Penwest Pharmaceuticals and its development and commercialisation partner Endo Pharmaceuticals announced Friday that the FDA has approved their opioids Opana (oxymorphone hydrochloride) and Opana ER. Both the immediate-release and extended-release formulations of the drug are indicated for the relief of moderate-to-severe pain, with Opana for acute pain and Opana ER for chronic pain.
"This is the first time oxymorphone will be available in an oral, extended-release formulation," according to an Endo statement. Endo also raised its projected annual revenue range to $880 million to $910 million from $860 million to $880 million but said its launch costs will result in lower profits. The company expects combined sales between $20 million and $30 million for both Opana formulations.
Endo said it plans to release both forms of the drug in the coming weeks and to expand its 370-person sales force by about 220 to market Opana and Opana ER as well as its existing portfolio of branded pain relief products. In a research note, Jefferies & Co. analyst David Windley said he plans to increase earnings per share estimates for Endo to reflect its "aggressive sales force expansion in 2006," MSN Money reported.
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