8 February 2019 No. 3941 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa the continuing crenezumab Phase III study taking place in Colombia, which is set to continue, Roche said on Jan. 30. That study, by the Alzheimer’s Pre- vention Initiative (API) is evaluating crenezumab in cognitively healthy indi- viduals who have an autosomal domi- nant mutation who are at risk of devel- oping familial Alzheimer’s. It is being conducted in collaboration with the US Banner Institute and is being funded by the National Institute on Aging. Further details of the interim analysis were not outlined but will be presented at a forthcoming medical conference. The CREAD 1 and 2 trials each involve 1,500 patients with early AD with con- firmed evidence of cerebral beta-amy- loid pathology, using four times higher doses than those used in Phase II stud- ies. CREAD 1 started in early 2016, and Another Alzheimer’s Failure: CREAD 2 in mid-2017. Roche may have been dismayed by the Crenezumab Bites The Dust CREAD results, but it still has an anti-am- yloid MAb, gantenerumab, in the Phase JOHN DAVIS [email protected] III GRADUATE studies, with initial data expected in around three years, and it oche is discontinuing two Phase Co. Ltd. with aducanumab, they added is collaborating with AC Immune on the III clinical studies of crenezumab in a Jan. 30 note. AC Immune’s share price development of an anti-tau compound, Rafter an independent interim on Nasdaq declined markedly during the RG6100, which is in Phase II studies. Jeffer- analysis concluded the anti-beta amy- morning of Jan. 30, dropping by 69.25% in ies analysts expect data from the Phase II loid monoclonal antibody is unlikely to early trading. TAURIEL study to be available in the sec- meet the studies’ primary endpoints, Roche said that the studies’ Indepen- ond half of 2020. news that continues a long-line of clin- dent Data Monitoring Committee had Roche noted that gantenerumab is an ical trial disappointments in this thera- concluded that crenezumab was un- IgG1 MAb with a mechanism of action peutic sector. likely to show an effect on the change distinct from crenezumab; it is designed Crenezumab was being developed from baseline in clinical dementia rat- to bind to aggregated forms of beta-am- in collaboration with the originator, the ing-sum of boxes (CDR-SB) score, the yloid and has previously shown amyloid Swiss biotech, AC Immune SA, and the primary endpoint in the CREAD 1 and plaque lowering in Alzheimer’s patients. failure is likely to “weigh heavily on both CREAD 2 Phase III studies in patients Gantenerumab is the only late-stage anti- Roche but particularly partner AC Im- with prodromal to mild sporadic Al- amyloid program being developed for mune,” commented analysts at Jefferies. zheimer’s disease. No safety signals subcutaneous administration, the Swiss The failure could also impact others active were observed in the pre-planned anal- multinational said. in the sector, including Biogen Inc./Eisai ysis. The decision casts a shadow over CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Starter For Ten Long Time Coming On The Market Novartis’ blockbuster plans Mylan’s generic Advair Takeda’s HQ sale adds revealed in earnings call. (p6) finally approved. (p15) to company coffers. (p18) IN THIS ISSUE from the editor [email protected] Yet another Alzheimer’s candidate failing to show an ef- that the beta-amyloid peptide is the main cause of Alz- fect is bad news in a field that has seen so much invest- heimer’s and that decreasing its production should ment for so little reward. However, all is not completely treat the disease. One possible reason for the failure of lost for the drug in question, Roche/Genentech’s cren- so many Abeta-targeting drugs is that they have been ezumab (see cover story). It continues to be studied in used too late in the the disease to impact its progres- people in people who are at higher risk of developing the sion. While treating the disease once its symptoms are disease but who have not yet shown cognitive symptoms. evident would be more practical, even a preventive drug Biogen, which is still optimistic that its Abeta anti- would be a major breakthrough, if something of a co- body candidates aducanumab and BAN2401 (partnered nundrum for cash-strapped healthcare systems. with Eisai) will prove successful in treating symptomat- Meanwhile, Roche continues its work on Abeta also ic Alzheimer’s, has also just announced it will launch a with the ongoing development of gantenerumab, which trial of aducanumab to prevent the development of the is in late-stage trials. Given previous challenges with disease before symptoms are evident (see p4). its development, and the generally poor outcomes in Catching Alzheimer’s early enough has been one of the field, hopes are muted. But in the absence of other the major challenges that has hamstrung the valida- breakthroughs, patients and pharma companies alike tion of the beta-amyloid hypothesis, which proposes cling to those hopes. