Endo Withdraws Frova sNDA For Menstrual Migraine Prevention
This article was originally published in The Pink Sheet Daily
Executive Summary
Action comes days after former Johnson & Johnson exec Holveck takes the helm as president and CEO.
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Endo will not pursue FDA approval of a new indication for the migraine treatment Frova (frovatriptan) for the short-term prevention of menstrual migraine for the time being, the company announced April 7. The Chadds Ford, Pa., company has withdrawn the sNDA for Frova 2.5 mg tablets for the indication. "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," the company said. Endo announced receipt of the "not approvable" letter last year, citing FDA's concerns weighing the potential for vascular risk versus the efficacy benefit (1 (Also see "FDA “Not Approvable” Letter Questions Benefit Of Endo’s Frova In Menstrual Migraine" - Pink Sheet, 1 Oct, 2007.)). The news follows a change of leadership at Endo. David Holveck took the helm as president and CEO April 1, joining the company from Johnson & Johnson, where he worked most recently as president of J&J Development Corporation and as VP-corporate development. He was president and CEO of Centocor until its acquisition by J&J in 1999. Frova is approved for the acute treatment of migraine attacks with or without aura in adults. Endo, which markets Frova with its British partner Vernalis, had been hoping to position Frova as the first triptan indicated for menstrual migraine. In February, however, Vernalis gave up its U.S. co-promotion rights to Frova as part of a loan settlement agreement with Endo. The company owed Endo $56 million, which was due for repayment in August 2009, but the loan was cancelled based on the settlement, and Vernalis agreed to pay Endo $7 million (2 (Also see "Vernalis Restructures, Gives Up U.S. Frova Rights To Increase Cash Reserves" - Pink Sheet, 20 Feb, 2008.)). Endo said it is continuing to evaluate development opportunities for Frova for menstrual migraine, as well as other related indications. In a coinciding announcement, Endo said it will return rights to Chronogesic in the U.S. and Canada to delivery systems company DURECT, in Cupertino, Calif. The firms had been developing the sufentanil-containing implantable device for the treatment of moderate-to-severe chronic pain. Under the terms of the licensing agreement, Endo is not responsible for development costs for the drug prior to May 1, 2008, as long as notification of termination is provided to Durect by April 30. The firms are also developing a sufentanil transdermal patch, which Endo has rights to in the U.S. and Canada. The action on Chronogesic will have no impact on the other collaboration, Endo noted. Endo is currently undertaking a comprehensive review of its R&D pipeline, and the company said it will not provide guidance on pipeline projects until after the review is complete. The firm has also withdrawn guidance as to the potential NDA filing timelines for its Phase III projects: the cancer pain management drug Rapinyl and a ketoprofen patch for pain related to tendonitis or bursitis of the shoulder, elbow or knee. -Jessica Merrill ([email protected]) |