Navigation Links
DURECT's Collaboration With Alpharma Clears HSR Review and Is Effective

CUPERTINO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- 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(TM), 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 (

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(R) (morphine sulfate extended-release) Capsules, and the FLECTOR(R) 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(R), POSIDUR(TM), ELADUR(TM), and TRANSDUR(TM)-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

NOTE: KADIAN(R) is a registered trademark of Alpharma Pharmaceuticals LLC. FLECTOR(R) is a registered trademark of IBSA Institut Biochimique SA. POSIDUR(TM), ELADUR(TM) and TRANSDUR(TM) 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."

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Therapure Biopharma Inc. announces collaboration with Induce Biologics Inc.
2. Medivation Announces Expiration of Hart-Scott-Rodino Waiting Period for Collaboration With Pfizer
3. Radiation Therapy Oncology Group and US Oncology Enter Collaboration to Increase Patient Access to National Clinical Trials
4. Genmab Reaches Milestone in Ofatumumab Collaboration
5. Titan Spine Teams Up With Syndicom, Inc. to Utilize Internationally Recognized SpineConnect Collaboration Platform
6. ThalesNano, Inc. Forms Collaborations with Leading US Universities based on the Award Winning H-Cube(R) and H-Cube Midi(TM)
7. Galenea and Otsuka Pharmaceutical Extend & Expand Schizophrenia Research Collaboration
8. Covance and Lilly Finalize 10-Year, $1.6 Billion Strategic R&D Collaboration
9. GeneGo Is Awarded NCI Grant for Development of Systems Biology Database and Tools for Nutrition in Cancer in Collaboration with the FDA
10. RainDance Technologies Signs a Collaboration Agreement with sanofi-aventis and Louis Pasteur University to Launch dScreen Consortium within ALSACE BIOVALLEY cluster
11. Affitech Announces Second Milestone in Roche Antibody Discovery Collaboration
Post Your Comments:
(Date:10/12/2015)... 2015 cell surface marker detection market ... according to a new report by Grand View Research, Inc. ... incidence of oncology diseases and other cell-associated disorders. --> ... reach USD 6.49 billion by 2022, according to a new ... can be attributed to rise in incidence of oncology diseases ...
(Date:10/12/2015)... 12, 2015 LabStyle Innovations Corp. ... Solution, today announced its Medical Director, Dr. Moshe ... MobiHealth,s 5th EAI International Conference on Wireless Mobile ... innovations in mobile and wireless technologies," the conference will ... from October 14 - 16, 2015. The conference is ...
(Date:10/12/2015)... ... 2015 , ... NeuMedics Inc., is a specialty biopharmaceutical company focused on identifying ... chronically be administered as an eye drop, announced today it has been selected to ... taking place October 25th to October 28th at The Cleveland Clinic, Cleveland, Ohio. ...
(Date:10/10/2015)... Maryland , 10. Oktober, 2015 ... Matsui (Abgeordnete der Demokratischen Partei für Kalifornien) ihre ... bis 17. Oktober) in die Aufzeichnungen des Kongresses ... Plasma Protein Therapeutics Association (PPTA) und ihren ... , Hebung des Bewusstseins über Plasmaspenden weltweit ...
Breaking Biology Technology:
(Date:9/28/2015)... , September 28, 2015 According ... (Hardware & Software), Product (Scanner & Others), Application (Access ... Defense, & Others) & Geography Global - Forecast to ... to reach USD 3627.90 Million by 2020, at a ... Browse 65 market data T ables and ...
(Date:9/24/2015)... , Sept. 24, 2015  EyeLock LLC, a market ... its award winning and latest technology in Booth #602 ... California . EyeLock,s iris authentication technology ... unmatched biometric accuracy, making it the most proven way ... uses video technology to deliver a fast and friendly ...
(Date:9/10/2015)... Report Details Emerging Biological ... and Revenue Prospects to Help You Stay Ahead ... new drug classes? Get the latest technological and ... market data and industry knowledge, benefitting your influence. ... and sales predictions. Visiongain,s new study reveals ...
Breaking Biology News(10 mins):