BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Ester Neurosciences Ltd. Gets FDA Orphan Drug Status For Myasthenia Gravis


10/19/2005 5:09:15 PM

HERZLIA, Israel--(BUSINESS WIRE)--Nov. 24, 2003--Ester Neurosciences announced today that the U.S. Food and Drug Administration has granted the company Orphan Drug Designation status for Monarsen, (formerly known as EN101), for the treatment of myasthenia gravis (MG).

Orphan Drug Designation status gives Ester, upon marketing approval, the exclusive right to market a drug of this kind for MG in the US for seven years. In addition to marketing exclusivity, the advantages of the designation include eligibility for research grants to conduct clinical trials, certain tax benefits, and an exemption from certain user fees at the time of submission for marketing approval of a new drug application. A similar Orphan Drug application has been made to European regulatory authorities.

"Obtaining orphan drug designation marks an important step in our regulatory strategy for Monarsen," said Dr. Eli Hazum, CEO of Ester Neurosciences.

"Current MG treatments which include anti-cholinesterases, steroids and immunosuppressants, offer limited efficacy and often cause unpleasant and sometimes dangerous side effects. Monarsen offers the prospect of an efficacious and safe product that can address a very large market," added Dr. Hazum.

The results of a successful Phase Ib trial for Monarsen were presented at a special Late Breaking Science session of the National Academy of Neurology earlier this year.

The breakthrough study was the first demonstration of the safe and effective use of an orally-administered anti-sense therapy for a neurological disease.

This study, where sixteen patients received oral liquid Monarsen, demonstrated significant improvement in MG symptom severity, with no cholinergic effects, nor significant adverse events. Fourteen out of sixteen patients had better scores on the Quantitative Myasthenia Gravis (QMG) scale on the last day of dosing as compared to the initial baseline. Improvement of total QMG score for these days ranged from 27.8% to 53.4% (p less than 0.01). The Phase Ib trial results showed that Monarsen appears to have superior efficacy, longer duration of action and a more favorable side effects profile than currently used medications. Patient recruitment for extended clinical trials with Monarsen is underway.

Monarsen is based on pioneering research carried out by Prof. Hermona Soreq of the Hebrew University, who serves as Ester's Chief Scientific Advisor. Monarsen offers a novel mechanism of action for the control of an isoform of the acetylcholinesterase enzyme that is believed to play a key role in the onset and progression of MG.

Myasthenia gravis is a chronic and debilitating autoimmune disease in which the body's immune system attacks acetylcholine receptors at the neuromuscular junction, interfering with normal muscular function. MG is characterized by general muscle weakness and excessive fatigue. In severe cases the disease can involve the respiratory muscles, causing potentially life-threatening respiratory failure.

Ester Neurosciences Ltd. is a clinical stage biotech company committed to the discovery and development of novel therapeutic products for the treatment of neurological disorders.

For more information visit www.esterneuro.com or contact: Eli Hazum, PhD Ester Neurosciences 11 Hamanofim Street Herzlia Pituach, Israel Tel: 972 9 9601900 Fax: 972 9 9542266 ehazum@esterneuro.com

Contact:

Ester Neurosciences Eli Hazum, 972 9 9601900 Fax: 972 9 9542266 ehazum@esterneuro.com

Source: Ester Neurosciences



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES