Eucrisa thumbs up validates Pfizer’s takeover strategy – partly

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Quick FDA approval of the eczema ointment Eucrisa has made Pfizer’s takeover of its originator Anacor Pharmaceuticals look like a reasonably canny move, but at $5.2bn the deal price is still some way above Eucrisa’s net present value of $3.3bn. The product will need to outperform expectations if Pfizer is to get its money's worth.

EvaluatePharma consensus of sellside estimates puts Eucrisa’s 2022 sales at $1.3bn. Eucrisa will benefit from being the first truly differentiated agent specifically for eczema, noted Evercore ISI analyst Vlad Nikolenko, so these estimates could rise, but with other PDE4 inhibitors in development Pfizer will need to make the most of its first-mover advantage (see table below).

The launch of Eucrisa could also be a test of how the market will react to Sanofi and Regeneron’s injectable antibody dupilumab, which is due an approval decision next March. 

Different markets

The products are targeting different markets – Eucrisa’s approval came in mild to moderate eczema, while dupilumab is taking aim at moderate to severe disease. 

Mild disease is thought to account for around 70% of patients, so Eucrisa has the larger slice of the market. But analysts have bigger expectations for dupilumab, with a consensus forecast of $4bn by 2022.

This could be explained by dupilumab’s price tag – as a monoclonal antibody it is likely to cost a lot more than topically applied Eucrisa, which will have a wholesale acquisition cost of $580 per 60g tube, a spokesperson for Pfizer told EP Vantage.

Eucrisa, whose active ingrerdient is crisaborole, is more likely to compete with other topical eczema therapies including steroid creams, which cause side effects like thinning skin and are not recommended for long-term use. Other eczema creams are simply moisturisers and are only effective for managing symptoms rather than reducing inflammation.

Eucrisa was not compared with steroid cream in its pivotal trials, instead going up against a non-medicated ointment, but this was likely because it would not have been possible to give steroid cream over the 28-day study period.

PDE4 rivals

PDE4 is an enzyme active in the immune and central nervous systems whose action is thought to have far-reaching effects. Blocking it is thought to have potential in cognition, wakefulness, inflammation and respiratory disorders, and some PDE4 inhibitors have even been tested in multiple sclerosis, Huntington’s disease, stroke and Alzheimer’s disease.

However, they also cause vomiting, and the antidepressant rolipram, for instance, was discontinued owing to gastrointestinal problems, though it is still sold in Japan. However, three PDE4 inhibitors are marketed in the US for a variety of uses: Celgene’s psoriasis drug Otezla, Astrazeneca’s COPD treatment Daliresp and Abbott’s antispasmodic Drotaverine.

Rolipram was earlier abandoned for eczema, while development of Glenmark’s asthma project revamilast was discontinued in rheumatoid arthritis and multiple sclerosis.

Eucrisa will be the fourth PDE4 blocker to hit the US market, and the first for eczema, which Pfizer no doubt hopes will help it take share from the existing imperfect options. But it might not be alone for long, and its smooth regulatory journey could prompt other manufacturers to investigate eczema as an additional indication. 

Selected phosphodiesterase 4 (PDE4) inhibitors
Project Company Lead indication
Marketed
Otezla (apremilast) Celgene Psoroasis, psoriatic arthritis
Daliresp (roflumilast) Astrazeneca/Allergan COPD
Drotaverine Abbott Laboratories Antispasmodic for cervical dilation in childbirth
Rolipram Bayer Antidepressants
Approved
Eucrisa (crisaborole) Pfizer Eczema
Phase II
RVT-501 Eisai/Roivant Eczema
TA-7906 Mitsubishi Tanabe Pharma Eczema
OPA-15406 Otsuka Eczema
CHF6001 Chiesi Asthma
Revamilast Glenmark Asthma
HT-0712 Dart Neuroscience Nootropics
Phase I
CTP-730 (deuterated apremilast analogue) Concert Pharmaceuticals/Celgene Inflammatory disease
DNS-001 Dart Neuroscience Nootropics
HPP737 VTV Therapeutics Inflammatory disease

To contact the writers of this story email Madeleine Armstrong or Jacob Plieth in London at news@epvantage.comor follow @ByMadeleineA or @JacobPlieth on Twitter

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