Abbvie, Ablynx Ink Up To $840M RA, SLE Collaboration

Sep 23 2013

AbbVie will join Ablynx in further developing and commercializing the latter's ALX-0061 nanobody® targeting the interleukin-6 (IL-6) pathway into a therapy for inflammatory diseases, in a collaboration that could generate payments of up to $840 million, the companies said today.

Under a global license agreement, Ablynx agreed to complete Phase II development of ALX-0061 in both rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Based on undisclosed "predefined success criteria," AbbVie agreed to exercise its right to in-license ALX-0061 and oversee subsequent Phase III clinical development and commercialization-;though Ablynx will retain an option for co-promotion rights in Belgium, where the company is based, as well as in the Netherlands and Luxembourg.

AbbVie is looking to develop a successor to its blockbuster arthritis drug Humira (adalimumab), which racked up $9.265 billion in 2012 sales, up 19% from a year earlier, based on numerous inflammation indications, led by moderate to severe RA. Humira was last year's top best-selling drug [See "Top 20 Best-Selling Drugs of 2012," published in GEN on March 1].

In return for the licensing rights, AbbVie will pay Ablynx $175 million upfront, which the companies said will partly be used to fund the next phases of clinical development of ALX-0061, plus up to $665 million in payments tied to undisclosed development, regulatory, commercial, and sales-based milestones. Ablynx will also be eligible for double-digit tiered royalties on net sales of products commercialized through the collaboration.

Edwin Moses, Ph.D., Ablynx's chairman and CEO, said in a statement the current development plan calls for ALX-0061 to launch various clinical trials in both RA and SLE during 2014 and 2015.

"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," Dr. Moses said. "It also demonstrates that we are delivering on our business model of strategic partnering for the development and commercialization of selected programs within our pipeline."

The deal comes seven months after Ablynx's successful February completion of a Phase IIa study of ALX-0061, one of the company's three lead programs. Ablynx reported strong efficacy and safety data in patients with moderately to severely active RA on a stable background of methotrexate.

ALX-0061 targets the IL-6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA. Because of its small size, ALX-0061 is believed to penetrate more effectively into tissues, leading to improved trafficking to areas of inflammation.

Nanobodies are a class of therapeutic proteins based on single-domain antibody fragments, envisioned to fight inflammation as well as cancer and hematologic and pulmonary diseases. According to its website, Ablynx has six nanobodies in clinical development within a total 25 projects in its pipeline. 

This article was reprinted from Genetic Engineering & Biotechnology News (GEN) with permission from Mary Ann Liebert, Inc., publishers. Genetic Engineering & Biotechnology News (GEN) has retained its position as the number one biotech publisher around the globe since its launch in 1981. GEN publishes a print edition 21 times a year and has additional exclusive editorial content online, like news and analysis as well as blogs, podcasts, webinars, polls, videos, and application notes. GEN's unique news and technology focus includes the entire bioproduct life cycle from early-stage R&D, to applied research including omics, biomarkers, as well as diagnostics, to bioprocessing and commercialization.