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GlobalData Release: Reclaiming First-in-Class IL-1 Inhibitor Status in RA Therapy  
7/12/2012 10:17:17 AM

LONDON, UK (GlobalData), 12 July 2012 – This is an expert insight by GlobalData immunology and neurology analyst, Dina Rufo.

As announced on July 10, 2012, pharmaceutical firm Swedish Orphan Biovitrum (Sobi) will join Affibody AB, a Swedish biotechnology company, in a research collaboration to develop anti-inflammatory Interleukin-1 (IL-1) therapies. Sobi markets the novel recombinant IL-1 inhibitor known as Kineret (anakinra) for the treatment of rheumatoid arthritis (RA). Affibody AB is developing next-generation biopharmaceuticals using its technology platform of proprietary antibody molecules. Pipeline products from Affibody are in early clinical development and focus on oncology and inflammation and autoimmune diseases.

This joint venture could be a spark for Sobi to potentially reclaim revenue in the RA market. Kineret was launched in 2002 by Amgen, and licensed from Amgen by Sobi in 2008 for worldwide exclusive licensing. Interestingly, what was once touted as a promising novel IL-1 blockade therapy for the treatment of moderate to severely active RA has turned into a rarely used RA therapy. Kineret showed efficacy in early trials, but the effectiveness had become limited and safety data revealed an increase in serious infections versus placebo. Also, when Kineret was used in combination with anti-TNF drugs, there were signs of increased neutropenia, and the combination did not increase ACR response (American College of Rheumatology criteria for RA treatment). Currently, it is used more for other illnesses such as Still’s disease, and is being considered for type 2 diabetes therapy. With access to Affibody AB’s Affibody® molecules technology, it is possible that a new IL-1 inhibitor that is more efficacious and safer for the RA treatment paradigm will be forged.

Since Kineret seemed to lose efficacy over time, which led to it becoming a fourth-stringer and thus losing its novel place in the RA market, it is possible that Affibody’s proprietary Affibody® molecules could breathe life into a revamped Kineret. The Affibody® molecules are antibodies with unique binding sites and are relatively small at 6 kilodaltons. Affibody claims that its Affibody® molecules have an extended half-life which makes a better formulation for longer efficacy over time compared to monoclonal antibodies.

The next potential IL-1 inhibitor to enter the RA market will be years from now, as these drugs are only in preclinical and discovery phases. As it turns out, Affibody has an IL-1 inhibitor in preclinical phase development. Maybe this will replace the failed Kineret and become the reigning IL-1 inhibitor for the treatment of RA by claiming better efficacy and a more respectable safety profile.

The research collaboration agreement covers a two year period where Affibody will lead the discovery portion and Sobi will lead the clinical development. Sobi made an upfront payment worth 12m Swedish Krona, equivalent to over $1m US dollars. The agreement includes an option for Sobi to enter into a licensing agreement with worldwide exclusive rights to any of the developed projects. Also, future milestones and royalties after the two year period become options as well. The only IL-1 inhibitor compounds currently being developed are all in early phases; therefore it is possible the joint research team could produce a more superior IL-1 inhibitor to treat RA. While it is likely the two companies can co-develop drugs together, GlobalData feels any potential therapies they produce will not enter the market for years.

Related Report: Rheumatoid Arthritis -Global Drug Forecast and Treatment Analysis Report to 2022

- This expert insight was written by GlobalData immunology and neurology analyst, Dina Rufo

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