This Day On The Street
Continue to site
ADVERTISEMENT
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

Osiris Drags Feet on U.S. Approval Filing

COLUMBIA, Md. ( TheStreet) -- Osiris Therapeutics (OSIR - Get Report) is taking a very circuitous route towards seeking U.S. approval for its stem-cell therapy to treat graft-versus-host disease (GVHD).

Osiris CEO Randy Mills told investors last Friday that the company requested a meeting with the U.S. Food and Drug Administration to get a better sense of what regulators might want to see in a potential Prochymal approval data package. Mills said this meeting might take place early next year.

"What we're hoping to do out of this meeting is to gain consensus from FDA on specifically the regulatory pathway forward for Prochymal for approval for graft versus host disease, and talk more about the indication and specifically what data they want in the complete package," said Mills on the Osiris third-quarter conference call.

Mills added, "As we've said a number of times, what we don't want to do is jam something down the FDA's throat that the FDA doesn't want."

Amen to that! The only thing I'd add to Mills' comments is that FDA probably has little appetite for data culled from two failed Prochymal studies, which are the only data Osiris has to offer.

Osiris might believe presenting these negative Prochymal results on a silver platter will make them more palatable; my guess is FDA still gags and sends the company back to the kitchen.

If Osiris persists and decides to seek Prochymal's approval based on data from two failed studies, FDA won't bar the door but the agency won't approve the drug either.

Mills knows this, which is why Osiris is dragging out the Prochymal regulatory process. Data from the two failed Prochymal studies were announced in September 2009 -- 14 months ago. The negative results should have spelled the end of Prochymal, but that would have forced Osiris to shutter because the company has little else in its pipeline. It's a miracle that Genzyme (GENZ), Osiris' Prochymal partner, hasn't walked away, particularly since its actions are being heavily scrutinized in the midst of a takeover attempt by Sanofi-Aventis (SNY - Get Report).

Drug companies are loathe to shut down when they still have investors' money they can burn, so Osiris has spent the last year on a fruitless exercise to re-work data from the failed studies to find a subset of patients for which Prochymal might be effective.

This intense data-mining project -- a non-starter for FDA approval purposes -- allows Mills to make head-scratching statements about Prochymal:

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
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!
SYM TRADE IT LAST %CHG
OSIR $16.33 -1.57%
SNY $51.75 -0.02%
AAPL $130.28 0.47%
FB $81.53 -1.07%
GOOG $565.06 3.30%

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs