Dr. Lee S. Simon, Former FDA Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products and Dr. Allan Green, Co-Managing Directors of SDG, LLC, Will Assist in Navigating FDA Approval Process for Impracor Topical NSAID
SOLANA BEACH, Calif., Sept. 10, 2012 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. today announced the appointment of two new members of its Science and Regulatory Advisory Board - Drs. Lee S. Simon and Allan Green, who both have extensive experience in the pharmaceutical industry, particularly with regard to the U.S. Food and Drug Administration's approval process.
Simon and Green will join Dr. Gerald Yakatan on the advisory board, whose first task will be to provide advice and guidance as Imprimis conducts Phase 3 clinical trials of its topical analgesic and anti-inflammatory drug, Impracor. Additionally, the Imprimis Science and Regulatory Advisory Board will work closely with Company management as Imprimis moves forward with the development of its patented Accudel topical drug delivery platform for other drug development products.
"We welcome the arrival of Dr. Lee Simon and Dr. Allan Green to our Science and Regulatory Advisory Board. As members of this important arm of the Company, they will provide invaluable insights and guidance throughout the process of FDA approval, from the design and management of clinical trials to the communication, organization and submission of data. We intend to leave no stone unturned as we navigate the approval process and communicate with our counterparts at the FDA. These two gentlemen, along with Dr. Yakatan, will help us reach our goals of approval of Impracor and as well as future submissions," said Mark L. Baum, CEO of Imprimis Pharmaceuticals.
Simon has served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, and on multiple FDA advisory committees. He has extensive experience in drug development as a senior investigator for celecoxib in the U.S. Simon was a senior consultant to Pharmacia/Searle on COX-2 development and has served on consulting advisory boards for numerous other pharmaceutical companies. Simon is on the editorial boards of multiple journals and has authored more than 110 original publications, reviews and book chapters, and has edited several text books.
Green is a physician, attorney, and research scientist who has significant operating management experience with a number of successful biomedical companies. Dr. Green has provided counsel to companies, hospitals and medical research foundations and has served as a technical consultant to government committees. He has successfully represented many American and non-U.S. clients in their relationships with the FDA and has organized a number of multi-disciplinary conferences on healthcare, pharmaceutical and funding issues. He has held several medical school appointments and currently is Adjunct Professor at Boston College Law School, where he teaches food and drug law.
Both Simon and Green are principals with Cambridge, MA-based SDG, LLC, which provides FDA regulatory expertise, advice on clinical study design and data interpretation and strategic planning for FDA-regulated industry.
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 to launch in September 2012.
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: Mark L. Baum
SOURCE Imprimis Pharmaceuticals, Inc.