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Roche to keep focus on targeted personalized therapies - 'future drug development'
  Kevin Grogan
Roche's chief executive has told Reuters that he expects half of the Swiss major's portfolio to be made up of targeted drugs in 10 years. In an interview with the news agency, Severin Schwan (pictured) added that "I would assume in 20 years this percentage is going to increase". Half of the products in Roche's late-stage pipeline already have companion diagnostics and he believes the firm's diagnostics-pharma combination will give it a march on rivals. "We believe that by having it integrated at a very, very early stage, we have a competitive edge," Mr Schwan said.
He expects autoimmune diseases like asthma to be the next field to benefit from the targeted approach after cancer, and spoke enthusiastically about lebrikizumab, a humanised monoclonal antibody designed to block interleukin-13, which has moved into Phase III. "If this works, I believe this will change the standard of care for asthma treatment," he added.
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Mr Schwan went on to tell Reuters that he believes Roche will be able to charge a premium for targeted therapies despite government spending cuts." Allocation of healthcare resources will go where you have the biggest impact in terms of improvement of health for the individual patient," he said, noting that the costs of developing drugs could potentially fall, as fewer patients will be required for trials.
August 31, 2011
Roche to maintain lead in targeted drugs
By Katie Reid
Roche expects a new generation of drugs targeted at specific groups of patients to make up half its portfolio in 10 years, a shift that is pushing the boundaries of modern medicine.
In an interview, Roche Chief Executive Severin Schwan compared advances in molecular biology that are improving understanding of how cells work to the revolution in medicine several centuries ago when doctors first started opening up patients' bodies.
"In 10 years we would see half of our portfolio to be targeted therapies. And if anything, I would assume in 20 years this percentage is going to increase," Schwan told Reuters.
Roche, the world's largest maker of cancer drugs, leads the pack in targeted therapies thanks in part to its closely integrated diagnostics arm that helps its pharma division pinpoint the gene mutations its drugs should zero in on. Its 5.4 billion Swiss franc ($6.6 billion) breast cancer drug Herceptin broke new ground in the field a decade ago as a drug designed to treat only women who make too much of the HER2 protein, around 20 percent of sufferers.
Half of the products in Roche's late-stage pipeline already have companion diagnostics -- tests that determine if the patients are a genetic fit with the therapies.
Schwan, who took over as head of Roche in 2008 after leading its diagnostics unit for nearly two years, believes the diagnostics-pharma combination will give the company an edge for years to come as the model is hard for rivals to copy. "We believe that by having it integrated at a very, very early stage, we have a competitive edge," Schwan said at Roche's elegant 1930s headquarters on the banks of the Rhine.
The 115-year-old company has just won U.S. backing for a revolutionary melanoma drug and its companion test to treat those patients who have a specific mutation of this disease.
Players like cross-town rival Novartis and U.S. group Pfizer , which are also active in oncology, are among those following in Roche's footsteps, said Schwan, a lawyer by training who has a background in economics.
"Everybody is forced to follow the science," he said, adding he expects autoimmune diseases like asthma to be the next field to benefit from such a targeted approach after cancer, and perhaps even central nervous system illnesses too.
Schwan has high hopes for Roche's asthma drug Lebrikizumab, now in late-stage trials: "If this works, I believe this will change the standard of care for asthma treatment."
Schwan is convinced he will be able to charge a premium for targeted therapies despite worldwide healthcare spending cuts.
"Allocation of healthcare resources will go where you have the biggest impact in terms of improvement of health for the individual patient," Schwan said. Better targeted medicines will also help cut costs as those patients whose genetic makeup means they will not benefit from a drug simply will not get it, reducing spending on administering drugs as well as the cost of potential side effects, he said.
The costs of developing drugs could potentially also fall, Schwan said, as fewer patients will be required for a drug to meet its endpoint in a late-stage trial. Schwan, a softly-spoken Austrian with an Innsbruck University doctorate in law, said that making drugs for smaller patient populations did not spell the end of blockbusters, those that rake in sales of more than $1 billion, pointing to the success of Herceptin.
