Navigation Links
Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension
Date:5/15/2008

APPENZELL, Switzerland, May 15 /PRNewswire/ -- Ergonex Pharma today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the treatment of pulmonary arterial hypertension (PAH). Terguride is currently being evaluated for PAH in a pivotal Phase II trial in Europe.

"The FDA's grant of orphan drug designation to Terguride for PAH encourages and strengthens our development program by offering regulatory, clinical development and commercial benefits," said Dr Rudolf Reiter, CEO of Ergonex Pharma. "We believe that Terguride can provide a significant therapeutic benefit in PAH by inhibiting excess serotonin signalling."

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases, which affect 200.000 persons or less in the United States. Under the Orphan Drug Act, upon marketing authorization, the FDA does not accept or approve other applications to market the same medicinal product for the same indication for a seven-year period. In addition to potential market exclusivity, orphan drug designation provides protocol assistance, advice on the conduct of clinical trials, tax credits for clinical research expenses, grant funding for research of rare disease treatments and waiver of the Prescription Drug User Fee Act filing fee.

About Terguride

Terguride has strong anti-serotoninergic activity by acting as a potent antagonist on 5-HT2B and 5-HT2A receptors: It has anti-proliferative and anti-fibrotic activity and drives reverse remodelling processes. Serotonin is a signal molecule in the body with many functions. In the blood vessel walls of the lung it stimulates proliferation of smooth muscle cells and narrowing of the blood vessels, which leads to PAH. Excessive proliferative effects of serotonin on the heart contribute directly to progression towards heart failure.

