Amgen and its partner AstraZeneca are headed to a scientific conference in Istanbul this weekend to lay out a slate of upbeat mid-stage data on a closely-watched psoriasis treatment now in Phase III. Top scientists at both companies say that the interleukin-17 targeting brodalumab continued to reflect the initial promise seen in the first round of Phase II data. And they'll be positioning the drug against a heavily competitive field that includes a heavyweight contender from Novartis ($NVS).
"The Phase II data demonstrate that the primary and secondary end points were met, including many patients achieving and maintaining total skin clearance with continued brodalumab therapy," said Dr. Sean Harper, executive vice president of R&D at Amgen.
Amgen ($AMGN) and investigators at MedImmune, the big AstraZeneca ($AZN) subsidiary focused on biologics work, pushed brodalumab into Phase III last fall, anxious to follow up on promising results that made this program one of the top late-stage prospects at both companies. Part of the presentation includes 96-week data from the extension study. AstraZeneca partnered with Amgen on this and other therapies in early 2012, and it's emerged as a crucial play for the European pharma giant, which badly needs to demonstrate that it can pick winners for the late-stage pipeline.
The data, though, will not be viewed in isolation. Eli Lilly ($LLY)--which has just as much to prove as AstraZeneca when it comes to drug development--has been hustling along with its IL-17 therapy, ixekizumab, which showed last year that 82% of patients on the 150 mg dose, 83% on the 75 mg dose and 77% on the 25 mg dose had a 75% improvement, compared with 8% in the placebo group after 12 weeks. Celgene ($CELG) is advancing apremalist, building its regulatory case for psoriatic arthritis, as Merck ($MRK) pushes ahead with a program for MK-3222, making for a very crowded field.
Angling for the lead is Novartis, an R&D powerhouse which spends more than $9 billion a year on drug development. Novartis has been focused on its anti-IL17A drug secukinumab, which nabbed all the primary and secondary endpoints in a late-stage study. Last July Novartis reported that its treatment had beat Enbrel--a blockbuster now being targeted by the biosimilar crowd--in a late-stage study. Enbrel and AbbVie's ($ABBV) Humira account for the lion's share of the psoriasis market today.
A few days ago Novartis said that its latest data on secukinumab demonstrated that 77% of patients recorded a 75% clearance rate, setting up a regulatory filing for later this year.
Tim Anderson at Bernstein has estimated that the Big Pharma companies are angling for a market likely to deliver anywhere from $500 million to $700 million a year by 2020, with Novartis coming out on the top of that range for its product.
Some analysts expect that new psoriasis treatments could double the overall market by 2022. And despite Amgen's recent win on the patent front, Cipla has begun rolling out a biosimilar to Enbrel, while Novartis's Sandoz unit has a Phase III biosimilar program under way as well.
GlobalData recently concluded that the sudden arrival of competing therapies is likely to jam the market, making it hard for any one company to come out on top.
- here's the release from Amgen
- read the story from PMLiVE
- see the release from GlobalData