-----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, OY5j4kTRJTCtjDVSHCacENEsjhJplnFfe8HA02d5irxJuoRm4x1vu2lo3ngBxVja 1GlNueoCozTyLx+3i6ADng== 0001193125-05-201407.txt : 20051014 0001193125-05-201407.hdr.sgml : 20051014 20051014070447 ACCESSION NUMBER: 0001193125-05-201407 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051014 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051014 DATE AS OF CHANGE: 20051014 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: 051137706 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

 

October 14, 2005

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 October 14, 2005, DURECT Corporation, a Delaware corporation (“DURECT”), announced the initiation of dosing for the Phase III clinical studies for the DURIN™-based leuprolide program under development with Voyager Pharmaceuticals for the treatment of Alzheimer’s disease (the Memryte™ implant). This Current Report is filed to disclose nonpublic information required to be disclosed by Regulation FD. 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 October 14, 2005


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 14, 2005   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 14, 2005
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

DURECT Corporation Announces Initiation of Dosing for Phase III Clinical Program for Memryte (DURIN™-Leuprolide Implant) Program Under Development with Voyager Pharmaceuticals

 

Cupertino, CA

 

October 14, 2005

 

DURECT Corporation (NASDAQ: DRRX - News), an emerging specialty pharmaceutical company announced today the initiation of dosing for the Phase III clinical studies for the DURIN™-based leuprolide program under development with Voyager Pharmaceuticals for the treatment of Alzheimer’s disease (the Memryte™ implant).

 

“We are delighted to meet this significant milestone in development,” stated James E. Brown, DVM, President and CEO of DURECT. “It has been a pleasure to work with Voyager on this important program over the last three years to develop a product candidate that utilizes our proprietary drug delivery expertise to treat such a chronic debilitating disease.”

 

Pivotal Phase III Clinical Program Design

 

The pivotal Phase III program will consist of approximately 1,100 patients in two randomized, double blind, placebo controlled, 56-week clinical trials using Memryte as an adjunctive therapy with acetyl cholinesterase inhibitors (ACIs) for the treatment of mild to moderate Alzheimer’s disease.

 

Alzheimer’s disease is an incurable, neurodegenerative disorder that affects over 4 million Americans. This disease is a huge unmet medical problem that typically leads to progressive memory loss, impairments in behavior and language, and physical deterioration. The market potential for Alzheimer’s disease treatments is estimated to be in excess of $10 billion.

 

DURECT’s DURIN biodegradable implant technology is a platform for parenteral delivery of drugs for periods of weeks to six months or more. The technology is based on the use of biodegradable polymer excipients, which have a proven record of safety and effectiveness in approved drug delivery and medical device products.

 

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 or episodic diseases and enable biotechnology products. These platform technologies include the SABER™ Delivery System (a patented and versatile depot injectable useful for protein and small molecule delivery), the ORADUR™ sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the DURIN™ Biodegradable Implant (drug-loaded implant system), the TRANSDUR™ transdermal technology and the MICRODUR™ Biodegradable Microparticulates (microspheres injectable system). DURECT also collaborates with pharmaceutical companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has five disclosed on-going development programs of which four are in collaboration with pharmaceutical partners. Additional information about DURECT is available at www.durect.com.

 

NOTE: SABER™, ORADUR™, DURIN™, TRANSDUR™ and MICRODUR™ are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.


DURECT Forward-Looking Statement

 

The statements in this press release regarding DURECT’s and its collaborative partners’ products in development, anticipated product benefits, and clinical trial results and 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 (and that of its third-party collaborators’, where applicable) abilities 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, Executive Director, Investor Relations and Strategic Planning of DURECT Corporation, +1-408-777-1417

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