Following up my previous piece on drug repositioning by Orexigen with its diet pill, Contrave, I spoke with Dr. Aris Persidis, President and co-founder of Biovista- a leading company in the drug repositioning business. Drug repositioning is the discovery and development of novel indications for approved drugs.
As Dr. Persidis told me in a phone interview, while studying drug treatment adverse effects (AEs), he and brother Andreas realized AEs themselves- as a result of a drug’s mechanism of action- represented therapeutic opportunities for that drug. Seeing a need in the pharmaceutical industry for such discovery services they launched Biovista together in 1996.
Biovista’s major technology is called Clinical Outcome Search Space (COSS). This technology is based on a computational approach to analyzing the mechanism of action (MOA) of all approved drugs of known diseases and adverse events. Based on this MOA approach, the technology is being applied both as a tool to predict adverse effects and discovery tool to find novel indications.
According to Dr. Persidis, of approved drugs, there are 23,000 indications and 29,000 possible clinical outcomes, creating significant opportunities for product development. While most drugs are developed for a single or multiple closely related indications, development for truly novel indications have usually been serendipitous- there has previously been little systematic effort to make these discoveries.
In Dr. Persidis’ view, this leaves many drug pipelines at risk of encroachment by competitor companies. Even while a drug is under patent protection, competitors who develop novel uses for that drug may file a patent on the specific use, leading to a lost opportunity for the innovator company. Dr. Persidis suggests Biovista’s technology can immunize their partner’s pipelines by identifying alternative uses before their competitors.
As a show of strength, Biovista signed a partnership deal with Pfizer on November 9 to identify three novel indications for a number of Pfizer drug candidates, for an undisclosed upfront fee and success based milestone payments. Dr. Persidis indicated that his company is on course to sign another such deal in 2011. Big Pharmas, he says, are now becoming increasingly interested in drug repositioning, with many forming dedicated units for that purpose.
Biovista’s AE prediction is another interesting facet of its technology. Through a licensing deal with the FDA, the company is working to predict patient adverse event to help guide healthcare providers. The collaboration is also being used to assist patient population selection with appropriate inclusion/exclusion criteria in clinical trials, based once again on mechanistic based AE prediction. According to Dr. Persidis, Biovista provides the analysis while the FDA works with the sponsor companies and ultimately makes the decisions.
Biovista is also developing its own pipeline of compounds through drug repositioning. While the company has not calculated the possible savings from developing repositioned drugs compared to novel entities, Dr. Persidis says they are able go from identifying a clinical need to pre-clinical development in a matter of weeks. On top of that, only two compounds need to be identified by the COSS system for actual laboratory testing, with 70% successfully achieving successful pre-clinical results. This compares well with the 3-5 years timeline for a typical discovery program.
The company now has candidates in Multiple Sclerosis, Epilepsy, among others. Dr. Persidis remarked that they intend to develop their compounds through proof of concept before contemplating licensing or partnership deals.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.