Vernalis

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

Related Articles:
Vernalis may be in play after dramatic reorg. Vernalis report
Endo, Vernalis get FDA rejection for Frova. Vernalis report
Vernalis reports "striking" weight loss in trial. Vernalis report
Vernalis acquires Cita, adds drugs to pipeline. Vernalis 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, 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

ALSO NOTED: Vernalis reports "striking" weight loss in trial; Genmab shares surge on Phase III; FDA wants more time on Entereg;

Thu, 13 Sep 2007 06:59:50 -0400

> Vernalis is reporting "striking" weight loss results in its Phase I trial of the obesity drug V24343. Release

> Shares of Genmab surged today after the company reported that it's pushing HuMax-EGFr (zalutumumab) into Phase III for head and neck cancer. Report

> Adolor says that the FDA wants more time to review submissions before it decides on whether it will lift a clinical hold on Entereg for postoperative ileus. Report

> A new study of the breast cancer drug tamoxifen demonstrates that it not only works against bipolar disease, it also works faster than many standard therapies. Report

> Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America announced that the first patient has been enrolled in a Phase III study of lubiprostone for opioid-induced bowel dysfunction. Release

> Anesiva has initiated a new Phase II study of Adlea for the relief of post-operative pain in patients undergoing total knee replacement surgery. Release

> Trasylol got something of a reprieve yesterday when an FDA advisory panel recommended that it stay on the market. Report

> When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling. If this sounds like Lipitor to you, you're right. Report

And Finally… A U.S. biotech company, Yorktown Technologies, is seeking regulatory permission to import and sell fish that have been genetically modified to glow. Researchers have been developing the fish to identify contaminated waters--though it looks like there could be quite a market among exotic fish lovers. Report