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 permeation 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.