Released date: July 7, 2016

From Doomed to Deemed: Brodalumab Continues Its Long Fateful Journey

Leo Pharma, an established company in psoriasis treatment, took analysts by surprise when it obtained the development and commercialization rights in Europe for brodalumab, an IL-17R antagonist. Valeant Pharmaceuticals had previously acquired broad worldwide rights to brodalumab from AstraZeneca in Q3 of 2015. In this new amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the US. Due to termination of the European rights, AstraZeneca will pay Valeant an upfront payment and certain sales-based milestone payments and, in addition, a reduced pre-launch milestone payable by Valeant to AstraZeneca under the original license.Brodalumab has managed to stay in the limelight not only due to the high-profile licensing events, but also due to the fact that it has been associated with a rare incidence of suicide in treated patients. Despite this, brodalumab continues its march towards clinical development with regulatory filings in US, EU and Japan. The twisted fate of brodalumab began in May 2015, when Amgen returned brodalumab back to AstraZeneca due to “events of suicidal ideation and behavior” that occurred during the Phase III program that likely would restrict the label and negatively impact the sales of the drug. Among the Phase III head-to-head studies against ustekinumab, 4 instances of suicidal “ideation” occurred across 3,180 brodalumab patients (0.13 %) compared to 1 instance of suicidal “ideation” across 613 ustekinumab patients (0.16 %). 3 suicide attempts occurred in 3,180 brodalumab patients (0.09 %), compared to 1 suicide attempt in 613 ustekinumab patients (0.16 %). Importantly, 2 actual suicide related fatalities occurred in the brodalumab arm compared to none in the ustekinumab arm. In an audacious business decision, Valeant Pharmaceuticals came forward as a savior for AstraZeneca and acquired US and EU rights for brodalumab. At that time, a vital aspect of the making of this deal was the business model of Valeant which targeted risk associated assets and scooped up such assets at a discount. A year later, brodalumab is again in the news, only this time Valeant lost its European rights to Leo Pharma. Perhaps not a bad outcome for the potential success of brodalumab considering all of the ongoing financial troubles of Valeant.

The PharmGPS® Advantage

image3308702 PharmGPS® predicted the efficacy of brodalumab as compared to the current benchmark ustekinumab and predicted its potential much before the current licensing imbroglio. The safety issues associated with brodalumab however, cannot be overlooked by either Valeant or Leo Pharma, which may impact future sales. Both staunchly believe that it will benefit a segment of patients who have already been cured with brodalumab (AMAGINE-I, II and III studies). Brodalumab is expected to have a slow commercial start but will rapidly capture a larger market share and has the potential to reach peak sales of $3.9 billion in 2020.Valeant, Leo Pharma and AstraZeneca will soon benefit if the Dermatologic and Ophthalmic Drugs Advisory Committee votes in favor of Valeant’s BLA for brodalumab, which is due on July 19, 2016.

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PharmGPS® includes analyses on pipelines for inflammatory diseases such as RA and Psoriasis that provide insights to help prioritize promising drugs