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Success rate of developing new therapies is declining: BIO study

The success rate of bringing new medicines to market in recent years is only about half of what it had been previously, according to a new study conducted by Biotechnology Industry Organization (BIO) and BioMedTracker.

This is despite the fact that biotech drugs are twice as likely to gain US approval compared to traditional chemical drugs.

Reportedly, the study which was conducted from 2004 through 2010 reviewed more than 4,000 drugs from companies large and small and both publicly traded and private.

According to the study biologics had a 15% chance of going from Phase I through to FDA approval, compared to a 7% success rate for traditional small molecule chemical drugs, reuters.com reported.

In the therapeutics sector, the highest overall success rate from Phase 1 through likelihood of approval was infectious diseases, followed by endocrine system drugs at 10.4%, autoimmune diseases at 9.4%, the cancer drug success rate of 4.7%, and the cardiovascular drugs rate at 5.7% bringing up the rear.

Reuters.com has quoted BIO managing director for investor relations John Craighead as saying that clinical trial goals and the approval pathways for infectious diseases and diabetes drugs are clear and very well-established.

"The Phase II results are very predictive of the Phase III outcomes and very predictive of approval. The overall success rate in oncology was the lowest of the therapeutic areas that we looked at," Craighead said.

The largest dropout rate along the clinical pathway came in advancing drugs from mid-stage Phase II studies to late-stage Phase III testing because of the latter stage’s requirement of larger and much more expensive clinical trials, reported the news agency.