DrugPatentWatch recently published a copy of a paper originally published in the Journal of Applied Pharmaceutical Science.
In the paper, authors Emanuel Almeida Moreira de Oliveira and Karen Luise Lang explore the potential of a technique called drug repositioning, or DR, in lowering the high research and development costs associated with the formulation of new pharmaceutical products.
The Problem with Production
The study found that developing a drug from scratch cost an average of $1.4 billion over the course of one to nearly two decades.
Rapid advances in a number of medical fields in the 20th and early 21st century provided a huge boost to the number of FDA-approved drugs that were hitting the markets. In recent years, however, as the returns on these technological advances continue to diminish, the number of new drugs entering the market has dropped considerably – dropping some 50% every nine years.
It seems that for many drug manufacturers, the risk of investment in a new drug is simply too great for too little a reward. There is no guarantee a drug will make it to market at any point until it gains final approval, after repeatedly proving its safety and efficacy. Most drugs fail to leave phase 2 testing, in which the effect of the drug in humans is first evaluated.
Even established biotechnology companies with long histories of developing new products are seeing their number of annual drug approvals drop.
As a response to this, many are advocating the development of new strategies to combat the rising costs of drug development.
The Advantages of Drug Repositioning
One of the more promising strategies is so-called “drug repositioning.” A clear and concise definition of the term has yet to be agreed upon, but generally it refers to the study and, if possible, re-purposing of already existing drugs to treat conditions other than what they were originally designed for.
That can mean a number of things, from treating new conditions with old medications, to the creation of revised “reformulated” drugs that may have been previously abandoned.
The thinking behind drug repositioning has existed for some time, even though the name for the process itself is relatively new. In the 1990s the infamous drug thalidomide, whose use caused numerous birth defects in the 1960s, was repositioned to provide effective treatment to a grave condition associated with leprosy.
Drug repositioning techniques can lead to greatly decreased research and development times for pharmaceutical companies. Drugs being repositioned do not have to undergo the many months of toxicology and health screenings that new formulas must undergo, since that data already exists from earlier clinical study. The 10 to 17 year R&D period associated with the creation of a new drug drops to 3 to 12 years when a drug has instead been repositioned.
Challenges to Come
Drug repositioning is not, however, some solve-all for the numerous challenges posed to drug manufacturers.
There are occasionally difficulties associated with adjusting dosages for repositioned drugs while remaining within limits safe for human use. This cuts into the advantage afforded by the otherwise minimized amount of time spent in formulation.
In the United States especially, drug repositioning will come into conflict with certain regulatory or intellectual property statutes. The potential for a drug repositioning candidate is highly dependent on the sometimes complex legal situation of the existing drug.
More is Yet to Come
Although the ideas behind DR have been a normal part of medical discourse for several decades now, newfound emphasis on the importance of the technique or those like it may lead to a surge in repositioned drugs.
Additional legal considerations to ease some of the intellectual property concerns with drug repositioning would doubtlessly remove confusion from the situation, though that seems unlikely for now.
Those interested in reading the original publication from the Journal of Applied Pharmaceutical Science in full can do so here.
