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 18mg treatment group (7.0%) and ustekinumab group (2.5%), 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% across the dose groups and 2.4 – 7.0%, 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% 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.
More than 100 million people suffer from psoriasis, a chronic, systemic, immune-mediated disease.2 Psoriasis is a chronic skin disease of scaling and inflammation and can result in severe physical discomfort and disability.
Under the terms of the license agreement, AbbVie will make an initial upfront payment of US$ 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.
About BI 655066
BI 655066 selectively blocks IL-23, a key protein involved in skin inflammation which has been linked to an overactive immune system, and is one of the key drivers of psoriasis.
NB: BI 655066 is not approved by regulatory authorities and its safety and efficacy is being investigated.
About BI 655064
BI 655064 is an antagonistic anti-CD40 antibody. The CD40-CD40L pathway may play a major role in immune disease such as lupus nephritis, Crohn’s disease and ulcerative colitis.
NB: BI 655064 is not approved by regulatory authorities and its safety and efficacy is being investigated.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.com
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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