24 May 2019 No. 3956 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa (esketamine) for depression are viewed as future blockbuster brands. “We will drive growth through addi- tional market share gains, increased pen- etration and entry into new populations,” Taubert said of the 14 current currently marketed drugs with growth potential. J&J is planning some 40 line extensions for those products through 2023, 10 of which could offer $500m or more in added rev- enue potential. MIXED SUCCESS Whether or not J&J will meet its goal to bring forward 10 new filings remains to be seen. The company had mixed success with the 10 drugs it promised investors it would deliver back in 2017, with three having been approved by FDA, but four having been discontinued or returned to partners. (Also see “J&J Plots Five-Year J&J Plans 10 Potential Blockbuster Pharma Growth Plan Around Mega-Brands And Launches” - Scrip, 17 May, 2017.) Filings By 2023 Among the positive advancements were the approvals of Tremfya in 2017, JESSICA MERRILL [email protected] Erleada (apalutamide) for prostate can- cer in 2018, Spravato in March and Bal- ohnson & Johnson expects to with blockbuster-level sales and bring varsa (erdafitinib) for urothelial cancer achieve above-market compound new $1bn-plus products to market. in April. Tremfya was already pending Jannual growth in its pharmaceuti- “We will deliver on our robust pipeline at FDA at the time of the 2017 analyst cals business between 2019 and 2023, of transformational medicines with at meeting and was not included in the including from current and future least 10 NME filings or launches antici- list of 10 filings. growth drivers. The company highlight- pated through 2023, each with more than Several drugs J&J had promised to ed its pharma portfolio in a six-hour ana- $1bn potential,” Worldwide Chairman- file by 2021 have met their demise, like lyst meeting at its headquarters in New Pharmaceuticals Jennifer Taubert said. the interleukin-6 inhibitor sirukumab for Brunswick, NJ, on 15 May, the first such Among the current blockbusters are rheumatoid arthritis, which was never overview in two years. anchor brands like Stelara (ustekinumab) brought to market as the commercial Similar to the last meeting in May and Simponi (golimumab) in immunol- prospects diminished. (Also see “J&J Im- 2017, management provided investors ogy, Imbruvica (ibrutinib) and Darzalex munology Growth Now Hinges On Ste- with an update on blockbuster medi- (daratumumab) in oncology, the Invega lara, Tremfya After RA Setback” - Scrip, 17 cines already in the portfolio and tar- (paliperidone) franchise in neurology Oct, 2017.) Another disappointment cost geted regulatory filing dates for new and Xarelto (rivaroxaban) in cardiovascu- J&J substantially, when the company dis- medicines. The company said it expects lar disease. But new brands like Tremfya continued development of lumicitabine to have 14 currently marketed medicines (guselkumab) for psoriasis and Spravato CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Takeda Digests Shire Pfizer In Gene Therapy ASCO Kick Off More divestments in the offing (p5-7) How it built its business (p8) Abstract drop gives the flavor of the meeting (p13-18) IN THIS ISSUE from the editor [email protected] Out with the old and in with the new. This might be some tentacles to get in on this act. Pfizer’s another ex- the motto for the biopharma industry, which invests ample: you can read an interview with the head of its more of its revenues in R&D than any other industry gene therapy business Robert Smith on p8. Since cell (16.3% for the top 29 pharma investors, according to and gene therapy enthusiasm has led to a number of EY). It’s also something of a theme in this week’s issue notable acquisitions (eg Gilead Sciences/Kite Pharma; of Scrip. Celgene/Juno Therapeutics; Roche/Spark Therapeu- Our cover story on Johnson & Johnson’s vision of 10 tics; Novartis/AveXis), it feels like there’s a ticking M&A new blockbusters to be filed over five years includes a re- time bomb around firms in the space that remain inde- minder of how quickly hot new hopes can be consigned pendent. Bluebird bio is a case in point: read about its to the rubbish heap: of 10 promising filings J&J had analyst day on p12. spotlighted just two years ago, 40% are now discontin- Meanwhile, Takeda, still working through the Shire ued or back in the hands of its partners. acquisition, is more focused on “out with the old” than We also bring you more detail on J&J’s interest in the most: it says 25% of revenue is “non-core” and it’s look- technologies du jour: cell, gene and RNA-based thera- ing to divest around $5bn worth of products after dis- pies (p4). Most big pharma companies are putting out posing of dry eye product Xiidra. Read more on p5. 