SkyePharma's Flutiform recovers momentum
London, UK-based SkyePharma has completed enrolment of patients into the three double-blind efficacy trials currently underway for Flutiform (a formoterol and fluticasone combination in a metered-dose inhaler), its lead development product for the treatment of asthma.
The agent has seen several recent setbacks in its development. Shares in SkyePharma fell 16.3% to 18 pence on August 8, because the US Food and Drug Administration said that the New Drug Application for Flutiform would be delayed after the agency queried one particular aspect of the design of the clinical trial program (Marketletter August 13). But investors were encouraged by the latest news and the shares gained 3.7% to 13.75 pence on the day full enrollment was announced, December 18.
The three efficacy trials, involving nearly 1,400 patients, will provide core clinical data for the NDA to be filed with the FDA and will also support the European Marketing Authorization Application, the firm noted. The trials are scheduled to be fully completed in April 2008.
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 accountTry before you buy
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze