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Stock Market & Financial Investment News

News Breaks
August 21, 2014
07:38 EDTACT, SUPNSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
Supernus Pharmaceuticals (SUPN) announced that on August 20, the company received a Paragraph IV Notice Letter from Actavis Laboratories FL advising Supernus of the filing by Actavis (ACT) of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by three issued patents that are listed in the FDA's Orange Book and expire no earlier than 2027.
News For SUPN;ACT From The Last 14 Days
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January 27, 2015
17:04 EDTACTShire granted petitiion by U.S. Supreme Court
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January 26, 2015
17:34 EDTACTActavis registration statement for Allergan acquisition declared effective
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07:34 EDTACTActavis to acquire Auden Mckenzie for GBP306M accretive in FY15
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January 22, 2015
05:57 EDTACTActavis, Valeant raise prospects of more healthcare deals, Financial Times says
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January 21, 2015
16:32 EDTSUPNSupernus sues TWi for infringement of Oxtellar XR patents
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12:30 EDTACTGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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07:22 EDTACTActavis price target raised to $330 from $280 at Deutsche Bank
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January 20, 2015
05:34 EDTACTActavis reports positive Phase III results for cariprazine
Gedeon Richter and Actavis announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses in the cariprazine group versus 47 relapses in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo.
January 16, 2015
17:04 EDTSUPNSupernus sues Par Pharmaceuticals for patent infringement
Supernus Pharmaceuticals announced that it sued generic drug makers Par Pharmaceutical Companies, and Par Pharmaceutical, collectively known as Par, for infringement of four patents covering its antiepileptic drug Trokendi XR. Supernus' United States Patents Nos. 8,298,576, 8,298,580, 8,663,683 and 8,877,248 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR expires no earlier than 2027. The complaint, filed in the U.S. District Court for the District of New Jersey, alleges that Par infringed Supernus' Trokendi XR patents by submitting to the FDA an Abbreviated New Drug Application, ANDA, seeking to market a generic version of Trokendi XR prior to the expiration of Supernus' patents. Filing its complaint within 45 days of receiving Par's Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Par's ANDA for 30 months.

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