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Celgene's apremilast set for 2013 filing

Pharma company releases positive phase III results for psoriasis candidate

Celgene is on course to file for approval of psoriasis candidate apremilast later this year after phase III data backed its safety and efficacy.

Celgene's first pivotal trial for apremilast - ESTEEM 1 - found that 33 per cent of patients treated with the drug achieved a 75 per cent improvement in the psoriasis area and severity index (PASI) after 16 weeks' treatment, compared to just over 5 per cent of the placebo group.

The results were presented over the weekend at the American Academy of Dermatology annual conference in Miami, Florida, and were generally well-received, although some observers noted that the top-line efficacy data was a little shy of that seen in the phase IIb PSOR-005 trial.

ESTEEM 1 enrolled 844 patients, including around a third who had not received any form of prior therapy for psoriasis - including drugs or phototherapy - and another third who had previously been treated with biologics such as AbbVie's Humira (adalimumab), Amgen/Pfizer's Enbrel (etanercept) and Johnson & Johnson's Stelara (ustekinumab).

Apremilast is a small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase, given orally twice a day, and one of its primary draws is a benign safety profile compared to other psoriasis treatments

In ESTEEM 1 the drug again appeared to be well-tolerated, with no cases of tuberculosis or lymphoma seen and no increased risk of cardiovascular events or serious opportunistic infection. The most common adverse events were diarrhoea and nausea but these were only seen with initial therapy and reduced over time.

"I see this as a prime candidate for future management of psoriasis that allows us to treat a range of patients, including more moderate cases earlier on," commented Kristian Reich of the SCIderm Research Institute and Dermatologikum in Hamburg, Germany, who presented the data at the AAD meeting.

Even if its efficacy does not match that of biologic therapies, aprelimast's ease of administration and tolerability is expected to make it a key new therapy for psoriasis and related conditions such as psoriatic arthritis if approved. 

Analysts have suggested Celgene's drug could achieve peak sales of $500m or more, although there is plenty of competition in the offing in the psoriasis sector from candidates such as Pfizer's oral JAK inhibitor Xeljanz (tofacitinib) and new biologics such as Novartis' secukinumab, Eli Lilly's ixekizumab and Amgen/AstraZeneca/Kyowa Hakko Kirin's brodalumab, according to Decision Resources.

4th March 2013

From: Sales

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