SAN DIEGO, Aug. 12, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), which is focused on the commercialization of drug formulations utilizing the FDA 505(b)(2) drug development pathway, today announced that last week it was notified by its contract manufacturing supplier, DPT Laboratories, Ltd. ("DPT"), that its recently produced placebo formulation batch failed, and its active batch showed a lower than expected specification result. As a result, Imprimis announced that there would likely be a delay in the initiation of its Impracor Phase III topical NSAID program. Imprimis is awaiting the receipt of the full CMC report to evaluate its options regarding these manufacturing issues.
Imprimis CEO Mark L. Baum, stated, "Our company is committed to transparency, excellent stewardship of corporate resources and, in every case, responsibility. For this reason, upon confirmation of these manufacturing issues with our clinical trial material, we notified our shareholders and the market."
Baum continued, "Prior to the recent production at DPT, Imprimis contracted with a seasoned CMC expert to review our manufacturing protocols in connection with the production of our clinical trial materials. Additionally, both our CMC expert and our Chief Medical Officer were present at DPT during the production of both the active and placebo batches. Nevertheless, DPT notified Imprimis that preliminary test results were not within specifications for the placebo formulation and that there was a lower than expected specification result for the active formulation. While DPT has successfully produced two batches of our active material in the past, they have recently experienced challenges with our protocols. I have requested a comprehensive report on the recent production activities at DPT in order to help guide future manufacturing activities for the Impracor program."
Baum concluded, "We value providing transparency to our shareholders. We expect to thoroughly investigate the matter, assess our options, preserve our portfolio of assets, and ultimately provide guidance on our clinical trial activities as soon as we practicably can. We are committed to these goals."
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