Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies, and AbbVie have entered into a global license agreement to develop and commercialize the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases.
ALX-0061, Ablynx's proprietary anti-IL-6R Nanobody, successfully completed a phase IIa study in February, reporting strong efficacy and safety data in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Ablynx will be responsible for completing phase II clinical development in both RA and systemic lupus erythematosus (SLE). Upon the achievement of pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent phase III clinical development and commercialization. Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg.
Ablynx will receive an upfront payment of $175 million, which will partly be used to fund the next phases of clinical development of ALX-0061. Ablynx will be eligible to receive additional milestone payments totaling up to $665 million, as well as double-digit tiered royalties on net sales upon commercialization.
Edwin Moses, Ph.D., chairman and chief executive officer of Ablynx, said, "The combined clinical expertise of AbbVie and Ablynx will allow us to progress with the rapid development of ALX-0061, with the current plan being the initiation of various clinical trials in both RA and SLE during the course of 2014 and 2015.”