Terguride is cli
'/>"/>

SOURCE Ergonex Pharma GmbH
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
5. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
6. CryoCor Receives FDA Approval for Right Atrial Flutter
7. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
8. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
9. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
10. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
11. The Female Health Company Receives USAID DELIVER PROJECT Order for 5 Million Units
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... WOODCLIFF LAKE, N.J. and SAN DIEGO ... Pharmaceuticals, Inc. (NASDAQ: ARNA ) announced today that ... Phase 3 trials of lorcaserin entitled, "Early Weight Loss While ... 52 Weight-Loss Outcomes," was recently published in the online issue ... The Obesity Society. The objective of these analyses was to ...
(Date:7/30/2014)... NEW YORK , July 30, 2014 /PRNewswire/ ... new products for oncology supportive care, announced that its ... been featured in an article on OncLive.com titled, "Study ... and Neck Cancers."  Dr. Steve Sonis , a ... growing demand seen in the oncology community for evidence-based ...
(Date:7/30/2014)... July 30, 2014 /PRNewswire-iReach/ -- This is a ... Chinese Heparin sodium (CAS 9041-08-1) & calcium (CAS ... information of Heparin sodium (CAS 9041-08-1) & calcium ... technology. The report then explores global and China,s ... calcium (CAS 37270-89-6) listing their product specification, capacity, ...
Breaking Medicine Technology:Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 2Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 3Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 4Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 5Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 6Eisai and Arena Pharmaceuticals Announce Publication of Post-Hoc Analyses of Lorcaserin Phase 3 Clinical Trial Results in Obesity 7Access Pharmaceuticals Featured On OncLive.com 2Access Pharmaceuticals Featured On OncLive.com 3Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 2Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 3Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 4Heparin Sodium & Calcium Industry for Global and Chinese Markets Forecast to 2019 5
... number of costs associated with nonprescription drug manufacturing and ... half years. Certain material costs for plastic bottles and ... time, increasing packaging expenses. Advertising and marketing expenses continue ... of marketers reduced advertising costs in 2009, and in ...
... ERES ) announced today that it will release ... 4, 2010, after the market closes. After the release, the ... that day. For the conference call, interested ... or 1-412-858-4600 when calling internationally. There will be a playback ...
Cached Medicine Technology:Nonprescription Drugs Cost Structures Fluctuate with Increased Cost of Goods, According to Kline 2Nonprescription Drugs Cost Structures Fluctuate with Increased Cost of Goods, According to Kline 3ERT to Announce Third Quarter 2010 Results on November 4, 2010 2
(Date:7/31/2014)... July 31, 2014 Eden Lew ... ‘Chuck’ Forman - Crawford Technologies" Scholarship through ... was created to honor the contributions Chuck Forman ... his industry. Chuck lost his battle with cancer ... outstanding, and we are thrilled to see her ...
(Date:7/31/2014)... Chicago, IL (PRWEB) July 31, 2014 ... Brickner; “no, not the summer’s hottest metal bands ~ ... Homeostatic Cannabinoid Science ~ Publius’ July Roundup, new ... articles are noted on homeostasis and the cannabinoid system ... modulation of our health and wellness: three directly on ...
(Date:7/31/2014)... 2014 Daily Gossip reveals in its review ... discover some breakthrough weight loss tips. , The author ... recommendations are very simple to implement. Users don’t have to ... no need to start counting calories. , The Flat ... fact created a 12 weeks weight loss program to help ...
(Date:7/31/2014)... 2014 In its latest blog post, ... that having family close by during a stay in rehab ... process is successful, is looking at 11 drug addiction facts ... be. , “While some kids learn a little ... class, the coverage is typically woefully inadequate,” commented Best Drug ...
(Date:7/31/2014)... 2014 Dolce Vite Chocolatto®, world's ... in New York's favorite specialty coffee roaster and DUMBO ... for their commitment to Fair Trade coffee and was ... the new sensation from Italy as the world’s best ... highly popular Italian dessert descended from European Royalty. Prepared ...
Breaking Medicine News(10 mins):Health News:Eden Lew Recipient of 2014 EDSF Scholarship Honoring Chuck Forman 2Health News:Eden Lew Recipient of 2014 EDSF Scholarship Honoring Chuck Forman 3Health News:Homeostatic Cannabinoid Science ~ Publius’ July Roundup on the Bryan William Brickner Blog 2Health News:New Best Drug Rehabilitation Blog Posts Looks at 11 Drug Addiction Facts they Don’t Teach in School 2Health News:Dolce Vite Chocolatto® - World's Best Thick Dark Italian Hot Chocolate Now Available at NYC's Favorite Cafe Brooklyn Roasting Company 2
... and 24 are smokers, and most say they keep lighting up ... have found that when it comes to quitting, a little bit ... plan in helping women not only keep off the weight, but ... to keep their weight down and for body image reasons, and ...
... in breakthrough creativity in the DTC category, Med Ad ... Wellness as the winner of both the Most Creative ... commenting on the awards, Saatchi & Saatchi Wellness Managing ... advertising icon Helayne Spivak and I knew we needed ...
... diabetes therapy, positively influencing compliance and persistency; electronic ... of dispensing ACCU-CHEK(R) test strips.INDIANAPOLIS, April 24 ... eVoucherRx(TM) pilot program in Florida, designed to make ... their co-pay savings on ACCU-CHEK test strips. The ...
... lowers patients, financial responsibility for their diabetes therapy, ... works in real time at point of dispensing ... today the launch of its new eVoucherRx(TM) pilot ... for patients with diabetes to receive their co-pay ...
... continuing to rise even though the number of cases ... reveals. , The report entitled Cancer incidence, mortality, treatment ... 1994-2004, was compiled by the Northern Ireland Cancer Registry ... Registry (NCRI) of Ireland, in Cork. , This is ...
... help look out for seniors, welfareDETROIT, April 24 ... the lookout and help identify potentially vulnerable elderly customers ... more necessary as Michigan,s economy continues to tumble."Times are ... to do our part to help ensure people don,t ...
Cached Medicine News:Health News:Mind over muscle 2Health News:Saatchi & Saatchi Wellness Wins Creative Awards Honored At 20th Annual Manny Awards 2Health News:Roche Announces New Co-pay Program in Florida that Makes It Easier for Patients with Diabetes to Receive Savings on ACCU-CHEK(R) Blood Glucose Test Strips 2Health News:Roche Announces New Co-pay Program in Florida that Makes It Easier for Patients with Diabetes to Receive Savings on ACCU-CHEK(R) Blood Glucose Test Strips 3Health News:Roche Announces New Co-Pay Program in California That Makes it Easier for Patients With Diabetes to Receive Savings on ACCU-CHEK(R) Blood Glucose Test Strips 2Health News:Roche Announces New Co-Pay Program in California That Makes it Easier for Patients With Diabetes to Receive Savings on ACCU-CHEK(R) Blood Glucose Test Strips 3Health News:Survival rates for cancer rise across Ireland 2Health News:Survival rates for cancer rise across Ireland 3Health News:DTE Energy Asks Employees to Help Safeguard Customers 2