-----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, VgvHl9QhgMZtKZbWhudSEmyt23LwLzqubcvRunAD5StEZJ9/sFMwjlHzNQ9lDiTb yTj+11nGIIDPZ0r689GcCQ== 0001193125-08-185443.txt : 20080827 0001193125-08-185443.hdr.sgml : 20080827 20080827161606 ACCESSION NUMBER: 0001193125-08-185443 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080827 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080827 DATE AS OF CHANGE: 20080827 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: 081042240 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

August 27, 2008

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 August 27, 2008, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release reporting that Pain Therapeutics (Nasdaq: PTIE), its licensee, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioid pain drug candidate based on DURECT’s patented ORADUR™ technology. 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 August 27, 2008


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: August 27, 2008   By:  

/s/    Matthew J. Hogan

    Matthew J. Hogan
    Chief Financial Officer


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

99.1

   Press Release of DURECT Corporation dated August 27, 2008
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Announces the IND Submission for a Third Abuse-Resistant Opioid Pain Medication based on its ORADUR™ Technology

CUPERTINO, CA, August 27, 2008 /PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) today reported that Pain Therapeutics (Nasdaq: PTIE), its licensee, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioid pain drug candidate based on DURECT’s patented ORADUR™ technology. This is the third ORADUR-based opioid drug candidate covered by DURECT’s collaboration with Pain Therapeutics, for which King Pharmaceuticals (NYSE: KG) holds the commercialization rights. Pain Therapeutics and King Pharmaceuticals have stated that they expect to announce shortly the initiation of a clinical study with this new investigational drug candidate.

“We are very pleased with the progress and speed with which Pain Therapeutics and King Pharmaceuticals are developing this series of four opioids licensed from us,” stated James Brown, Chief Executive Officer of DURECT. “This marks another milestone for our ORADUR technology as a versatile platform that provides for the controlled delivery of pharmaceuticals that are commonly abused.”

This new drug candidate is the third ORADUR-based opioid drug to enter development. The first drug candidate, REMOXY® (ORADUR-based oxycodone), submitted a New Drug Application with the FDA on June 10, 2008 and has been granted Priority Review Designation by the FDA. Pain Therapeutics has previously announced positive results from a Phase I clinical trial for a second of these drug candidates. The active pharmaceutical drug in the second and third ORADUR-based opioid drug candidate has not been disclosed.

About ORADUR™ Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of being less prone to abuse (e.g. by crushing or water extraction) than other controlled release dosage forms on the market today.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology which incorporate four specified opioid compounds. Under the license agreement, DURECT is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates. In addition, if commercialized, DURECT will receive royalties for REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net sales of the drug candidate depending on sales volume as well as a mark-up on DURECT’s supply of key excipients used in the manufacture of the licensed drug candidates. Pain Therapeutics sublicensed the commercialization rights of REMOXY and other licensed drug candidates to King Pharmaceuticals in November 2005.

About DURECT Corporation

DURECT is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR™, and TRANSDUR™-Sufentanil. DURECT’s proprietary oral, transdermal and injectable depot delivery


technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit www.durect.com.

NOTE: POSIDUR™, SABER™, ORADUR™, TRANSDUR™, and ELADUR™ are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been 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 REMOXY and the second and third abuse-resistant opioid pain medicines under development with King Pharmaceuticals and Pain Therapeutics, their potential attributes and market potential, development plans and future clinical trials 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) 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 product candidate, obtain regulatory 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 August 8, 2008 under the heading “Risk Factors.”

SOURCE:

DURECT Corporation

CONTACT:

Matthew J. Hogan, Chief Financial Officer, DURECT Corporation, +1-408-777-4936

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