This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

MannKind's Mysterious Lung-Safety Study Is Open But Shhh...Don't Talk About It

VALENCIA, Calif. ( TheStreet) -- MannKind (MNKD) founder and CEO Al Mann has assured investors that positive results from two phase III studies of his inhaled, fast-acting insulin Afrezza due in August will lead quickly to an FDA approval filing.

But no one at MannKind, including Mann, talks at all about a third, ongoing phase III lung safety study of Afrezza. Strange. This 510-patient study, currently open and enrolling, is titled "Evaluate Safety of Technosphere Insulin Inhalation Powder on Diabetic Subjects With Mild Obstructive Pulmonary Disease." Technosphere Insulin Inhalation Powder is Afrezza.

According to the registry, MannKind last updated and verified this large Afrezza lung safety study in February with scheduled completion in 2015.

Remember, MannKind is promising to re-file Afrezza with the FDA before the end of the year on the basis of two efficacy studies known as Affinity-1 and Affinity-2. But if FDA doesn't also want to review data from this separate and equally large lung-safety study set to complete in 2015, why is MannKind spending the money to run it?

One possibility, of course, is that FDA wants more lung safety data on Afrezza. That's not surprising, given the poor tolerability and depressed lung function attributable to Afrezza in a previous, large safety study conducted by MannKind and reported first in 2009. Results from this safety study were included in MannKind's original approval application for Afrezza rejected twice by FDA already.

The two-year study enrolled 2053 patients with Type 1 and Type 2 diabetes and compared changes in lung function between Afrezza or usual diabetic therapy (Usual Care.) MannKind announced results of this Afrezza lung safety study in 2008 and data were presented at a European diabetes conference in 2009. The study was also published in the journal Diabetes, Obesity and Metabolism in February 2012.

MannKind has long claimed the safety study showed no difference in adverse events or lung function between Afrezza-treated patients and those on usual care. The actual data from the study tell a different story.

The drop-out rate for Afrezza patients was 49.4% compared to 30.4% in the usual car arm. Cough was the leading cause of discontinuation for Afrezza patients and was reported as an adverse event by 28% of Afrezza patients overall. Only 4% of patients treated with usual care reported cough as an adverse event.
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
MNKD $0.97 0.00%
AAPL $94.02 0.00%
FB $104.07 0.00%
GOOG $683.57 0.00%
TSLA $162.60 0.00%


Chart of I:DJI
DOW 16,204.97 -211.61 -1.29%
S&P 500 1,880.05 -35.40 -1.85%
NASDAQ 4,363.1440 -146.4150 -3.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs