Cancer drug Apealea submitted to EMA

9 February 2016

A new ovarian cancer drug has been submitted for marketing authorization to the European Medicines Agency (EMA) by Swedish firm Oasmia Pharmaceutical.

Oasmia (Nasdaq: OASM) has made the application for its lead cancer product Apealea (also known as Paclical). Apealea is a formulation of paclitaxel based on the patented excipient platform XR-17, which forms micellar nanoparticles with paclitaxel.

Oasmia executive chairman Julian Aleksov said: "After many years of significant efforts by everyone involved in this project, it is with great satisfaction that we are finally able to announce the regulatory filing of an application for marketing authorization of Apealea in the EU. Apealea, once approved, we believe would be able to take a share of the market for cytostatics in EU, which currently amounts to more than 5 billion euros [$5.57 billion] annually."

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