Noven Pharmaceuticals, Inc. and Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. announced that they have signed an agreement under which Noven will license the US and Canadian rights to its developmental transdermal fentanyl patch to Endo. The agreement also establishes an ongoing collaboration between the two companies for the development of additional prescription transdermal products.

Noven's fentanyl patch is a transdermal delivery system for the management of chronic pain. It is intended to be the generic equivalent of Johnson & Johnson's Duragesic (fentanyl transdermal system), which had US sales of approximately $1.3 billion in 2003. An Abbreviated New Drug Application for Noven's patch is pending at the US Food & Drug Administration.

"With market leadership in pain management and outstanding generic drug distribution capabilities, Endo is an ideal commercialization partner for our fentanyl patch," said Robert Strauss, Noven's CEO and chairman.

"With our proven success within selective generic markets, including pain management, we see this agreement with Noven to market a generic fentanyl patch as a natural fit, and we also look forward to benefiting from their considerable expertise in patch technology to potentially develop and commercialize innovative branded transdermal products as well," said Carol Ammon, Endo's chairman and CEO.

Noven received $8.0 million from Endo upon signing the agreement. Upon Endo's first commercial sale of the fentanyl patch, Noven is entitled to receive an additional payment ranging from $5.0 million to $10.0 million, depending on the timing of launch and the number of generic competitors on the market. Noven will manufacture and supply the product at its cost, and the two companies will share profits on undisclosed terms.

Based on the current patent and exclusivity status of Duragesic, the companies believe that the generic fentanyl patch could be launched in January 2005, assuming FDA approval is received by that time. Noven has retained all rights to the fentanyl patch outside of the U.S. and Canada, and is exploring strategies to commercialize the product in other territories.

In addition to the fentanyl license, Noven and Endo have established a collaboration to identify and develop additional new transdermal therapies. As part of this effort, Noven will undertake feasibility studies to determine whether certain compounds identified by the parties can be delivered through Noven's transdermal patch technology. Endo is expected to fund and manage clinical development of those compounds proceeding into clinical trials.

"Endo shares our commitment to developing a range of innovative prescription transdermal products," said Strauss. "We hope to build a successful and productive collaboration that extends beyond generic fentanyl and ultimately expands the universe of proprietary transdermal therapies."