Top R&D Drug Failures

July 7, 2011 - PRLog -- The majority of major drug failures are in the field of oncology, because the number of ongoing trials is highest for this indication compared to other diseases. Pharmaceutical companies invest substantial sums of money in drug development, and sponsor companies only start Phase III trials after receiving promising results from preclinical studies and early pivotal studies. In the initial phases, clinical trials explore the safety and efficacy of the drug, investigations which do not necessarily give the same results when tested in a larger population and for longer durations in Phase III. The results of Phase III also depend on the trial design of the study for that phase. For a drug to be successful in the trial, it has to demonstrate its efficacy and safety within the regulatory requirements, in order to achieve approval for marketing.

The areas of oncology and heart failure are more susceptible to drug failures, as the drugs for these indications must possess a life saving capacity. Indications related to the central nervous system, such as Alzheimer’s disease and multiple sclerosis, are also a key area in which major drugs fail. Due to the complexity of such areas, it is very difficult to find a drug which is appropriate for approval.

For the last number of years, pharmaceutical companies have been investing significant amounts in R&D processes, due to the impending patent the patent expiries of their blockbuster drugs and failing trials. During 1996–2009, Roche accounted for the highest R&D expenditure, followed by Pfizer, Novartis, J&J and Sanofi. Roche invested $8.7 billion in R&D during 1996–2009, the highest expenditure of any pharmaceutical company during that period.

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For the last number of years, pharmaceutical companies have been investing a huge amount in R&D processes. Companies are struggling to combat the impending patent expiries of blockbuster drugs, and the expense associated with failed trials. Roche recorded the highest R&D expenditure during 1996–2009, with investment of $8.7 billion, followed by Pfizer, Novartis, J&J and Sanofi.

Leading business intelligence provider, GBI Research, has released its latest research report, ‘Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure’, which provides insight into major drug failures during 2005–2010. The 20 drugs included in the report belong to key pharmaceutical companies, and were undergoing research for a major indication. The report also includes the total investment of top pharmaceutical companies in R&D during 1996–2009 and an assessment of the financial loss faced by the company when a drug fails in late stage development

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