Positive results with MannKind's type 1 diabetes drug please investors

15 August 2013

There was good news for loss-making US drugmaker MannKind (Nasdaq: MNKD), when the company announced positive preliminary results from Study 171, a Phase III clinical trial of Afrezza (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation (Gen2) inhaler (also known as the Dreamboat inhaler), in patients with type 1 diabetes.

Development of Afrezza was stalled a while back, when the US Food and Drug Administration issued a complete response letter, calling for additional information (The Pharma Letter January 21, 2011). Sales of the product, given it finally gains approval, have been forecast as $2 billion to $3 billion. Release of the latest research pushed the company’s shares up as much as 30% to $8.90 in pre-market trading yesterday (August 14).

Having first filed for US approval of Afrezza in 2009, MannKind indicated that it plans to use results from these studies in another application and expects to file with the FDA early in the fourth quarter of this year.

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