-----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, ByfIF/EMzT/rY9Wpr7rFmHQmG5lQU+9K6y59txw5yqOwVYCZrUi5UHDe7Q1zYzBb f58dr8jDSXtU72oy9a40Xw== 0001193125-09-177301.txt : 20090818 0001193125-09-177301.hdr.sgml : 20090818 20090818120751 ACCESSION NUMBER: 0001193125-09-177301 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090818 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090818 DATE AS OF CHANGE: 20090818 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: 091021005 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

 

 

UNITED STATES

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

Date of Report: August 18, 2009

(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)

  (Commission File Number)  

(IRS 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)

 

 

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 (see General Instruction A.2. below):

 

¨ 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 18, 2009, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing it has signed a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT’s ORADUR® Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD). 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 18, 2009


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 18, 2009   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 August 18, 2009
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Announces License of ADHD Drug Candidate in Selected Asian and South Pacific Countries to Orient Pharma

CUPERTINO, CA, August 18, 2009 /PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) today announced that it has signed a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT’s ORADUR® Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD). This drug candidate (ORADUR-ADHD) is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of these types of drugs. North American, European, Japanese and select other countries’ rights to this drug candidate are retained by DURECT.

Under this agreement, the parties will collaborate to perform a clinical development program through a Phase II study intended to produce a data package that will support later stage development of the drug candidate by DURECT as well as Orient Pharma in their respective territories. DURECT will be responsible for formulation and study design of the pre-defined clinical program which Orient Pharma will fund and execute. Orient Pharma would be responsible for all remaining development and commercialization activities for this ORADUR-ADHD product in the licensed territory. If commercialized, DURECT would receive a royalty on sales of ORADUR-ADHD by Orient Pharma. Orient Pharma will supply a portion of DURECT’s commercial requirements for ORADUR-ADHD in all territories other than the United States.

“We’re pleased to announce this collaboration with Orient Pharma which will put us in a position to generate Phase II data for our ORADUR-ADHD program, provide us with a commercial supply source as well commercially exploit this product opportunity in this region with an established company,” stated James E. Brown, President and CEO of DURECT. “Abuse of stimulants remains a major healthcare problem and we look forward to working with Orient Pharma to applying our ORADUR technology to this product category.”

“We believe that this ORADUR-ADHD product has the potential to be differentiated from existing products in its class by combining all day efficacy with tamper-resistance, and we are excited to collaborate with DURECT on this opportunity,” stated Peter Tsai, Chairman of Orient Pharma. “This collaboration represents an important step in our company’s establishment as a partner of choice in Southeast Asia for American biopharmaceutical companies.”

Attention Deficit Hyperactivity Disorder (ADHD) is a neurobehavioral condition that is estimated to affect approximately 7.8% of US children ages 4-17, according to the US Centers for Disease Control and Prevention (CDC). The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition presents itself in childhood and can be life long as 65% of children with ADHD continue to present symptoms as adults. According to the CDC, 2.5 million youth (56% of those with a diagnosis) were receiving medical treatment for this disorder. The National Survey on Drug Use & Health estimates that 1.4 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness. Sales of ADHD treatments were approximately $4.0 billion in 2008.

About ORADUR® Technology

The ORADUR Technology is a patented technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of being less prone to common methods of abuse and misuse than other controlled release dosage forms on the market today. REMOXY®, a long acting oral formulation of oxycodone based on the ORADUR Technology intended to treat moderate to severe pain, has been submitted for and is awaiting approval with the U.S. Food and Drug Administration (FDA).

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 FDA or other health authorities.


About Orient Pharma Co., Ltd.

Orient Pharma was established in 2008 and is located in the Central Taiwan Science Park in Yunlin. Orient Pharma is building a new pharmaceutical manufacturing facility that is designed to comply with the international standards of the U.S. FDA and the European PIC/S. The first phase of the project is expected to be finished by late 2009 and the entire construction is slated for completion in 2010.

Orient Pharma is applying its platform technologies for the development of specialty pharmaceutical products and is capable of manufacturing pharmaceutical products under cGMP. Current technologies include multi-stage liquid fill and transdermal. Products under development include a next-generation drug to lower cholesterol, new combinations, as well as others indicated for cardiovascular, Alzheimer’s disease, and neurodegenerative disorders. Orient Pharma will use its new facility to manufacture its own products and also to conduct contract manufacturing business for international pharmaceutical companies.

DURECT Forward-Looking Statement

The statements in this press release regarding ORADUR-ADHD, its potential attributes including tamper-resistant and once-a-day dosing characteristics, intended clinical trials and potential data generated therefrom, future development plans, potential commercialization of ORADUR-ADHD and royalties to be received by DURECT 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, difficulties or delays in the development, testing, regulatory approval, production and commercialization of ORADUR-ADHD, and unexpected adverse side-effects or inadequate therapeutic efficacy of ORADUR-ADHD that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials and tests are not necessarily indicative of future results of clinical trials and tests). Further information regarding these and other risks is included in DURECT’s Form 10-Q dated August 4, 2009 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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