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Abbott signs autoimmune deal with Galapagos worth $1.35bn

Collaboration involves Galapagos' oral JAK1 inhibitor, which could be a successor to Abbott's rheumatoid arthritis drug Humira

Abbott has signed a deal worth up to $1.35bn with Belgium-based Galapagos to develop and commercialise a potential treatment for multiple autoimmune diseases including rheumatoid arthritis (RA).

The collaboration involves Galapagos' GLPG0634, an oral JAK1 inhibitor currently in phase II development, and could provide Abbott with a successor for its own RA drug Humira (adalimumab).

The TNF inhibitor is approved for several conditions in Europe, include RA and several other varieties of arthritis and is currently the company's biggest selling drug, taking in almost $8bn during 2011.

GLPG0634's oral formulation would give it an edge over the injectable Humira, if it can match that drug's efficacy and safety.

According to Abbott, results from a four-week phase IIa study involving GLPG0634 were positive, with few side effects experience by patients. An additional phase IIa dose-range finding study with GLPG0634 is expected to begin soon.

The deal will see Abbott will pay an initial upfront fee of $150m, with Galapagos to receive another one-time fee of $200m upon successful completion of the current phase II studies in RA.

Once the drug enters phase III development, Abbott will assume sole responsibility for clinical development and commercialisation of the product, with Galapagos eligible to receive further milestone payments of $1bn.

Royalties will also be available to Galapagos, and the company will retain co-promotion rights in Belgium, the Netherlands and Luxembourg.

Onno van de Stolpe, Galapagos' CEO, said: “We are excited to continue the phase II trials and expect to deliver to Abbott a complete phase II package in 2014.

“This collaboration is transformational for Galapagos, providing the means to progress these innovative products into the clinic."

JAK inhibitors are a relatively new treatment method against autoimmune diseases and are designed to work by blocking enzymes that play a role in the signalling mechanism used by a number of cytokine protein molecules. Inflamed cytokines are involved in incidences of autoimmune disease.

The first JAK inhibitor to be approved was Incyte Corp's Jakafi (ruxolitinib). The US Food and Drug Administration (FDA) cleared the drug for the treatment of patients with the rare bone marrow disease myelofibrosis.

Novartis has rights to the drug outside the US, with hopes for approval in several other indications.

Pfizer also has its own JAK inhibitor candidate, with tofacitinib currently under review by the European Medicines Agency (EMA) for treatment in RA.

1st March 2012

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