26 May 2017 No. 3855 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa summer or autumn. So, we feel good about that progression.” He is predicting a dramatic acceleration for Entresto this year. Jefferies analysts have joined Novartis’s optimistic bandwagon – a May 15 note from the group highlights that Entresto has seen a recent upturn in the US. They point out that Entresto saw one round of accel- eration in spring 2016 when new treatment guidelines were introduced, but that this was mostly swallowed by a poor launch performance (see box on p10). Now they predict this second wave of acceleration will hold steadfast for Entresto “as payer hur- dles continue to fall and enthusiasm builds among cardiologists.” Still, consensus estimates remain mostly conservative for the drug at $3.1bn by 2021. Shutterstock: samantha cheah samantha Shutterstock: Jefferies now estimates that Entresto rev- enues will reach $4.7bn by that time. Novartis’s Entresto Voyage: WHAT WENT WRONG? First approved in the US in July 2015 as a treatment for CHF, Entresto (valsartan/sacubi- Hindsight Is 20/20 tril) was predicted to be a prominent growth LUCIE ELLIS [email protected] driver for Novartis’s pharmaceutical unit. However, the launch got off to a slow start s a novel treatment for heart failure to piece together why a successful product and sales for its first full year on the market coming into a marketplace that had with a large target market missed the mark missed the big pharma’s own target: Entres- Aseen little innovation in recent years, in its first 18 months post-launch. to’s 2016 sales were $170m, while Novartis with a proven effect on morbidity and mor- Only now, after the close of 2017’s first had forecast $200m for the period. However, tality, Entresto should have been a ground- full quarter, is Entresto beginning to earn the company believes its full year sales target breaking US launch in 2015 for Novartis AG its keep for Novartis. The drug saw sales of for 2017 of $500m is still “very achievable.” – a region where nearly 5 million people are $84m in the first quarter compared with First-in-class Entresto, an angiotensin currently living with congestive heart failure just $17m in the year-ago quarter. Paul Hud- receptor blocker/neutral endopeptidase (CHF) and approximately 550,000 new cases son, who heads Novartis’ pharmaceuticals (ARB/NEP) inhibitor, is a fixed dose combi- are diagnosed each year. But the drug suf- operations, said in the company’s 1Q 2017 nation comprising valsartan (Novartis’s an- fered a slower-than-expected start in its big- earnings call this strong revenue rise is be- giotensin receptor blocker Diovan, a mega- blockbuster franchise that faced generic gest market and missed out on sales targets cause of doctors’ increased familiarity with competition in 2014) and the NEP inhibitor in 2016 despite Novartis introducing new the drug and a stronger sales force. prodrug sacubitril. value-based reimbursement methods to Hudson said the full deployment of the Slow uptake of the drug in the US was tempt US payers. Novartis sales force for the product “hap- unexpected, but is understandable because In light of these unusual circumstances, pened at the beginning of [this] year and Scrip has taken a look back at Entresto’s story the true operational impact will come late CONTINUED ON PAGE 10 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Business Strategy Drugs To Watch At ASCO Exclusive Interview The three anchors steadying Pfizer’s Abstracts hint it’s not all about Novo Nordisk CEO to empower regions, oncology ship (p14) I-O Drugs (p16) cut red tape (p18) IN THIS ISSUE from the editor [email protected] If you’re limbering up for the American Society of Clini- to a new contender and from a major cancer to a rare cal Oncology meeting in Chicago, check out Mandy one – we might also see data that could lead to a filing Jackson’s piece on seven drugs to watch at ASCO on for Loxo Oncology’s TRK inhibitor larotrectinib in glio- page 16. Our colleagues at Informa Pharma Intelli- blastoma, bringing the Stamford, Conn.