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): October 2, 2014
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
Incorporation)
0-50440 |
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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 8.01 Other Events
On October 2, 2014, Supernus Pharmaceuticals, Inc issued a press release announcing that it initiated litigation against generic drug makers Actavis plc, Actavis, Inc., Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. for infringement of three patents covering its antiepileptic drug Trokendi XR®. 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 October 2, 2014.
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: October 3, 2014 |
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
FOR IMMEDIATE RELEASE
Supernus Sues Actavis for Infringement of Trokendi XR® Patents
Rockville, MD., October 2, 2014 Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that earlier today it sued generic drug makers Actavis plc, Actavis, Inc., Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Watson Laboratories, Inc., and Anda, Inc. (collectively Actavis) for infringement of three patents covering its antiepileptic drug Trokendi XR®. Supernus United States Patents Nos. 8,298,576, 8,298,580, and 8,663,683 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR® does not expire until 2029.
The Complaintfiled in the U.S. District Court for the District of New Jerseyalleges that Actavis infringed Supernus Trokendi XR® patents by submitting to the Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Trokendi XR® prior to the expiration of Supernus patents. Filing its Complaint within 45 days of receiving Actavis Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Actavis ANDA for 30 months.
Supernus President and CEO Jack Khattar confirmed that Supernus intends to vigorously enforce its patent rights.
Supernus is represented by attorneys from Frommer Lawrence and Haug 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, or CNS, 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 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 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 Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 21, 2014 under the caption Risk Factors and the updates to these risk factors in the Companys quarterly report form 10-Q filed with the commission on August 12, 2014. 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 A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
301-838-2591
or
INVESTOR CONTACT:
COCKRELL GROUP
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com