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): June 27, 2013

Supernus Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

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):

[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

 

Item 8.01            Other Events 

            On June 27, 2013, Supernus Pharmaceuticals, Inc. (“Supernus”) issued a press release announcing that on June 26, 2013 it received a Paragraph IV Notice Letter from Watson Laboratories, Inc. ("Watson") advising

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Supernus of the filing by Watson of an Abbreviated New Drug Application seeking approval for oxcarbazepine extended-release tablets.  Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Oxtellar XR. The product is currently protected by two issued patents that are listed in the FDA’s Orange Book.  A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.    

 

 

Item 9.01            Financial Statements and Exhibits

(d)        Exhibits

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

Exhibit 99.1     –    Press Release Dated June 27, 2013.

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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.

 

 

SUPERNUS PHARMACEUTICALS, INC.

 

DATED:  July 2, 2013By:  /s/   Gregory S. Patrick                        

Gregory S. Patrick

Vice-President and Chief Financial Officer

 

 

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EXHIBIT INDEX

 

NumberDescription

99.1Press Release dated June 27, 2013.                                                            Attached

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Exhibit 99.1

FOR IMMEDIATE RELEASE                   

 

Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR™ 

Rockville, MD, June 27, 2013 -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) today announced that on June 26, 2013 the Company received a Paragraph IV Notice Letter from Watson Laboratories,  Inc. ("Watson") advising Supernus of the filing by Watson of an Abbreviated New Drug Application seeking approval for oxcarbazepine extended-release tablets.

Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Oxtellar XR. The product is currently protected by two issued patents that are listed in the FDA’s Orange Book. 

 

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, or CNS, diseases. The Company has one marketed product for epilepsy, Oxtellar XR^TM (extended release oxcarbazepine), and one tentatively approved product for epilepsy, Trokendi XR^TM (extended release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

 

Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s 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 Company’s Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 15, 2013 and under the caption “Risk Factors” and the updates to these risk factors in the Company’s quarterly report form 10-Q that was filed with the commission on May 15, 2013.   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.

CONTACTS:

Jack Khattar, President  & CEO

Gregory S. Patrick, Vice President and CFO

Supernus Pharmaceuticals, Inc.

Tel: (301) 838-2591

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