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): December 9, 2014
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
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 December 9, 2014, Supernus Pharmaceuticals, Inc. issued a press release announcing that it received a Paragraph IV Notice Letter from Par Pharmaceutical, Inc. (“Par”) advising Supernus of the filing by Par of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by five issued patents that expire no earlier than 2027. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
On December 10, 2014, Supernus Pharmaceuticals, Inc. issued a press release announcing that it received a Paragraph IV Notice Letter from TWi Pharmaceuticals, Inc. (“TWi”) advising Supernus of the filing by TWi 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 four issued patents that expire no earlier than 2027. 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 December 9, 2014.
Exhibit 99.2 — Press Release Dated December 10, 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: December 11, 2014 |
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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 December 9, 2014. |
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Attached |
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99.2 |
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Press Release Dated December 10, 2014. |
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Attached |
EXHIBIT 99.1
FOR IMMEDIATE RELEASE
Supernus Announces Paragraph IV ANDA Filing for Trokendi XR®
Rockville, MD, December 9, 2014 — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) today announced that on December 8, 2014 the Company received a Paragraph IV Notice Letter from Par Pharmaceutical, Inc. (“Par”) advising Supernus of the filing by Par of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules.
Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by five issued patents that expire no earlier than 2027.
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 on March 21, 2014 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:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Or
INVESTOR CONTACT:
COCKRELL GROUP
877.889.1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
EXHIBIT 99.2
FOR IMMEDIATE RELEASE
Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR®
Rockville, MD, December 10, 2014 — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) today announced that on December 9, 2014 the Company received a Paragraph IV Notice Letter from TWi Pharmaceuticals, Inc. (“TWi”) advising Supernus of the filing by TWi 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 four issued patents that expire no earlier than 2027.
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 on March 21, 2014 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:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
Or
INVESTOR CONTACT:
COCKRELL GROUP
877.889.1972
investorrelations@thecockrellgroup.com
cockrellgroup.com