Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

IST Drug Receives Orphan Drug Status

By Drug Discovery Trends Editor | June 27, 2011

Australian monoclonal antibody company, Immune System Therapeutics Limited (IST), announced that its antibody treatment for terminal blood cancer had received Orphan Drug Designation from US health regulators.

Orphan drug status is granted by the United States Food and Drug Administration (FDA) to drugs that treat rare diseases and to diseases that have few available treatments. It also gives the drug maker marketing exclusivity if approved, during which time competing drug makers cannot enter with rival treatments. In the United States, the effective period of exclusivity for orphan drugs is now 12 years with the potential for an accelerated review process by the FDA.

IST Chief Executive Officer, Mr Alan Liddle, said, “This is another positive step towards achieving our business goal of developing an effective treatment for patients suffering from multiple myeloma.  We are making excellent progress towards putting in place a robust global licensing structure that will expedite the clinical and regulatory processes needed to commercialise this promising new medical treatment.”

The FDA granted orphan drug designation for MDX-1097 based on review of the application, which included clinical and preclinical data demonstrating a favorable efficacy and safety profile.

On 17 June, IST announced it would expand the Phase 2 clinical trial of MDX-1097 in Australia following encouraging responses from the first dosed patients and a positive review of safety and efficacy data by an independent Data Monitoring Committee.

The Orphan Drug Designation is the first awarded to IST for its portfolio of antibody platform technologies currently being developed to target and treat a range of other cancers and diseases with major unmet clinical needs.

Date: June 26, 2011
Source: Immune System Therapeutics Limited 


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50