07 Mar ABBVIE AND BOEHRINGER INGELHEIM ANNOUNCE GLOBAL COLLABORATION ON PROMISING IMMUNOLOGY COMPOUNDS
– ANTI-IL-23 ANTIBODY NOW IN PHASE 3 FOR PSORIASIS DEMONSTRATED GREATER EFFICACY OVER USTEKINUMAB IN PHASE 2 CLINICAL STUDIES WITH A POTENTIAL FOR QUARTERLY DOSING
– POTENTIAL TO BECOME BEST-IN-CLASS TREATMENT IN PSORIASIS WITH ADDITIONAL PHASE 2 DEVELOPMENT IN CROHN’S DISEASE, PSORIATIC ARTHRITIS AND ASTHMA; OBSERVED SAFETY PROFILE IS CONSISTENT WITH THE IL-23 CLASS
– ABBVIE ALSO GAINS RIGHTS TO AN ANTI-CD-40 ANTIBODY CURRENTLY IN PHASE 1 DEVELOPMENT; NEXT STEPS OF CLINICAL DEVELOPMENT ARE LED BY BOEHRINGER INGELHEIM
– ABBVIE UPDATES 2016 ADJUSTED DILUTED EARNINGS PER SHARE GUIDANCE TO REFLECT 2016 PHASE 3 DEVELOPMENT COSTS
AbbVie (NYSE: ABBV) and Boehringer Ingelheim today 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.
“This collaboration positions BI 655066 as AbbVie’s lead investigational compound in psoriasis, complementing our robust immunology pipeline,” said Michael E. Severino, M.D., executive vice president and chief scientific officer, AbbVie. “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.”
“Our Immunology R&D teams have successfully brought forward compounds that have the potential to transform the way immune diseases are treated. I believe the collaboration with AbbVie is the best way to ensure broad access for patients to BI 655066 and BI 655064,” said Dr. Michel Pairet, Member of the Board of Managing Directors responsible for R&D nonclinical at Boehringer Ingelheim. “Our company remains strongly committed to establishing immunology as a core area of expertise and building our pipeline and capabilities in this important therapeutic area.”
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.
The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
AbbVie expects this transaction to be approximately $0.08 dilutive to our ongoing earnings per share in 2016, as a result of ongoing investment in the clinical program for BI 655066, including the Phase 3 program for psoriasis. As a result, AbbVie is updating its 2016 adjusted diluted earnings per share guidance to $4.82 to $5.02. This updated guidance range reflects adjusted earnings per share growth of nearly 15 percent at the midpoint.