CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

7 July 2014
casi-big

US-based pharmaceutical company CASI (Nasdaq: CASI), which develops therapeutics for the treatment of cancer and other diseases, has received Orphan Drug designation from the US Food and Drug Administration for its orally-active treatment of hepatocellular carcinoma (HCC).

The Aurora A/aniogenic kinase inhibitor, ENMD-2076, has a unique kinase selectivity profile. It has been granted orphan drug status for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.

Orphan Drug designation is granted by the FDA where therapeutics will treat rare diseases, affecting less than 200,000 people in the USA. This designation entitles the sponsor to seven years of market exclusivity, and opportunities for additional funding and expert protocol assistance.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical