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: March 18, 2009
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|(Commission File Number)|| |
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 March 18, 2009, BioDelivery Sciences International, Inc. (the Company) issued a press release announcing the preliminary results from a Phase 1 study assessing two new formulations of the analgesic buprenorphine utilizing the Companys proprietary BEMA drug delivery technology. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
|Item 9.01.||Financial Statements and Exhibits.|
|Press release, dated March 18, 2009, relating to the initial results of a Phase 1 study regarding analgesic buprenorphine utilizing the Companys proprietary BEMA drug delivery technology.|
This Current Report on Form 8-K and the exhibits hereto and the statements of representatives and partners of 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, could, would, should, believes, expects, anticipates, estimates, intends, plans 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: (i) actual sales results and royalty or milestone payments, if any, (ii) the application and availability of corporate funds and the Companys need for future funds, or (iii) the timing for completion, and results of, scheduled or additional clinical trials and the FDAs or other regulatory review and/or approval and commercial launch of the Companys formulations and products and regulatory filings related to the same, 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).
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.
|March 18, 2009||BIODELIVERY SCIENCES INTERNATIONAL, INC.|
|Name:||James A. McNulty|
|Title:||Secretary, Treasurer and Chief Financial Officer|