Autoimmune Disease Vies With Cancer To Dominate The Class Of 2017

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by: EP Vantage

Given the stunning multiple sclerosis data seen with Roche’s (OTCQX:RHHBY) Ocrevus it could come as a surprise that this agent is not the biggest expected launch of 2017. That honor belongs to Sanofi (NYSE:SNY)/Regeneron’s (NASDAQ:REGN) dermatitis hopeful Dupixent, which thus also edges out AstraZeneca’s (NYSE:AZN) (OTCPK:AZNCF) (AZNDF) first shot at checkpoint blockade, durvalumab.

Among non-biologicals, meanwhile, the drug to watch is Novo Nordisk’s (NYSE:NVO) 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 (NYSE:JNJ) 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 (NYSE:LLY) Olumiant and Pfizer’s (NYSE:PFE) 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 (NASDAQ:TSRO) niraparib, which could seriously challenge AstraZeneca’s Lynparza and Clovis’ (NASDAQ:CLVS) 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 (NYSE:BMY), Merck (NYSE:MRK) & 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

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