-based upstart gence’s Biomedtracker analyst service pulled apart the within spitting distance of commercialization. conference abstracts released last week –we’ve taken Back in IO territory, where combination testing is their digest and distilled it further for your delectation. all the rage, indoleamine 2,3-dioxygenase is the rather Immuno-oncology will be a dominant theme, no unlikely name on everyone’s lips. Or rather, IDO is. In- doubt, but progress in other areas of cancer therapy hibiting this immunosuppressive enzyme at the same as is worth watching too. For example, details of Roche’s targeting immune checkpoints like PD-1 and CLTA-4 successful APHINITY trial of Perjeta combined with looks set to drive further advances in therapeutic effica- Herceptin and chemotherapy as an adjuvant therapy for cy. Incyte’s epacadostat is the one to watch; ASCO will breast cancer are expected to enable the triple combo’s provide a chance to see new data on its combination move from a conditional to a full approval. At the op- with Merck & Co’s PD-1 inhibitor Keytruda. NewLink posite end of the spectrum – from a cancer behemoth Genetics will also present IDO inhibitor study data. 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ISSN 0143 7690. 2 | Scrip intelligence | 26 May 2017 © Informa UK Ltd 2017 Real World Changing The ‘Think Global, Evidence? Diversity Narrative Act Local’ 20 9 20 18 exclusive online content inside: COVER / Novartis’s Entresto Voyage: Hindsight Is 20/20 Merck Develops ‘New And Improved’ CRISPR http://bit.ly/2r8SnNU 4 J&J Plots Five-Year Pharma Growth Plan Around Merck of Germany has developed a new genome editing tool Mega-Brands And Launches that it believes improves on the popular, but IP battle-worn, CRISPR technology. How this will affect the existing IP landscape 6 Ipsen’s New CEO Targets At Least One New Drug is as yet unknown. Annually ‘Forever’ 7 Infographic Infant Bacterial Therapeutics Harnesses Microbiome To Treat Preterm Babies 8 More Pressure On Pradaxa? US Payers May Narrow Coverage http://bit.ly/2qOauW4 Of NOACs By harvesting Lactobacillus reuteri from lactating mothers, Infant Bacterial Therapeutics has developed an approach to 9 MedImmune’s Bahija Jallal On Changing The treat necrotizing enterocolitis, a major killer of premature babies. Diversity Narrative 11 Takeda Picks Next Big Thing In Immunotherapy: Gamma Sinergium’s Gateway To Latin American Vaccine & Delta T Cells Biologics Markets http://bit.ly/2q8OrZk 13 AstraZeneca’s Iressa May Pave Way For EGFR Inhibitors In With the Latin American vaccines market forecast to more than Adjuvant Lung Cancer quadruple in size from just over $150m to 2015 to just under $700m in 2020, opportunities abound for both homegrown 14 Pfizer’s Oncology Strategy Centers On Three Anchors To businesses and multinationals looking to tap into local markets. Steady The Ship 15 Humira’s Formulation Patent Loss Boosts Biosimilar Mitochondrial Medicine Focus Drives NeuroVive Manufacturers Orphan Ambitions http://bit.ly/2rKbiuw 16 It’s Not All About IO: Seven Drugs To Watch At ASCO Erik Kinnman, CEO of NeuroVive Pharmaceutical, spoke to Scrip about the company’s work in mitochondrial medicine. 18 ‘Think Global, Act Local’ – Novo Nordisk CEO To Empower The company aims to develop orphan drugs to treat rare Regions, Cut Red Tape genetic conditions and seek partners for its NASH and liver cancer projects. 19 Novo Nordisk CEO Puts Pricing On The Line Avir BD Execs On Innovative Meds For Canadians 20 Real World Evidence Is Critical To Pharma’s Future: Can We Agree On What It Is? http://bit.ly/2q2MLo7 Avir Pharma’s business development associate Vanessa 22 Pipeline Watch Fortin and VP of business development Kaled Kadri talk to Scrip about the company’s business model and strategy for bringing innovative medicines to Canada 23 Henri Termeer Dies Aged 71 23 Appointments @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmamedtechbi.com 26 May 2017 | Scrip intelligence | 3 COMPANY STRATEGY J&J Plots Five-Year Pharma Growth Plan Around Mega-Brands And Launches JESSICA MERRILL [email protected] ohnson & Johnson’s strategy to outpace its branded pharma- Drugs On Track For Filing By 2021 ceutical peers by achieving above-market compound annual • apalutamide (ARN-509) for pre-metastatic prostate cancer Jgrowth over the five-year period from 2016 to 2021 will require • esketamine for treatment-resistant depression building several blockbuster brands into “mega-blockbusters” and • talacotuzumab (CSL362) for acute myeloid leukemia launching new commercial successes, worldwide chair-pharmaceu- • erdafitinib (FGFR Inhibitor) for solid tumors ticals Joaquin Duato said during an R&D briefing on May 17.