On October 19, 2017 Roche reported strong sales growth in the first nine months of 2017 (Press release, Hoffmann-La Roche, OCT 19, 2017, View Source [SID1234521020]).
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Group sales increase 5%1 at constant exchange rates and in Swiss francs
Pharmaceuticals Division sales up 5%, driven mainly by Ocrevus, Tecentriq and Perjeta
Diagnostics Division sales grow 5%, primarily due to immunodiagnostics
Third-quarter approvals: Tecentriq for two types of metastatic bladder cancer and a specific type of metastatic lung cancer, Gazyvaro for previously untreated advanced follicular lymphoma, RoActemra for giant cell arteritis (all in the EU); Actemra for CAR-T-induced cytokine release syndrome (US)
Dow Jones Sustainability Indices recognise Roche as Group Leader in sustainability within the Pharmaceuticals,
Biotechnology and Life Sciences Industry for the ninth consecutive year
Outlook for 2017 confirmed
Commenting on the Group’s sales, Roche CEO Severin Schwan said: “Based on the strong sales growth of our Pharmaceuticals and Diagnostics Divisions in the first nine months, I am confident that we will achieve our full-year targets. The growth is largely driven by new product launches. I am particularly pleased about the regulatory approvals of Tecentriq, Gazyvaro and RoActemra in the EU.”
Group
Strong sales growth in both divisions
Group sales rose 5% to CHF 39.4 billion. Sales in the Pharmaceuticals Division increased 5% to CHF 30.6 billion. The recently launched medicines Ocrevus, Tecentriq and Alecensa contributed CHF 0.9 billion to new sales, accounting for more than half of the division’s growth. Perjeta continued its strong sales increase. This was partially offset by lower sales of Tarceva, Avastin and Tamiflu. In the US, overall sales advanced 10%, led by Ocrevus, Tecentriq, Xolair and MabThera. Sales declined 2% in Europe, where lower sales of MabThera and Avastin offset the sales growth of Perjeta and Actemra/RoActemra. In the International region, sales grew by 4%, led by the Latin America and Asia-Pacific subregions. Japanese sales increased 2%.
Diagnostics Division sales increased 5% to CHF 8.8 billion. Centralised and Point of Care Solutions (+7%) was the main contributor, led by the growth of its immunodiagnostics business (+13%). In regional terms, growth was driven in particular by Asia-Pacific (+15%), with continued strong growth in China (+21%). Sales increased 3% in EMEA2, 1% in North America, 1% in Japan and 11% in Latin America.
Important regulatory approvals in Pharmaceuticals
In September, the European Commission (EC) granted approvals for three Roche medicines in additional indications: Tecentriq, Gazyvaro and RoActemra. Tecentriq was approved as monotherapy for the treatment of people with locally advanced or metastatic bladder cancer who have been previously treated with platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status. This approval is based on results from the randomised IMvigor211 study (phase III) and cohorts 1 and 2 from the single-arm IMvigor210 study (phase II). The EC also granted marketing authorisation for Tecentriq as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with chemotherapy, regardless of PD-L1 status. This approval is based on results from the large randomised phase III Oak study and the randomised phase II Poplar study.
RoActemra was approved for the treatment of giant cell arteritis, a chronic and potentially life-threatening autoimmune condition. Approval was also granted to Gazyvaro in combination with chemotherapy as a new treatment for people with previously untreated advanced follicular lymphoma. Both approvals represent additional indications for these two medicines.
In August, the US Food and Drug Administration (FDA) approved Actemra intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. CRS is caused by an overactive immune response and has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy for certain cancers.
Important regulatory milestones
In October, the European Union’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Alecensa as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced NSCLC. It simultaneously recommended conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to full marketing authorisation.
In September, the FDA granted Priority Review to Perjeta in combination with Herceptin and chemotherapy for adjuvant (post-surgery) treatment of HER2-positive early breast cancer.
In August, the FDA granted Priority Reviews to Gazyva, emicizumab and Alecensa as follows: Gazyva, for the treatment of previously untreated follicular lymphoma; emicizumab prophylaxis (preventative), as a once-weekly subcutaneous treatment for adults, adolescents and children with haemophilia A with factor VIII inhibitors; Alecensa, as an initial (first-line) treatment for people with ALK-positive, locally advanced or metastatic NSCLC as detected by an FDA-approved test.
In the third quarter, the FDA granted Breakthrough Therapy Designation (BTD) to Venclexta in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy. BTD status was also granted to polatuzumab vedotin in combination with bendamustin plus MabThera/Rituxan for the treatment of recurrent/refractory diffuse large B cell lymphoma. Overall, Roche has received 18 BTDs.
Clinical trial results support Roche medicines
In September, results of several clinical studies were announced or published. The phase III Murano study, which evaluated Venclexta/Venclyxto in combination with MabThera/Rituxan in people with relapsed or refractory chronic lymphocytic leukaemia, met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing when treated with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus MabThera/Rituxan.
Results of a six-month study combining Esbriet and nintedanib treatment for idiopathic pulmonary fibrosis (IPF) were presented in September, showing a similar safety profile for the combination treatment to that expected for each treatment alone.3 The majority of patients with IPF will be treated with either Esbriet or nintedanib, but robust information regarding the safety and tolerability of the combination therapy was not available until now. The results support Esbriet’s known efficacy profile and suggest stability over time in King’s brief interstitial lung disease parameters in patients completing six months of combination treatment.
Roche announced results from the global phase III Alur study, showing that Alecensa significantly reduced the risk of disease worsening or death (progression-free survival) by 85% compared to chemotherapy in patients with ALK-positive advanced NSCLC who had progressed following treatment with platinum-based chemotherapy and crizotinib. In patients with measurable manifestation of disease in the central nervous system, the overall response rate was 54% for Alecensa versus 0% for chemotherapy.
New generation of diagnostics products
Roche launched the Navify Tumour Board solution, a clinical workflow and decision support software that optimises decision-making for cancer patient case reviews in the clinic, so-called tumour boards, or multi-disciplinary team meetings. This is the first product from Roche’s Navify portfolio which provides healthcare professionals with digital decision support solutions that transform patient care.
The portfolio will evolve to include additional decision support applications and workflow products that address challenges faced by healthcare providers, as well as research and development applications.
The FDA approved the cobas Zika test for use on cobas 6800/8800 Systems. The cobas Zika test is the first commercially available test for detection of Zika virus RNA in samples of human plasma and is intended for use in screening blood donations.
Sustainability – an integral part of Roche’s business strategy
In September, Roche was recognised as a sustainability leader within the Pharmaceuticals, Biotechnology and Life Sciences Industry index of the Dow Jones Sustainability Indices (DJSI) for the ninth year in a row. The company performed particularly well in categories addressing the burden of healthcare costs, ethical marketing practices and climate strategy. This recognition is based on an in-depth analysis of economic, social and environmental performance.