AlphaRx Inc. and Proprius Pharmaceuticals, Inc. have entered into a license agreement giving Proprius exclusive global rights (with the exception of Asia and Mexico) to AlphaRx's topical NSAID, Indaflex 2.5% Indomethacin Cream. Indaflex, which makes use of AlphaRx's proprietary formulation technology to deliver indomethacin through the skin and directly to the soft tissue surrounding the joint, is currently in Phase II clinical development in Canada for the treatment of osteoarthritis.
In addition to Indaflex, the agreement gives Proprius rights to successor products and to all other topical NSAID products developed by AlphaRx.
Under the terms of the agreement, AlphaRx will receive an up-front payment of $1 million and will be eligible to receive additional milestone payments of up to $116 million for the successful development and commercialization of Indaflex, as well as double-digit royalties on worldwide sales. In addition, Proprius will assume the clinical development costs going forward.
"Given the adverse event profiles of oral NSAIDs and COX-2 inhibitors, and the withdrawals of rofecoxib and valdecoxib from the market, we believe Indaflex has the potential to fill a significant unmet clinical need," said Michael J. Walsh, President and CEO of Proprius. "With the right formulation, a topical NSAID offers the potential of matching or surpassing the efficacy of oral treatments while avoiding the side effects associated with circulating levels of these drugs. The preclinical and early clinical data with Indaflex are quite encouraging, and we believe Indaflex could be a market leader in this important area," he added.
Dr. Lee Simon, a Rheumatologist and former Director of the FDA's Anti-Inflammatory, Analgesic and Ophthalmic Drug Products Division and a clinical and regulatory consultant to AlphaRx said, "Indomethacin is considered one of the most potent NSAIDs available, and Indaflex was shown to be superior to both oral indomethacin and rofecoxib in a non-clinical study. In addition, Phase I data show negligible concentrations of circulating indomethacin in human volunteers once topically applied, suggesting a very low probability of systemic adverse events, such as gastrointestinal or cardiovascular safety concerns."
"We believe Proprius is an ideal partner to maximize the potential of our topical NSAID drugs," Michael Lee, CEO of AlphaRx said adding, "The Proprius management team has a proven track record of successful development and commercialization of pharmaceutical products, and has previously been instrumental in raising hundreds of millions of dollars in private and public capital. We are confident Indaflex will be a major focus of the company and that they are committed to moving it forward aggressively."