AbbVie and Boehringer Ingelheim have formed a global alliance focused on the development and commercialisation of BI 655066, a biologic therapy in Phase III development for psoriasis.
The deal follows promising Phase II head-to-head data which showed that the drug had greater efficacy over Johnson & Johnson’s Stelara (ustekinumab) in patients with moderate-to-severe plaque psoriasis: after nine months, 69 percent of those taking BI 655066 maintained clear or almost clear skin (PASI 90) in the higher dose group compared to 30 percent in the ustekinumab arm.
Patients also achieved this skin clearance faster (around eight weeks versus around 16 weeks) and for more than two months longer (_ 32 weeks vs 24 weeks) than those on ustekinumab, while completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066 (43 percent versus 15 percent).
The companies are also planning to evaluate the anti-IL-23 antibody in Crohn’s disease (currently in Phase II), psoriatic arthritis (about to enter Phase II) and asthma. AbbVie will be solely responsible for commercialisation of the anti-IL-23 antibody, while Boehringer will retain an option to co-promote the compound in asthma.
Under the deal, AbbVie also gains rights to an anti-CD-40 antibody, BI 655064, currently in Phase I development. BI will retain responsibility for further development of the drug, and AbbVie can elect to advance the programme after completion of certain undisclosed clinical achievements.
On the financial side, AbbVie will make an initial upfront payment of $595 million to Boehringer, which also stands to receive additional development and regulatory milestone payments and royalties on net sales, the terms of which were not disclosed.
"This collaboration positions BI 655066 as AbbVie’s lead investigational compound in psoriasis, complementing our robust immunology pipeline," said Michael Severino, AbbVie’s chief scientific officer. “Our expertise in developing and commercialising 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.”