Forest Labs and Almirall opt to delay US filing for combo COPD drug

15 August 2013

USA-based Forest Laboratories (NYSE: FRX) and Spain’s largest drugmaker Almirall (ALM:MC) said late yesterday (August 14) that they will delay the planned fourth-quarter 2013 submission of a New Drug Application for the combination of aclidinium bromide, a long acting muscarinic antagonist and formoterol fumarate, a long acting beta agonist, for the indication of chronic obstructive pulmonary disease (COPD).

The news pushed Almirall’s shares 7.5% lower to 9.66 euros in early morning trading, while Forest’s shares dipped just 0.14% to $43.28 in after-market trading in New York last night.

This decision was based on comments provided by the US Food and Drug Administration at a recent pre-NDA meeting. The delay is related to resolving chemistry, manufacturing and control (CMC) specifications associated with the combination formulation, the companies noted.

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