SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 24, 2014
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
801 Corporate Center Drive, Suite #210
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: 919-582-9050
(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 to the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
|Item 8.01.||Other Information.|
On December 23, 2014, BioDelivery Sciences International, Inc. (the Company) issued a joint-press release with Endo Pharmaceuticals Inc. (Endo) announcing the submission to the U.S. Food and Drug Administration of a New Drug Application (the NDA) for Buprenorphine HCl Buccal Film (the Product) for the management of severe pain. The NDA was a joint submission by the Company and Endo who are developing the Product pursuant to a worldwide license and development agreement between the Company and Endo. A copy of such press release is attached as Exhibit 99.1 hereto.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press release, dated December 23, 2014, regarding NDA Submission for Buprenorphine HCl Buccal Film.|
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, the press release included herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the Company) related thereto contain, or may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Companys plans, objectives, projections, expectations and intentions and other statements identified by words such as projects, may, will, could, would, should, believes, expects, anticipates, estimates, intends, plans, potential or similar expressions. These statements are based upon the current beliefs and expectations of the Companys management and are subject to significant risks and uncertainties, including those detailed in the Companys filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Companys NDA application, and FDA review of the NDA application, for Buprenorphine HCl Buccal Film) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Companys control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|December 24, 2014||BIODELIVERY SCIENCES INTERNATIONAL, INC.|
|Name:||Ernest R. De Paolantonio|
|Title:||Chief Financial Officer and Secretary|