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Novartis Swaps Two Avexis Executives for One Following No. 3969 August 23, 2019 and CSO that the Kaspars have not been involved in the Novartis subsidiary’s op- erations since early May. Asked whether more AveXis employees will exit the company due to the preclini- cal safety data manipulation revealed on 6 August or whether other actions will be taken by Novartis in relation to the matter, Althoff told Scrip: “We cannot comment on the specifics of who is involved, but we can confirm this issue was not widespread, ei- ther in our overall dataset nor in our com- pany or any function within our company and was limited to a few individuals.” Novartis CEO Vas Narasimhan said in a 7 August conference call about the Zol- gensma data controversy that the compa- ny was in the process of “exiting the small number of AveXis scientists involved” in the data manipulation, which occurred Novartis Swaps Two AveXis before Novartis bought the gene therapy firm. (Also see “Novartis CEO Explains De- lay In Telling US FDA About Zolgensma Executives For One Following Data Fraud: We Wanted To Understand It First” - Pink Sheet, 7 Aug, 2019.) Zolgensma Data Manipulation Novartis acquired AveXis for $8.7bn MANDY JACKSON [email protected] last year. (Also see “Novartis Goes Big On Gene Therapy With $8.7bn AveXis Acquisi- ovartis AG said when it disclosed the Zolgensma BLA was manipulated. Page tion” - Scrip, 9 Apr, 2018.) Zolgensma was that preclinical safety data for Zol- Bouchard, whose most recent function was the lead asset in AveXis’s R&D pipeline and Ngensma were manipulated in the bi- global head of preclinical safety for Novar- won US Food and Drug Administration ologic license application for the gene ther- tis Institutes of Biomedical Research (NIBR), approval in May, becoming the world’s apy that the company would be “exiting” was named senior vice president and chief most expensive drug with a $2m list price. employees involved in the ethical breach. scientific officer at AveXis on 5 August. (Also see “It’s Official: Novartis SMA Gene And on 14 August, the subsidiary respon- AveXis noted that Bouchard is a 27-year Therapy Zolgensma Is World’s Most Expen- sible for the spinal muscular atrophy (SMA) biopharmaceutical industry veteran and sive Drug” - Scrip, 24 May, 2019.) treatment’s development announced that has been involved in more than 100 inves- Zolgensma has been closely watched two executives – including a co-founder of tigational new drug programs and dozens because of the multibillion-dollar sum No- AveXis Inc. – have been replaced. of new drug application and BLA filings. vartis paid for the product via the acqui- Notably, AveXis co-founder and chief He’s worked at Novartis for 10 years. sition of AveXis, its status as the second scientific officer Brian Kaspar and his Novartis spokesman Eric Althoff could gene therapy approval in the US, the treat- brother, senior vice president of research not confirm whether the Kaspars were ment’s high price tag and Novartis’s plans and development Allan Kaspar, have been fired, only that they are no longer with to negotiate with payers for annuity-style replaced by a single long-time Novartis the company. AveXis said in its statement payment options. executive with expertise in the area where about Bouchard’s appointment as SVP CONTINUED ON PAGE 4 FOR THE LATEST BUSINESS INSIGHT ON THE BIOPHARMA INDUSTRY VISIT: SCRIP.PHARMAINTELLIGENCE.INFORMA.COM Taltz Vs Tremfya AbbVie After Humira Scrip Infographic Which came out on top Strategizing for the future How pharma’s blockbusters in psoriasis study? (p20). with Rinvoq (p15). evolved (p12-13). IN THIS ISSUE from the US executive editor [email protected] Surely the US Food and Drug Administration’s clearance risk around IV ports and renal toxicity seen in preclini- of Sarepta’s Exondys 51 (eteplirsen) was one of the strang- cal models. “In our view, Sarepta is being slapped on the est approvals of all time. The exon 51-skipping Duchenne wrist for the prior questionable accelerated approval of muscular dystrophy therapy came to market in 2016 via Exondys 51,” SVB Leerink analysts said. intervention by FDA drug center director Janet Wood- The FDA has a reputation to uphold as a science- cock, who reversed the decision of the office director and based agency. And its traditional release of (redacted) review staff. This followed extensive lobbying efforts by review documents made it easy to see how information DMD advocates, including meetings with Woodcock. was weighed and decisions were made – as was true for So when the company’s next DMD therapy, the exon eteplirsen (Pink Sheet did an intensive review). But the 53-skipping golodirsen, received a complete response “streamlined” action package introduced last year and letter on 19 August some industry observers (many on the new integrated review template loses a lot of that Twitter) questioned whether this reflected some degree clarity and transparency – leaving agency decisions of regulatory payback. The issues aren’t around the sig- open to more interpretation. That’s bad for everyone. nificance of the endpoint, the same one that was the The comment period hasn’t closed on this yet: you have major problem with eteplirsen. The CRL cites infection until 26 August to weigh in here. