Endo Parmaceuticals

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

ALSO NOTED: Acorda shares bounce on new data; Endo CEO hits the exit door; BioSante in protocol deal; and much more...

Tue, 29 Jan 2008 06:59:50 -0500

> 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 higher than a placebo. Release

> Endo Pharmaceuticals CEO Peter Lankau has handed in his walking papers. Endo says he is leaving March 1 and will be replaced by its COO and CFO on an interim basis. Release

> BioSante Pharmaceuticals has reached agreement with the FDA on a special protocol assessment for its Phase III trials for LibiGel--a therapy for female sexual dysfunction. Report

> Following a recommendation from the FDA, NPS Pharmaceuticals is preparing a confirmatory late-stage study of Gattex in patients with short bowel syndrome. Report

> Shares of Medarex were buoyed yesterday by an analyst's remark that its cancer drug--ipilimumab--which delivered disappointing data in December, may yet demonstrate its ability to improve overall survival rates. Report

> Amsterdam-based Pharming says it expects a final EMEA decision on Rhucin in the second quarter and is close to detailing its request that the EMEA reexamine its application to market Rhucin in Europe. Report

> The FDA issued a warning letter to Replidyne regarding antibiotic faropenem medoxomil 300 mg. Letter

> Pipex Pharmaceuticals announced that its New Drug Application for oral tetrathiomolybdate has not been accepted by the FDA for further review as submitted. Release

> As if questions about the effectiveness of cholesterol meds weren't enough, now research is casting blood pressure remedies into doubt. Report

> Workers at Pfizer's Terre Haute, Indiana, plant where the ill-fated Exubera was made are, shall we say, less than exuberant today. The company has decided to cut 660 jobs there. Report

And Finally... Here's a troubling milestone: Bird flu deaths in Indonesia have hit 100. 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: Agensys gains $41M of venture funds; Endo patch fails trials; Barrier reports positive data; and much more...

Thu, 12 Jul 2007 06:59:50 -0400

> 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. Release

> Endo Pharmaceuticals has had to withdraw its blueprint for developing a skin patch to treat pain and inflammation patch after it failed two late-stage studies. Endo had expected to file for approval in the first half of next year. Report

> Barrier Therapeutics announced positive results from its completed Phase 2 dose-finding study of Oral Rambazole in moderate to severe psoriasis. Release

> Germany's Eppendorf is taking New Brunswick Scientific private in a deal valued at $110 million. NBS is a provider of biotech research equipment. Release

> Bioheart has boosted the size of its IPO, increasing its expected gain to $45 million. Report

> Amgen has granted Daiichi Sankyo exclusive rights to develop and commercialize denosumab in Japan in post-menopausal osteoporosis and oncology with the potential for additional indications. Release

> Labopharm and Paladin Labs announced that they have completed a licensing and distribution agreement which grants Paladin the exclusive right to market Labopharm's once-daily tramadol product in Canada. Labopharm will retain co-promotion rights. Release

> Pharmasset earned a $7.5 million payday from Roche in their collaboration on a new therapy for hepatitis C. Release

> Genentech has once again beat The Street, seeing earnings swell 41 percent in the second quarter. Report

And Finally... A pilot program is paying doctors a bonus for saving Medicare money. Article

Biovail shares rebound on reorganization effort

Tue, 05 Dec 2006 19:01:37 -0500

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 sales and marketing infrastructure that was not properly leveraged," said Biovail CEO Douglas Squires. "Accordingly, management believes that the elimination of long-term debt, a focused and robust investment in research and development, and increasing dividends to our shareholders are more fiscally prudent uses of cash."

- read the AP report on Biovail

Related Articles:
Biovail chairman charged with securities violations. Report
Biovail loses effort to stop generic Wellbutrin. Report
Biovail drops spin off plans. Report

Endo to buy RxKinetic for $20M up front

Thu, 12 Oct 2006 20:01:34 -0400

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 Endo.

"The acquisition of RxKinetix is consistent with our strategic goal of expanding into therapeutic areas that are complementary to pain," said Peter A. Lankau, president and chief executive officer of Endo.

- read the report on the buyout from The Rocky Mountain News

EpiCept pain therapy patch fails Phase III trial

Tue, 05 Sep 2006 20:01:34 -0400

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 pain." EpiCept secured a $10 million loan a week ago. Endo Pharmaceuticals has signed on as a commercialization partner for LidoPAIN.

- see the release on LidoPAIN

SPOTLIGHT: Endo plans for the future

Wed, 05 Jul 2006 20:01:33 -0400

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.)

Endo, Penwest boosted by new Opana approval

Thu, 22 Jun 2006 20:01:37 -0400

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 370. Penwest was responsible for developing the successful delivery mechanism for the extended release form.

- here's the AP report on Opana