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward, Christopher Keeling Paul Wilkinson Karen Coleman DESIGN SUPERVISOR SUBSCRIPTIONS Gayle Rembold Furbert Scrip Dan Simmons, Shinbo Hidenaga EDITORS IN CHIEF Andrea Charles EDITORIAL OFFICE Ian Haydock (Asia) John Davis Christchurch Court Eleanor Malone (Europe) Kevin Grogan 10-15 Newgate Street Denise Peterson (US) Ian Schofield London, EC1A 7AZ Vibha Sharma CUSTOMER SERVICES Joanne Shorthouse EXECUTIVE EDITORS US Toll-Free: +1 888 670 8900 COMMERCIAL Sten Stovall US Toll: +1 908 547 2200 Alexandra Shimmings (Europe) UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) US Australia: +61 2 8705 6907 Michael Cipriano POLICY AND REGULATORY Japan: +81 3 6273 4260 Derrick Gingery Maureen Kenny (Europe) Email: clientservices@ Joseph Haas Nielsen Hobbs (US) pharma.informa.com Emily Hayes ASIA Mandy Jackson Cathy Kelly TO SUBSCRIBE, VISIT Anju Ghangurde scrip.pharmaintelligence.informa.com Jung Won Shin Jessica Merrill TO ADVERTISE, CONTACT Brian Yang Brenda Sandburg Bridget Silverman [email protected] Sue Sutter 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 | 8 February 2019 © Informa UK Ltd 2019 Downward Humira Guidance Darzalex Patent Amicus’ Bradley Ruling Campbell 20 12 20 21 exclusive online content inside: COVER / Another Alzheimer’s Failure: Crenezumab Bites The Dust Celgene Gives Reassurances That Key 3 Celgene Gives Reassurances That Key Products Products And Programs Remain On Track And Programs Remain On Track MANDY JACKSON [email protected] 4 Biogen To Launch Phase III Alzheimer’s Prevention Study 6 Carry On Cosentyx As Novartis Lines Up More Blockbusters 7 Pfizer: Time To Face The Lyrica Pain 9 New Products Soar And Old Stand Their Ground As Roche Heads Off Biosimilar Threat 10 Amgen Explains How Big A Hit It May Take From Biosimilars, Pricing Pressures 12 AbbVie’s Downward Humira Guidance Worries Analysts With Bristol-Myers Squibb Co.’s $74bn acquisition of Cel- gene Corp. set to close in the third quarter – a deal that 14 Allergan Thinks It’s Ready To Withstand Restasis Generics requires shareholder approval – Celgene spent its Jan. 31 earnings conference call reassuring investors that sales of 15 Generic Advair: Finally Approved, A Long Time Coming its marketed drugs are growing and its pipeline programs remain on track. 16 Novartis’ Entresto Faces Challenge From Natco In India In addition to Celgene’s four blockbuster commercial 17 Fresh EU Okay For Rubraca Boosts Clovis products, Bristol highlighted five late-stage assets with US FDA approvals expected by 2020 as a big part of the justi- 18 Real Estate Sale, Including Osaka HQ, To Raise $347m fication for its big purchase when the deal was announced For Takeda in early January. Three are crucial for Celgene sharehold- ers to realize the full value of the transaction – payment of 19 Embattled Midatech Receives Lifeline From China a contingent value right (CVR) depends on approvals for To Save Cancer Candidate ozanimod, lisocabtagene maraleucel (liso-cel or JCAR017) and bb2121 within specific timeframes. 20 Shaken MorphoSys ‘Assessing Options’ After Losing “For Celgene shareholders, it’s quite clear how this [deal US Darzalex Patent Ruling with Bristol] unlocks and recognizes a lot of the value that the market has not assigned to us more recently,” Celgene 21 Amicus To See If Its Fabry Drug Galafold Can Benefit CEO Mark Alles said during the Q&A portion of the com- From Mis-Diagnosed MS pany’s fourth quarter earnings call. “The notion that we would create a new company that would have very dra- 22 Pipeline Watch matic leadership in the high specialty areas of oncology, 23 Appointments inflammation and immunology is, again, quite clear.” Published online 31 January 2019 To read the rest of this story go to: https://bit.ly/2D8XyRf @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 8 February 2019 | Scrip | 3 HEADLINE NEWS/ALZHEIMER’S DISEASE CONTINUED FROM PAGE 1 Among other companies developing Biogen To Launch Phase III candidate Alzheimer’s therapies, Biogen said during its fourth-quarter conference Alzheimer’s Prevention Study call on Jan. 29 that it was starting a new Phase III study of its anti-amyloid beta ELEANOR MALONE [email protected] antibody, aducanumab, for early use to prevent or delay the clinical onset of Al- iogen Inc. will launch a new Phase stake in the beta amyloid cleaving en- zheimer’s disease. III study of its anti-amyloid-beta an- zyme (BACE) inhibitor elenbecestat, and Btibody aducanumab for early use another antibody against the amyloid- The decision casts a to prevent or delay the clinical onset of beta peptide, BAN2401.