-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, E+uZ+WiSCg9kDn60q7yFTXqVN/Ib0ttYY+tc1b5/TW0gXFh2bOZVR897ZqT/0eHZ QqOYIaCZIICQkHTWOCVHQA== 0001193125-06-012480.txt : 20060126 0001193125-06-012480.hdr.sgml : 20060126 20060126103644 ACCESSION NUMBER: 0001193125-06-012480 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060126 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060126 DATE AS OF CHANGE: 20060126 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DURECT CORP CENTRAL INDEX KEY: 0001082038 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943297098 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31615 FILM NUMBER: 06551969 BUSINESS ADDRESS: STREET 1: 10240 BUBB RD CITY: CUPERTINO STATE: CA ZIP: 95014 BUSINESS PHONE: 4087771417 MAIL ADDRESS: STREET 1: 10240 BUBB ROAD CITY: CUPERTINO STATE: CA ZIP: 95014 8-K 1 d8k.htm FORM 8-K Form 8-K

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

 

January 26, 2006

Date of Report

(Date of earliest event reported)

 


 

DURECT CORPORATION

(Exact name of Registrant as specified in its charter)

 


 

Delaware   000-31615   94-3297098

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

 

10240 Bubb Road

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

 

(408) 777-1417

(Registrant’s telephone number, including area code)

 

 

(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:

 

¨ 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 Events.

 

On January 26, 2006, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing that it plans expand its worldwide development program for its post-operative pain relief depot, SABER-Bupivacaine, by initiating additional Phase II studies for soft tissue and orthopedic surgical procedures. In addition, DURECT announced that clinical studies will be conducted in the U.S. under the accepted U.S. Investigational New Drug (IND) application for SABER-Bupivacaine. A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(c) Exhibits

 

99.1   Press Release of DURECT Corporation dated January 26, 2006


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.

 

    DURECT Corporation
Date: January 26, 2006   By:  

/s/ James E. Brown


        James E. Brown
        President and Chief Executive Officer


DURECT CORPORATION

 

INDEX TO EXHIBITS

 

Exhibit
Number


 

Description


99.1   Press Release of DURECT Corporation dated January 26, 2006
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

DURECT to Expand Clinical Program to Additional Surgical Procedures and to Initiate U.S. Clinical Studies and for its Post-Operative Pain Relief Depot

 

Cupertino, CA-

 

January 26, 2006

 

DURECT Corporation (NASDAQ: DRRX - News), an emerging specialty pharmaceutical company, announced today that it plans to expand its worldwide development program for its post-operative pain relief depot, SABER™-Bupivacaine, by initiating additional Phase II studies for soft tissue and orthopedic surgical procedures. In addition, clinical studies will be conducted in the U.S. under the accepted U.S. Investigational New Drug (IND) application for SABER-Bupivacaine.

 

“The recent acceptance of our U.S. IND allows us to initiate clinical studies with some of the leading surgeons in the U.S. in addition to other countries around the world as we expand this clinical development program into additional surgical procedures,” said James E. Brown, President and CEO of DURECT. “DURECT intends to initiate the Phase III clinical program in the second half of 2006.”

 

About SABER-Bupivacaine

 

SABER-Bupivacaine is based on DURECT’s patented SABER delivery technology and is intended to be administered around the surgical site after surgery to provide 3 days or more of local analgesia. DURECT recently announced positive preliminary results for a Phase II dose escalation study in inguinal hernia patients in Australia. DURECT believes that its post-operative pain relief depot, if approved, has the potential to improve pain control, reduce opioid consumption and their associated side effects and hospital stays for patients that undergo surgery.

 

About DURECT Corporation

 

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies that treat chronic debilitating diseases and enable biotechnology products. Additional information about DURECT is available at www.durect.com.

 

DURECT Forward-Looking Statement

 

The statements in this press release regarding DURECT’s products in development, anticipated product benefits, and clinical trial plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT’s ability to successfully enroll and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 filed with the SEC on October 13, 2005 under the heading “Factors that may affect future results.”

 

SOURCE DURECT Corporation

 

CONTACT: Schond L. Greenway, Vice President, Investor Relations and Strategic Planning of DURECT Corporation,

+1-408-777-1417

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