Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Aspireo Receives Positive Opinion from EMA for Orphan Disease Designation for Somatoprim

Published: Monday, November 26, 2012
Last Updated: Monday, November 26, 2012
Bookmark and Share
Somatoprim recommended for designation as orphan medicinal product for acromegaly.

Aspireo Pharmaceuticals Limited has announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion on an application for orphan medicinal product status for Aspireo’s Somatoprim (DG3173) for the treatment of acromegaly.

The positive opinion and recommendation has been forwarded to the European Commission for approval.

The designation would grant Aspireo ten years of marketing exclusivity in the European Union upon obtaining market authorization as an orphan medicinal product. In addition, Aspireo would benefit from reduced regulatory fees.

“EMA’s decision to recommend Somatoprim for orphan medicinal product status is an important milestone in the development of this drug”, said Carsten Dehning, CEO of Aspireo.

Dehning continued, “By this resolution, EMA recognizes the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it. The ongoing clinical phase 1b and phase 2a studies are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients.”


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Researchers Find Key Player in Diabetic Kidney Disease Through Power of Metabolomics
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Adaptimmune’s NY-ESO-1 TCR-engineered T-Cells Demonstrate Durable Persistence
Study has been published in Nature Medicine.
First Made-in-Singapore Cancer Drug Enters Clinical Testing
The drug prevents cancer progression and paves the way for new advancements in cancer therapeutics.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!