Amgen and its partner AstraZeneca ($AZN) are winding up to deliver U.S. and European applications for their big blockbuster hopeful brodalumab for plaque psoriasis by midyear. But their last shot to push ahead with the drug in asthma ran into defeat, with Amgen ($AMGN) announcing Tuesday afternoon that it pulled the plug on a Phase IIb following a futility assessment.
The news was included in Amgen's quarterly report today, which also outlined a 14% drop in R&D spending as deep cuts are starting to deliver some significant savings for the Big Biotech.
"Based on the recommendation of an independent data monitoring committee, Amgen stopped the brodalumab Phase IIb asthma study due to lack of observed efficacy in a planned interim analysis," a spokesperson tells FierceBiotech. "The decision to stop the study was based on a lack of efficacy and was not based on safety findings. Amgen remains committed to developing brodalumab for patients with psoriasis and psoriatic arthritis, for which positive efficacy has been previously shown. We don't have any other ongoing studies underway in asthma with brodalumab."
The spokesperson deflected a question about how many patients were in the study and whether this meant the end of the asthma program, saying that the company would spell out more about the drug in a future scientific publication.
But this isn't the first time that brodalumab failed in asthma. The drug failed its Phase II trial in 2013, according to the study results.
"While there was a lack of observed efficacy in the overall Phase II study," says the spokesperson, "brodalumab did demonstrate benefit in a subgroup of patients. These patients were further investigated in the Phase IIb study, and unfortunately, brodalumab did not show benefit."
|AstraZeneca's headquarters in London--Courtesy of AstraZeneca|
Amgen and AstraZeneca have been racking up a full slate of promising psoriasis studies for the IL-17 drug. Three straight successful Phase IIIs--including a head-to-head with Stelara that read out last November--positioned the company for filings with regulators. But it also faces some headwinds once it makes a likely debut on the market.
Novartis ($NVS) is already well in front with its IL-17 program for secukinumab, approved in January as Cosentyx. Eli Lilly ($LLY) has also been racking up positive late-stage studies for its IL-17-blocking ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) IL-23 inhibitor guselkumab.
Back when AstraZeneca was making its case against a megamerger with Pfizer ($PFE), the pharma giant assessed brodalumab's market potential at an ambitious $500 million to $1.5 billion a year, based on the analysts it listens to. But Amgen stands to gain the lion's share of the sales revenue. AstraZeneca put up $50 million in cash to partner with Amgen on brodalumab and a portfolio of anti-inflammatories back in 2012. Amgen took the lead on brodalumab, retaining commercial rights to the big U.S. market.
- here's the release on the quarter