Alliqua completes transdermal pain patch initial in vitro study for treatment of PHN

Mar 8 2011

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.