-----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, E+vTlyfa/rVNLONS/Ur94JWAl2cRZpZ5leRZ87XiuJ0qOdIixNhDpRhJiwvJ57vb GgjUHgzG+muDSLinlv213w== 0001193125-08-218434.txt : 20081029 0001193125-08-218434.hdr.sgml : 20081029 20081029073141 ACCESSION NUMBER: 0001193125-08-218434 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081029 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081029 DATE AS OF CHANGE: 20081029 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: 081146334 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 29, 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 October 29, 2008, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing that its previously announced development and license agreement with Alpharma Ireland Limited, an affiliate of Alpharma Inc. (NYSE: ALO), granting such party the exclusive worldwide rights to develop and commercialize ELADUR™, DURECT’s investigational transdermal bupivacaine patch, has cleared review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and has become effective.

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 October 29, 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: October 29, 2008     By:   /s/ James E. Brown
     

James E. Brown

President and Chief Executive Officer


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

99.1    Press Release of DURECT Corporation dated October 29, 2008
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT’s Collaboration with Alpharma Clears HSR Review and is Effective

CUPERTINO, CA, October 29, 2008 / PRNewswire-First Call via COMTEX/ — DURECT Corporation (Nasdaq: DRRX) announced today that the previously announced development and license agreement with Alpharma Ireland Limited, an affiliate of Alpharma Inc. (NYSE: ALO), granting such party the exclusive worldwide rights to develop and commercialize ELADUR™, DURECT’s investigational transdermal bupivacaine patch, has cleared review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and has become effective.

Under the terms of the agreement between Alpharma Ireland Limited and DURECT, Alpharma has paid DURECT an upfront license fee of $20 million, with possible additional payments of up to $93 million upon the achievement of predefined development and regulatory milestones spread over multiple clinical indications and geographical territories as well as possible additional payments of up to $150 million in sales based milestones. If ELADUR is commercialized, Durect would also receive a royalty on product sales. Alpharma will control and fund the development program.

“We’re pleased to be working on the development and commercialization of this product candidate with a team at Alpharma that has been very creative and aggressive in building a leading pain franchise,” stated James E. Brown, President and CEO of DURECT.

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application. DURECT has previously announced positive results for ELADUR from a 60 patient Phase IIa clinical trial of patients suffering from PHN. A poster describing this study was presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and is accessible on DURECT’s website (http://www.durect.com/wt/durect/page_name/Publications).

The US Food and Drug Administration (FDA) has granted to DURECT orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia (PHN). Bupivacaine is a long-acting, local anesthetic drug used in regional anesthesia for local tissue infiltration, nerve block, and epidural and intrathecal anesthesia. If ELADUR is the first bupivacaine product approved for PHN, under the 1983 Orphan Drug Act, ELADUR would receive seven years of market exclusivity following the approval of the product by the FDA.

About Alpharma

Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 80 countries. Alpharma has a growing branded pharmaceutical franchise in the U.S. pain market with its KADIAN® (morphine sulfate extended-release) Capsules, and the FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%. Alpharma is also internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.


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: KADIAN® is a registered trademark of Alpharma Pharmaceuticals LLC. FLECTOR® is a registered trademark of IBSA Institut Biochimique SA. POSIDUR™, ELADUR™ and TRANSDUR™ are trademarks of DURECT Corporation. 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.

Forward-Looking Statement

The statements in this press release regarding ELADUR, its anticipated attributes and commercial potential, its potential to receive seven years of market exclusivity as an orphan drug and the milestone and royalty payments and other consideration that may be potentially paid to DURECT under DURECT’s license agreement with Alpharma Ireland Limited 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, the risk that ELADUR may not be the first bupivacaine product approved for PHN, Alpharma’s and DURECT’s ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of ELADUR, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize ELADUR, marketplace acceptance of the product candidate and that the agreement may be terminated under conditions specified in the agreement. Further information regarding these and other risks is included in DURECT’s Form 10-Q dated August 8, 2008 filed with the Securities and Exchange Commission under the heading “Risk Factors.”

SOURCE:

DURECT Corporation:

Matthew J. Hogan

Chief Financial Officer

DURECT Corporation

408-777-4936

Matt.hogan@durect.com

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