-----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, SmhNl6iMTigt9qXPIH59brH5bzQZHjRBOwWMV+uL/APtYFCJINxKC4I+bErIt7ag V99S70v+FqkPxsRJbIGc/A== 0001193125-07-143740.txt : 20070627 0001193125-07-143740.hdr.sgml : 20070627 20070627091700 ACCESSION NUMBER: 0001193125-07-143740 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070627 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070627 DATE AS OF CHANGE: 20070627 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: 07942621 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

June 27, 2007

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.)

2 Results Way

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 June 27, 2007, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing the initiation of the sufentanil patch Phase II study by Endo Pharmaceuticals. 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.

(d) Exhibits

 

99.1    Press Release of DURECT Corporation dated June 27, 2007

 


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: June 27, 2007

    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 June 27, 2007

 

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Announces the Initiation of Sufentanil Patch Phase II Study by Endo Pharmaceuticals

CUPERTINO, CA, June 27, 2007/ PRNewswire-First Call via COMTEX/ — DURECT Corporation (Nasdaq: DRRX) announced today that Endo Pharmaceuticals Inc. (Nasdaq: ENDP) has commenced its Phase II clinical program designed to evaluate the conversion of patients being treated with various opioids to sufentanil patches utilizing DURECT’s TRANSDUR™ technology. DURECT had previously announced positive results from an initial Phase II clinical study conducted by DURECT utilizing patches made by DURECT; that earlier study was an open label study designed to evaluate the transition of chronic pain patients from Duragesic® (transdermal fentanyl patch) to the sufentanil patch.

“This is an important step forward for this program. Because the sufentanil patch is designed for once-a-week dosing, we believe it will provide meaningful patient benefits if approved,” stated James Brown, President and CEO of DURECT Corporation.

DURECT’s proprietary sufentanil patch is intended to provide extended chronic pain relief for up to seven days from a single application, as compared to the three days of relief provided with currently available opioid patches. DURECT anticipates that the small size of the sufentanil patch, potentially as small as 1/5th the size of currently marketed transdermal fentanyl patches for a therapeutically equivalent dose, may offer improved convenience and compliance for patients.

In March 2005, DURECT entered into an agreement granting Endo exclusive rights to develop, market and commercialize the sufentanil patch in the U.S. and Canada.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company developing pharmaceutical systems based on its proprietary drug delivery platform technologies. The Company currently has a number of late-stage pharmaceutical products in development addressing large markets in pain management, with a number of research programs underway targeting chronic disease and other therapeutic areas. For more information, please visit www.durect.com.

Forward-Looking Statement

The statements in this press release regarding the sufentanil patch, its potential performance and attributes, and future development plans for the sufentanil patch 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, Endo and our abilities to design, enroll, conduct and complete clinical trials, obtain successful results from such clinical trials, complete the design, development, and manufacturing process development of the sufentanil patch, obtain regulatory and manufacturing approvals from regulatory agencies, and manufacture and commercialize the sufentanil patch, as well as marketplace acceptance of the sufentanil patch. Further information regarding these and other risks is included in DURECT’s Form 10-Q dated May 9, 2007 under the heading “Risk Factors.”

 


NOTE: TRANSDUR™ is a trademark of DURECT Corporation. DURECT’s sufentanil patch is under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.

SOURCE DURECT Corporation

CONTACT:

Matthew J. Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936

Media Contact:

Feinstein Kean Healthcare

Jeremiah Hall, Senior Vice President, 415 677-2700, jeremiah.hall@fkh

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