Lilly lifted by psoriasis results

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Lilly has unveiled strong phase III results for its psoriasis drug ixekizumab, showing it to be superior to Pfizer's Enbrel (etanercept) and placebo on all skin clearance.

The company disclosed top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis, and confirmed that the drug would be submitted to regulators in the first half of 2015.

The data showed that up to 41 per cent of those treated with the drug were able to achieve clear skin at week 12, with just one injection per dose.

"These results give us confidence that if approved, ixekizumab could make complete resolution of psoriasis possible for significantly more people," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines.

Analysts have, until now, forecast the drug reaching no higher than $700 million in peak sales. This is short of the blockbuster territory that Lilly needs from its next generation of medicines, in order to replace lost revenues from previous top sellers such as Cymbalta and Zyprexa.

"Ixekizumab was discovered and engineered to achieve high affinity and specificity to the IL-17A cytokine by Lilly Research Laboratories scientists, and is the most advanced asset in Lilly's pipeline of biotechnology-based medicines for the treatment of autoimmune diseases," said Tom Bumol, PhD, senior vice president of biotech discovery research, Lilly Research Laboratories, and president, Applied Molecular Evolution.

Ixekizumab is administered via subcutaneous injection. The drug is also in clinical development for the treatment of psoriatic arthritis.

Lilly's drug faces competition from two other drugs which target the IL-17 mechanism. The first is Novartis' secukinumab, which recently met all its primary and secondary goals in late-stage trials, and also showed superiority to Enbrel in one trial.

The second competitor IL-17 competitor is brodalumab, being co-developed by Amgen and AstraZeneca (AZ), with positive phase II results presented in June. Amgen and AZ are also developing their drug for use in asthma as well as psoriatic arthritis.

Link

Phase II for immunomodulators: what hypotheses should we test?

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Linda Banks

22 August, 2014