Imprimis Pharmaceuticals Concludes Type C Meeting at the FDA
Published: Apr 18, 2013
SOLANA BEACH, Calif., April 18, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY) today announced that on April 15th, 2013, the Company attended its Type C meeting with the U.S. Food and Drug Administration (FDA) which included the review of the development plan for its lead Phase III drug candidate, Impracor, a topical cream Non-Steroidal Anti-Inflammatory Drug (NSAID) based on the combination of Imprimis' patented Accudel technology and 10% of the active pharmaceutical ingredient ketoprofen.
"The Type C meeting with the FDA allowed us to review our drug development program before we begin enrolling our Phase III clinical trial," said Dr. Joachim Schupp, Imprimis Chief Medical Officer.
Mark L. Baum, Imprimis Pharmaceuticals CEO stated, "We truly appreciate the FDA granting the meeting and for assisting us in better understanding the regulatory pathway as we move forward with our Impracor Phase III clinical trial. We are very grateful to our regulatory advisers, Drs. Lee Simon and Allan Green, of SDG, LLC, and Dr. Nathaniel Katz of Analgesic Solutions for participating in the meeting."
About Imprimis Pharmaceuticals, Inc. Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY) is a specialty pharmaceutical Company focused on the commercial development of compounded drug formulations. Through our exclusive strategic relationship with Professional Compounding Centers of America (PCCA), the largest compounding pharmacy organization in North America, Imprimis expects to use its proprietary Accudel drug delivery technologies, as well as proprietary formulations for new indications, and market data, to identify 505(b)(2) pharmaceutical development opportunities where there is a significant unmet medical need. In addition, Imprimis is internally developing a non-invasive, topically delivered Phase III product candidate called Impracor. Impracor utilizes the Accudel topical formulation to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), through the skin directly into the underlying tissues where the drug exerts its localized anti-inflammatory and analgesic effects. Imprimis intends to expand the Accudel brand beyond topical drug delivery in order to create a family of drug delivery platforms that will enable targeted site-specific drug delivery and treatment.
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.
Contact: Josh Berg
Imprimis Pharmaceuticals, Inc.
SOURCE Imprimis Pharmaceuticals, Inc.