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

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Part 4
Roche's Drugs, Trials, and FDA Approvals after 1H17 PART 4 OF 11

Alecensa Could Boost Roche’s Long-Term Revenue Growth

Alecensa’s revenue trends

In the first half of 2017, Roche’s (RHHBY) Alecensa generated revenues of CHF1 148.0 million. In that period in the US and Japanese markets, Alecensa generated revenues of CHF 73.0 million and CHF 65.0 million, respectively.

Alecensa Could Boost Roche’s Long-Term Revenue Growth

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Phase 3 ALUR trial

In September 2017, Roche presented the results of the Phase 3 ALUR trial, which was conducted to evaluate the safety and efficacy of Alecensa for the treatment of individuals with anaplastic lymphoma kinase (or ALK) positive advanced non-small cell lung cancer (or NSCLC) whose disease progressed after treatment with platinum-containing chemotherapy.

In the Phase 3 ALUR trial, patients on Alecensa therapy had median progression-free survival (or PFS) of 9.6 months compared to 1.4 months for patients on chemotherapy. Evaluation of PFS was the primary endpoint of the trial. The Phase 3 ALUR trial also demonstrated that patients on Alecensa had an overall response rate (or ORR) of 36.1% compared to 11.4% for patients on chemotherapy. Patients on Alecensa therapy demonstrated a disease control rate and median duration of response of 80.6% and 9.3 months, respectively, compared to 28.6% and 2.7 months, respectively, for patients on chemotherapy.

In August 2017, the FDA (U.S. Food & Drug Administration) accepted Roche’s sNDA (supplemental New Drug Application) for Alecensa as a first-line therapy for individuals with ALK-positive, locally advanced, or metastatic NSCLC. The sNDA was based on the results from the Phase 3 J-ALEX and Phase 3 ALEX trials. The FDA has granted the application a priority review designation.

In the Phase 3 ALEX trial, Alecensa demonstrated that it diminished the risk of death or disease worsening by 53.0% compared to crizotinib. In the Phase 3 J-ALEX trial, Alecensa showed a decrease in the risk of disease worsening or death by 62.0% compared to crizotinib. In the J-ALEX trial, patients on Alecensa had a median PFS of 25.9 months compared to 10.2 months for patients on crizotinib.

Roche’s peers in the NSCLC drugs market include Merck & Co. (MRK), Bristol-Myers Squibb (BMY), Eli Lilly, AstraZeneca, Pfizer (PFE), Novartis, and others. The Vanguard FTSE All-World ex-US ETF (VEU) invests ~0.73% of its total portfolio holdings in Roche Holding.

  1. Swiss franc

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