NEW YORK--(BUSINESS WIRE)--Alliqua, Inc. (OTCBB: ALQA) (FWB: HL1) (“Alliqua”), an advanced biomedical products company focused on the development and manufacturing of proprietary drug delivery and liver health technologies, announced today the successful completion of its initial in vitro permeation study for its transdermal pain patch project. These results represent an important milestone in the development of a transdermal pain patch. Alliqua previously announced the successful completion of its dissolution study.
In the comparative in vitro permeation study, the Alliqua patch demonstrated mean cumulative drug permeation that was competitive with the market leading product for the treatment of pain associated with post-herpetic neuralgia (‘PHN”) or shingles, a rising medical problem in the United States and around the world as countries continue to struggle with increasingly elderly populations. In the in vitro permeation study, multiple formulations were evaluated, with some achieving mean cumulative drug permeation amounts much higher than the market leading product, indicating the potential for an improvement over the existing product. Alliqua believes that the results provide it with options to pursue a 505(b)(2) type of a New Drug Application (NDA), along with a generic route for an Abbreviated New Drug Application (ANDA). Based on the positive results, Alliqua will proceed to the next stage of its developmental program.
Management estimates that global value of the PHN pain patch market today is approximately US$ 1.4 billion.
"The continued success of our developmental efforts further validates our delivery platform and our belief in the ultimate success in our specialized transdermal pain patch," said Richard Rosenblum, President and Director of Alliqua. “Utilizing our proprietary hydrogel technology and our existing facilities, we believe Alliqua can become a high quality, low cost producer of this next generation transdermal pain patch, with the possibility for significant market share.”
Alliqua also intends to continue pursuing a generic version of an existing pain management patch for the treatment of PHN.
Management estimates that the total U.S. market for pain management pharmaceuticals, exclusive of over-the-counter (OTC) products, totaled in excess of $20 billion in 2009, with the market for existing prescription pain patches in excess of $1 billion in the U.S. alone. According to the Centers for Disease Control, approximately 1 million cases of shingles occur in the United States annually, and approximately 20% of shingles cases result in PHN. Alliqua's patch technology enables the delivery of drugs and active ingredients directly through the stratum corneum, avoiding 'first pass' of the digestive system and the liver.
About Alliqua Inc.
Alliqua, Inc. (OTCBB: ALQA) (“Alliqua”), is an advanced biomedical products company focused on the development and manufacturing of proprietary technologies in the fields of drug delivery, advanced wound care and liver health preservation. Through its wholly-owned subsidiary, Alliqua BioMedical, Inc., Alliqua intends to develop active ingredient and transdermal drug delivery products, primarily utilizing the proprietary hydrogel technology platform of AquaMed Technologies, Inc. (“AquaMed”), Alliqua’s subsidiary.
AquaMed manufactures custom hydrogels used for transdermal drug delivery, wound care, medical diagnostics, and cosmetics. These products use proprietary manufacturing technologies which enable AquaMed to produce what is known in the healthcare industry as high water content, electron beam cross-linked aqueous polymer sheet hydrogels. AquaMed believes that it is one of two manufacturers in the world for these gels. Alliqua’s third subsidiary, HepaLife Biosystems, Inc., focuses on the development of a cell-based bioartificial liver system, known as HepaMate™.
Any statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.
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