Development phases

The three phases of clinical development

Clinical Phase I involves studies performed on a small group of healthy volunteers. The purpose initially is to study how the new product is metabolized in the human body, and then to determine the dose and dosage interval that will have a positive effect on the disease without causing unwanted side-effects.

Clinical Phase II involves treating a larger group of patients (usually 50-200). The purpose is to demonstrate the drug's efficacy and to confirm its safety. Comparisons are often made with a group receiving inactive placebo treatment.

Clinical Phase III is sometimes referred to as confirmation studies. The main goal is to prove that the promising effects seen in Phase II are also obtained in larger patient groups (usually 100-1,000 people). At Phase III, great importance is also attached to safety issues, documentation and production preparations.

SEK 500 - 700 million for a successful project

The costs involved in the clinical development of a new drug are somewhere in the region of SEK 500-700 million for a successful project. The average development time is six to seven years from the first human trials. This includes the time required for reporting and for the compilation of the documentation necessary to obtain the permission of the authorities to proceed from one phase to the next.

The probability that a project that has reached clinical Phase I will reach the market is on average around 20 per cent. This means that a maximum of one in five projects is successful. For projects that reach Phase II, the probability of success is higher, or around 30 per cent, and rises to around 70 per cent in Phase III.

Clinical Phase I Clinical Phase II Clinical Phase III
1-1.5 years 1.5-2.5 years 2-4 years
SEK 50-75 million SEK 100-200 million SEK 250-500 million

The sale of a product that successfully reaches the market has to cover not only its own development costs, but also the costs involved in projects that are not successful. A pharmaceutical's total development costs can thus be estimated to total SEK five to ten billion.

Pre-clinical development

Pharmaceutical development is a complex and time-consuming process that is generally divided into different phases. The most commonly used terms are Drug Discovery and Drug Development. Active Biotech took a strategic decision in February 2004 to focus operations fully towards Drug Development i.e on projects in clinical or late pre-clinical phase.

The development phase is devoted to work on a chemical struture that has already been identified. Its properties are meticulously studied and all aspects are considered, including manufacturing, side-effect profile and clinical effect, all of which are documented in accordance with the requirements and regulations issued by the authorities.

The development phase can be divided into pre-clinical and clinical phase. The clinical phase starts when the candidate drug first is tested on humans.