Advantages and Challenges in Drug Re-Profiling

Abstract

EditorialThe drug re-profiling, also coined the term repurposing, repositioning, reusing and rediscovery, is the usage of known drugs for new diseases. The main objective of drug re-profiling is to discover methods for using approved drugs or discarded clinical candidates in the treatment of new diseases. Few examples of repositioned drugs include, Celgene's Thalomid ® , which is repositioned thalidomide, and its derivative Revlimid ® (lenalidomide), are relaunched to the market and signify a combined global revenue stream of more than $2.8 billion for Celgene [1]. Since 2007, 30-40% of drugs or biologics that are introduced to the market in United States were either drugs reprofiled for new indications, reformulations or new amalgamations of existing drugs [2]. Besides this, drug re-profiling has also been performed on a regular basis by some companies such as, Pfizer, Novartis, Eli Lilly, Ore Pharmaceuticals, Biovista, Numedicus, Melior Discovery and SOM Biotech [3].Drug re-profiling has extra advantage over conventional drug development as it reduces the development cost for the drugs, because they have already been gone through toxicity and other tests such as clinical trials. According to a recent report [4] which is based on a survey of 30 pharmaceutical and biotechnology companies, the cost to re-introduce a repurposed drug averages $8.4 million, whereas to relaunch a new formulation of an existing drug in its original indication costs an average $41.3 million. They have higher success rate than the original drugs, because of the availability of comprehensive information on their pharmacology, formulation, potential toxicity, safety and adverse drug reaction issues, thereby waning their attrition rate. Since repurposing is based upon previous research and development efforts, new drug candidate could be set for clinical trials quickly, speeding their review process by the Food and Drug Administration (FDA) and if approved, their incorporation into health care and thus diminishing their entire processing time.In addition, re-profiled drugs can circumvent initial cost and time needed to introduce a drug to the market. As developing a brand-new drug takes massive time, money and effort. Overall, translation of a promising drug candidate into an approved drug often takes more than 15 years. Therefore, it is critical to improve strategies for drug repurposing in order to decrease the time and cost of drugs along with enhancement in their success rates. Furthermore, the rates for repurposed compounds that reach to the market are 25% from Phase II and 65% from Phase III clinical trials, in comparison to new molecular entities are 10% and 50%, respectively.

Neuroinflammation as a Factor of Neurodegenerative Disease: Thalidomide Analogs as Treatments

“…The cost of clinical trials to demonstrate safety and efficacy of an original drug can take up to 15 years and $2.6 billion (DiMasi et al, 2016). In comparison, repurposing an existing drug provides an accelerated route in light of its known clinical safety and pharmacokinetic data – resulting in substantially lower costs [as low as $8.4 million and 3–12 years (Agrawal, 2015; Hernandez et al, 2017)] and a lower rate of attrition. As a pertinent example, thalidomide was successfully repurposed by Celgene for the treatment of a broad number of systemic inflammatory disorders and cancers.…”

Value added medicines: what value repurposed medicines might bring to society?

“…The situation where the new indication involves a different pharmacological target (off-target repositioning) is the only exception where a new use in a similar indication will be covered by the actual definition.’ [ 9 ] Drug re-profiling/ Drug reusing/ Drug rediscovery ‘The usage of known drugs for new diseases. The main objective of drug re-profiling is to discover methods for using approved drugs or discarded clinical candidates in the treatment of new diseases.’ [ 31 ] …”

Body of evidence and approaches applied in the clinical development programme of fixed‐dose combinations in the European Union from 2010 to 2016

“…Bupropion has in this case been re‐profiled as it is most commonly used in the treatment of depression and is therefore classified for the nervous system. Although the landscape for FDCs predominantly (50/72, 69%) consists of improvement within a therapeutic area, the small group (4/72, 6%) of re‐profiling drugs represent an interesting opportunity as the development cost is greatly reduced and the success rate is markedly higher for re‐profiled drugs …”