Roche CEO Severin Schwan said: "We have started the year with solid growth in both our Pharmaceuticals and Diagnostics Divisions. The marketing applications of important investigational medicines are well underway. The FDA granted priority review for atezolizumab in two indications and breakthrough therapy designation for ocrelizumab in primary progressive multiple sclerosis. Overall, we are on track to meet our full-year targets for 2016."
In Diagnostics, sales grew 5% to CHF 2.6 billion, driven primarily by strong growth in Asia-Pacific (+16%) and Latin America (+21%). In Europe, the Middle East, and Africa (EMEA) sales increased 1% while they remained stable in North America and declined by 3% in Japan. Strong growth was recorded for the immunodiagnostic, molecular and tissue diagnostics businesses. Diabetes Care sales were impacted by challenging market conditions, especially in North America.
In March and April respectively, Roche's lead investigational cancer immunotherapy medicine atezolizumab was granted priority review by the FDA for marketing applications in two indications, advanced bladder cancer and non-small cell lung cancer (NSCLC). Both filings were submitted under FDA breakthrough therapy designations and are based on pivotal phase II data. Atezolizumab is being investigated in a broad phase III clinical programme in solid and hematologic cancers.
The FDA granted breakthrough therapy designation (BTD) for ocrelizumab in primary progressive multiple sclerosis in February. Ocrelizumab is the first investigational medicine to receive BTD in multiple sclerosis. Since 2013, the FDA has granted BTDs for 12 indications of Roche medicines. Roche plans to file ocrelizumab for both relapsing and primary progressive multiple sclerosis in the first half of 2016.
In March, Roche provided an update on two identical phase III studies of lebrikizumab in people with severe asthma. While one study met its primary clinical endpoint, the second did not achieve statistical significance. Roche is analysing the data to help determine next steps in the asthma programme.
In April, the FDA granted Venclexta (venetoclax) accelerated approval for people with a hard-to-treat type of chronic lymphocytic leukemia. Venclexta is the first approved medicine designed to help restore a process in which cells self-destruct by selectively blocking a protein called BCL-2. Venclexta is being jointly developed with AbbVie.
In February, Roche received US approval for Gazyva for the treatment of people with relapsed or rituximab-refractory follicular lymphoma, the most common type of indolent non-Hodgkin lymphoma (NHL), based on phase III results. European approvals are expected later this year. Gazyva is being studied in a large clinical programme in NHL, and phase III data in diffuse large B cell lymphoma, an aggressive type of NHL, are expected later this year.
Outlook for 2016
In 2016, Roche expects sales to grow low- to mid-single digit at constant exchange rates. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
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