phase III clinical study (the KATHERINE study), evaluating efficacy and safety of Kadcyla adjuvant therapy compared to Herceptin in almost 1,500 people with HER2-positive early breast cancer who had invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy including Herceptin.”

 

Bavencio (avelumab) / EMD Serono, Pfizer
Bavencio clinical trial estimate: Data from P3 A-Brave trial (NCT02926196) for TNBC in mid-2021 – Aug 28, 2019 – A subscription to Thomson ONE is required to gain full access to report 67838763; Page no: 13; REPORT TITLE: “Adjuvant Immuno-oncology 2.0: Revisiting potential winners in new $30bn+ market”; AUTHOR: Pharma team, European, et al; DATE: 08/19/2019

 

Tecentriq (atezolizumab) / Roche
Roche launches VENTANA PD-L1 (SP142) assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq (Roche Press Release) – Aug 29, 2019 – “Roche…announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine Tecentriq® is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab)5 plus chemotherapy (nab-paclitaxel).”

 

Talzenna (talazoparib) / Pfizer
Pfizer wastes no time to launch Talzenna in Argentina (GBI Health) – Aug 28, 2019 – “Pharmaceutical major Pfizer this week launched its anti-breast cancer PARP inhibitor Talzenna (talazoparib) to the Argentina market, less than a month after its approval was published by the National Administration of Drugs, Foods and Medical Devices (ANMAT), as GBI reported. The drug was shown in the Phase III EMBRACA clinical trial to stop disease progression in 63% of patients with BRCA-mutated (gBRCAm) breast cancer versus only 27% in the chemotherapy control group, while increasing progression-free survival (PFS) to 8.6 months compared to 5.6 months in the control arm.”

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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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