Historically the pharmaceutical market has functioned on the basis of ‘blanket bombing’ everyone with drugs that only work for a few.  The completion of the ‘genome project’ a few years ago has opened up a wide range of new therapeutic applications in healthcare. The use of an individual’s DNA to help design new drugs, regenerate organs or to personalise medical treatment enables an individual to benefit from treatment pathways that are specific to he individual. The elimination of this ‘One Size Fits All’ philosophy from medical care is exemplified by the drug Herceptin® which is highly effective in 24% of women with primary breast cancer. The 76% of women whom the drug is ineffective know in advance that alternative treatments are better for them; Physicians know which effective therapy to best invest their time and budget.

Designer drugs and organ regeneration remain several years from joining mainstream applications. However, the ability to personalise treatment regimes is rapidly becoming available as new biomarkers relating to existing drugs are identified.

Pharmacogeneti cs involves the use of an individual’s DNA to identify their likely response to a specific course of medication. It enables a physician to personalise treatment by reducing the risk of adverse reactions to particular drugs.  Insight to this risk allows an individual to avoid adverse reactions and debilitating side-effects to optimise the performance of the treatment and ensure the right product is selected at the right dose from the outset.

Market

Pharmacogenetics helps identify the association between an individuals’ genetic profile and their likely response to a specific drug or treatment. This is important because adverse reactions costs the NHS £466million annually and accounts for 1 in 16 hospital beds in UK. In the USA unintentional drug overdoses in the United States nearly doubled from 1999 to 2004, and are now the second-leading cause of accidental death, behind automobile crashes.

The USA represents 60% of the world diagnostic market, Japan 16% and UK only 4%. We are therefore using the UK as a test-bed for developing the product and generating supporting data for international sales in the larger markets.

The National Institute for Health & Clinical Excellence (NICE) is amidst a review of NHS guidelines for smoking cessation and has requested data from us to demonstrate the clinical utility of our lead product.

The international trend is for increased tobacco control legislation. Several European countries already have restrictions in place. Litigation in the USA has established many precedents for assigning liability. The quantity of published research that shows smoking as an underlying causal factor behind a broad range of diseases is incontrovertible and as a result preventative measures are now being taken by both public and private stakeholders. This is creating a sympathetic environment and a demand for our lead product.