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ISSN 0143 7690. 2 | Scrip | 24 May 2019 © Informa UK Ltd 2019 Bluebird’s Nest Eggs ASCO Lookout 15 Fighting Antibiotic Resistance 20 12 20 exclusive online content inside: COVER / J&J Plans 10 Potential Blockbuster Filings By 2023 Joy For SMA Patients As NICE And Biogen 4 Where Is J&J Investing For The Future? Cell Therapy, Break Spinraza Deadlock Gene Therapy And RNA KEVIN GROGAN [email protected] 5 More Divestments In Store As Takeda Digests Shire, Faces Expiries 7 Takeda Sees Strong Fundamentals Despite Post-Shire Loss Outlook 8 BI Bags Third Place For Humira Biosimilar in US With AbbVie Pact 8 Pfizer’s Smith On Building A Gene Therapy Business 12 Bluebird Lays Some New Eggs, But They’ll Take Time The news that NHS England has finally agreed to fund To Hatch Biogen Inc.’s Spinraza looks like a victory for common sense, with the company, the country’s healthcare cost 13 What Late-Breakers To Look Out For At ASCO 2019 watchdog and patient groups all lauding the negotiations that will finally result in the spinal muscular atrophy (SMA) treatment being made available to children with the rare 15 Five Companies To Watch This ASCO and fatal muscle-wasting condition. The National Institute for Health and Care Excellence 19 Merck KGaA Keen To Remain Key Player In MS Now (NICE) has recommended funding on the NHS for Spinra- And In Future za (nusinersen) for the treatment of infants, children and adults with 5q SMA. The decision follows a managed ac- 20 Merck & Co And The ‘Strange Business’ Of Antibiotics cess agreement (MAA) inked between NHS England and Biogen which will see the former fund treatment with the drug, an antisense oligonucleotide designed to treat 22 Pipeline Watch the root cause of the life-threatening disorder for a time- limited period, allowing further data to be collected on 23 Appointments its effectiveness. Spinraza will be made available to the youngest and most severely affected (SMA type 1) patients immedi- ately by Biogen, with NHS England offering funding on NICE’s publication of final guidance next month. Those with less severe symptoms (SMA types 2 and 3) will get access shortly. Published online 15 May 2019 @PharmaScrip /scripintelligence To read the rest of this story go to: https://bit.ly/2JtOooc /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 24 May 2019 | Scrip | 3 HEADLINE NEWS/COMPANIES CONTINUED FROM PAGE 1 for respiratory syncytial virus (RSV). (Also Where Is J&J Investing For The see “Alios Buy Best Forgotten For Johnson & Johnson As RSV Failure Costs It Dear” - Future? Cell Therapy, Gene Therapy Scrip, 22 Mar, 2019.) The company also discontinued de- velopment of talacotuzumab for acute And RNA myeloid leukemia (AML) and it backed JESSICA MERRILL [email protected] out of a deal with Geron Corp. to devel- op the telomerase inhibitor imetelstat ohnson & Johnson’s Janssen unit is in- development armamentarium as the first for myelofibrosis. (Also see “Geron Has vesting in cell therapy, gene therapy drugs developed on all three modalities Cash, But Does It Have The Imetelstat Jand RNA therapeutics as modalities have reached the market. Nonetheless, Data To Push On Without Janssen?” - that could deliver highly innovative new the development challenges in each of Scrip, 27 Sep, 2018.) drugs, Janssen global head of R&D Mathai the areas remains daunting, and the man- Several drugs mentioned in 2017 re- Mammen explained while outlining the ufacturing and commercial challenges are main on the updated list: GlaxoSmithKline company’s research priorities during a notable as well.