Roche is set to strengthen its global leadership position in oncology and to expand in therapeutic areas such as metabolism, inflammation and diseases of the central nervous system. At its first investor conference following the successful integration of Roche and Genentech, the company highlighted its vision and the strategy that it intends to pursue in order to ensure a stable flow of novel medicines from its rich development pipeline.
"Roche is uniquely positioned to deliver sustainable, long-term growth. Our success derives from the diversity of approaches applied by our Pharmaceuticals and Diagnostics R&D centres, which offer outstanding scientific excellence and an unparalleled breadth and depth of expertise in translational medicine and clinical science," said Severin Schwan, CEO of Roche. "In order to develop more efficacious and safer medicines, we pursue a seamless cooperation between our Pharmaceuticals and Diagnostics units from research through to the market to implement Personalised Healthcare as an integral part of our drug development efforts."
Based on its strong late-stage pipeline which comprises more than 35 additional indications for existing products and ten new molecular entities (NMEs) that all offer the potential to be first- or best-in-class medicines, a new generation of medicines for patients suffering from cancer, metabolic and autoimmune diseases and CNS disorders is expected to expand the current product portfolio:
New phase II data for RG1678, a Glycine transporter-1 inhibitor for negative symptoms of schizophrenia, were reported during the investor conference. Negative symptoms including apathy, lack of pleasure, lack of emotion and poor social functioning can be core clinical features in more than 50% of schizophrenia patients. In a Phase II proof-of-concept study patients on RG1678 experienced a significant improvement in the change of the so-called Negative Symptom Factor Score from baseline within 8 weeks (from -4.86 in the placebo group to -6.65 in the treatment group, p<0.05, per-protocol population). In terms of other endpoints, 83% of patients receiving RG1678 described an improvement of negative symptoms on the CGI-I1 compared to 66% of patients receiving placebo (p<0.05, per-protocol population).
Ocrelizumab is an investigational humanised monoclonal antibody that selectively binds to a particular protein - the CD20 antigen - on the surface of B-cells, which are believed to play a critical role in the pathology of immunological diseases as relapsing-remitting multiple sclerosis (RRMS). In a phase II study in RRMS, Ocrelizumab has shown a strong effect with a highly statistically significant reduction in signs of disease activity as measured by brain lesions.
Building on its leading position in oncology, Roche is developing the next generation of promising anticancer medicines with the goal of improving the chances of survival or cure for cancer patients: pertuzumab and T-DM1 for HER2-positive breast cancer, two innovative monoclonal antibody therapies with the potential to further improve treatment outcomes for breast cancer patients beyond the benefits already achieved with Herceptin; RG7204, a targeted BRAF inhibitor for the treatment of malignant melanoma; GA101/RG7159, the first glyco-engineered humanized anti-CD20 monoclonal antibody for chronic lymphocytic leukemia and non-Hodgkin's lymphoma; RG3616, a Hedgehog pathway inhibitor for the treatment of advanced basal cell carcinoma, and potentially other cancers such as colorectal cancer.
A significant flow of late-stage clinical data results from these innovative anti-cancer compounds is expected over the next two years, with first major regulatory submissions expected from 2011 and beyond. Roche is also developing new formulations of existing cancer medicines such as Herceptin and MabThera/Rituxan that can be administered by more convenient subcutaneous injection instead of intravenous infusion, thereby potentially improving convenience and reducing side effects.