Autoimmune disease vies with cancer to dominate the class of 2017

Given the stunning multiple sclerosis data seen with Roche’s Ocrevus it could come as a surprise that this agent is not the biggest expected launch of 2017. That honour belongs to Sanofi/Regeneron’s dermatitis hopeful Dupixent, which thus also edges out Astrazeneca’s first shot at checkpoint blockade, durvalumab.

Among non-biologicals, meanwhile, the drug to watch is Novo Nordisk’s once-weekly semaglutide, EvaluatePharma figures suggest (see tables below). The data, compiled using sellside consensus 2022 sales forecasts, show that alongside cancer therapies it is drugs against autoimmune diseases that will dominate this year’s big launches.

Overall this year’s expected tally of launches comprises no fewer than 15 blockbusters, plus another three drugs that are seen almost hitting $1bn of sales in 2022. The leading biological, Dupixent, is also the biggest expected launch overall, with 2022 revenue amounting to $4.6bn.

Dupixent is due a US approval decision on March 31, and a key worry now is whether the manufacturing problems that recently delayed Sanofi/Regeneron’s rheumatoid arthritis project sarilumab might also hit Dupixent.

Other autoimmune disease-targeting biologicals that could be launched this year include Johnson & Johnson’s sarilumab competitor sirukumab, as well as its psoriasis asset guselkumab and the Roche CD20-targeting MAb Ocrevus.

The last of those has generated highly positive data in primary progressive multiple sclerosis, and could become the first drug specifically indicated for this use. However, it too has suffered a minor delay, with review of its commercial manufacturing process pushing the FDA’s decision deadline out by three months to March 28.

The 10 biggest biologicals slated for launch in 2017
Product Company Therapy area Pharmacology 2022e sales ($m) Status
Dupixent Sanofi Dermatitis Anti-IL-4 & IL-13 MAb      4,558 Filed
Ocrevus Roche Primary progressive multiple sclerosis Anti-CD20 MAb      3,985 Filed
Durvalumab AstraZeneca Bladder cancer Anti-PD-L1 MAb      2,308 Filed
Spinraza Biogen Spinal muscular atrophy Antisense      1,467 Approved
KTE-C19 Kite Pharma Non-Hodgkin's lymphoma Anti-CD19 CAR-T therapy      1,415 Phase II
Guselkumab Johnson & Johnson Psoriasis Anti-IL-23 MAb      1,172 Filed
Sirukumab Johnson & Johnson Rheumatoid arthritis Anti-IL-6 MAb      1,134 Filed
Shingrix GlaxoSmithKline Shingles Herpes zoster vaccine         993 Filed
CTL019 Novartis Paediatric ALL Anti-CD19 CAR-T therapy         917 Phase III
Benralizumab AstraZeneca Asthma Anti-IL-5 MAb         806 Phase III
Source: EvaluatePharma January 30, 2017

Autoimmune disease also features among 2017’s biggest launches of non-biologicals, with Lilly’s Olumiant and Pfizer’s Eucrisa expected to sell $1.8bn and $1.2bn respectively in 2022. The former has had its action date delayed to April 19 by the need to review additional data analyses, while the latter is already approved.

While 2022 sales of semaglutide, Novo Nordisk’s GLP-1 agonist, are set to top $2bn on hopes that it might boast a cardiovascular claim on its label, it is oncology that stands out among conventional drug launches. Most important among these is Tesaro’s niraparib, which could seriously challenge Astrazeneca’s Lynparza and Clovis’s Rubraca when it faces an FDA decision on June 30.

Meanwhile, Puma’s neratinib is an extremely risky bet, given its serious gastrointestinal side effects and marginal benefit in breast cancer. J&J’s apalutamide and Astra’s acalabrutinib are key franchise extensions, and will show the value of sourcing products externally, having come through takeovers of Aragon Pharmaceuticals and Acerta Pharma respectively.

High altar

Of course, oncology also features among this year’s top biotech launches, with Astra looking to join Bristol-Myers Squibb, Merck & Co and Roche at the high altar of immuno-oncology. However, its initial durvalumab filing is in bladder cancer, and how the market will play out in the all-important first-line NSCLC indication is still anybody’s guess.

2017 could also see the approval of the first two CAR-T therapies, and with Novartis recently underlining its commitment to file CTL019 this year Kite will be up against a formidable opponent right from the start. Still, manufacturing and the durability of response beyond three months are uncertainties.

As such these are two of 2017’s riskier launches, and things are unlikely to go smoothly for all of the class of 2017. However, forecast sales give investors bemoaning the state of the markets something positive to look forward to.

The 10 biggest small-molecule agents slated for launch in 2017
Product Company Therapy area Pharmacology 2022e sales ($m) Status
Semaglutide Novo Nordisk Type 2 diabetes Once-weekly GLP-1 agonist            2,093 Filed
Niraparib Tesaro Ovarian cancer Parp inhibitor            1,794 Filed
Olumiant Eli Lilly Rheumatoid arthritis Jak-1/2 inhibitor            1,784 Filed
Ribociclib Novartis Breast cancer CDK 4 & 6 inhibitor            1,502 Filed
Apalutamide Johnson & Johnson Prostate cancer Anti-androgen            1,449 Phase III
Neratinib Puma Biotechnology Breast cancer EGFR & Her2/4 inhibitor            1,246 Filed
Eucrisa Pfizer Psoriasis PDE4 inhibitor            1,151 Approved
SD-809 Teva  Huntington's disease VMAT2 inhibitor            1,019 Filed
Ingrezza Neurocrine Biosciences Tardive dyskinesia VMAT2 inhibitor               971 Filed
Acalabrutinib AstraZeneca CLL BTK inhibitor               968 Phase III
Source: EvaluatePharma January 30, 2017

To contact the writers of this story email Jacob Plieth or Edwin Elmhirst in London at or follow @JacobPlieth or @EPVantage on Twitter

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