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

PART:
1 2 3 4 5 6 7 8 9 10 11
Part 10
Roche's Drugs, Trials, and FDA Approvals after 1H17 PART 10 OF 11

Roche’s Avastin, Tarceva, and Gazyva after 1H17

Avastin revenue trends

In the first half of 2017, Roche’s (RHHBY) Avastin reported revenues of CHF1 3.4 billion, which is a 1.0% fall on a YoY (year-over-year) basis. In that period in the US, European, and Japanese markets, Avastin generated revenues of CHF 1.5 billion, CHF 881.0 million, and CHF 390.0 million, respectively, which reflected ~3.0%, ~5.0%, and ~3.0% falls on a YoY basis.

In 2Q17, Avastin generated revenues of CHF 1.7 billion, which reflected a ~2.0% rise on a QoQ (quarter-over-quarter) basis.

Roche’s Avastin, Tarceva, and Gazyva after 1H17

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Tarceva revenue trends

In the first half of 2017, Tarceva reported revenues of CHF 436.0 million, which is a ~17.0% fall on a YoY basis. In that period in the US, European, and Japanese markets, Tarceva generated revenues of CHF 230.0 million, CHF 73.0 million, and CHF 46.0 million, respectively.

In 2Q17, Tarceva generated revenues of CHF 225.0 million, which is a ~14.0% fall on a YoY basis and a ~7.0% rise on a QoQ basis.

Gazyva revenue trends

In the first half of 2017, Gazyva reported revenues of CHF 133.0 million, which is a 44.0% rise on a YoY basis. In that period in the US and European markets, Gazyva generated revenues of CHF 77.0 million and CHF 36.0 million, respectively.

In August 2017, the FDA (U.S. Food & Drug Administration) accepted Roche’s sBLA (supplemental Biologics License Application) for Gazyva plus chemotherapy followed by a Gazyva alone therapy for the treatment of individuals with previously untreated follicular lymphoma. Roche’s sBLA was based on the results from the Phase 3 GALLIUM trial.

The phase 3 GALLIUM trial demonstrated that patients on a Gazyva-containing regimen reduced the risk of worsening of disease or death by 30.0% versus a Rituxan-containing regimen. The regulatory approval of Gazyva could help in label expansion of the drug.

Roche’s peers in the leukemia drugs market include Novartis (NVS), Bristol-Myers Squibb, Amgen (AMGN), Johnson & Johnson (JNJ), and others. Growth in sales of Roche’s Gazyva could boost the share prices of the Vanguard International Dividend Appreciation ETF (VIGI). Roche Holding makes up ~2.9% of VIGI’s total portfolio holdings.

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