SAN DIEGO, July 23, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), which is focused on the commercialization of drug formulations utilizing the FDA 505(b)(2) drug development pathway, today announced that as part of the recently announced Buderer Drug Company Asset Purchase Agreement, Imprimis acquired intellectual property for IPI-120, a novel drug formulation of both tranexamic acid, a synthetic derivative of the amino acid lysine, and an antibiotic. The company's recently-filed patent application combines tranexamic acid with an antibiotic so as to provide the clotting effects along with protection or treatment against infection in a transdermal, local intra-wound application or intra-cavity instillation formulation.
Imprimis believes that IPI-120, a locally-acting drug candidate, can reduce or stop bleeding while at the same time prevent or treat infection. As a wound healing product, IPI-120 could help patients with genetic and acquired bleeding disorders. Lower strength IPI-120 formulations for OTC applications may also be used to stop bleeding and prevent or treat infection in common wounds, cuts and bruises.
Tranexamic acid, which is approved in intravenous and oral dosage forms, is frequently used in surgeries with high risk of blood loss such as cardiac, liver, vascular and large orthopedic procedures. Imprimis believes that IPI-120 may have important application in targeted compromised populations of patients with bleeding disorders, such as hemophilia patients, and may qualify as an orphan drug development candidate.
IPI-120 was created by a pharmacist interested in offering a transdermal wound management product that not only acted as an antibiotic, but that also helped control bleeding. Imprimis believes that IPI-120 has the ability to be a true "next generation" functional antibiotic and wound management product.The US wound care market is expected to reach nearly $21 Billion by 2015, from $16.8 Billion in 2012. 7 million Americans suffer from chronic wounds and the market is expected to grow in part due to the aging U.S. population and ongoing proliferation of diabetes and other chronic illnesses. Imprimis CEO Mark L. Baum said, "We are pleased to have completed our initial feasibility work, including a review of the IP landscape, for this important 'functional antibiotic' drug development opportunity. The culmination of the initial phase of the IPI-120 program was the recent filing of a patent to protect what we believe is a unique opportunity to develop a drug where there is a large unmet need in the marketplace, both for patients who suffer from bleeding and clotting disorders as well as the opportunity to use our core IP to develop formulations for the OTC wound healing and management market." Baum added, "Invented at the Buderer Drug Company, a compounding pharmacy in Ohio, IPI-120 has been used by patients in a real world setting under the supervision of a physician. This unique clinical experience, the resulting patient experience, along with the market potential of IPI-120 gives this formulation a distinct advantage as we consider its commercial pathway." Imprimis Chief Medical Officer Dr. Joachim Schupp explained, "Control of bleeding and infection is an integral part of the wound healing process. The normal blood clotting process depends on the interplay of various proteins in the blood. Bleeding disorders may be caused by reduced levels or absence of blood-clotting proteins, known as clotting factors or coagulation factors. A reduction in those clotting factors is found in genetic disorders, such as hemophilia A (Factor VIII), hemophilia B (Factor IX) and von Willebrand disease (vW Factor). Bleeding disorders can also be acquired such as in end stage liver disease, acute leukemia or Vitamin K deficiency. The transdermal, local intra-wound application or intra-cavity instillation of a novel pharmaceutical composition such as IPI-120 could become a valuable treatment option for conditions with high risk of bleeding and infections with a potential lower risk of systemic side effects." Imprimis VP of Corporate Development Gary Seelhorst commented, "Our analysis of the market denotes that this combination formulation may provide an excellent opportunity to greatly affect the bleeding and clotting disorder market which is expected to grow from $8.5 Billion in 2011 to $11.4 Billion in 2016 as well as the much larger over-the-counter (OTC) wound care market. Further, the applications in emergency medicine could be profound because transexamic acid is already being used in that capacity. Our proposed formulation in combination with an antibiotic could offer ease-of-use benefits as well." Mark L. Baum, CEO of Imprimis concluded, "The addition of IPI-120 to Imprimis's growing 505(b)(2) pipeline is a further step to broaden our ability to develop proprietary drug formulations with a real world clinical experience, from strong relationships we are forging with pharmacist and physician drug developers across the United States." About Imprimis Pharmaceuticals, Inc. Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY) is a specialty pharmaceutical company focused on the commercial development of drug formulations utilizing the FDA 505(b)(2)drug development pathway. Through its exclusive strategic relationship with the largest compounding pharmacy organization in North America as well as through a growing network of commercial development relationships with pharmacists and physicians across the United States, Imprimis expects to use proprietary drug delivery technologies, proven drug formulations and proprietary market data to identify and pursue pharmaceutical development opportunities where there is a significant unmet medical need. Imprimis' most near term drug candidate, Impracor, is a Phase III product candidate that utilizes its patented Accudel topical cream 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. For more information, visit http://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 Imprimis' 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 obtain intellectual property protection for its assets, including newly acquired intellectual property, the success of additional research and development activities related to potential product candidates, its ability to raise additional funding, its 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, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. 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. Contact: Josh BergImprimis Pharmaceuticals, Inc.(858) 704-4041 SOURCE Imprimis Pharmaceuticals, Inc.
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