Frova

Vernalis inks financing deal

Mon, 21 Apr 2008 06:59:55 -0400

Vernalis has signed a €18.4M financing agreement with Paul Capital Healthcare for frovatriptan, Vernalis' migraine drug. In return for the cash, Paul Capital Healthcare will receive approximately 90 percent of Menarini's payments to Vernalis under their agreement for the commercialization of frovatriptan. According to Hemscott, "the plan was a way for it to meet its debt obligations to U.S. Frova marketing partner Endo Pharmaceutical, which had been valued at $56 million and represented a 'sword of Damocles' for Vernalis." In a release, Vernalis' CFO Tony Weir said the financing deal will allow the company to rebuild new shareholder value in the medium term.

- here's the release
- read the Hemscott report

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Endo pulls Frova app after mulling FDA response

Tue, 08 Apr 2008 06:59:54 -0400

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. The Chadds Ford, PA-based developer has already won approval for the use of Frova against acute migraine for patients with a clear diagnosis. And without explanation Endo says it will return the rights to Chronogesic to Durect.

"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Endo CEO Dave Holveck (photo).

- here's the release
- read the report in the Philadelphia Business Journal

Related Articles:
Endo, Vernalis get FDA rejection for Frova. Report
Endo plans for the future. Report

Vernalis may be in play after dramatic reorg

Wed, 20 Feb 2008 06:59:56 -0500

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 for sale. Out the door goes CEO Simon Sturge as Vernalis' U.S. operations and lead drug Apokyn go on the sales block. Analysts immediately began to speculate that the restructuring may put the company in play, with a buyer moving in to take control. New money is needed to meet its obligations to Endo Pharmaceuticals on the migraine drug Frova. Last October the FDA dealt a major blow to Vernalis when it rejected the company's application for another indication on Frova. Vernalis is contesting the decision. Vernalis' executive chairman Peter Fellner told Thomson Financial that the company has enough cash to continue operations for two years and was selling off further assets to beef up its cash stake.

- here's the release
- read the report in Hemscott

Related Articles:
Endo, Vernalis get FDA rejection for Frova. Report
Vernalis reports "striking" weight loss in trial. Report
Vernalis acquires Cita, adds drugs to pipeline. Report

Endo touts successful Phase III in cancer pain

Mon, 17 Dec 2007 06:59:56 -0500

Endo Therapeutics' late-stage trial for Rapinyl, a cancer pain therapy, demonstrated that the therapy was highly effective, hitting all primary and secondary goals. The biotech said the trial was so successful--relieving cancer pain for a statistically significant group within 30 minutes--that it may go ahead with an application for marketing approval even as it recruits patients for another Phase III trial. The side effects of the drug were in line with other opioids. That's all good news for Orexo AB, which licensed the therapy to Endo.

"We remain confident that Rapinyl's quick dissolution and rapid absorption profile make it a potentially attractive treatment for breakthrough cancer pain," said David A. Lee, M.D., Ph.D., the company's CSO.

- check out the release for more info

Related Articles:
Endo plans for the future. Report
Endo, Vernalis get FDA rejection for Frova. Report
Endo shares up on positive painkiller data. Report

Endo, Vernalis get FDA rejection for Frova

Mon, 01 Oct 2007 06:59:54 -0400

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 migraines, but the FDA called the sNDA weak, and questioned whether trial results were clinically significant for menstrual migraine. "The FDA raised a number of issues that will need to be fully analyzed and then discussed with the FDA. Following this discussion with the FDA, Endo and Vernalis will decide upon the appropriate course of action," stated Peter A. Lankau, Endo President and CEO.

- see the release for more

Related Articles:
Endo plans for the future. Report
Vernalis reports "striking" weight loss in trial. Report
Vernalis acquires Cita, adds drugs to pipeline. Report