OREANDA-NEWS. Roche Delivers Continued Drowth in the first half of 2016
  • Group sales increased by 5% at constant exchange rates, 6% in Swiss francs
  • Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines
  • Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care
  • Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs
  • OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review
  • Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US
  • cobas e801 immunodiagnostic module launched for high-volume testing
  • Outlook for 2016 confirmed

Group

Strong performance in both divisions

Sales increased 6% in the first half, with significant growth of sales of oncology and immunology medicines. There was also strong growth in the Diagnostics Division, driven particularly by immunodiagnostic and molecular diagnostics products.

In the Pharmaceuticals Division, 5% sales growth was driven by medicines to treat HER2-positive breast cancer (Herceptin, Perjeta, Kadcyla, combined +21%) and Avastin (+9%), which saw very strong growth in use for cervical and ovarian cancers. Avastin is now used to treat seven different types of cancer. MabThera/Rituxan (+6%) for blood cancers and rheumatoid arthritis continued to grow solidly. Actemra/RoActemra (+25%), which is used mainly to treat rheumatoid arthritis, also remained a significant growth contributor in the first six months. Xolair (+28%), which is now used in the treatment of chronic hives as well as asthma, continued to grow strongly. Uptake of Esbriet was very strong in the first six months (229 million Swiss francs). Sales of oral chemotherapy drug Xeloda and anti-viral medicine Valcyte declined as these medicines are no longer patent protected. Sales of hepatitis medicine Pegasys and eye medicine Lucentis were lower as a result of increased competition.

In the Diagnostics Division, sales increased 7%, driven primarily by immunodiagnostic products from the Professional Diagnostics business area (+7%). The Molecular and Tissue Diagnostics business areas also performed well, each up 12%, and sales in Diabetes Care increased 1%, despite ongoing challenging market conditions.

The Swiss franc strengthened considerably against the euro during the first half of 2015, after the Swiss National Bank lifted its exchange rate peg in January, whilst weakening against the US dollar. The Japanese yen continued to further weaken against the Swiss franc, as did most European and Latin American currencies. Overall, there was a significant negative currency impact of 3 percentage points on sales.

Regulatory approvals

In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.

Strong Pharma pipeline

Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.

In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.

At the American Society of Clinical Oncology (ASCO) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.

In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.

Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.

Portfolio progress in Diagnostics

In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.