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An Update on Roche’s Immunology Drugs: Xolair and Esbriet

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Xolair’s revenue trends

Roche’s (RHHBY) Xolair reported revenues of 928.0 million Swiss francs in the first half, compared to 866.0 million Swiss francs in the first half of 2017, which reflected ~10% YoY (year-over-year) growth at CER (constant exchange rates).

In the second quarter, Xolair generated revenues of 486.0 million Swiss francs, which reflected ~14% YoY growth at CER.

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Recent developments

In August, the FDA granted Roche’s Xolair (omalizumab) a breakthrough therapy designation (or BTD) for the prevention of severe allergic reactions due to exposure to foods in individuals with allergies. The FDA’s BTD to Roche’s Xolair is expected to help the company accelerate the regulatory filing and review process.

The FDA’s BTD was granted based on the data from seven clinical trials that Roche conducted over the last ten years. These trials investigated the safety and efficacy of Xolair in addressing a wide range of food allergens.

Novartis and Roche jointly develop and commercialize Xolair. Novartis (NVS) generated revenues of $261.0 million from the sales of Xolair, reflecting ~15% YoY growth.

Esbriet’s revenue trends

Roche’s Esbriet reported revenues of 472.0 million Swiss francs in the first half compared to 418.0 million Swiss francs in the first half of 2017, reflecting ~14% YoY growth at CER. In the first half in the United States and Europe, Esbriet reported revenues of 335.0 million Swiss francs and 114.0 million Swiss francs, respectively, reflecting ~10% and 20% YoY growth.

Esbriet reported revenues of 250.0 million Swiss francs in the second quarter, reflecting ~15% YoY growth at CER. In the United States and Europe, Esbriet reported second-quarter revenues of 180.0 million Swiss francs and 58.0 million Swiss francs, respectively, which is ~12% and ~19% YoY growth at CER.

Esbriet is used for the treatment of idiopathic pulmonary fibrosis. In the marketplace, Boehringer Ingelheim’s Ofev is Esbriet’s peer.

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