Date: 2016-07-01
Type of information: Licensing agreement
Compound: brodalumab
Company: AstraZeneca (UK) Valeant Pharmaceuticals (Canada)
Therapeutic area: Autoimmune diseases - Dermatological diseases
Type agreement: licensing development commercialisation
Action mechanism: monoclonal antibody. Brodalumab is a highly-selective human monoclonal antibody that binds to and blocks signaling via the interleukin-17 (IL-17) receptor. The IL-17 pathway plays an important role in inducing and promoting inflammatory disease processes. Blocking inflammatory signaling at the IL-17 receptor may be beneficial in the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and potentially other immune-mediated diseases.
In April 2012, Amgen and AstraZeneca have announced an agreement to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab - AMG 827). With oversight from joint governing bodies, Amgen leads clinical development and commercialization for brodalumab (Phase 3 for moderate-to-severe plaque psoriasis and psoriatic arthritis, Phase 2 for asthma) and AMG 557/MEDI5872 (Phase 1b for autoimmune diseases such as systemic lupus erythematosus). AstraZeneca , through its biologics arm MedImmune, leads clinical development and commercialization for MEDI7183/AMG 181 (Phase 2 for ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase 2 for Crohn's disease) and MEDI9929/AMG 157 (Phase 2 for asthma).
Disease: moderate-to-severe plaque psoriasis, psoriatic arthritis
Details: * On September 1, 2015, AstraZeneca announced that it has entered into a collaboration agreement with Valeant Pharmaceuticals under which it will grant an exclusive license for Valeant to develop and commercialise brodalumab.Under the agreement, Valeant will hold the exclusive rights to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen Inc., the originator of brodalumab. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in US and EU for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015. Brodalumab is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted that brodalumab 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 210 mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.
Financial terms: Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100 million as well as additional pre-launch milestones of up to $170 million and further sales related milestone payments of up to $175 million following launch. After approval, AstraZeneca and Valeant will share profits. The transaction is expected to complete in the fourth quarter of 2015, subject to customary closing conditions, and it does not materially impact AstraZeneca’s financial guidance for 2015. As AstraZeneca continues to retain a significant interest in brodalumab, the upfront payment and any potential subsequent milestone payments are expected to be reported as Externalisation Revenue.
Latest news: * On July 1, 2016, Valeant Pharmaceuticals announced that its affiliate and AstraZeneca have amended Valeant's license for brodalumab to terminate Valeant's right to develop and commercialize brodalumab in Europe. Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the U.S, as well as the remainder of the territory outside of Europe. As consideration for the termination of the European rights, AstraZeneca will pay to Valeant an upfront payment and certain sales-based milestone payments and, in addition, one of the pre-launch milestones payable by Valeant to AstraZeneca under the original license has been reduced. With the termination of Valeant's licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting Leo Pharma the exclusive rights to develop and commercialize brodalumab in Europe.
