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Valeant’s Xifaxan and Developments for Ortho-Dermatologics

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Xifaxan: Revenue trends

In 4Q17, Valeant Pharmaceuticals International’s (VRX) Xifaxan generated revenues of $275 million, compared to $251 million in 4Q16. That was a 10% growth on a YoY (year-over-year) basis and a 4% decline quarter-over-quarter.

In fiscal 2017, Xifaxan reported revenues of $979 million, a 5% YoY organic growth.

In 4Q17, Xifaxan saw a 4% growth in its total prescription volume compared to 4Q16.

Valeant Pharmaceuticals’ expansion in primary care and sales force training on proper dosing for IBS-D (irritable bowel syndrome with diarrhea) primarily attributed to Xifaxan’s revenue growth.

Valeant Pharmaceuticals is investing in further research into new formulations for Xifaxan and its use for other indications. Xifaxan’s peers in the treatment of diarrhea include Johnson & Johnson’s (JNJ) Imodium and Pfizer’s (PFE) Zithromax.

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Recent developments in Ortho-Dermatologics

In January 2018, the FDA accepted Valeant Pharmaceuticals’ NDA (New Drug Application) for Altreno lotion for the treatment of acne. The FDA gave a PDUFA (Prescription Drug User Fee Act) action date of August 27, 2018. In the United States, studies estimate that about 50 million individuals have acne. The launch of Altreno is expected to boost growth for the Ortho-Dermatologics segment.

In November 2017, the FDA accepted Valeant Pharmaceuticals’ NDA for Duobrii (IDP-118) lotion for the topical treatment of individuals with plaque psoriasis. The FDA has provided a PDUFA action date of June 18, 2018.

In February 2018, the FDA accepted Valeant Pharmaceuticals’ NDA for Jemdel lotion for the treatment of plaque psoriasis. The FDA has provided a PDUFA action date of October 5, 2018. If Jemdel lotion is approved by the FDA, it will become the first high-potency topical steroid treatment for plaque psoriasis.

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