Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Entry into a Material Definitive Agreement

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Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.

On March 6, 2017, Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) entered into a binding term sheet (the “Term Sheet”) with Actavis Laboratories, FL, Inc., Actavis Pharma, Inc., and Watson Laboratories, Inc. (collectively, “Actavis,” now a subsidiary of Teva Pharmaceuticals Industries, Ltd.), to settle ongoing patent litigation regarding Actavis’ filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of the Company’s Trokendi XR® (extended-release topiramate) capsules. The ANDA included a paragraph IV certification seeking approval to engage in the manufacture, use and sale of the Actavis product prior to the expiration of United States Patent Nos. 8,298,576 (the “‘576 Patent”), 8,298,580 (the “‘580 Patent”), 8,663,683 (the “‘683 Patent”), 8,877,248 (the “‘248 Patent”), 8,889,191 (the “‘191 Patent”), and 8,992,989 (the “‘989 Patent,” and together with the ‘576 Patent, the ‘580 Patent, the ‘683 Patent, the ‘248 Patent, and the ‘191 Patent, the “Patents-in-Suit”).

Under the terms of the Term Sheet, the Company and Actavis will enter into settlement and license agreements with respect to Actavis’ ANDA, and the Company will grant to Actavis and its affiliates a non-exclusive license, beginning on January 1, 2023, or earlier under certain circumstances.

During the term of the license agreement, Actavis will make royalty payments to the Company. The Company retains the right itself or through an affiliate to market an authorized generic product and grant additional licenses under the Patents-in-Suits to third parties.

Item 8.01 Other Events.

On March 7, 2017, the Company issued a press release announcing it had entered into a binding term sheet with Actavis involving the ongoing patent litigation regarding Actavis’ filing of an ANDA seeking approval to market generic versions of the Company’s Trokendi XR® (extended-release topiramate) capsules. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibit

The following document is filed as an Exhibit  to Item 8.01 hereof:

Exhibit 99.1 — Press Release Dated March 7, 2017.


About Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN)

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company offers products for the treatment of epilepsy, which include extended-release oxcarbazepine (Oxtellar XR) and extended-release topiramate (Trokendi XR). It develops multiple product candidates in psychiatry for the treatment of Impulsive Aggression (IA) and attention deficit hyperactivity disorder (ADHD). Its psychiatry product candidates include SPN-810 (molindone hydrochloride) and SPN-812 (viloxazine hydrochloride). It is also developing SPN-810 as a treatment for IA in patients who have ADHD and SPN-812 for the treatment of ADHD. It is developing SPN-809 (viloxazine hydrochloride) for the treatment of depression. It markets its products in the United States through its own specialty sales force and has collaborations with other pharmaceutical companies to license its products outside the United States.

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) Recent Trading Information

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) closed its last trading session down -0.45 at 27.35 with 594,299 shares trading hands.