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August 9, 2013
17:48 EDTIMMYImprimis says manufacturing issues to cause delay of clinical trials
In August, Imprimis Pharmaceuticals, was notified by its manufacturing supplier, DPT Laboratories of preliminary stability test results related to clinical materials of active and placebo bulk batches of the companyís Impracor drug to be used in planned Phase 3 clinical trials, which were manufactured at DPTís San Antonio, Texas facility. The preliminary test results revealed an out of specification result for the placebo formulation and a lower than expected specification result for the active formulation. Shortly thereafter, a retest was performed, which confirmed the out of specification results for the placebo batch and revealed continued decreasing stability results related to the active batch. On August 9, the company concluded that due to the decreasing stability results for the active batch, packaging of the materials would be put on hold, as further decrease in stability levels was likely and would result in the material being unusable for the upcoming planned Impracor clinical trials. The company is evaluating its options regarding these manufacturing issues, which include re-manufacturing the clinical materials at DPTís facilities, which would result in a delay of the its planned clinical trials by 1-2 months, or moving the formulation and manufacturing process to another third party vendor, which could cause a delay of up to 6 months. The company is working with its vendors to evaluate further options related to the production of clinical materials for the Phase 3 clinical trials and the continuation of the planned Impracor Phase 3 clinical program.
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