On October 17, 2018 Roche reported very strong growth in the first nine months of 2018 (Press release, Hoffmann-La Roche, OCT 17, 2018, View Source [SID1234529993]).
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Group sales increase 7% [1] at constant exchange rates and in Swiss francs
Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus, Perjeta, Alecensa and Tecentriq
Diagnostics Division sales grow 6%, primarily due to demand for immunodiagnostic solutions
Recent approvals: Hemlibra for people with haemophilia A without factor VIII inhibitors, Actemra sub-cutaneous formulation for active systemic juvenile idiopathic arthritis and prefilled syringes for Xolair in the US; Alecensa for a form of lung cancer in China
Outlook for 2018 confirmed
Commenting on the Group’s results, Roche CEO Severin Schwan said: "In the first nine months of the year, both our Pharmaceuticals and Diagnostics Divisions achieved very strong sales growth. The uptake of our new medicines continued to be strong in the third quarter. I am also very pleased that following the recent additional FDA approval, Hemlibra is now broadly available in the US for people with haemophilia A. Based on the performance in the first nine months of the year, we will achieve our full-year targets."
Group sales
Very strong sales growth in both divisions
In the first nine months of 2018, Group sales rose 7% to CHF 42.1 billion. Sales in the Pharmaceuticals Division increased 7% to CHF 32.7 billion. Key growth drivers were the recently launched medicine Ocrevus, used to treat two forms of multiple sclerosis, and cancer medicines Perjeta, Alecensa and Tecentriq. As expected, the strong growth reported for the Pharmaceuticals Division was partially offset by lower sales of MabThera/Rituxan and of Tarceva.
In the US, sales increased 14%, led by Ocrevus, Herceptin and Perjeta. Ocrevus sales were supported by continued strong new patient demand. The 30% sales increase of Perjeta was driven by its use for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer at high risk of recurrence. [2]
In Europe (-8%), strong launches of our new medicines Ocrevus, Tecentriq and Alecensa, especially in Germany, partially offset declining sales of MabThera/Rituxan (-48%) and Herceptin (-10%), which were impacted by biosimilar competition. Perjeta sales continued to grow, specifically in the metastatic and neoadjuvant settings. In the International region, sales grew 8%, led by the Asia–Pacific and Latin America subregions. In the Asia–Pacific region, growth was driven by sales in China. In Japan, sales were stable.
Diagnostics Division sales increased 6% to CHF 9.4 billion. Centralised and Point of Care Solutions (+7%) was the main contributor, led by the growth of its immunodiagnostics business (+10%). Sales increased in all business areas and all regions. Growth was driven by the Asia–Pacific (+13%) and North America (+6%) regions. Sales increased 2% in EMEA [3], 8% in Latin America and 3% in Japan.
Milestones for Roche medicines
In recent months, health authorities granted approvals for several Roche products. The US Food and Drug Administration (FDA) approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, aged newborn and older, with haemophilia A without factor VIII inhibitors.
Approval was granted by the FDA for single-dose prefilled syringes for Xolair as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. Further, US approval was granted for the subcutaneous formulation of Actemra for the treatment of active systemic juvenile idiopathic arthritis in patients aged two and older.
The China National Drug Administration (CNDA) granted marketing authorisation for Alecensa as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
The European Committee for Medicinal Products for Human Use (CHMP) recommended the approval of the subcutaneous formulation of RoActemra for the treatment of active systemic juvenile idiopathic arthritis in patients aged one and older. The CHMP also recommended the approval of Venclyxto in combination with MabThera for the treatment of people with chronic lymphocytic leukaemia who have received at least one prior therapy.
The FDA granted Breakthrough Therapy Designation for Xolair for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.
The European Medicines Agency (EMA) granted PRIME (PRIority MEdicines) designation for Roche’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD).
Clinical trial results on Roche medicines
Results from a number of late-stage studies were announced in recent months: results from the phase III Katherine study showed that treatment with Kadcyla as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (eBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment.
Five-year data from the phase III open-label extension studies of Opera I, Opera II and Oratorio show that Ocrevus efficacy is maintained on key measures of disease activity and that people treated earlier with Ocrevus had superior disability progression outcomes compared with RMS patients who switched from interferon beta-1α or PPMS patients who switched from placebo.
Positive results from the phase III IMpower133 study of Tecentriq plus carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of people with previously untreated extensive-stage small cell lung cancer (ES-SCLC) showed that Tecentriq and chemotherapy helped people live significantly longer compared with chemotherapy alone in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone.
An integrated analysis of the pivotal entrectinib phase II Startrk-2, phase I Startrk-1 and phase I Alka trials showed that entrectinib shrank tumours (objective response rate; ORR) in 77.4% of people with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). In addition, entrectinib demonstrated a durable response of more than two years (duration of response = 24.6 months).
The phase III Capstone-2 study showed treatment with baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time of 73.2 hours versus 102.3 hours) in people at high risk of serious complications from the flu, which includes adults aged 65 years and older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease. Baloxavir marboxil is the first potential influenza treatment in clinical trials to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications.
Interim clinical data were announced from the dose-finding parts of the pivotal Firefish and Sunfish studies investigating risdiplam (RG7916) in SMA. In the Firefish study in type 1 SMA, six out of 14 infants (43%) were able to sit (with or without support), including three (21%) who achieved unassisted stable sitting after eight months of treatment. In addition, four infants (29%) demonstrated rolling to the side; seven (50%) kicking and six (43%) achieved upright head control. These milestones were assessed according to the Hammersmith Infant Neurological Examination Module 2 and are key secondary endpoints in the confirmatory part of Firefish.
Results from the phase III IMpower132 study of Tecentriq plus pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the initial (first-line) treatment of people with non-squamous NSCLC showed that Tecentriq and chemotherapy reduced the risk of disease worsening or death (progression-free survival, PFS) by 40% compared with chemotherapy. While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival (OS) was observed, at this interim analysis statistical significance has not yet been met.
Roche announced the global availability of FoundationOne Liquid, a liquid biopsy test. FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours, including microsatellite instability, a genomic signature which may help inform cancer immunotherapy-based treatment decisions. From a single blood sample, the liquid biopsy offers a quick and convenient option for some patients with solid tumours.
Advancing personalised healthcare
Roche completed the transaction to take 100% ownership of Foundation Medicine (FMI), Inc., US, in late July 2018. A tender offer had been launched on 2 July 2018. This transaction broadens Roche’s personalised healthcare strategy and aims to further advance molecular insights and the broad availability of high-quality comprehensive genomic profiling, both key enablers for the development of new cancer treatments and optimal patient care.
Diagnostics – tools for decision support
As part of its public-private partnership with the Kenya Medical Research Institute (KEMRI), Roche installed a cobas 8800 System for state-of-the-art diagnostic testing, including HIV diagnosis, in Nairobi, Kenya. This laboratory will support local efforts in the fight against HIV/AIDS.
The cobas MTB and cobas MAI tests for use on the cobas 6800/8800 Systems have become available in countries accepting the CE Mark.
The first two Navify clinical decision support apps were launched, expanding the Navify eco-system; the Navify Clinical Trial Match and Navify Publication Search apps help oncology care teams access relevant clinical trial information and publications more effectively.
Three new next-generation sequencing (NGS) Avenio Tumor Tissue Analysis Kits (research use only) were made available globally: the Avenio Tumor Tissue Targeted Kit, Expanded Kit and Surveillance Kit. The kits, which detect all four mutation classes in solid tumours, complement Roche’s NGS ctDNA kits for oncology research.