CellAct Pharma receives orphan drug designation in EU for cancer drug

16 July 2014

The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists CellAct Pharma orphan drug designation to the company’s CAP7.1, an adapted version of the well-established anticancer agent etoposide, for the treatment of biliary tract cancers.

The granting of European Union orphan drug designation provides CellAct with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralized review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives. CellAct is currently recruiting patients for a randomized, multicenter, proof-of-concept Phase II study with CAP7.1 in adults with refractory biliary tract carcinomas in Germany.

European regulation based on study of oncology patients

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

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