The article aims to answer the question, 'Is Personalised Medicine Getting Closer?'

1. Is personalised medicine
getting closer?
Excerpted from an article by Johanna Kleine, Senior Editor of IMS Company Profiles.

2. "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 person's 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 actively
science fiction, but personalised medicine working on biomarkers programmes, like
and 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 some
targeted therapies for cancer can confirm. GSK, for example, has been collecting DNA
Seen as the future of healthcare, samples from all clinical trial patients for
personalised medicine is predicted to biomarker analysis since 2003. Pfizer has been
bring massive changes to the doing the same. Speaking at the FT Global
pharmaceutical industry's 'blockbuster' Pharmaceuticals and Biotechnology
model. Customising treatments to suit Conference in London, in September 2006,
different categories of patients is, perhaps, Dr Jean-Jacques Garaud, Global Head of
the biggest challenge, and possibly also Exploratory Development at Novartis,
the biggest opportunity, facing the industry highlighted that biomarkers should make
today. R&D less risky and save time in development,
in addition to bringing better benefit for the
Some companies are overcoming their patient and better return in price for the
resistance to change and are now taking manufacturers.
the challenge very seriously. It is easy to
see why. Pharmacogenomics may increase Cancer drugs lead the way
chance of cure for the patient, who can be Oncology is at the forefront of
selected to maximise benefit and minimise pharmacogenomics, given that testing of
toxicity. It also has the potential to reduce genetic variation in drug receptors is frequently
deaths and unnecessary hospitalisation due used to characterize tumours.
to drug adverse reactions, bringing down Roche/Genentech's breast cancer therapy
healthcare costs as a result. Most important Herceptin (trastuzumab), linked to the HER2
from the industry point of view, however, is gene, is by far the best publicised of the target
the 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, and
make it through all the phases of Roche/Genentech/OSI's Tarceva (erlotinib), for
development and onto the market. lung cancer. All are associated with tests that can
show if the patient's genetic makeup would
Focus on use of biomarkers respond to the drug.
The science of pharmacogenomics has
advanced significantly in research and Roche expects its test for Tarceva to be available
pharma companies are investing hugely in in 2007 or 2008.
programmes to identify biomarkers to reduce
the attrition rate in drug development, since As pharmacogenomics may reduce costs for
only one in 15 drugs entering Phase I ever payers, regulatory agencies support the new
reach the market, with the great majority of model and have made the progression of
compounds failing in Phase II. personalised medicine a priority.

3. The FDA considers pharmacogenomics to be Joachim Eberle, Head of R&D at Roche
a major opportunity on the critical path to Centralised Diagnostics, told investors in
new medical products and has begun June 2006 that Roche has extensive joint
encouraging submissions of genomic data programmes for all drugs throughout their
through its voluntary genomic data lifecycle. "No drug programme starts at Roche
submission programme. The agency is also without a diagnostic project," he said during
considering developing a standardised an oncology event promoted by the
labelling format for pharmacogenomic company. Roche's main five oncology drugs
information. - Herceptin, Tarceva, Xeloda (capecitabine),
MabThera/Rituxan (rituximab) and Avastin
Although big pharma's efforts in (bevacizumab) - all have biomarker tests
pharmacogenomics have been concentrated either on the market or in Phase III
in oncology, pipelines show that this is slowly development. Besides that, the company also
changing. Gradually big pharma is expanding develops tests that allow the selection of one
pharmacogenomics to therapeutic areas other or several therapies. The AmpliChip CYP450
than oncology. J&J's Invega (paliperidone), Test - launched in the EU in 2004 and in the
approved by the FDA in December 2006 as a USA in 2005 - can identify how individuals
treatment for schizophrenia, and Wyeth's metabolise many of today's most widely
Pristiq (desvenlafaxine), submitted for the prescribed drugs. By analysing the variations
treatment of depression, for example, are in two genes, the test predicts whether a
two CNS drugs that could possibly have person is a slow, normal or rapid metaboliser
commercial genetic tests associated with them. of a particular drug.
In both cases, the action of the drug may be
affected by poor or ultrarapid drug Similarly, Enzyme has been involved in
metaboliser CYP2D6 gene status, which the diagnostic testing for many years. Specialised
patient could be tested for. Novartis' in treatments for lysosomal storage disorders
indacaterol, in Phase II trials for asthma and (LSDs), genetic diseases caused by enzyme
chronic obstructive pulmonary disease, is deficiencies, the company has developed
another example. The respiratory drug could genetic tests in LSDs and now is expanding
be approved with a genetic test for its diagnostics and therapeutics connection
polymorphism 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 in
Diagnostics being developed in parallel Clostridium difficile colitis - it has a Phase III
Since personalised medicine is intrinsically drug for this indication, tolevamer, expected
linked to the development of diagnostic to be launched in 2008.
tests, the diagnostics side of the healthcare
industry is expected to benefit a great deal With the support of government institutions
from this shift, especially companies that like the FDA, which is stimulating
have coordinated pharma and diagnostics pharmacogenomic dosing information in
divisions. Roche, currently the world leader labelling and the availability of diagnostic
in oncology drugs, believes it is uniquely tests, the stage is set and personalised
positioned in this arena. The company plans medicine may be closer than we think.
to take advantage of its knowledge base in
both pharma and diagnostics to develop
new tailor-made products and services.