This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Medivation: Biotech Stock Mailbag

BOSTON ( TheStreet) -- Medivation's (MDVN - Get Report) Alzheimer's drug, Dimebon, failed an important phase III study, the company announced today.

Sigh. Welcome to a depressing, bonus Biotech Stock Mailbag where I will take my lumps and try to dissect some lessons learned.

Medivation's Next Moves

I wrote an account of the failed Dimebon study earlier today.

Via Twitter, @xietrank writes, " U go 2 hell."

Along those same lines, Stan P. emails, " Nice job, chump. How do you feel now?"

I feel bad. I feel disappointed. I was never a table-thumping Medivation bull when it came to the Dimebon study results in Alzheimer's, but I did give the study a 60:40 chance of being successful. Clearly, I was very, very wrong on that count. My apologies all around.

@bobbandera tweets, " Can't trust clinical trials in Russia. Phase II was done there."

Yes. One of the big lessons from this carnage is that investors should think twice (three, four or five times, perhaps) before believing phase II data generated from studies conducted in Russia -- or from Eastern Europe for that matter.

Recall that the phase II Dimebon study was conducted in Russia and was amazingly positive. Too positive, it turns out now, since it's clear those results were an outlier at best, or, at worst, were somehow mis-interpreted or even manufactured.

In this case, the Russian data were heavily scrutinized, picked over, audited and even published in the Lancet, a well-respected medical journal. None of that mattered.

If you're keeping score, Poniard Pharmaceuticals (PARD), Novelos Therapeutics (NVLT.OB) and Cell Therapeutics (CTIC - Get Report) have all fallen prey to the "Russian data" sinkhole. The only company I can think of that succeeded with a phase III study conducted almost entirely in Russia was Abraxis BioScience (ABII) and its breast cancer drug Abraxane.

Tom M. emails, " The Dimebon result is a clear negative, but is there anything positive to salvage from the study? What happens to the other Dimebon studies in Alzheimer's?"

Medivation disclosed more data in Wednesday's press release than I expected, not much of it promising. It seems clear that Dimebon didn't provide any benefit at all compared to placebo when patients were measured by ADAS-cog and CIBIC-plus, the two most important cognitive and memory scales used in Alzheimer's studies.

The placebo patients did remain essentially stable through the six months of the study, which is a bit of a surprise given their relatively poor cognitive function at baseline. When I previewed the phase III study, I said one of the keys to success would be getting patients in the phase III -- both those treated with Dimebon and placebo -- to behave like they did in the phase II study.

1 of 3

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
ELN $0.00 0.00%
CTIC $1.80 -6.00%
PARD $0.12 -7.69%
MDVN $128.32 -1.30%
LLY $73.46 -1.20%


DOW 17,678.03 -40.51 -0.23%
S&P 500 2,058.21 -2.84 -0.14%
NASDAQ 4,867.4670 -9.0520 -0.19%

Partners Compare Online Brokers

Free Reports

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