Illustrating his points by scribbling a graph or sketching a diagram, Schwan said another blockbuster candidate is MetMAb, a lung cancer drug targeting about 50 percent of patients who overexpress a receptor on the cancer cell:
"Imagine we move the standard of care for 50 percent of lung cancer patients. If it works ... of course it will be a blockbuster driven by the enormous medical value it offers."
Despite a string of setbacks last year that prompted it to slash thousands of jobs in a cost saving program, Roche has been more than twice as successful as the rest of the industry at getting drugs to market over the past five years. The group has fared better so far this year too, and Schwan said the group was slightly ahead of schedule on plans to shave off 1.8 billion francs in costs this year and realize annual savings of 2.4 billion francs by the end of 2012. Some analysts have questioned whether the Swiss franc, which has soared this year, may have chewed up much of the progress made by Roche so far, but Schwan said the currency's fluctuations have not had any impact on the program.
"Just as innovation is not over, our productivity improvements will not be over," he said.
And he reaffirmed Roche's commitment to its home town despite the strong franc: "I'm really a big fan of Switzerland overall and of Basel in particular. Why is this the case? Most importantly because of the access to talent. Because in our business it's all about innovation." ($1 = 0.818 Swiss Francs)
Roche, Novartis "set to be leaders in personalised medicine:" study
World News | April 12, 2011
Roche and Novartis are the only two out of a group of 10 leading pharmaceutical companies with at least one targeted drug therapy on the market which are likely to become leaders in the field of personalised medicine, says a new study.
The report classifies the two companies as "disruptors," ie, those able to competitively reshape therapy areas via personalised medicine. Both Roche and Novartis have the capacity to "upset normal competitive dynamics in a specific therapy area by shaping payers', regulators' and physicians' expectations of value," according to Peter Keeling, chief executive of change management and consulting firm Diaceutics, which carried out the research.
The firm's review of the 10 leading drugmakers, which classifies them according to their potential to capitalise on opportunities in personalised medicine, sees at Roche an excellent capacity for personalised medicine innovation and a robust strategy in the field, while Novartis has more recently focused on building its internal molecular diagnosis unit and has developed a clinical pipeline with a focus on personalised medicine, it says.
The next rank after the "disruptors" are "breakaway" companies, ie those positioned - based on the carefully selected, proactive investments which they have made - to migrate their operating models and corporate structures in order to successfully commercialise targeted therapies.
Diaceutics finds four such "breakaway" firms - AstraZeneca, Eli Lilly, Bristol-Myers Squibb and Pfizer - which, it believes, are likely to accelerate their activities and improve their commercial infrastructure for targeted therapies over the next 24-36 months. It judges all four companies as having roughly equal potential to commercialise targeted therapies, but believes that AstraZeneca, Lilly and Bristol-Myers Squibb, with their internal personalised medicine strategy teams, will likely be better organised internally to develop potential therapies and companion diagnostics. Pfizer, on the other hand, has a promising clinical pipeline for personalised medicine, it adds.
Whether these four attain "disruptor" status depends on whether their boards and senior management decide to migrate to a future culture and infrastructure based predominantly on personalised medicine, says the study.
The four remaining companies - GlaxoSmithKline, Sanofi-Aventis, Amgen and Merck & Co - are rated as "followers," ie, most likely to respond to the actions of other companies.
"Followers" have few commercial successes in this space and thus little commercial experience, and are more likely to strive to maintain their existing business models, rather than adapt them for personalised medicine, says the report.
Most drugmakers say they are ready for personalised medicine, and their development pipelines are filling up with opportunities, says Diaceutics, whose report finds that 46% of all new therapies currently in Phase III R&D could benefit from a personalised medicine strategy. Other studies have suggested that only 10% of such therapies are potential personalised medicine/targeted therapies, but the firm believes that the standard definition being used in the industry is narrow.
