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Omeros Corporation (OMER) Message Board

  • t_c16@ymail.com t_c16 Nov 20, 2013 8:19 AM Flag

    Pipeline reality check

    Only 11% of drugs in Phase 1 testing get FDA approval. The % of Phase 1 trials that advance to Phase 2 trials 68%, Phase 3 trials 22%, Application 13%, Approval 11%. I am not bearish on the stock, but I was surprised at the failure rate for new drugs, only 1 in 6 drugs from Phase 2 get approved.

    The above data was from a 11/18/13 WSJ article titled "Drug Makers Use Simulations To Devise Better-Designed Trials". A couple of other highlights from article.

    Drug companies hope computer simulators can improve the odds of medications getting a fair trial. Designing clinical tests requires a variety of choices that can affect the outcome, such as the number of people to test, the drug dose to use and the duration of the trial. Simulators help researchers make those decisions by showing them whether a certain set of test parameters will yield a statistically significant result for a given treatment. The researchers can keep tinkering until they design a test that accurately measures the effects of a drug. Then they can run that study in humans.

    The technology is just now coming into use. In June, the U.S. Food and Drug Administration and the European Medicines Agency endorsed the first simulator, from Critical Path Institute, for use in the development of treatments for Alzheimer's disease. Simulators are in development for tuberculosis, Huntington's disease and Parkinson's disease, Dr. Stephenson says.

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