It is the BMI Pharmaceuticals and Healthcare team's view that personalised medicines - defined as the use of information about a person's genes to prevent, diagnose and treat a disease - will play a greater role in the treatment of patients in future. Medicines that offer fewer side-effects and target illnesses more efficiently are increasingly subject to pharmacoeconomic analysis, especially as ageing populations and chronic disease burdens command high healthcare budgets.
Highlighting drugmakers' recognition of personalised medicines as a highly lucrative sector, multinational drugmaker Sanofi-Aventis has entered an agreement with privately-held US-based company AgaMatrix to develop and commercialise blood glucose monitoring (BGM) devices. The devices utilise AgaMatrix's WaveSense technology to personalise each BGM test, employing a new detection method called dynamic electrochemistry to detect and correct errors caused by differences in blood samples (such as hematocrit levels or chemical interferences from food and drink) and environmental conditions (such as altitude and/or temperature when the sample is taken).
Sanofi-Aventis is to sell the BGM devices alongside its blockbuster diabetes therapies Lantus (insulin glargine) and Apidra (insulin glulisine). Lantus is the number-one prescribed insulin worldwide and in 2009 became Sanofi-Aventis's leading product with revenues of US$4.16bn, achieving sales growth of 25.71% and accounting for a significant 11.93% of the drugmaker's pharmaceuticals revenues. Sanofi-Aventis will start selling the first products under the agreement in the second half of 2010.
BMI believes that coupling the drug with a personalised test for BGM will provide Sanofi-Aventis with significant revenue earning opportunities - accuracy is particularly important to diabetes patients in order to safely adjust their insulin dose. Developing tests for a therapy that is costly and for a growing disease area (in both developed and emerging markets) will also improve revenue-earning opportunities, especially as the medicine's usage would be more targeted, relevant and more efficient. BMI notes that Sanofi-Aventis has already shown how innovation can provide a significant revenue stream - the company developed the Lantus SoloSTAR pen, a pre-filled disposable pen that enables patients to set appropriate dosage units, therefore creating a more convenient method for the administration of their daily insulin.
We believe that obvious benefits of personalised medicines have and will continue to drive collaborations between drugmakers and diagnostic companies. Additionally, the patent cliff will continue to force drugmakers to look for ways to maintain both revenue and profits and diversifying into diagnostics may be a profitable solution. With reference to patent expirations, Lantus is set to lose its regulatory exclusivity in the European Union (EU) in 2010. The BGM device and SoloSTAR pen are likely to enable Sanofi-Aventis to maintain its high reliance on the revenue stream it receives from Lantus sales in the event of generic competition.
Regulatory agencies such as the US FDA and the UK's National Institute for Health and Clinical Excellence (NICE) are becoming increasingly strict in terms of approving medicines. As a result, biomarkers are becoming more important for formulating and performing meaningful clinical tests and proving the cost-effectiveness of medicines, further encouraging alliances between drugmakers and the diagnostic industry.
BMI believes that in addition to drugmakers, insurance companies have recognised the benefits of the targeted prescription methods that arise as a result of personalised medicines. Highlighting this, Medco Health Solutions, the second-largest manager of US drug benefits, is encouraging doctors to use genetic tests in order to determine whether the drugs they are prescribing will work for particular patients.
In February 2010, highlighting the recognition of the benefits of personalised medicine as a way of containing healthcare costs by a national government, it was revealed that a joint public-private partnership in the Netherlands between the Centre for Translational Molecular Medicine (CTMM), BioMedical Materials (BBM) and the Top Institute Pharma (TI Pharma) is to invest EUR28mn (US$38mn) into the research and development (R&D) of personalised medicines.