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Is personalised medicinegetting closer?Excerpted from an article by Johanna Kleine, Senior Editor of IMS Company Profiles.
"The right dose of the right drug to the right patient at the right time." That is the promise of personalised medicine - the use of information about a persons genetic makeup to tailor strategies for the detection, treatment or prevention of disease.A few decades ago, this would sound like Most big pharma companies are activelyscience fiction, but personalised medicine working on biomarkers programmes, likeand pharmacogenomics are becoming J & J, Roche GSK, Merck & Co and Pfizer,more and more real. In fact, the model is just to name a few.already operative on a small scale, as sometargeted therapies for cancer can confirm. GSK, for example, has been collecting DNASeen as the future of healthcare, samples from all clinical trial patients forpersonalised medicine is predicted to biomarker analysis since 2003. Pfizer has beenbring massive changes to the doing the same. Speaking at the FT Globalpharmaceutical industrys blockbuster Pharmaceuticals and Biotechnologymodel. Customising treatments to suit Conference in London, in September 2006,different categories of patients is, perhaps, Dr Jean-Jacques Garaud, Global Head ofthe biggest challenge, and possibly also Exploratory Development at Novartis,the biggest opportunity, facing the industry highlighted that biomarkers should maketoday. R&D less risky and save time in development, in addition to bringing better benefit for theSome companies are overcoming their patient and better return in price for theresistance to change and are now taking manufacturers.the challenge very seriously. It is easy tosee why. Pharmacogenomics may increase Cancer drugs lead the waychance of cure for the patient, who can be Oncology is at the forefront ofselected to maximise benefit and minimise pharmacogenomics, given that testing oftoxicity. It also has the potential to reduce genetic variation in drug receptors is frequentlydeaths and unnecessary hospitalisation due used to characterize tumours.to drug adverse reactions, bringing down Roche/Genentechs breast cancer therapyhealthcare costs as a result. Most important Herceptin (trastuzumab), linked to the HER2from the industry point of view, however, is gene, is by far the best publicised of the targetthe fact that pharmacogenomics may bring drugs currently on the market, but other well-down drug development costs, ensuring known names are Novartis Gleevec (imatinib),that a higher proportion of drugs actually for chronic myeloid leukaemia, andmake it through all the phases of Roche/Genentech/OSIs Tarceva (erlotinib), fordevelopment and onto the market. lung cancer. All are associated with tests that can show if the patients genetic makeup wouldFocus on use of biomarkers respond to the drug.The science of pharmacogenomics hasadvanced significantly in research and Roche expects its test for Tarceva to be availablepharma companies are investing hugely in in 2007 or 2008.programmes to identify biomarkers to reducethe attrition rate in drug development, since As pharmacogenomics may reduce costs foronly one in 15 drugs entering Phase I ever payers, regulatory agencies support the newreach the market, with the great majority of model and have made the progression ofcompounds failing in Phase II. personalised medicine a priority.
The FDA considers pharmacogenomics to be Joachim Eberle, Head of R&D at Rochea major opportunity on the critical path to Centralised Diagnostics, told investors innew medical products and has begun June 2006 that Roche has extensive jointencouraging submissions of genomic data programmes for all drugs throughout theirthrough its voluntary genomic data lifecycle. "No drug programme starts at Rochesubmission programme. The agency is also without a diagnostic project," he said duringconsidering developing a standardised an oncology event promoted by thelabelling format for pharmacogenomic company. Roches main five oncology drugsinformation. - Herceptin, Tarceva, Xeloda (capecitabine), MabThera/Rituxan (rituximab) and AvastinAlthough big pharmas efforts in (bevacizumab) - all have biomarker testspharmacogenomics have been concentrated either on the market or in Phase IIIin oncology, pipelines show that this is slowly development. Besides that, the company alsochanging. Gradually big pharma is expanding develops tests that allow the selection of onepharmacogenomics to therapeutic areas other or several therapies. The AmpliChip CYP450than oncology. J&Js Invega (paliperidone), Test - launched in the EU in 2004 and in theapproved by the FDA in December 2006 as a USA in 2005 - can identify how individualstreatment for schizophrenia, and Wyeths metabolise many of todays most widelyPristiq (desvenlafaxine), submitted for the prescribed drugs. By analysing the variationstreatment of depression, for example, are in two genes, the test predicts whether atwo CNS drugs that could possibly have person is a slow, normal or rapid metabolisercommercial genetic tests associated with them. of a particular drug.In both cases, the action of the drug may beaffected by poor or ultrarapid drug Similarly, Enzyme has been involved inmetaboliser CYP2D6 gene status, which the diagnostic testing for many years. Specialisedpatient could be tested for. Novartis in treatments for lysosomal storage disordersindacaterol, in Phase II trials for asthma and (LSDs), genetic diseases caused by enzymechronic obstructive pulmonary disease, is deficiencies, the company has developedanother example. The respiratory drug could genetic tests in LSDs and now is expandingbe approved with a genetic test for its diagnostics and therapeutics connectionpolymorphism at beta-adrenergic receptors in other genetic diseases and in cancer.that may affect drug action. Genzyme has launched four new cancer tests linked to targeted therapies in the last year and is developing a diagnostic test inDiagnostics being developed in parallel Clostridium difficile colitis - it has a Phase IIISince personalised medicine is intrinsically drug for this indication, tolevamer, expectedlinked to the development of diagnostic to be launched in 2008.tests, the diagnostics side of the healthcareindustry is expected to benefit a great deal With the support of government institutionsfrom this shift, especially companies that like the FDA, which is stimulatinghave coordinated pharma and diagnostics pharmacogenomic dosing information indivisions. Roche, currently the world leader labelling and the availability of diagnosticin oncology drugs, believes it is uniquely tests, the stage is set and personalisedpositioned in this arena. The company plans medicine may be closer than we think.to take advantage of its knowledge base inboth pharma and diagnostics to developnew tailor-made products and services.