"In fact, any therapy that will directly benefit from a new or reshaped diagnostic approach should be considered personalised medicine," according to Mr Keeling. Moreover, the analysis finds that, in contrast to the belief held by many firms that personalised medicine will create smaller markets or less revenue, about half of the companies assessed in the report have a personalised therapy currently on the market that is near or above blockbuster-level sales of $1 billion.
Roche Takes a Step Forward with Personalized Medicine published by Patricia Van Arnum on August 31, 2011
Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche's strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines.
Earlier this month, FDA approved Roch's Zelboraf (vemurafenib) and companion diagnostic for BRAF mutation-positive metastatic melanoma. Zelboraf is an oral, small-molecule kinase inhibitor indicated for treating patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by the cobas 4800 BRAF V600 Mutation Test, a polymerase chain reaction-based diagnostic test developed by Roche. The B-Raf protein is a key component of the Ras-Raf pathway involved in normal cell growth and survival. Mutations that keep the B-Raf protein in an active state may cause excessive signaling in the pathway, leading to uncontrolled cell growth and survival. These mutations of the B-Raf protein are thought to occur in an estimated half of all melanomas and 8% of solid tumors. Zelboraf is being codeveloped under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group. "The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options," said Hal Barron, M.D., chief medical officer and head of global product development at Roche, in a company press release.
Among the pharmaceutical majors, Roche is most active in pursuing a strategy of combining molecular diagnostics with targeted drug development. Such an approach has the potential of developing more clinically efficacious drugs, albeit to a smaller, but better defined patient population, which serves the pharmaceutical side of the business, but also Roche' molecular diagnostics business. In reporting its 2010 results in February 2011, Roche reported that it had 12 new molecular entities in late-stage development, of which six were potential personalized healthcare medicines with planned companion diagnostic tests. The recently approved Zelboraf and related diagnostic test was one of those six treatments.
Analysts are bullish on Zelboraf as a potential blockbuster due to the drug's potential in addressing an unmet medical need in treating metastatic melanoma. It will be important to watch the financial results for this newly approved drug and related diagnostic as well as the pipeline progression of Roche's other personalized medicines to see whether the marriage of targeted therapeutics with related molecular diagnostics may indeed represent a new winning paradigm in drug development.
Basel and New York, 18 March 2010
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.


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:
All trademarks used or mentioned in this release are protected by law.
1) CGI-I Clinical Global Impression of Improvement of Negative symptoms 2) pRED (pharma Research and Early Development), gRED (genentech Research and Early Development)
NATAP Reports
Two new drugs extend survival for melanoma patients - (08/18/11)
FDA approves melanoma drug Zelboraf from Roche - (08/18/11)
Switch in Cell's 'Power Plant' Declines with Age, Rejuvenated by Drug: anti-aging blood pressure drug losartan - (08/18/11)
Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation (phase 3 study results) - (08/18/11)
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma - (08/18/11)
Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma - (08/18/11)
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer: Second melanoma drug approved this year that improves overall survival - (08/18/11)
FDA Approves Zelboraf (Vemurafenib) and Companion Diagnostic for BRAF Mutation-Positive Metastatic Melanoma, a Deadly Form of Skin Cancer - Genentech press release - (08/18/11)
FDA Approves Zelboraf (Vemurafenib) and Companion Diagnostic for BRAF Mutation-Positive Metastatic Melanoma, a Deadly Form of Skin Cancer - Genentech press release, Patient Access Programs - (08/18/11)
Two new drugs extend survival for melanoma patients - (08/18/11)
Bristol-Myers Squibb and Roche Enter into a Clinical Collaboration Agreement to Conduct Combination Studies with YERVOY_ (ipilimumab) and Vemurafenib - (08/18/11)
Investigational Compound Ipilimumab Demonstrates Improved Overall Survival in Phase 3 Trial of Previously-Treated Patients with Metastatic Melanoma - (08/18/11)
FDA Approves YERVOY_ (ipilimumab) for the Treatment of Patients with Newly Diagnosed or Previously-Treated Unresectable or Metastatic Melanoma, the Deadliest Form of Skin Cancer - (08/18/11)
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