Roche uniquely positioned to deliver long-term growth
Leading late-stage pipeline and innovation strategy presented at investor conference
Roche (SIX: RO, ROG; OTCQX: RHHBY) 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:
Central nervous system: two potential breakthrough medicines in late-stage development
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.
Oncology: Five NMEs in late-stage development
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.
Metabolic diseases: targeting patients with high unmet medical need
Late-stage development of taspoglutide for the treatment of Type 2 Diabetes and dalcetrapib for atherosclerosis in high-risk cardiovascular patients remains on track with regulatory submissions planned for 2011 and 2013, respectively. For taspoglutide, results of five phase III studies that met their primary efficacy endpoints will be presented at ADA in June this year. These studies belong to the T-emerge Phase III clinical trial programme consisting of eight studies. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone. Roche also announced that aleglitazar for cardiovascular disease in high-risk type 2 diabetes patients has started recruitment in a large phase III study aimed at reducing morbidity and mortality in patients who recently experienced a cardiac event.
To realize the potential of Personalised Healthcare, Roche has several biomarkers in development including the BRAF mutation assay for malignant melanoma. This assay is being developed as a companion diagnostic for Roche's investigational BRAF inhibitor RG7204, a targeted medicine in development for malignant melanoma, the most aggressive form of skin cancer. At the conference, preliminary data to identify diagnostic biomarkers that may predict improved clinical responses to lebrikizumab were also presented. Lebrikizumab is a humanized monoclonal antibody currently developed in phase II for asthma. It binds and blocks interleukin-13, a key mediator of asthma responses such as airway inflammation, obstruction and hyper-reactivity.
Roche builds on its unique innovation network of independent research and development centers. This network includes the two major centers of research and early development pRED and gRED2 as well as world class diagnostic research allowing for a unique ability to drive Personalised Healthcare. Platforms include novel technologies such as next-generation antibodies, RNAi therapeutics, stem cell techniques as well as high-throughput DNA sequencing, tissue-based diagnostics and DNA- and protein-based chip technologies. This diversity of research approaches is complemented by unique initiatives as the recently announced Translational Research Hub in Singapore and more than 150 partner organizations world-wide, giving access to even more intellectual property, new technologies and innovative molecules and compounds.
Overview on ten new molecular entities in ongoing or planned late-stage studies Compound Indication Status Market potential
trastuzumab-DM1 HER2-positive metastatic breast cancer phase III started Q1 2009 (2nd-line treatment) first in class
pertuzumab HER2-positive metastatic breast cancer phase III started in 2008 first in class
RG7159 (GA101) non-Hodgkin's lymphoma and chronic lymphocytic leukemia phase III started Q4 2009 (chronic lymphocytic leukemia) best in class
RG7204 (PLX4032) malignant melanoma phase III started in Q1 2010 first in class
RG3616 (hedgehog pathway inhibitor) advanced basal cell carcinoma pivotal phase II started Q1 2009 first in class
RG1678 (GlyT-1 inhibitor) negative symptoms of schizophrenia positive phase II results in Q4 2009, phase III planned to start in 2010 first in class
ocrelizumab Multiple sclerosis positive phase II results in Q4 2009, phase III decision to be taken in 2010 first in class
aleglitazar cardiovascular high risk in type 2 diabetes phase III initiated in Q1 2010 first in class
taspoglutide type 2 diabetes first positive phase III results (T-emerge) in Q4 2009, additional results expected in 2010 best in class
dalcetrapib dyslipidemia, cardiovascular high risk phase III enrolment ongoing first in class
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.