In the first three months of 2019, Group sales rose 8% to CHF 14.8 billion. Sales in the Pharmaceuticals Division increased 10% to CHF 11.9 billion. Key growth drivers were the multiple sclerosis medicine Ocrevus and cancer medicines Perjeta and Tecentriq as well as the new haemophilia medicine Hemlibra. As expected, the strong uptake of newly introduced medicines was partially offset by lower sales of Herceptin and of MabThera/Rituxan.
In the US, sales increased 14%, led by Ocrevus, Hemlibra, Perjeta and Tecentriq. Ocrevus sales were driven by both new and continuing patient demand.
In Europe (-6%), sales were affected by competition from biosimilars for Herceptin (-44%) and MabThera/Rituxan (-38%). This decline was partially offset by the strong growth of Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra.
In the International region sales grew 17%, mainly driven by China. In Japan, sales increased 7%, driven by recently launched products, including Tecentriq, Hemlibra and Perjeta. This growth was partially offset by biosimilar competition for MabThera/Rituxan (-50%) and Herceptin (-9%).
Diagnostics Division sales increased 1% to CHF 2.9 billion. Molecular Diagnostics (+7%) was the main contributor, led by the growth of its cervical cancer business. In regional terms, growth was reported in EMEA2 (+3%) and Latin America (+8%). Sales were impacted by one-time supply chain effects in Centralised and Point of Care Solutions in Asia-Pacific and in coagulation monitoring systems in North America.
Important milestones for Roche medicines
In the first quarter, regulatory authorities approved new indications for a number of Roche medicines, granted priority review procedures for and recommended approvals of several Roche drug candidates.
The US Food and Drug Administration (FDA) approved Tecentriq in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer. This approval is based on results from the phase III IMpower133 study.
The FDA granted accelerated approval to Tecentriq plus chemotherapy (paclitaxel protein-bound particles for injectable suspension) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumours express PD-L1, as determined by an FDA-approved test. This decision is based on progression-free survival (PFS) data from the phase III IMpassion130 study.
The European Commission approved Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), including EGFR mutant or ALK-positive NSCLC after failure of appropriate targeted therapies.
Furthermore, the European Commission approved Hemlibra for routine prophylaxis of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors. Hemlibra can be used in all age groups, and now also at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors.
The FDA approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. This new treatment includes the same monoclonal antibody as intravenous Herceptin in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin.
The European Commission approved MabThera for the treatment of adults with moderate to severe pemphigus vulgaris, a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes. Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death.
Progress in the product pipeline
The FDA granted priority review for entrectinib for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumours who have either pro...
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