Agreements

Date: 2016-03-07

Type of information: Development agreement

Compound: BI 655066, BI 655064

Company: Abbvie (USA - IL) Boehringer Ingelheim (Germany)

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Respiratory diseases

Type agreement:

development

commercialisation

Action mechanism:

monoclonal antibody. BI 655066 is  an anti-IL-23 monoclonal biologic antibody.
BI 655064 is an antagonistic anti-CD40 antibody.

Disease: asthma, Crohn's disease, psoriasis, psoriatic arthritis

Details:

* On March 7, 2016, AbbVie and Boehringer Ingelheim announced a global collaboration to develop and commercialize BI 655066, an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis. AbbVie and Boehringer Ingelheim also are evaluating the potential of this biologic therapy in Crohn's disease, psoriatic arthritis and asthma. In addition to the anti-IL-23 antibody, AbbVie gains rights to an anti-CD-40 antibody, BI 655064, currently in Phase 1 development. Boehringer Ingelheim will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after completion of certain undisclosed clinical achievements.

Recent Phase 2 head-to-head study results in patients with moderate-to-severe plaque psoriasis showed that BI 655066 had greater efficacy over ustekinumab1, a commonly used treatment for this life-impacting skin condition. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab.

Patients also achieved this skin clearance faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43 percent versus 15 percent).

Additional data obtained from a pre-defined analysis reflecting the primary endpoint at 12 weeks is presented below:                                                               

BI 655066 is administered as a subcutaneous injection and was generally well-tolerated in the 12-week treatment portion of the Phase 2 study. Serious adverse events were reported for patients in the BI 655066 18 mg treatment group (7.0 percent) and ustekinumab group (2.5 percent), while there were no serious adverse events in the 90 mg and 180 mg treatment groups. One patient discontinued treatment in the BI 655066 18mg dose group. The most common adverse events across the BI 655066 treatment groups were common cold and headache, at 7.3 – 11.6 percent across the dose groups and 2.4 – 7.0 percent, respectively. The most common adverse events in the ustekinumab group were common cold, injection site pain and redness, sore throat and myalgia; each of which occurred in 5.0 percent of patients.

BI 655066 is in Phase 2 development for Crohn's disease and asthma and is about to enter Phase 2 development for psoriatic arthritis. In addition, Phase 2 data for Crohn's disease will be presented at an upcoming medical meeting.

Financial terms:

Under the terms of the license agreement, AbbVie will make an initial upfront payment of $595 million. Boehringer Ingelheim will be eligible to receive additional development and regulatory milestone payments and royalties on net sales, the terms of which are not disclosed. In the initial period, the companies will share the responsibility for future development of BI 655066. AbbVie will be solely responsible for commercialization of BI 655066, while Boehringer Ingelheim will retain an option to co-promote the compound in asthma. The companies will also establish a joint Steering Committee for the development as well as the initial commercialization phase.

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