Diclofenac is a leading non steroidal anti-inflammatory drug (NSAID) widely used for sprains and strains. Voltaren, which is manufactured by Novartis is the market leader and is sold for both oral and topical applications. Voltaren generated sales of approximately US$800 million in 2011.
Phosphagenics’ TPM™ pharmaceutical delivery technology can be used as a targeted, localised delivery system, to increase the delivery of actives such as diclofenac to targeted areas, while minimising exposure to the rest of the body.
A Phase IB human study was completed in 2009 and demonstrated that Phosphagenics’ TPM/diclofenac formulation results in more effective permeatiation of diclofenac into the skin than the currently available Voltaren® gel. The study showed that dermal absorption of diclofenac was increased compared with Voltaren® gel, while maintaining similar levels of systemic exposure.
In November 2011, Phosphagenics announced an agreement with Themis Medicare Pvt Ltd of India to manufacture and sell a diclofenac gel incorporating Phosphagenics’ TPM® delivery technology. The agreement provides Themis with exclusivity within the Indian market. Phosphagenics also receives a royalty on sales of the product and will supply the TPM® raw material.
In March 2012, Phosphagenics completed a Material Transfer Agreement (MTA) with Nippon Zoki of Japan. This agreement enables Nippon Zoki to test and assess Phosphagenics’ patented TPM/diclofenac topical non-steroidal formulation for its suitability as a prescription item in the USA and Japanese markets.