Siliq (brodalumab) approved by the US FDA for adult patients with moderate-to-severe plaque psoriasis

AstraZenecaAstraZeneca'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."

About Siliq
Siliq (brodalumab) is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

The FDA approval is based on data from the three AMAGINE Phase III pivotal studies that demonstrated that Siliq has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, Siliq was shown to be efficacious in total skin clearance of psoriasis with approximately twice as many patients on Siliq achieving total skin clearance compared to ustekinumab at week 12 in two replicate comparator trials involving over 2,400 patients.

About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Most Popular Now

GSK reaches agreement with Novartis to acquire ful…

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has reached an agreement with Novartis for the buyout of Novartis' 36.5% stake in their Consumer Healthcare Jo...

Canadian neuroscientists say daily ibuprofen can p…

A Vancouver-based research team led by Canada's most cited neuroscientist, Dr. Patrick McGeer, has successfully carried out studies suggesting that, if started early enou...

Merck partners with Medisafe to help improve medic…

Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication ...

New immunotherapy for lung cancer shows promise of…

In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at contro...

Boehringer Ingelheim and OSE Immunotherapeutics an…

Boehringer Ingelheim and OSE Immunotherapeutics, a biotechnology company focused on the development of innovative immunotherapies, have announced a collaboration and excl...

Taking a standard prostate cancer drug with food b…

By taking a high-cost drug with a low-fat meal - instead of on an empty stomach, as prescribed - prostate cancer patients could decrease their daily dose, prevent digesti...

Personalized tumor vaccine shows promise in pilot …

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and...

New targeted therapy schedule could keep melanoma …

Skin melanoma, a particularly insidious cancer, accounts for the vast majority skin cancer deaths and is one of the most common cancers in people under 30. Treatment for ...

Researchers identify chemical compound that inhibi…

An organic chemical compound shows effective antiviral activity against Ebola virus and several other viruses, according to a study led by Georgia State University. The r...

When drugs are wrong, skipped or make you sick: Th…

Rising drug prices have gotten a lot of attention lately, but the actual cost of prescription medications is more than just the dollars and cents on the bill. Researchers...

New class of drugs could help tackle treatment-res…

Researchers have discovered a new class of drug that has the potential to help cancer patients who no longer respond to existing therapies. The drug may not become availa...

Researchers propose key elements of antimicrobial …

Antimicrobial stewardship programs (ASPs) in hospitals play a vital role in managing the threat of antibiotic resistance. To be of maximum effectiveness, essential elemen...