Imprimis Pharmaceuticals Signs Agreement With DPT Labs For Clinical Supplies In Advance Of Planned Phase 3 Studies For Its Ketoprofen-Based Topical Anti-Inflammatory Drug
SOLANA BEACH, Calif., Aug. 20, 2012 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (OTC Markets Group: IMMY), a specialty pharmaceutical company developing non-invasive, topically delivered products, announced that it has signed an agreement with DPT Labs (www.dptlabs.com) 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."
About Imprimis Pharmaceuticals, Inc.
Imprimis Pharmaceuticals is a specialty pharmaceutical company developing non-invasive, topically delivered products. Our innovative patented Accudel cream formulation technology is designed to enable highly targeted site specific treatment. Impracor, our lead pain product candidate, utilizes the Accudel platform technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where the drug exerts its localized anti-inflammatory and analgesic effects. We intend to leverage the Accudel platform technology to expand and create a portfolio of topical products for a variety of indications. The Imprimis Pharmaceuticals, Inc. website is currently under construction and is expected launch in August of 2012.
About DPT Labs
DPT is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile pharmaceutical development and manufacturing needs through innovation, technology and service. Specializing in semi-solid and liquid dosage forms, DPT has a reputation for quality, unmatched technical expertise, extensive manufacturing capabilities and an exemplary regulatory compliance record. With five cGMP facilities in San Antonio, Texas, and Lakewood, New Jersey, DPT offers full-service outsourcing solutions including pharmaceutical development, site transfers, state-of-the-art pharmaceutical manufacturing, packaging and distribution services.
For More Information
Contact: Mark L. Baum
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products and to enter into strategic alliances and transactions, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Imprimis Pharmaceuticals, Inc.