The recently passed Drug Quality and Security Act allows large drug-compounding facilities, which mix ingredients to make a custom blend of medicine, to register as "outsourcing facilities." Imprimis continues to track recent guidance from the FDA on the newly passed law and expects to participate in the discussion related to final rules for the implementation of the law and hopes to eventually establish and voluntarily register its outsourcing facilities and be subject to these requirements and regular FDA inspection.
"We believe that bipartisan passage of this law sends a clear signal that our leaders in Washington recognize the broad benefits of compounding pharmacies and the important role they play in the evolving healthcare delivery landscape and we applaud their creation of a regulatory framework to oversee the compounding industry, which we believe is favorable to our business strategy," said Mark L. Baum, Chief Executive Officer of Imprimis.
"Establishing centers of pharmacy excellence that use the highest standards to make and then efficiently distribute our growing portfolio of proprietary compounded drug formulations will advance Imprimis' business strategy of taking small ideas from the clinical interaction between pharmacists, physicians and their patients and turning them into big ideas for physicians across America to prescribe as a compounded drug for their patients. We believe that this idea in practice will reduce healthcare costs and provide Americans access to previously unavailable medicines and that our unique business of repurposing the more than 7,500 FDA-approved generic drugs for new uses will help us transform and advance personalized medicine while delivering near-term and affordable medical solutions."
Working alongside leading physicians and pharmacists, Imprimis owns intellectual property for proprietary pharmaceutical formulations and plans to begin commercialization activities in 2014, while continuing to advance the expansion of its asset-base of proprietary compounded drug and drug delivery vehicle formulations.
ABOUT IMPRIMIS PHARMACEUTICALS
San Diego-based Imprimis Pharmaceuticals, Inc. (Nasdaq: IMMY) is a pharmaceutical company focused on the commercial development of novel drug formulations and drug delivery technologies. Imprimis believes that patients deserve personalized medicines that are made under best-practice quality standards and are available at affordable prices. Through a growing network of healthcare professionals, Imprimis strives to harness the clinical interaction between a doctor and a patient in order to discover new uses for already FDA-approved drugs. For more information, please visit www.imprimispharma.com
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 expectations and are subject to risks and uncertainties which may cause 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 Imprimis' ability to acquire, develop, commercialize and market new formulations and technologies, establish and voluntarily register its outsourcing facilities, enter into strategic alliances and transactions, including arrangements with pharmacies, physicians and healthcare organizations, commercialize its formulations and technologies, obtain intellectual property protection for its assets, accurately estimate its expenses and cash burn, and raise additional funds, as well as the success of additional research and development activities related to its formulations and technologies, the projected size of the potential market for its technologies and formulations, unexpected new data, safety and technical issues, regulatory and market developments impacting compounding pharmacies, outsourcing facilities, and the pharmaceutical industry, competition and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. 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.