Drug Discovery Process

SWITCH BIOTECH takes a unique approach to the rapid identification and development of compounds and to risk management of the drug development process. SWITCH projects are usually based on new biological principles together with existing compounds for which second medical use patents can by filed for dermatological applications.

A growing in-house database catalogs and tracks more than 370,000 relevant substances under development and drugs on the market. SWITCH monitors and evaluates these substances for potential re-profiling candidates and to provide competitive intelligence. To make practical use of this large volume of data, SWITCH employs proprietary data mining technology to match biological and compound data in order to select potential drug candidates. SWITCH has established and validated various cell culture and animal models that allow researchers to predict clinical efficacy. SWITCH BIOTECH′s re-profiling approach requires only 6-12 months from target identification to the start of preclinical development, a fraction of the time that is usually necessary for drug discovery.

During the drug development process, SWITCH reformulates these drugs to a topical application, verifies local tolerance, allergic potential, skin penetration, photo-stability and photo-toxicity, and then rapidly checks their relevance in one or more clinical trials. After a successful validation, a program to identify novel compounds with a composition-matter claim is launched. In the short term, this will be achieved in collaboration with companies that have capacities in medicinal chemistry. In the mid-term, SWITCH plans to build capacities for the independent optimization of chemical leads.

The drug re-profiling approach has been used successfully by other companies, but only opportunistically and frequently with drugs already available within the company. SWITCH BIOTECH is the only dermatology company to have established a development strategy based on systematic drug re-profiling.  Re-profiling has also lead to other non-dermatologic therapeutic areas which the company is currently investigating.

The Value of Drug Re-profiling is Three-fold

SWITCH can obtain a clinical proof of concept for the novel biological principle within a short period of time and with limited expense.

The re-profiled drugs that were used for this validation can be commercialized to mid-size pharma companies that are looking for clinically validated drugs.

Once a new biological principle is validated in clinical trials with a re-profiled drug, SWITCH is then well-positioned to develop novel compounds based on this newly validated principle which will yield second generation drugs that are optimized and have a composition matter claim patent. Through this strategy, SWITCH greatly reduces many of the risks associated with drug development.

The Value of Re-profiling for Dermatology

The dermatology market is particularly amenable to a re-profiling strategy because of the built-in intellectual property protections that are created by the use of topical formulations. Through SWITCH BIOTECH′s re-profiling strategy, all re-profiling candidates are checked for the possibility of filing second medical use patents. In most therapeutic areas, second medical use patents can be circumvented by off-label use of generic compounds, because most compounds are approved for systemic administration (i.e. few physicians will prescribe a more expensive branded product for a condition when an equivalent generic version exists, even if the generic equivalent is not officially indicated for this condition). However, if SWITCH BIOTECH′s re-formulation of a systemic compound results in a new topical formulation, the IP position of the product is much stronger, and off-label use is prevented: SWITCH BIOTECH and its partners will be the only companies marketing the topical formulation.