Amgen and AstraZeneca have racked up their third straight Phase III win for brodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.
There are two key scores in this study, dubbed AMAGINE-2; 100% skin clearance (PASI 100) and 75% clearance (PASI 75).
The numbers: 44.4% of patients in the brodalumab 210-mg group, 33.6% of patients in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140-mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved total clearance of skin disease (PASI 100). The showdown numbers were a bit mixed for PASI 75: 86.3% of patients in the brodalumab 210-mg group, 77% of patients in the brodalumab weight-based group, 66.6% of patients in the brodalumab 140-mg group, 70% of patients in the Stelara group and 8.1% of patients in the placebo group achieved PASI 75.
The two pharma giants, though, have other rivals than Stelara to worry about.
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.
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| Amgen R&D chief Dr. Sean Harper |
Back when AstraZeneca ($AZN) was making its case against a megamerger with Pfizer ($PFE), AstraZeneca assessed brodalumab's market potential at $500 million to an ambitious $1.5 billion a year, based on the analysts it listens to. But Amgen ($AMGN) 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.
"Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75 percent improvement in their disease," said Amgen R&D chief Dr. Sean Harper in a statement. "AMAGINE-2 is the third and final pivotal study in our Phase III psoriasis program and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities."
- here's the release