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Valeant Pharmaceuticals’ Siliq Approved for Plaque Psoriasis

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Siliq approval

In February 2017, the FDA (Food and Drug Administration) approved Valeant Pharmaceuticals’ (VRX) Siliq injection for the treatment of adults with moderate to severe plaque psoriasis who are subjects for systemic therapy.

Siliq (brodalumab) is a human monoclonal antibody that binds to the interleukin-17 receptor A and blocks inflammatory signaling by inhibiting the binding of different types of IL-17 to the receptor.

In August 2015, Valeant Pharmaceuticals entered a collaboration agreement with AstraZeneca where Valeant received global development and commercialization rights for Siliq except in Japan and certain Asian countries. Later, in July 2016, AstraZeneca and Valeant Pharmaceuticals amended Valeant’s license agreement on brodalumab and granted Leo Pharma exclusive rights for development and commercialization in Europe.

In April 2017, after evaluation and approval of Siliq by the Patient Access and Pricing Committee (or PAPC), Valeant Pharmaceuticals decided to list the Siliq injection at $3,500 per month, which is also the lowest injectable biologic presently available for the treatment of psoriasis.

AMAGINE-2 trial

In October 2017, Valeant Pharmaceuticals presented the results from the pivotal phase three long-term extension trial AMAGINE-2. In the long-term AMAGINE 2 trial, Siliq demonstrated a persistent high level of skin clearance, or PASI 100 (100% reduction in Psoriasis Area and Severity Index score). In the long-term extension AMAGINE-2 trial, at week 120, 59% of the patients who were on Siliq during the induction phase, maintenance phase, and long-term extension phase demonstrated PASI 100, and 76.4% of the patients demonstrated PASI 90. Siliq also demonstrated good tolerability and a good safety profile throughout.

The superior clinical trial results and tolerability profile are expected to strengthen Siliq’s commercialization capabilities. Siliq will compete with Johnson & Johnson’s (JNJ) recently launched Tremfya, Celgene’s (CELG) Otezla, AbbVie’s (ABBV) Humira, and Eli Lilly’s (LLY) Taltz. The PowerShares Dynamic Pharmaceuticals Portfolio (PJP) invests ~3.2%, ~5.2%, and 5.1% in Valeant Pharmaceuticals, Eli Lilly, and AbbVie, respectively.

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