Abbott and Biotest AG announced a global agreement to develop and commercialize BT-061, a novel anti-CD4 antibody for the treatment of rheumatoid arthritis (RA) and psoriasis. BT-061 is currently in phase II clinical trials for RA and psoriasis, with preclinical studies underway to study its potential use in other immune-related diseases.

CD4 is expressed on T-cells and is involved in T-cell mediated modulation of immune responses. BT-061 is a humanized monoclonal antibody that works by activating the body’s T-regulatory cells, a subset of T-cells, strengthening a natural function of the body that prevents excessive immune reactions. Unlike other anti-CD4 antibodies that have been in development, BT-061 does not cause depletion of CD4 positive T-cells that would give rise to weakened immune responses.

“Though the research is still early, BT-061 has the potential to become an important treatment option for patients suffering from autoimmune diseases,” said John Leonard, M.D., senior vice president, global research and development, Abbott. “This novel compound will strengthen Abbott's immunology pipeline and we look forward to continuing to build on our expertise in exploring multiple mechanisms and approaches to treat inflammatory diseases.”

"Biotest is pleased to continue the development of BT-061 together with Abbott, one of the world leaders in the development and commercialization of biologic drugs for the treatment of immunological diseases," emphasized Prof. Dr. Gregor Schulz, CEO of Biotest AG. "With its tremendous experience in the field and its global commercial strength and presence, Abbott is the perfect partner for maximizing the therapeutic and commercial potential of BT-061."

Under the terms of the agreement, Abbott and Biotest will co-promote BT-061 in the five major European markets (Germany, France, United Kingdom, Italy and Spain) and Abbott will have exclusive global rights to commercialize BT-061 outside those countries. Biotest will receive an upfront fee of $85M. Pending achievement of certain development, regulatory, commercial and sales-based milestones, Biotest would be eligible to receive additional milestone payments from Abbott, potentially amounting to a total of $395M, and royalties. Biotest will be responsible for manufacturing the initial clinical supply of BT-061 and the companies will share responsibility for commercial production.

Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of clinical immunology, haematology and intensive medicine.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.