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Roche's Drugs, Trials, and FDA Approvals after 1H17

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Part 6
Roche's Drugs, Trials, and FDA Approvals after 1H17 PART 6 OF 11

How Roche’s Rituxan and Acterma Are Positioned after 1H17

Rituxan/MabThera revenue trends

In the first half of 2017, Roche’s (RHHBY) Rituxan/MabThera reported revenues of CHF1 3.8 billion, which is a 3.0% rise on a YoY (year-over-year) basis. In that period in the US, European, and Japanese markets, Rituxan/MabThera generated revenues of CHF 2.1 billion, CHF 923.0 million, and CHF 137.0 million, respectively.

In 2Q17, Roche’s MabThera generated revenues of CHF 1.9 billion, which is a 3.0% rise on a YoY basis and a 2.0% rise on a QoQ (quarter-over-quarter) basis.

How Roche’s Rituxan and Acterma Are Positioned after 1H17

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In March 2017, the FDA (U.S. Food & Drug Administration) granted Rituxan/MabThera breakthrough therapy designation in PV (pemphigus vulgaris). Presently, Roche is enrolling individuals with moderate to severe PV for conducting a Phase 3 trial with Rituxan/MabThera.

In June 2017, the FDA approved Rituxan Hycela for the treatment of adult individuals with treatment naïve and relapsed or refractory follicular lymphoma and treatment naïve diffuse large B-cell lymphoma (or DLBCL). The FDA also indicated the use of Rituxan Hycela for both previously treated and previously untreated individuals with chronic lymphocytic leukemia (or CLL).

Actemra/RoActemra revenue trends

In the first half of 2017, Actemra/RoActemra reported revenues of CHF 922.0 million, which is a 13.0% rise on a YoY basis. In that period in the United States, Europe, and Japan, Actemra/RoActemra generated revenues of CHF 365.0 million, CHF 306.0 million, and CHF 140.0 million, respectively.

In 2Q17, Actemra/RoActemra generated revenues of CHF 477.0 million, which reflected an ~11.0% rise on a YoY basis and a ~7.0% rise on a QoQ basis.

Actemra (tocilizumab) is used for the treatment of individuals with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (or PJIA), and systemic juvenile idiopathic arthritis (or SJIA).

In August 2017, the FDA approved Actemra/RoActemra for the treatment of individuals aged two years and above with chimeric antigen receptor (or CAR) T cell–induced severe or life-threatening cytokine release syndrome (or CRS).

In June 2017, the EC’s (European Commission’s) CHMP (Committee for Medicinal Products for Human Use) recommended a positive opinion for marketing approval of Actemra/RoActemra for the treatment of individuals with giant cell arteritis (or GCA).

Roche’s peers in the immunology drugs market include AbbVie (ABBV), Johnson & Johnson (JNJ), Amgen (AMGN), Merck & Co., Astellas, Novartis, and others. The Vanguard International Dividend Appreciation Index ETF (VIGI) invests ~2.9% of its total portfolio holdings in Roche.

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