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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Biotech Stock Mailbag: MannKind, Osiris, BioCryst, Vical, Amarin

BOSTON (TheStreet) -- This is the "Catching Up With Stuff I Missed While On Vacation" Biotech Stock Mailbag.

The Afrezza data, as disclosed by MannKind (MNKD) last week, are:

1. Mediocre.

2. Incomplete.

3. "Positive" if one defines the term only as a drug that technically meets a study's primary endpoints but with data that are neither exciting nor groundbreaking. (See: Mediocre.)

4. Barely approvable, but only if 1) MannKind isn't hiding additional negative data, or 2) FDA doesn't give a crap and simply wants Al Mann to go away. (See: Incomplete.)

5. Insufficient to support MannKind's $1.7 billion market value. (Add in debt, options, warrants and restricted stock, MannKind's enterprise value is a voluminous $2.7 billion.)

In the AFFINITY-1 study of Type 1 diabetics (also known as Study 171), Afrezza delivered via the second-generation "Dreamboat" inhaler was numerically inferior to Novo Nordisk's (NVO) Novolog in terms of A1c reduction, the study's primary endpoint. (-0.21% vs. -0.40% A1c reduction.)

The upper end of the confidence interval for the difference between Afrezza and Novolog was 0.36%, which didn't exceed the 0.40% difference that would have caused the study to fail. Therefore, MannKind can claim Afrezza Dreamboat is statistically non-inferior to Novolog -- hence a "positive" study -- but just barely.

Afrezza Dreamboat performed worse than Novolog in terms of the percentage of Type 1 patients achieving A1c levels of less than 7% or 6.5% -- important markers of glucose control.

Afrezza demonstrated a numerically lower severe hypoglycemic event rate than Novolog but the difference was not statistically significant. MannKind didn't disclose exact numbers.

An important goal of the AFFINITY-1 study was to demonstrate equivalence between the new Dreamboat inhaler and the older Medtone inhaler. Here, MannKind is being very opaque about results, stating only that the two devices were "comparable" with respect to lung function, as measured by FEV1. MannKind did not disclose any efficacy results from the Medtone arm of the study. The company clearly has the data, so why is it being withheld?

Both Afrezza inhalers cause decreased lung function in patients. MannKind says the lower FEV1 is not clinically significant, but of course, this will be a safety issue only settled by FDA and/or an advisory panel. Some 30% of the patients using the Afrezza Dreamboat inhaler reported cough as an adverse event.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,063.99 -34.46 -0.20%
S&P 500 2,003.12 -0.25 -0.01%
NASDAQ 4,587.0320 +6.7610 0.15%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs