Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.
Supernus Pharmaceuticals,Inc. (the “Company”) makes the following disclosure:
Enrollment in the Phase III studies has progressed ahead of schedule on SPN-812, and is now complete in the P301, P302 and P303 studies with data expected in 4Q 2018. Enrollment in the P304 study is at approximately 76%. Data are still expected in 1Q 2019. The table below summarizes the studies and their status:
|
SPN-812 |
P301 N=432 |
P303 N=300 |
P302 N=300 |
P304 N=234 |
|
ADHD Patients |
6-11 years |
6-11 years |
12-17 years |
12-17 years |
|
Total Daily Dose |
100 – 200mg |
200 – 400mg |
200 – 400mg |
400 – 600mg |
|
Enrollment |
Complete |
Complete |
Complete |
76% |
|
Data Expected |
4Q 2018 |
4Q 2018 |
4Q 2018 |
1Q 2019 |
Rollover from the Phase III trials to the open label extension remains at approximately 90%.
The Company continues to progress its plans to initiate the pivotal Phase III bipolar program in the second half of 2019. Recently, the Company completed certain activities, including market research and claims database analysis, on the use of oxcarbazepine in bipolar. The Company will be using information generated from these activities to finalize plans for the Phase III program. As a result, the Company deemed the investigator-initiated trial on Oxtellar XR in bipolar as no longer necessary, and has since stopped the study.
The Company is furnishing the foregoing information in this Current Report on Form8-K to comply with Regulation FD. Such information shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.
This Current Report on Form8-K contains “forward-looking statements” that do not convey historical information, but relate to predicted or potential future events, such as statements of our plans, strategies and intentions. These statements can often be identified by the use of forward-looking terminology such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate” or similar terminology. All statements other than statements of historical facts included in this Current Report on Form8-K are forward-looking statements. All forward-looking statements speak only as of the date of this Current Report on Form8-K. Except for the Company’s ongoing obligations to disclose material information under the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In addition to the risks and uncertainties of ordinary business operations and conditions in the general economy and the markets in which the Company competes, the forward-looking statements of the Company contained in this Current Report on Form8-K are also subject various risks and uncertainties, including those set forth in Item1A, “Risk Factors,” in the Company’s Annual Report on Form10-K for the fiscal year ended December31, 2017 (as filed on March1, 2018), and in its subsequent filings made with the Securities and Exchange Commission.
