-----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, Qq3Q1WzVJC4WfU2qhrlns8PsW4xhdMVQpyHpZ/ZdTJtxQSW05HET47dtszHbdVKR tH9bX/IcnldDWOYpk6OwnA== 0001193125-06-022892.txt : 20060208 0001193125-06-022892.hdr.sgml : 20060208 20060208064800 ACCESSION NUMBER: 0001193125-06-022892 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060208 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060208 DATE AS OF CHANGE: 20060208 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: 06587094 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

 

February 8, 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 February 8, 2006, DURECT Corporation, a Delaware corporation (“DURECT”), announced anticipated development program milestones for fiscal year 2006. 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 February 8, 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: February 8, 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 February 8, 2006
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

DURECT Corporation Announces Anticipated Development Program Milestones for Fiscal Year 2006

 

Cupertino, CA-

 

February 8, 2006

 

DURECT Corporation (NASDAQ: DRRX) today announced its intended development milestones for fiscal year 2006.

 

“These announced milestones are intended to assist the investment community to track our progress throughout the coming year,” said James E. Brown, President and CEO of DURECT. “DURECT will continue to drive forward our development programs in 2006. In addition, we intend to build-out our commercial specialty pharmaceuticals infrastructure and continue to forge commercial alliances for our products and technologies that build lasting value for our shareholders.”

 

Anticipated Development Program Milestones

 

Post-Operative Pain Depot

 

    Our post-operative pain relief depot is based on our 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.

 

    Within the first half of 2006, we intend to initiate additional Phase II studies in the U.S. for soft tissue and orthopedic surgical procedures, as well as continue our clinical studies outside of the U.S.

 

    We intend to present additional Phase II data in the first half of 2006.

 

    We intend to initiate the Phase III clinical program in the second half of 2006.

 

New Development Product

 

    We intend to complete a Phase I clinical study for a new development product during the second half of 2006.

 

    DURECT retains full rights to this new development product.

 

Remoxy™ (Collaboration with Pain Therapeutics, Inc. and its commercialization sub-licensee King Pharmaceuticals)

 

    Remoxy is a novel long-acting oral formulation of oxycodone based on DURECT’s ORADUR™ technology, a proprietary oral sustained release technology with several potential abuse deterrent properties.

 

    We intend to support the ongoing Phase III clinical program conducted by our commercialization partners. Pain Therapeutics and its commercialization sub-licensee King Pharmaceuticals have announced their intention to initiate the pivotal Phase III clinical study in the first half of 2006.

 

Transdermal Sufentanil Development Product (U.S. collaboration with Endo Pharmaceuticals)

 

    Our transdermal sufentanil patch (significantly smaller than the size of currently marketed transdermal fentanyl patches for a therapeutically equivalent dose) is intended to provide extended chronic pain relief for up to seven days, compared to three days of relief provided by currently available opiate patches.

 

    Our partner, Endo Pharmaceuticals, intends to conduct additional clinical studies in chronic pain patients during the year.


New ORADUR-based Opioid Development Product (Collaboration with Pain Therapeutics, Inc. and its commercialization sub-licensee King Pharmaceuticals)

 

    Our partner, Pain Therapeutics and its sub-licensee King Pharmaceuticals, have announced their intention to initiate Phase I clinical testing for the second ORADUR-based abuse deterrent sustained release oral formulation of an undisclosed opioid during the second half of 2006.

 

Memryte™ (Collaboration with Voyager Pharmaceuticals)

 

    Memryte is a novel treatment for patients suffering from Alzheimer’s disease, based on DURECT’s DURIN™ controlled release technology, a proprietary drug-loaded biodegradable implant.

 

    Our partner, Voyager Pharmaceuticals, has stated its intention to complete patient enrollment for the first Phase III clinical study in the second half of 2006.

 

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.

 

NOTE: SABER™, ORADUR™, DURIN™ and TRANSDUR™ 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 development products, their designs and intended uses, and DURECT’s and our collaborators’ product development 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 (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 development product, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the development product, as well as marketplace acceptance of the development product. 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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