Navigation Links
Dong-A PharmTech Co., Ltd. Announces Start of Phase III Trials for Udenafil, Its New Erectile Dysfunction Drug Under Development
Date:11/4/2009

SEOUL, Korea, Nov. 4 /PRNewswire/ -- Dong-A PharmTech Co. Ltd., announced that its U.S. partner, Warner Chilcott plc, has initiated two, phase III trials for udenafil, a new long acting drug under development for erectile dysfunction (ED). Each randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of udenafil, an orally administered selective inhibitor of phosphodiesterase versus placebo. The trials will be conducted in 80 sites in the U.S. and will enroll approximately 1,120 subjects with ED.

Mr. Dong Hyun Park, President & CEO of Dong-A PharmTech, commented that, "We are extremely pleased to be entering the last phase of our udenafil development program in the United States with our partner Warner Chilcott. We are aiming to complete the remaining clinical trials for the udenafil erectile dysfunction program in the U.S. and European Union as well as most other major markets within 2 years. In addition, based on recent positive meetings with the USFDA, we anticipate initiating Phase 2b clinical trials which will evaluate the safety and efficacy of udenafil for benign prostatic hyperplasia (BPH) and pulmonary arterial hypertension (PAH)".

Udenafil was approved for marketing by the Korean Food and Drug Administration in November of 2005 and launched commercially in Korea in early 2006 under the trade name Zydena®. From 2006 to the first half of 2009, over 1,000,000 prescriptions for more than 6 million tablets of Zydena® were written for men with erectile dysfunction in Korea.

Zydena was also approved for marketing by the Russian Food and Drug Administration in July of 2008 and launched commercially in Russia in March 2009 under the trade name Zydena®.

If approved, udenafil is expected to participate in a growing prescription ED market by offering a long acting and safe product that will compete with Viagra® (Pfizer), Cialis (Lilly) and Levitra (Bayer/GSK).

About Dong-A PharmTech Co., Ltd.

Dong-A PharmTech is a late-stage pharmaceutical company incorporated in Korea, focused on the development and commercialization of udenafil worldwide excluding Korea.

Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.

    Contact:
                 Mr. Won Geun KIM
                 General Manager
                 Tel: +82 2 560 8008
                 Fax: + 82 2 563 6517
                 Email: wgkim@donga.co.kr

SOURCE Dong-A PharmTech Co. Ltd.


'/>"/>
SOURCE Dong-A PharmTech Co. Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Dong-A PharmTech Co., Ltd. Announces Portal Hypertension Clinical Trial With Udenafil
2. Access Licenses ProLindac(TM) and MuGard(TM) to JCOM Ltd, an Affiliate of DONG-A Pharmaceuticals in Korea
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
5. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
8. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
9. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
10. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
11. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
(Date:10/4/2017)... OBP Medical , a leading ... today announced regulatory approval from Brazil,s ... Nacional de Vigilância Sanitária (ANVISA)) to market ... with integrated LED light source and smoke evacuation ... of a tissue pocket or cavity during surgical ...
(Date:10/2/2017)... -- Halo Labs announces the European launch of their new low ... MIBio 2017 in Cambridge, U.K on October ... biopharmaceutical samples with unprecedented speed and sensitivity while using far less ... Imaging. ... analysis system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important ... problem. Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed ... darkness or restricted lighting. As such, it eliminates the need to turn on a ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history of ... Brink” is the creation of published author, William Nowers. Captain Nowers and his ... veteran, he spent thirty years in the Navy. Following his career as a ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
Breaking Medicine News(10 mins):