Upon disclosing the completion of one licensing deal for a migraine drug, Endo Pharmaceuticals Inc. said it has entered another - the second, an agreement for development and marketing rights to a breakthrough cancer pain product.

The first deal, worth up to $400 million to London-based Vernalis plc, revolves around the approved migraine therapy Frova. That agreement was announced in July, and Endo will begin marketing the product now in North America. The drug was launched in the U.S. in June 2002 and had net sales of $37.5 million in 2003.

The second deal, disclosed last week, is for Chadds Ford, Pa.-based Endo to gain exclusive rights to develop and market a product by the Swedish company Orexo AB, called Rapinyl, a sublingual mucoadhesive fentanyl product designed to treat breakthrough cancer pain.

"We're very excited to add these two products to our portfolio," said Bill Newbould, vice president of corporate communications at Endo. "Our vision is to be the premiere specialty pharmaceutical company anchored in pain management, but with a focus in complementary therapeutic areas. I think both of these products are clearly in line with that strategy."

As part of the most recent agreement, Endo will make an up-front license fee payment of $10 million to Uppsala-based Orexo, which also could receive up to $22.1 million in license fees and developmental and regulatory milestone payments. In addition, privately held Orexo is entitled to double-digit royalties and milestone payments if certain sales thresholds are achieved.

Endo plans to conduct a confirmatory Phase II trial of Rapinyl later this year, and to move the product into a Phase III trial in 2005. If all goes as planned, the company could file a new drug application in late 2006 or early 2007. Newbould could not discuss the market potential for Rapinyl, but he compared the product to Cephalon Inc.'s Actiq, which grew 77 percent in 2003. Cephalon estimates U.S. revenues of Actiq to be between $325 million and $375 million this year.

"By the time [Rapinyl] gets to market later on this decade, we anticipate the market will grow at an 8 percent annual growth rate," Newbould told BioWorld International.

Rapinyl, which is based on Orexo's technology for sublingual administration, is believed to include a fast onset of action and added convenience, which should improve patient compliance, Newbould said.

"It's dissolved and absorbed in 30 seconds vs. about 10 to 15 minutes with Actiq," he said.

Actiq (oral transmucosal fentanyl citrate) is indicated for breakthrough cancer pain, but through its recent acquisition of CIMA Labs Inc., West Chester, Pa.-based Cephalon gained another product for the indication, OraVescent Fentanyl. That product moved into a Phase III trial earlier this year.

Breakthrough cancer pain goes beyond the moderate to severe pain felt by cancer patients.

"The pain will spike from time to time so the medication they're on may not address [that]," Newbould said. "They would use a product like Rapinyl for what's called breakthrough pain."

Endo is the maker of the pain drug Percocet, which has been on the market since 1976 and became genericized in October. The company's best-selling product, Lidoderm, is a topical patch indicated for management of pain for post-herpetic neuralgia. Endo estimates net sales of the product will be about $300 million for 2004.

Two more of Endo's products are headed toward the market. Through the licensing agreement with Vernalis that closed this week, the company gained a migraine product with the already approved Frova. And in May, it received FDA approval for DepoDur, which will be launched by the end of this year for post-operative pain relief.

The company expects to have 70 sales representatives to launch DepoDur. In addition, it has 230 sales representatives who sell Lidoderm to neurologists and other specialists, as well as general practitioners.

"We're going to increase that [Lidoderm] force by about one-third in early 2005 to have more reps to sell Frova," Newbould said.

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