After the markets closed Friday, Amgen ($AMGN) and AstraZeneca ($AZN) announced that their top psoriasis contender, brodalumab, scored a win in Phase III, with a large majority of patients in both dosage arms clearing the bar on a standard measure for efficacy. Investigators reported that 83% of the patients in the high-dose 210-mg group passed the mark on significant skin clearing, easily beating out the negligible response seen in the placebo arm.
Altogether 42% of the high-dose patients achieved a complete response, with the drug eliminating the red, scaly patches of skin on the patients afflicted by psoriasis. The positive data takes the IL-17 drug another big step toward regulators, a journey that can be completed after the companies get a look at head-to-head data against Stelara (ustekinumab) later this year.
Both companies have had high hopes for their drug (AMG827), particularly after the therapy racked up primary and secondary endpoint successes in Phase II. For Amgen it's a chance to expand its portfolio after investing heavily in its late-stage effort, while AstraZeneca has badly needed to demonstrate some pipeline successes as it tries to convince its big investors not to accept Pfizer's ($PFE) buyout offer.
Even if the drug looks increasingly like a winner, though, brodalumab will be up against a tough group of new rivals, all angling to divvy up a blockbuster market.
Just weeks ago Novartis ($NVS) pumped out more positive Phase III data for secukinumab, adding some patient satisfaction scores on the self-injected treatment. Celgene ($CELG) recently won an approval for Otezla (the oral apremalist) for psoriatic arthritis and filed its application on psoriasis last fall. If Celgene wins at the FDA later this year, a group of analysts estimate potential peak sales of the drug will hit about $1.2 billion. Eli Lilly ($LLY) has an IL-17 drug as well, ixekizumab, which is in Phase III. Merck's ($MRK) MK-3222 is also coming along. And cheaper biosimilars of Enbrel have been pushed along by Cipla and Novartis and others.
Coming up from behind is Johnson & Johnson's guselkumab, which is moving into Phase III this year. The drug targets IL23p19 and is partnered with MorphoSys AG. The drug is touted as a top contender in J&J's pipeline, with a prospective approval coming in the 2015-2017 time frame.
Amgen and AstraZeneca, though, sound quite confident about their chances. Earlier this week, while laying out its case against a Pfizer megamerger, 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.
"Data from the AMAGINE-1 study suggest that brodalumab may offer a new level of efficacy for patients with moderate-to-severe plaque psoriasis, a disease that affects more than 100 million people globally," Amgen R&D chief Sean Harper said in a statement. "This is the first read-out from our Phase III psoriasis clinical program and we look forward to obtaining additional Phase III data from our two head-to-head studies versus ustekinumab (Stelara) later this year."
- here's the release