Siliq Approved By the FDA for Adult Patients with Moderate-to-Severe Plaque Psoriasis

AstraZeneca’s partner Valeant Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Siliq (brodalumab) injection for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Siliq is an IL-17 receptor monoclonal antibody for patients with moderate-to-severe plaque psoriasis, a chronic, debilitating skin disease that causes red patches of skin covered with silvery scales.

Through a collaboration agreement, AstraZeneca granted Valeant, an expert in dermatology, the exclusive license to develop and commercialise Siliq globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd through an agreement with Amgen, and in Europe, where LEO Pharma holds exclusive rights to develop and commercialise brodalumab through an agreement entered in July 2016.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We are pleased that our commitment to Siliq, from its development in our biologics pipeline through to our partnership with Valeant, has led to a new treatment option for psoriasis patients, many of whom have previously not been able to achieve full clearance of their skin."

Financial considerations

Under the terms of the agreement, AstraZeneca will receive a milestone payment of $130 million from Valeant at first regulatory approval. This milestone will be recorded in the AstraZeneca financial statements as Externalisation Revenue. Following the approval, AstraZeneca and Valeant will share profits from the sale of Siliq in the US market.

Marc Dunoyer, Chief Financial Officer, AstraZeneca said: "Our agreement with Valeant supports our externalisation strategy, which allows us to focus on our three main therapy areas while partnering other assets for the benefit of patients, generating sustainable revenue for the future."