News briefs from Bayer, AstraZeneca and Valeant/Galderma

6 December 2012

German drug major Bayer (BAYN: DE) and partner Regeneron (Nasdaq: REGN) submitted a marketing application to the European Medicines Agency seeking approval of Eylea (aflibercept solution for injection) for macular edema) following central retinal vein occlusion. The submission is based on data from Phase III COPERNICUS and GALILEO studies.

The news, along with the European approval of its new long-term contraceptive system Jaydess a day earlier (The Pharma Letter December 6), pushed Bayer's shares 3.4% higher to 72.54 euros, compared with a 1.1% rise in the Xetra Dax index.

Eylea was approved in the USA for the treatment of wet AMD in November 2011 and for macular edema following CRVO in September 2012. It was also approved in Europe, Japan, Australia, and in several other countries earlier this year for use in wet AMD. Phase III trials are currently under way with Eylea in the treatment of diabetic macular edema (DME), branch retinal vein occlusion (BRVO), and myopic choroidal neovascularization (mCNV).

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