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): August 15, 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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01 Other Events.
On August 15, 2017, Supernus Pharmaceuticals, Inc. issued a press release announcing that the United States District Court for the District of New Jersey ruled that TWi Pharmaceuticals, Inc. and its subsidiary infringed three Oxtellar XR® Orange Book patents and that all three patents are valid. 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 furnished as an Exhibit pursuant to Item 8.01 hereof:
Exhibit 99.1 Press Release Dated August 15, 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: August 17, 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 Defeats Second Generic Challenger to Oxtellar XR®
Federal Court Finds Supernus Patents Valid and Infringed by TWi
ROCKVILLE, Md., August 15, 2017 (GLOBE NEWSWIRE) Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced, following a four-day bench trial, that the United States District Court for the District of New Jersey ruled that TWi Pharmaceuticals, Inc. and its subsidiary infringed U.S. Patent Nos. 7,722,898, 7,910,131, and 8,821,930 by submitting to the FDA an Abbreviated New Drug Application (ANDA) seeking permission to market a generic version of Oxtellar XR® before the expiration of Supernus patents. The District Court ruling also confirmed the validity of U.S. Patent Nos. 7,722,898, 7,910,131, and 8,821,930.
We are very pleased with the District Courts ruling that TWi infringed our Oxtellar XR® patents and the reaffirmation of the validity of those patents, stated Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. Supernus will continue to actively enforce and expand its Oxtellar XR® patent portfolio.
In addition to the three patents that were the subject of the District Courts decision, Oxtellar XR® is further protected by four other patents that are also listed in the Orange Book. The Orange Book lists all seven of Supernus Oxtellar XR® patents as expiring on April 13, 2027.
As of the date of this press release, Supernus is not aware of any FDA approval for the TWi ANDA.
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 currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. 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 Oxtellar 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 2016 Annual Report on Form 10-K that was filed with the United States Securities and Exchange Commission (SEC) on March 16, 2017, and the Companys Quarterly Report on Form 10-Q for the period ended June 30, 2017, that was filed with the SEC on August 3, 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: |
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Jack A. Khattar, President and CEO |
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Gregory S. Patrick, Vice President and CFO |
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Supernus Pharmaceuticals, Inc. |
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301-838-2591 |
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Or
Investor Contact: |
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Peter Vozzo |
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Westwicke Partners |
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Office: (443) 213-0505 |
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Mobile: (443) 377-4767 |
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Email: peter.vozzo@westwicke.com |
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