Endo Parmaceuticals news from FierceBiotech

Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. Read more...

The UK's Vernalis saw its shares shoot up after the drug developer announced a dramatic restructuring that will eliminate more than half of its work force and put significant parts of its business up Read more...

> Shares of Acorda Therapeutics took a big bounce yesterday when the company announced new data demonstrating that its multiple sclerosis drug Fampridine-SR does not raise heart-related risks Read more...

Endo Pharmaceuticals and Vernalis have received a "not approvable" letter for an additional indication for its migraine medicine Frova. The companies had hoped to gain an approval for menstrual Read more...

> The therapeutic antibody company Agensys has raised $41 million in its fourth round of venture capital. Duquesne Capital Management and Jafco co-led the round. Read more...

Embattled Biovail saw its fortunes improve somewhat after announcing that it was reorganizing and eliminating its direct sales group in the U.S. The Toronto-based drug developer said that it had tried to make an acquisition in the U.S. but had failed to find one that met its criteria. In addition, CFO Charles Rowland announced that he was leaving his job to take a position with Endo Pharmaceuticals. Kenneth G. Howling will take his place.

"We could no longer justify a U.S.-based …

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Endo Pharmaceuticals has agreed to buy Boulder, CO-based RxKinetic for $20 million up front and up to $95 million in milestones. RxKinetic is developing a therapy to treat oral mucositis-mouth sores-in cancer patients. The developer wrapped a Phase II trial of RK-0202 in March and announced positive data that would allow it to push into a late-stage trial. The company, which has 21 employees, will continue as a subsidiary of …

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EpiCept's LidoPAIN, an analgesic pain therapy patch, failed a Phase III trial in Europe. According to researchers, LidoPAIN SP "did not achieve a statistically significant effect relative to placebo with respect to the primary endpoint of self-assessed pain intensity between 4 and 24 hours. In addition, a statistically significant effect was not achieved in the trial's co-primary endpoint of patient use of "rescue" medications, i.e. systemically-delivered analgesics used to alleviate …

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The Wall Street Journal examines the work of Endo Pharmaceuticals in building up an impressive pain management portfolio and the risks it faces from early generic competition. Report (WSJ sub. req.)

Shares of Endo Pharmaceuticals and its development partner Penwest shot up this morning as news circulated of the FDA's approval of two new versions of its powerful new pain killer Opana. The agency approved an extended-release and immediate-release form of the opiate for chronic and acute pain. Endo officials trimmed their financial outlook on earnings, though, saying that it would bear the full cost of the drug's launch. Endo plans to add 220 sales reps to its current marketing force of …

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