UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 7, 2017
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
Incorporation)
001-35518 |
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20-2590184 |
(Commission File Number) |
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(IRS Employer Identification No.) |
1550 East Gude Drive, Rockville MD |
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20850 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (301) 838-2500
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 Companys 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 Companys 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 pursuant to Item 8.01 hereof:
Exhibit 99.1 Press Release Dated March 7, 2017.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SUPERNUS PHARMACEUTICALS, INC. | |
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DATED: March 9, 2017 |
By: |
/s/ Gregory S. Patrick |
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Gregory S. Patrick | |
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Vice-President and Chief Financial Officer |
Exhibit 99.1
Supernus Announces Settlement with Actavis on
Trokendi XR® Patent Litigation
ROCKVILLE, Md., March 07, 2017 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced that it has entered into a binding term sheet with Actavis Laboratories, FL, Inc. et al. (collectively, Actavis, now a subsidiary of Teva Pharmaceuticals Industries, Ltd.) involving the ongoing patent litigation regarding Actavis Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of Supernus Trokendi XR® (extended-release topiramate) capsules. The binding term sheet permits Actavis to begin selling a generic version of Trokendi XR® on January 1, 2023, or earlier under certain circumstances. The binding term sheet will be submitted to the applicable governmental agencies.
Supernus intends to continue its vigorous enforcement of its patent rights for Trokendi XR®. Patent protection for Trokendi XR® expires no earlier than 2027.
Supernus is represented by attorneys from Haug Partners LLP and its corporate counsel, Saul Ewing LLP.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company has two marketed products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates to address large market opportunities in psychiatry, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients and SPN-812 for the treatment of ADHD.
Forward Looking Statements
This press release contains forward-looking statements regarding the Companys ability to defend and enforce its intellectual property rights covering Trokendi XR®. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the ability of Supernus to finance potential litigation and to prevail in any such proceeding to successfully defend its intellectual property rights. For a further description of these and other risks facing the Company, please see the risk factors described in the Companys 2015 Annual Report Form 10-K/A that was filed with the United States Securities and Exchange Commission on January 20, 2017 under the caption Risk Factors. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
Contact:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
301-838-2591
Or
Investor Contact:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com