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 26, 2012
Supernus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
Incorporation)
0-50440 |
|
20-2590184 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
1550 East Gude Drive, Rockville MD |
|
20850 |
(Address of principal executive offices) |
|
(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 June 26, 2012, Supernus Pharmaceuticals, Inc. (the Company) issued a press release describing the Companys receipt of tentative approval of Trokendi XRTM from the Food and Drug Administration (the FDA). 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) Exhibits
The following document is furnished as an Exhibit pursuant to Item 8.01 hereof:
Exhibit 99.1 Press Release dated June 26, 2012 of the Company regarding receipt of tentative approval of Trokendi XRTM from the FDA.
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: June 26, 2012 |
By: |
/s/ |
Gregory S. Patrick |
|
|
|
Gregory S. Patrick |
|
|
|
Vice-President and Chief Financial Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Supernus Receives Tentative Approval of Trokendi XR from FDA
Rockville, MD, June 26, 2012 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administration (the FDA) for Trokendi XR, a once-daily extended release formulation of topiramate (formerly known as SPN-538). The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. Our initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
We are pleased to announce that the FDA granted us tentative approval for Trokendi XR and that all of the scientific and procedural conditions for approval have been met. We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval. said Jack Khattar, Chief Executive Officer, President and Director of Supernus.
The Company also learned that the FDA denied the Citizens Petition filed in 2011 by Upsher Smith Laboratories as it relates to its NDA on Trokendi XR.
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 is developing several product candidates in neurology and psychiatry to address large market opportunities in epilepsy and ADHD including ADHD patients with impulsive aggression. These product candidates include Trokendi XR (extended-release topiramate), formerly known as SPN-538 and SPN-804 (extended-release-oxcarbazepine) for epilepsy, 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 for Trokendi XR to treat epilepsy, its final approval, and the timing of its availability to physicians. 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 obtain final approval for its products, commercialize products successfully, whether physicians will prescribe and patients will use Trokendi XR, once available, and competition in the market for Trokendi XR. For a further description of these and other risks facing the company, please see the risk factors described in the companys Registration Statement on Form S-1 that was filed with the United States Securities and Exchange Commission and the amendments thereto, including those factors discussed under the caption Risk Factors in those filings. 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