A number of studies have shown that in the last 10 to 15 years, while R&D spending has steadily increased, the number of drugs actually making it to the market has not. At best, a molecule has only a one in 5,000 chance of approval, with just three out of 10 drugs that actually reach the market providing a return on the R&D investment. Of those drugs or biologics that made it to the market, 30-40% that were approved or launched for the first time were repositioned drugs.
Some of the key benefits of drug repositioning include reduced time, cost, and risk as well as providing the means for safer and more effective drugs to be made available to patients. Below are 4 key benefits in more depth. Please feel free to comment below if you have any to add.
1. Safety first: Existing drugs that are approved or have been shown to be safe in late-stage trials, can use their reduced development risk for potentially new indications. Since safety accounts for approximately 30% of drug failures in clinical trials, this is a key advantage that repositioned drugs can harness to great effect.
2. Saving time: Because repositioned drugs can rely on existing data, including efficacy and toxicity studies, the process is usually speedier than de novo development. Developing an NCE (new chemical entity) can take 10 to 17 years, depending on indication. For a drug repositioning company, the development process from compound identification to launch can be around 3 to 12 years. What's more, development of a single compound to enter clinical trials will cost around $10 to $20 million. The cost of identifying a repositioning candidate that already has phase 1 data varies but could be as low as $2 to $3 million.
3. Saving money: Along with saving time, saving money is also a key benefit. With a single compound to enter clinical trials costing around $10 to $20 million, the cost of identifying a repositioning candidate that already has phase 1 data could be as low as $2 to $3 million.
4. Potential for out-licensing: Pharmaceutical companies are said to be exploring new models to out-license some of their clinical drug candidates that may have been shelved, even though they have met their end points and have proven themselves to be safe. If such drugs were to be repositioned, then the pharmaceutical company increases the attraction these drugs have, and gives itself more options to find interested buyers.
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