-----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, AWeGQCGOO66zFDUEOwBu6UgIEE3EYUCoOgDwnkg+fR07o4mWeJzHBJAM6v6+Sdva mDMnunXsJ0XqPkfvKi3H4A== 0001193125-03-063147.txt : 20031017 0001193125-03-063147.hdr.sgml : 20031017 20031017061232 ACCESSION NUMBER: 0001193125-03-063147 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031017 ITEM INFORMATION: Other events FILED AS OF DATE: 20031017 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: 03944796 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 CURRENT REPORT ON FORM 8-K Prepared by R.R. Donnelley Financial -- Current Report on 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

 

October 17, 2003

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)



Item 5.   Other Events and Required FD Disclosure.

 

On October 16, 2003, DURECT Corporation, a Delaware corporation (“DURECT”) issued a press release announcing update to its CHRONOGESIC® program.

 

A copy of DURECT’s press release announcing the update is attached as Exhibit 99.1 hereto and incorporated by reference herein.

 


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: October 17, 2003

      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 October 16, 2003.
EX-99.1 3 dex991.htm PRESS RELEASE DATED 10/16/2003 Prepared by R.R. Donnelley Financial -- Press Release dated 10/16/2003

Exhibit 99.1

 

DURECT Announces Update to CHRONOGESIC Program

 

CUPERTINO, Calif., Oct. 16 /PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today that it has received data from a preclinical animal test with its CHRONOGESIC® (sufentanil) Pain Therapy Product which indicate that a small number of units (less than 2% in total) utilizing the new system design under evaluation by the Company experienced a premature shutdown (stop in delivery of drug).

 

In parallel track with the CHRONOGESIC development program using the current system design, DURECT has been exploring additional mechanisms to prevent any premature shutdown, and has already generated feasibility data relating to these mechanisms.

 

The Company is currently investigating the impact of these new data on the timing of the development program, but the Company expects that this will delay the restart of the product’s phase III clinical program previously anticipated to begin during the second half of 2003.

 

“We were disappointed to receive these unexpected data from the last of a series of confirmatory animal studies which just concluded on October 15,” stated Jim Brown, CEO of DURECT. “We have not observed this phenomenon in any of our previous studies utilizing the revised system design. We continue to believe in the value of the CHRONOGESIC program, and we remain committed to bringing this therapy to the patients.”

 

Conference Call and Webcast Information

 

DURECT Corporation will be hosting a conference call on Friday, October 17, 2003 at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time to discuss these recent developments. Participants can listen to the conference call via webcast on the Company’s website, www.durect.com.

 

DURECT Corporation (www.durect.com) is pioneering the development and commercialization of pharmaceutical systems for the treatment of chronic debilitating diseases and enabling biotechnology-based pharmaceutical products. DURECT’s goal is to deliver the right drug to the right site in the right amount at the right time. In addition to its rights to the CHRONOGESIC® product, DURECT owns three proprietary drug delivery platform technologies, including the SABER Delivery System (a patented and versatile depot injectable useful for protein delivery), the MICRODUR Biodegradable Microparticulates (microspheres injectable system) and the DURIN Biodegradable Implant (drug-loaded implant system).

 

NOTE: CHRONOGESIC®, SABER, MICRODUR and DURIN are trademarks of DURECT Corporation.

 

The statements in this press release regarding DURECT’s products in development and product development 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 complete the design, development, and manufacturing process development of its products, manufacture and commercialize its products, obtain product and manufacturing approvals from regulatory agencies, manage its growth and expenses, manage relationships with third parties, finance its activities and operations, as well as marketplace acceptance of DURECT’s products. Further information regarding these and other risks is included in DURECT’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002 filed with the SEC on March 14, 2003, DURECT’s Quarterly Report on Form 10Q and other periodic reports filed with the SEC under the heading “Factors that may affect future results.”

 

CHRONOGESIC is under development by DURECT and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.

 

CONTACT:

 

Schond L. Greenway,

 

Senior Director, Investor Relations and Strategic Planning of DURECT Corporation

 

Phone: +1-408-777-1417

 


Source: DURECT Corporation

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