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): January 16, 2015
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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(State or other jurisdiction of |
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Incorporation) |
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001-35518 |
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20-2590184 |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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1550 East Gude Drive, Rockville MD |
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20850 |
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(Address of principal executive offices) |
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(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))
Item 8.01 Other Events
On January 16, 2015, Supernus Pharmaceuticals, Inc. issued a press release announcing that it sued generic drug makers Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. for infringement of four 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.
On January 21, 2015, Supernus Pharmaceuticals, Inc. issued a press release announcing that it sued generic drug makers TWi Pharmaceuticals, Inc. and TWi International LLC (d/b/a TWi Pharmaceuticals USA) for infringement of four patents covering its antiepileptic drug Oxtellar XR®. A copy of this press release is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following documents are furnished as Exhibits pursuant to Item 8.01 hereof:
Exhibit 99.1 — Press Release Dated January 16, 2015.
Exhibit 99.2 — Press Release Dated January 21, 2015.
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: January 23, 2015 |
By: |
/s/ |
Gregory S. Patrick | |
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Gregory S. Patrick | |
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Vice-President and Chief Financial Officer | |
EXHIBIT INDEX
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Number |
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Description |
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99.1 |
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Press Release Dated January 16, 2015. |
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Attached |
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99.2 |
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Press Release Dated January 21, 2015. |
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Attached |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Supernus Sues Par for Infringement of Trokendi XR® Patents
Rockville, MD., January 16, 2015 — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it sued generic drug makers Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (collectively “Par”) for infringement of four patents covering its antiepileptic drug Trokendi XR®. Supernus’ United States Patents Nos. 8,298,576, 8,298,580, 8,663,683 and 8,877,248 cover once-a-day topiramate formulations and methods of treating seizures using those formulations. Patent protection for Trokendi XR expires no earlier than 2027.
The Complaint—filed in the U.S. District Court for the District of New Jersey—alleges that Par 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 Par’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Par’s 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 markets two 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 Company’s 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 Company’s Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission (“Commission”) on March 21, 2014 under the caption “Risk Factors” and the updates to these risk factors in the Company’s Quarterly Report form 10-Q filed with the Commission on November 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
Exhibit 99.2
FOR IMMEDIATE RELEASE
Supernus Sues TWi for Infringement of Oxtellar XR® Patents
Rockville, MD., January 21, 2015 — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it sued generic drug makers TWi Pharmaceuticals, Inc. and TWi International LLC (d/b/a TWi Pharmaceuticals USA) (collectively “TWi”) for infringement of four patents covering its antiepileptic drug Oxtellar XR®. Supernus’ United States Patents Nos. 7,722,898, 7,910,131, 8,617,600 and 8,821,930 cover once-a-day oxcarbazepine formulations and methods of treating seizures using those formulations. Patent protection for Oxtellar XR expires in 2027.
The Complaint — filed on January 16, 2015 in the U.S. District Court for the District of New Jersey — alleges that TWi infringed Supernus’ Oxtellar XR patents by submitting to the Food and Drug Administration (“FDA”) an Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Oxtellar XR prior to the expiration of Supernus’ patents. Filing its Complaint within 45 days of receiving TWi’s Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving TWi’s 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 markets two 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 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 (“Commission”) on March 21, 2014 under the caption “Risk Factors” and the updates to these risk factors in the Company’s Quarterly Report form 10-Q filed with the Commission on November 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