Ablynx and AbbVie have entered into a global license agreement to develop and commercialize ALX-0061, an anti-IL-6R Nanobody, to treat inflammatory diseases. ALX-0061 successfully completed a Phase IIa study in February 2013, 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 development in both RA and systemic lupus erythematosus (SLE). Upon achievement of pre-defined milestones, AbbVie will exercise its right to in-license ALX-0061 and be responsible for Phase III development and commercialization. Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg.

AbbVie will pay 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 of as much as $665 million, as well as double-digit tiered royalties on net sales upon commercialization.

Dr. Edwin Moses, chairman and chief executive officer of Ablynx, commented, “This deal represents a major milestone for Ablynx and confirms both the potential value of ALX-0061 and the ability of our Nanobody technology to generate clinical candidates with very exciting potential. It also demonstrates that we are delivering on our business model of strategic partnering for the development and commercialisation of selected programmes within our pipeline. We truly believe that AbbVie’s significant expertise in rheumatology aligns us with the ideal partner to further progress the development of ALX-0061 and to ensure we maximize the potential of this asset.”