Imprimis Pharmaceuticals, Inc. has announced that it has signed an agreement with DPT Labs to commence work on supplying Imprimis with quantities of its active topical anti-inflammatory drug, Impracor, for currently planned Phase 3 clinical trials.
Impracor is the first drug to be developed using Imprimis's patented Accudel™ topical delivery technology.
Imprimis Pharmaceuticals, Inc. CEO Mark L. Baum stated, "Imprimis is pleased to have entered into an agreement for manufacturing our active Impracor clinical supplies from DPT Labs, a worldwide leader in the contract formulation and production of semi-solid pharmaceutical products. This agreement was made in advance of planned Phase 3 clinical studies Imprimis intends to commence in the coming months.
Chief Medical Officer Dr. Joachim P.H. Schupp, added, "In addition to the production of Impracor, DPT Labs will also commence work on the formulation analysis and validation of the various quality assurance processes and procedures required for manufacturing Impracor as well as long-term stability testing. DPT has been diligent in dealing with the technical and physicochemical property requirements of Impracor as well as the placebo material required for our studies."
"We are delighted to be chosen by Imprimis and we look forward to leveraging our expertise in semi-solids and liquids to support further execution of clinical development and manufacturing strategies for Impracor," stated Paul Josephs, DPT Senior Vice President Sales, Marketing & Corporate Development.
Baum concluded, "We are very confident that choosing DPT Labs will provide Imprimis with the best semi-solid production capabilities in the United States and the flexibility of scale to manufacture Impracor. The DPT agreement means that Imprimis is one step closer to our goal to get Impracor approved for sale and into the hands of patients who are suffering from musculoskeletal pain and inflammatory conditions."