Roche has continued to focused on medical innovation and sustainable growth with stable R&D budget, striving for efficiency and sustainable cash flow. The investor event in London will showcase the progress of Roche’s late-stage pipeline. It has industry-leading pipeline with 72 new molecular entities (NMEs); 19 late-stage clinical trials, 12 of which involve NMEs, expected to read out over the next 18 months. Its personalised healthcare solutions progressing well by leveraging capabilities across pharma and diagnostics and at present there are more than 200 companion diagnostic projects within the Group.
Antibody–drug conjugates and synergistic combinations highlighted as two of the most promising new cancer technologies; a number of early-stage clinical candidates in addition to T–DM1 and Perjeta/Herceptin currently in development Pipeline in metabolism and neuroscience progressing well with aleglitazar confirming renal safety profile in AleNephro study and gantenerumab’s Alzheimer’s programme expanded.
Through its leadership in personalised healthcare, Roche is uniquely positioned to develop therapies that advance current standards of care and improve people’s lives. Innovative access strategies in developed and emerging markets will provide additional growth opportunities.
“Roche’s strategy is based on developing differentiated medicines and diagnostics in areas of high unmet need that bring true medical benefit to patients,” said Severin Schwan, CEO of Roche. “More than 60 per cent of our pharmaceutical pipeline projects are coupled with the development of companion diagnostics in order to make treatments more effective. The recent launches of our cancer medicines Perjeta and Zelboraf are examples of the concept of personalised healthcare becoming reality.”
Roche Diagnostics continues to improve testing efficiency at labs around the world through its unique and complete menu offering that includes high-value assays and enhanced platforms. Roche is leading the discovery of new biomarkers supported by clinical evidence, in collaboration with Roche Pharma and also third parties. By successfully tailoring its strategy to local conditions in different emerging markets, Roche Diagnostics has been expanding its commercial reach, continuing its double-digit sales growth and its leadership in these vibrant markets.
One of Roche’s core competencies is oncology, and about 50per cent of its R&D budget is allocated to this franchise. Over the next few years, new technologies are expected to expand the current product portfolio for patients suffering from cancer.
Roche is at the forefront in developing antibody–drug conjugates (ADCs) that combine the specificity of antibodies with the power of chemotherapy and may result in improved efficacy and fewer adverse events. T–DM1 is an investigational ADC that attaches trastuzumab to the chemotherapy agent DM1 via a stable linker. It is designed to target and inhibit HER2 signalling and deliver the chemotherapy directly inside HER2-positive cancer cells. Pivotal phase III data for T–DM1 showed significant and clinically meaningful improvements in progression-free and overall survival in pretreated patients with advanced HER2-positive breast cancer compared with lapatinib plus Xeloda chemotherapy. The data were submitted for approval to global health authorities in August 2012 and updated overall survival data will be presented at an upcoming medical meeting. T–DM1 will be used in patients identified with a HER2 companion diagnostic test.
Roche has a total of nine ADCs in its development pipeline. Today, preliminary data for RG7593, a humanised IgG1 anti-CD22 monoclonal antibody (anti-CD22) conjugated to an anti-mitotic agent, will be presented. RG7593 is currently being tested in phase I in haematological cancers. The data indicate very promising anti-tumour activity in patients with relapsed or refractory disease following treatment with anti-CD20 containing therapies.
Roche’s innovation-based strategy of combining Pharmaceuticals and Diagnostics under one roof has delivered a late-stage pipeline and growth opportunities that position the company well in continuing to create value for all stakeholders. Roche will continue to allocate the biggest part of its R&D investment to oncology, given the sustained high level of unmet medical need and Roche’s unsurpassed expertise in this area. However, the company remains committed to investing in other disease areas of high unmet medical need such as neuroscience, metabolism, inflammation and virology, whenever there are opportunities to significantly advance medical therapies.
At the same time Roche continues to improve R&D productivity by implementing rigorous portfolio prioritisation, innovative development designs, and cost saving measures. The recent initiative to streamline global pRED activities and to close the site in Nutley, New Jersey, frees up resources that will be reinvested in the growing pipeline allowing overall R&D expenditures to remain stable for the Group.