Washington, D.C. 20549




Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): December 13, 2018


Supernus Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)



(State or other jurisdiction of





(Commission File Number)


(IRS Employer Identification No.)


1550 East Gude Drive, Rockville MD



(Address of principal executive offices)


(Zip Code)


Registrant’s 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 1.02                                           Termination of a Material Definitive Agreement.


On February 27, 2018, Supernus Pharmaceuticals, Inc. (the “Company”) and Rockside-700 LLC (“Rockside”) entered into a Lease Agreement (the “Lease”) for the Company’s new headquarters to be located at 700 Quince Orchard Road, Gaithersburg, Maryland (the “Premises”).  On November 28, 2018, the Company notified Rockside that the Company intended to terminate the Lease in the event that the parties were unable to resolve a dispute over the provision of certain facilities included in the approved site plan.  On December 13, 2018 (the “Termination Date”), Rockside notified the Company that it accepted the Company’s termination notice and the Lease was thereby terminated.  As of the Termination Date, the term of the Lease had not commenced and the Company had not occupied the premises.  The Company has not incurred any material termination penalties in connection with termination of the Lease.


Item 8.01                                           Other Events.


On December 14, 2018, the Company issued a press release announcing that the United States Food and Drug Administration approved the Company’s supplemental new drug application to expand the Oxtellar XR® label to include monotherapy treatment for partial-onset seizures.  A copy of this press releases 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 December 14, 2018.






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.







DATED: December 19, 2018



/s/ Gregory S. Patrick



Gregory S. Patrick



Vice-President and Chief Financial Officer



Exhibit 99.1



Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR® Label to Include Monotherapy


ROCKVILLE, Md., December 14, 2018 — Supernus Pharmaceuticals, Inc. (NASADQ: SUPN) announced today that the United States Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for Oxtellar XR®. The application requested FDA approval to expand the indication for Oxtellar XR® beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.


“We are pleased with the timely approval of the expanded indication for Oxtellar XR. We look forward to launching Oxtellar XR in the first quarter 2019 as a new monotherapy treatment option for partial-onset seizures. We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR,” said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals.


About Oxtellar XR®


Oxtellar XR is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients 6 years of age and older. The product is available in 150mg, 300mg, and 600mg extended-release tablets.


For full prescribing and safety information



About Supernus Pharmaceuticals, Inc.


Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) 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 partial seizures. The Company is also developing several product candidates to address large opportunities in the CNS market, including SPN-810 for the treatment of Impulsive Aggression in ADHD patients, SPN-812 for the treatment of ADHD, and SPN-604 for the treatment of bipolar disorder.


Forward Looking Statements


This press release contains forward-looking statements regarding the timing of the Company’s ability to market Oxtellar XR® for monotherapy treatment in epilepsy. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the Company’s ability to commercialize its products successfully, whether physicians will prescribe and patients will use its products, once available, and competition in their respective markets. For a further description of these and other risks facing the Company, please see the risk factors set forth from time to time in the Company’s SEC



filings made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. 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.




Jack A. Khattar, President and CEO

Gregory S. Patrick, Vice President and CFO

Supernus Pharmaceuticals, Inc.





Investor Contact:

Peter Vozzo

Westwicke Partners

Office: (443) 213-0505

Mobile: (443) 377-4767

Email: peter.vozzo@westwicke.com