Shares of Mannkind surged on the news that two late-stage trials for the ultra-rapid-acting inhaled insulin product Afresa hit their primary endpoints. That marks a rare bit of good news in a field that has been blighted by failure. Pfizer, Eli Lilly and Novo Nordisk have all given up on once-promising inhaled insulin plans.
Mannkind says it will release more data on Type 1 and Type 2 diabetes patients later this month and will ready a new drug application for the FDA in early 2009.
"We are very pleased to announce the positive outcome of these, the last of our three pivotal Phase III studies," said Dr. Peter Richardson, MannKind's chief scientific officer. "We look forward to presenting more complete data, including analyses of secondary endpoints, as soon as they are available, which are expected before the end of this year.
- here's MannKind's release [1]
Related Articles:
Inhaled insulin shows signs of life after setbacks [2]
Inhaled insulin lung cancer warning riles investors [3]
MannKind bets the farm on inhaled insulin [4] (Nov 2007)
Links:
[1] http://www.fiercebiotech.com/press-releases/mannkind-corporations-two-phase-3-studies-meet-goal
[2] http://www.fiercebiotech.com/story/inhaled-insulin-shows-signs-life-after-series-setbacks/2008-09-16
[3] http://www.fiercebiotech.com/story/inhaled-insulin-lung-cancer-warning-riles-investors/2008-04-09
[4] http://www.fiercebiotech.com/story/mannkind-bets-farm-inhaled-insulin/2007-11-16