Key Developments: Depomed Inc (DEPO.O)

Latest Key Developments (Source: Significant Developments)

Depomed Inc Reaffirms FY 2013 Revenue Guidance
Wednesday, 8 May 2013 04:06pm EDT

Depomed Inc reaffirmed fiscal 2013 revenue guidance and expects total revenues of approximately $125 to $135 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $130 million for fiscal 2013. Full Article

Depomed Inc Issues FY 2013 Revenue Guidance Below Analysts' Estimates
Wednesday, 20 Feb 2013 04:01pm EST

Depomed Inc announced that for fiscal 2013, it expects total revenues of approximately $125 to $135 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $137 million for fiscal 2013. Full Article

Depomed Inc Announces Dismissal Of Suit Against Two Gralise ANDA Filers Following Withdrawal Of ANDA And Patent Challenge
Wednesday, 26 Dec 2012 04:05pm EST

Depomed Inc announced that its lawsuits against two filers of Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed. Watson Laboratories has withdrawn its Gralise ANDA. Par Pharmaceutical has amended its Gralise ANDA and is no longer seeking approval of the ANDA prior to the expiration of Depomed's patents listed for Gralise in the FDA publication commonly known as the Orange Book. As a result, the U.S. District Court for the District of New Jersey has granted the parties' request for dismissal of Depomed's lawsuits against Watson and Par for infringement of Depomed's Gralise patents. As previously disclosed, in October 2012 Depomed's patent lawsuit against Impax was dismissed following Impax's withdrawal of its Gralise ANDA. Depomed's patent litigation against the remaining three Gralise ANDA filers continues in the U.S. District Court for the District of New Jersey . Full Article

Depomed Inc Announces Serada NDA Acceptance And FDA Advisory Committee Meeting
Monday, 15 Oct 2012 08:00am EDT

Depomed Inc announced that New Drug Application (NDA) for Serada has been accepted for filing by the U.S. Food and Drug Administration (FDA). Depomed submitted the Serada NDA to FDA on July 31, 2012. Depomed is seeking approval to market and sell Serada in the United States for the treatment of menopausal hot flashes. Serada is an investigational product and is not approved to treat any disease or condition. Full Article

Depomed Inc Files Suit Against FDA Seeking Grant Of Orphan Drug Exclusivity For Gralise
Tuesday, 25 Sep 2012 04:30pm EDT

Depomed Inc announced that it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring the FDA to grant Gralise (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN). Gralise received orphan drug designation in November 2010 for the management of PHN and was approved for that use in January 2011. The FDA has not granted orphan drug exclusivity to Gralise, even though the product was approved for its orphan-designated use. Depomed believes Gralise is entitled to Orphan Drug exclusivity as a matter of law, and the FDA's action is not consistent with the statute or FDA's regulations related to orphan drugs. The lawsuit seeks a determination by the court that Gralise is protected by Orphan Drug exclusivity, and an order that FDA act accordingly. A grant of orphan drug exclusivity would provide Gralise marketing exclusivity in the United States for the management of PHN until January 28, 2018, seven years after the date of Gralise's approval for PHN. Full Article

Depomed Inc Licenses Acuform Patents To Janssen Pharmaceuticals, Inc.
Monday, 27 Aug 2012 04:10pm EDT

Depomed Inc announced that Janssen Pharmaceuticals, Inc., has licensed rights to Depomed's Acuform gastric retentive drug delivery technology. Under the terms of the agreement Janssen received a non-exclusive license and other rights to certain Acuform patents. In exchange, Depomed will receive an upfront payment of $10 million and will receive a low single digit royalty on net sales of NUCYNTA ER (tapentadol extended-release tablets) in the U.S., Canada and Japan from and after July 2, 2012 through December 31, 2021. In addition, Depomed is eligible for a one-time sales upon achievement of a specified level of quarterly net sales. Depomed has no development obligations under the agreement and expects to recognize the $10 million payment as revenue in the third quarter of 2012. Full Article

DepoMed, Inc. Announces Submission Of New Drug Application For Serada
Tuesday, 31 Jul 2012 04:31pm EDT

DepoMed, Inc. announced that it has submitted a New Drug Application (NDA) for Serada to the United States Food and Drug Administration. Serada is Depomed's extended release formulation of gabapentin in development for the treatment of menopausal hot flashes. Full Article

DepoMed, Inc. Announces Publication Of Phase III Data From Gralise (gabapentin) Clinical Trial
Monday, 23 Jul 2012 08:02am EDT

DepoMed, Inc. announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN). The results showed that patients treated with Gralise experienced a significant reduction (- 2.12) in their average daily pain intensity compared with placebo treated patients (-1.63; P=0.013). This difference from placebo was statistically significant after one week and continued to be superior through the duration of the study. The published results are from a randomized, multi-center Phase III clinical study of 452 patients with PHN that evaluated the efficacy and safety of once-daily Gralise compared to placebo. Other results showed that the frequency of adverse events commonly associated with gabapentin was as follows: dizziness (11.3% vs. placebo, 1.7%), somnolence (5.4% vs. placebo 3.0%), and peripheral edema (3.2% vs. placebo, 0.4%) with differences in dizziness and peripheral edema being statistically significant. Secondary endpoints showed that 43% of patients treated with Gralise reported much or very much improvement compared to 34% of placebo treated patients (P<0.0434). Full Article

DepoMed, Inc. Announces Acquisition Of From Xanodyne Pharmaceuticals, Inc.
Thursday, 21 Jun 2012 04:05pm EDT

DepoMed, Inc. announced that it has acquired all rights to Zipsor (diclofenac potassium) Liquid Filled Capsules from Xanodyne Pharmaceuticals, Inc. Zipsor is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. The product uses proprietary ProSorb delivery technology to deliver a finely dispersed, rapidly absorbed formulation of diclofenac. Full Article

Watson Pharmaceuticals Inc Confirms Glumetza Patent Challenge Against Depomed, Inc. And Valeant International (Barbados) SRL
Thursday, 19 Apr 2012 09:12am EDT

Watson Pharmaceuticals Inc announced that Watson's Metformin Hydrochloride Extended-release Tablets are a generic version of Depomed, Inc.'s Glumetza. Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Depomed, Inc. and Valeant International (Barbados) SRL filed suit against Watson on April 18, 2012 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 6,488,962 and 7,780,987. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner. Full Article

Depomed Inc News

FDA advisors vote against two drugs for menopausal hot flashes

WASHINGTON - Advisers to the Food and Drug Administration on Monday voted against approval of two drugs designed to reduce the frequency and severity of hot flashes associated with menopause, concluding that neither conferred enough benefit to offset their risk.

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