Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. and a market leader in pain management, has entered into a licensing agreement with Novartis to obtain the exclusive US marketing rights for the prescription medicine Voltaren gel (diclofenac sodium topical gel) 1 per cent.

Voltaren gel received regulatory approval in October 2007 from the US Food and Drug Administration, becoming the first topical prescription treatment for use in treating pain associated with osteoarthritis and the first new product approved in the US for osteoarthritis since 2001. Voltaren gel has been granted marketing exclusivity in the US as a prescription medicine until at least October 2010.

Voltaren gel provides 1 per cent diclofenac sodium in a topical gel formulation. It is a non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel delivers highly effective pain relief with a favourable safety profile. The amount of diclofenac sodium that is systemically absorbed from Voltaren gel is on average 6 per cent of the systemic exposure from a comparable dose of an oral form of diclofenac sodium.

Under the terms of the five-year agreement with Novartis, Endo will make an upfront cash payment of $85 million. Novartis is also eligible to receive a one-time milestone payment of $25 million if annual sales exceed $300 million. Novartis will receive royalties on the net sales of Voltaren gel in the US and will supply this product to Endo.

Voltaren gel, which is a nonsteroidal anti-inflammatory (NSAID) medication, is indicated for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Osteoarthritis is a chronic, painful condition characterized by the breakdown of cartilage in the joint, often leading to working limitations and reduced overall health.

Clinical trials have demonstrated Voltaren gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body's most commonly affected joints. Voltaren gel delivers effective pain relief with a favourable safety profile as its systemic absorption is on average 6 per cent of the systemic exposure from a comparable dose of an oral form of diclofenac sodium.

"Voltaren gel is an ideal strategic and commercial fit for Endo. It is an approved product that we plan to launch in the US as soon as possible," said Nancy J. Wysenski, chief operating officer of Endo Pharmaceuticals. "We believe it will further enhance our leadership position in pain management by extending our reach into the mild-to-moderate segment of the osteoarthritis pain market while adding growth and diversification to our revenue base. In addition, Voltaren gel will allow us to leverage our established expertise in marketing topical pain therapies. As a result, we expect market availability and momentum behind Voltaren gel to build rapidly and provide broader access to patients in the US suffering from pain associated with osteoarthritis."

Voltaren gel will compete in the emerging topical NSAID market, which is expected to grow given the aging US population. Of the estimated 84 million NSAID and Cox-II prescriptions written annually in the U.S., about 40 per cent are osteoarthritis-related. The dollar value of this market is approximately $3.3 billion, with roughly half of the value coming from NSAIDs and the remainder from Cox-IIs. Endo estimates US peak annual sales for Voltaren gel in treating osteoarthritis pain in the range of $250-300 million.

Endo expects to commercialize Voltaren gel without delay, initially using one of its two specialty sales forces, consisting of 160 representatives, prior to executing a full physician launch in late May with an additional 275 contract sales representatives targeting primary care physicians who prescribe NSAIDs and Cox-IIs.

Approximately 21 million people in the US have osteoarthritis, and the aging population in the US means 72 million more may be at risk for developing the condition by 2030.

Endo Pharmaceuticals Holdings Inc. is a specialty pharmaceutical company with market leadership in pain management. Through its wholly owned Endo Pharmaceuticals Inc. subsidiary, the company is engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain.