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): November 21, 2014
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
Incorporation)
001-35518 |
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20-2590184 |
(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 |
(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 November 21, 2014, Supernus Pharmaceuticals, Inc. issued a press release announcing that it sued generic drug makers Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited 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.
On November 24, 2014, Supernus Pharmaceuticals, Inc. issued a press release announcing the issuance of a fifth patent by the United States Patent and Trademark Office covering Trokendi XR®, its novel once-daily extended-release topiramate product. 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 November 21, 2014.
Exhibit 99.2 Press Release Dated November 24, 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: November 25, 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
Number |
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Description |
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99.1 |
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Press Release Dated November 21, 2014. |
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Attached |
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99.2 |
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Press Release Dated November 24, 2014. |
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Attached |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Supernus Sues Zydus for Infringement of Trokendi XR® Patents
Rockville, MD., November 21, 2014 Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it sued generic drug makers Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited (collectively Zydus) 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 Zydus 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 Zydus Paragraph IV certification notice entitles Supernus to an automatic stay preventing the FDA from approving Zydus 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 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 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.
Tel: (301) 838-2591
Or
INVESTOR CONTACT:
COCKRELL GROUP
877.889.1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
Exhibit 99.2
Supernus Announces Issuance of Fifth U.S. Patent Protecting Trokendi XR®
Rockville, MD, November 24, 2014 - Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced the issuance of a fifth patent (number 8,889,191) by the United States Patent and Trademark Office (USPTO) covering Trokendi XR, its novel once-daily extended-release topiramate product. The patent provides protection for the product with expiration that is no earlier than 2027.
We are very serious about securing intellectual property protection for our innovative products. This is now the second patent that issued this month on Trokendi XR. We will continue to build our patent estate to provide our products with the protection they are entitled to. We now have patent protection on Oxtellar XR® and Trokendi XR® through four and five issued U.S. patents, respectively, said Jack A. Khattar, President and CEO of Supernus.
Supernus has several additional patent applications for extended-release topiramate and extended-release oxcarbazepine pending in other geographic regions.
About Trokendi XR
Trokendi XR is the first approved novel once-daily extended release formulation of topiramate for the treatment of epilepsy. Trokendi XR is an antiepileptic drug indicated for initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures; and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome. The product is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
For full prescribing and safety information, click here.
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 potential of Trokendi XR and Oxtellar XR and intellectual property protection of these products. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding the companys ability to commercialize the product successfully, whether physicians will prescribe and patients will use the product, and competition in the market. 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 and under the caption Risk Factors and the updates to these risk factors in the Companys quarterly report form 10-Q that was 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.
Tel: (301) 838-2591
Or
INVESTOR CONTACT:
COCKRELL GROUP
877.889.1972
investorrelations@thecockrellgroup.com
cockrellgroup.com