Amgen and its Big Pharma partner AstraZeneca have roped in another round of promising Phase III plaque psoriasis data for their IL-17 blockbuster contender brodalumab, which beat Johnson & Johnson's big earner Stelara in a head-to-head study.
Investigators for the study, Amgen's ($AMGN) and Astrazeneca's ($AZN) second straight successful Phase III trial, say their drug achieved total clearance of skin disease (PASI 100) in 36.7% of patients in the brodalumab 210-mg group and 27% of patients in the brodalumab 140-mg group compared to 18.5% of patients in the Stelara group and 0.3% of patients in the placebo arm. In addition, 85.1% of patients in the brodalumab 210-mg group and 69.2% of patients in the brodalumab 140-mg group hit PASI 75 compared to 69.3% of patients in the Stelara group and 6% of patients in the placebo group.
Stelara brought in $543 million for J&J last quarter alone, a 47% spike that made a major contribution to the company's bottom-line growth. But Amgen and AstraZeneca are playing in a very competitive R&D field.
Novartis ($NVS) is already in front of regulators with its IL-17 program for secukinumab, which earned a unanimous nod recently from an outside group of FDA advisers. Eli Lilly ($LLY) is in the midst of Phase III with its IL-17-blocking ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) IL-23 inhibitor guselkumab.
AMAGINE-2, the final head-to-head study between brodalumab and Stelara, is due out before the end of this year.
Back when AstraZeneca was making its case against a megamerger with Pfizer ($PFE), AstraZeneca assessed brodalumab's market potential at $500 million to an ambitious $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.
|Amgen R&D chief Dr. Sean Harper|
"Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals," said Dr. Sean Harper, executive vice president of R&D at Amgen. "These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase III study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis."
For AstraZeneca, positive late-stage data will help keep some distance from Pfizer, which may still be interested in merging. The Big Pharma company has been wheeling and dealing over the past few years in a frenzied effort aimed at creating a pipeline after years of misdirection. At Amgen, the focus is on late-stage drugs. But the company--which is restructuring R&D--has experienced plenty of bumps along the way. Trebananib just failed at improving overall survival in a late-stage study for ovarian cancer, while their PCSK9 drug appears well along the way to an approval.
- here's the release