-----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, UBfigQReBzx+HefktpaFWcbrIGL95I1CYZ3vcHoE4iYUNFMqzRG618EGizfklgNO 3F7DMt2Kq27JjyFgYPUoDg== 0001193125-06-250014.txt : 20061211 0001193125-06-250014.hdr.sgml : 20061211 20061211064550 ACCESSION NUMBER: 0001193125-06-250014 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061211 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061211 DATE AS OF CHANGE: 20061211 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: 061267136 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

December 11, 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.)

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 December 11, 2006, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing positive Phase I study results with a new product in development. 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 December 11, 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: December 11, 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 December 11, 2006

 

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces Positive Phase I Study Results with New Product in Development

CUPERTINO, CA, December 11, 2006 / PRNewswire-First Call via COMTEX/ — DURECT Corporation (Nasdaq: DRRX) announced today that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.

“We are pleased to add another product candidate to our pipeline and with the rapid progress and positive results thus far,” stated James E. Brown, DVM, President and CEO of DURECT. “As a result of our recent collaboration with Nycomed covering POSIDUR, we are in a stronger financial position and therefore have decided to further develop this product on our own as part of our strategy to become a specialty pharmaceutical company. To that objective, for competitive reasons, DURECT is not disclosing at this time the specific drug delivery technology which underlies DUR-843 as well as the active pharmaceutical agent.”

The objectives of the Phase I clinical studies recently completed were to determine the safety and tolerability of DUR-843 in healthy human volunteers as well as evaluate the pharmacokinetics of the active pharmaceutical agent following administration of the product candidate. In these trials, DUR-843 appeared safe and well-tolerated.

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 focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit www.durect.com.

NOTE: DUR-843 is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT’s product candidate DUR-843, its attributes and commercial potential 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 design, enroll, conduct 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 Form 10-Q dated November 3, 2006 under the heading “Risk Factors.”


SOURCE:

DURECT Corporation

CONTACT:

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

+1-408-777-1417

Media Contact:

Feinstein Kean Healthcare

Jeremiah Hall, Senior Vice President, +415 677-2700, jeremiah.hall@fkhealth.com

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