Elan and BI Ink Deal for Development and Manufacture of Antibody Therapeutics

Elan and Boehringer Ingelheim (BI) inked a technical development and manufacturing agreement centered on antibody therapeutics. Elan will lead the discovery, preclinical, clinical, and commercialization activities, with BI providing technical development, clinical manufacturing, and all regulatory filing support services.

Elan suggests the agreement means both firms will be able to concentrate on their particular strengths and help speed the development of its next-generation antibody programs. “These programs are broad in scope and are innovative across technology, targets, and possible disease application,” claims Dale Schenk, Ph.D., executive vp and CSO at Elan.

“The combination of Elan’s successful track record in the discovery and clinical development of antibody-based therapeutics with our own proven expertise in technical development and manufacturing and in particular our BI HEX® platform, will be an optimal fit,” adds Simon Sturge, corporate svp for BI’s biopharmaceuticals division. “This is a first step in our new strategy engaging our technology platforms at a very early stage in product development.”

Elan’s foray into the antibodies field was embodied in its Alzheimer’s immunotherapy program, which it was carrying out through a neurodegenerative diseases collaboration with Wyeth (now owned by Pfizer). Lead products included Phase III-stage monoclonal antibody bapineuzumab (AAB-001) and a clinical-stage immunoconjugate vaccine, AAC-001.

Elan says it still retains about a quarter interest in the program, but in September 2009 sold the bulk of its Alzheimer immunotherapy collaboration assets to a newly established Johnson & Johnson subsidiary, Janssen Alzheimer Immunotherapy. Under terms of this deal, J&J made a $1 billion investment in Elan in return for newly issued American Depositary Receipts that represented about an 18.4% stake in the firm. Elan received a 49.9% equity interest in the new Janssen Alzheimer Immunotherapy business, and an entitlement to a 49.9% share of the profits and certain royalty payments on commercialization of relevant products.