AbbVie ($ABBV) is handing over $595 million in an upfront payment to partner with Boehringer Ingelheim on its late-stage psoriasis drug, the anti-IL-23 BI 655066.
Boehringer also gets a slate of milestones for the autoimmune deal, which weren't disclosed. AbbVie will also share in late-stage development while gaining sole marketing rights for the drug, which is in Phase III for psoriasis and is also being studied for Crohn's disease. And AbbVie gains rights to Boehringer's Phase I drug, the anti-CD-40 antibody BI 655064.
The privately held Boehringer will retain co-promotion rights for asthma.
For AbbVie, the deal marks its keen interest in a market that has delivered megablockbuster returns for Humira, which continues to dominate the charts in the commercial markets as Novartis ($NVS), Eli Lilly ($LLY) and others angle for a share of the market. Humira is losing patent protection in the U.S. in 2018, but AbbVie believes it can hold off generic competition for a while longer.
What AbbVie can't hold off, though, is the slate of immunology competitors that has been lining up to compete for the market. Novartis scored the first big approval in that field with the FDA's OK of Cosentyx, which quickly hit the inside track to blockbuster status last year. Eli Lilly has been angling for a 2016 OK for ixekizumab, one of its top late-stage drug candidates in the pipeline. Merck ($MRK) is working through a late-stage program for the IL-23-blocking MK-3222 (tildrakizumab), and J&J has begun late-stage testing on its similar guselkumab.
AstraZeneca ($AZN) had been in the midst of that scramble with the IL-17 brodalumab, but after Amgen ($AMGN) bowed out the pharma giant opted to punt, handing over the drug to Valeant ($VRX) in a $445 million deal. Amgen decided to get out after investigators linked the drug to suicidal thinking, which it believed made it a nonstarter in the market.
AbbVie will be competing with a drug that recently achieved a 69% PASI 90 score; with most of the patients achieving clear or nearly clear skin after 9 months of therapy at a high dose. The correlating rate for Stelara (ustekinumab, a favorite punching bag for late-stage contenders) was 30% in the study. And 43% of the Boehringer drug arm achieved PASI 100 (100% clearance) compared to 15% for ustekinumab.
Thinking about the competition, investigators say that there is potential to dose the drug quarterly. And AbbVie clearly believes that it now has rights to a drug that can line up among the best-in-class contenders.
"Our expertise in developing and commercializing the world's leading biologic, combined with Boehringer Ingelheim's clinical success to-date will enable us to offer patients a new treatment option with the potential to meaningfully improve the standard of care," noted Dr. Michael Severino, AbbVie's executive vice president and chief scientific officer.
- here's the release