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward, Christopher Keeling Paul Wilkinson Karen Coleman HEAD OF SUBSCRIPTIONS PUBLICATION DESIGN Dan Simmons, Gayle Rembold Furbert Shinbo Hidenaga EDITORS IN CHIEF Andrea Charles EDITORIAL OFFICE Ian Haydock (Asia) John Davis Blue Fin Building Eleanor Malone (Europe) Kevin Grogan 3rd Floor, 110 Southwark St Denise Peterson (US) Ian Schofield London, SE1 0TA Vibha Sharma CUSTOMER SERVICES Sten Stovall EXECUTIVE EDITORS US Toll-Free: +1 888 670 8900 COMMERCIAL US Toll: +1 908 547 2200 Alexandra Shimmings (Europe) US UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) Michael Cipriano Australia: +61 2 8705 6907 Derrick Gingery POLICY AND REGULATORY Japan: +81 3 6273 4260 Joseph Haas Maureen Kenny (Europe) Email: clientservices@ Mandy Jackson Nielsen Hobbs (US) pharma.informa.com Cathy Kelly ASIA Jessica Merrill Brenda Sandburg TO SUBSCRIBE, VISIT Anju Ghangurde scrip.pharmaintelligence.informa.com Jung Won Shin Bridget Silverman TO ADVERTISE, CONTACT Brian Yang Sue Sutter [email protected] EUROPE All stock images in this publication Neena Brizmohun courtesy of www.shutterstock.com Francesca Bruce unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2019: All rights reserved. ISSN 0143 7690. 2 | Scrip | August 23, 2019 © Informa UK Ltd 2019 AstronauTx’ Cash For Alzheimer’s Jazz’s Essential Tremor 20Focus 7 14 Imbruvica’s Path Forward 18 exclusive online content inside: Interview: Mereo All Set COVER / Novartis Swaps Two AveXis Executives For For Key Setrusumab Data One Following Zolgensma Data Manipulation KEVIN GROGAN [email protected] 4 Lundbeck Looks To Pipeline As Generic Competition Hits 5 Evotec Had Strong H1, Foresees Dual Track Growth After Entering Biologics Space 7 Jazz Pharma Zeros In On Essential Tremor With Cavion Buy 8 Inovio Eyes Expanded Asian Opportunities, Presence Via Korea Dual Listing 10 Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation Mereo BioPharma Group PLC is gearing up for a pivotal 11 Pharming Adds CDZ173 To Its Rare Disease Pipeline, Foresees Launch by 2022 fourth quarter which will see the readout of data on the UK company’s key asset, setrusumab for brittle bone disease. 12 Infographic: The Evolution of Pharma’s Blockbusters In an interview with Scrip, CEO Denise Scots-Knight noted that earlier this year, Mereo posted positive six-month data 14 UK’s AstronauTx Gets Cash For Alzheimer’s Programs from the open-label arm of its Phase IIb ASTEROID trial of setrusumab in brittle bone disease, the rare genetic disease 15 AbbVie’s Post-Humira Strategy Continues also known as osteogenesis imperfecta (OI). Now Mereo is Taking Shape With Rinvoq Approval preparing to unblind the results from three arms using low, 16 Roche/Genentech Set Lower Rozlytrek high and medium doses of the sclerostin inhibitor licensed Price To Catch Up With Bayer’s Vitrakvi from Novartis AG as part of a three-drug deal in 2015. Scots-Knight noted that 112 adults with type I, III or IV 17 Inrebic Approval Is A Boost For Myelofibrosis OI, which is characterized by fragile bones and reduced And Celgene’s Buyer Bristol bone mass, were enrolled in ASTEROID. “It’s the largest study that’s been done in this disease and should be very 18 Janssen’s Imbruvica Leads CLL informative,” she said, acknowledging that while recruit- Market Expansion In Europe ment “took a little while to get going…we relaxed a couple of the enrolment criteria and once we got all the technical 20 Taltz Tops Tremfya In Head-To-Head Psoriasis glitches sorted out, it went relatively quickly.” Study On Complete Skin Clearance Setrusumab has the potential to be the first approved 21 AZ Pushes Further Ahead In PARP Race therapy for OI and Scots-Knight said that Mereo could self- With Lynparza/Avastin Combo market in the US. “It’s a relatively small number of centers that kids are treated at,” she added, and especially for a pedi- 22 Pipeline Watch atric indication, “if you hit 50 centers in the US, you’re cover- ing quite a bit so it’s doable for a small company.” A study de- 23 Appointments sign has been agreed with the European Medicines Agency for a Phase III trial in children, based on a primary endpoint of fracture rate over a 12-month period and will be conducted in 165 children with severe disease aged five-18 years old. Published online 16 August 2019 @PharmaScrip /scripintelligence To read the rest of this story go to: https://bit.ly/31SnQSJ /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com August 23, 2019 | Scrip | 3 HEADLINE NEWS/SALES & EARNINGS CONTINUED FROM PAGE 1 lay Suggests Strong Displeasure With Han- and his Nationwide Children’s Hospital Then came the Swiss big pharma’s ac- dling Of Zolgensma Data Manipulation “ colleague Kathrin Meyer would remain knowledgement on 6 August that pre- - Pink Sheet, 7 Aug, 2019.) involved with Celenex’s programs.
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