Novartis stops PhIII trial of Genmab's Arzerra after buying rights from GSK

Novartis ($NVS) has stopped a Phase III trial of Genmab's (CPH:GEN) Arzerra in pemphigus vulgaris patients. The decision, which comes 7 months after Novartis agreed to buy the rights to Arzerra in autoimmune indications from GlaxoSmithKline ($GSK), will result in a focusing of attention on the testing of the monoclonal antibody as a treatment for relapsing multiple sclerosis. 

Genmab CEO Jan van de Winkel

For Genmab, the news ends the uncertainty about the future of Arzerra that began when Novartis picked up the rights to the drug in oncology indications as part of its asset swap with GSK. Novartis went some way to clarifying the situation in August when it agreed a $1 billion (€910 million) deal with GSK to acquire the rights to Arzerra in autoimmune indications. Now, the Swiss Big Pharma has gone a step further and provided additional details of its plans for the product, which include a shift in interest away from pemphigus vulgaris and toward the bigger prize of multiple sclerosis.

Stiefel, a GSK subsidiary, started a Phase III trial of Arzerra in pemphigus vulgaris--a rare, potentially life-threatening skin disorder--in 2014. At that time, Arzerra was seen as an alternative to high-dose systemic steroids for the 7 million people worldwide who live with pemphigus vulgaris, but Novartis has decided not to pursue the opportunity. The Phase III trial is being discontinued, a decision that Genmab said has nothing to do with the safety or tolerability of Arzerra. Genmab also revealed there are no plans to develop Arzerra as a treatment for neuromyelitis optica.

In dropping rare disease indications from its plans, Novartis has rested the fate of its $1 billion bet on Arzerra on a Phase III trial in relapsing multiple sclerosis. Work to generate data to support this use case is to start in the back half of the year when Novartis will begin a Phase III trial of a subcutaneous formulation of Arzerra in patients with relapsing multiple sclerosis. Novartis is aiming to have data to support a regulatory filing in 2019, setting it up to potentially add Arzerra to a multiple sclerosis portfolio that already features Gilenya and Extavia.

- read the statement

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