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!

Osiris Therapeutics Management Discusses Q2 2012 Results - Earnings Call Transcript

I see that there are many new callers on the line today, so let me start by providing you with a little perspective on how we developed Prochymal.

We were 20 years ago with a mission to responsibly develop and commercialize the stem cell-based therapy to address significant unmet medical needs. In 1992, we began performing the necessary laboratory work to enter human trials with mesenchymal stem cells. After 6 years of bench work, we initiated our first Phase I human clinical trial with MSCs in 1998. Since that time, Osiris has achieved many firsts in the field of stem cells including the first stem cell product to be awarded Fast Track status by the FDA; the first stem cell drug to be granted orphan drug status by FDA and EMA; the first Expanded Access Program to be approved for a stem cell drug, enabling patients all over the world to receive treatment with Prochymal; and finally, with Prochymal becoming the world's first approved stem cell drug and the first drug specifically approved for the management of acute GvHD.

None of these firsts happened because we took a shortcut. In fact, because it was the first stem cell therapy to be reviewed, the standards to which we were held were, in most cases, higher than that of a traditional drug. These accomplishments, instead, are the result of 20 years of hard work and determination.

With approvals in Canada and New Zealand, our work is transitioning into the commercial phase. Essential focus of this effort is ensuring fair but sufficient reimbursement for the product. Given Prochymal's 20-year development history and enormous development costs, premium pricing is appropriate. Fortunately, there are a number of factors that favorably impact reimbursement discussions around Prochymal. GvHD is a rare disease with an inherently limited market. It is an acute disease, meaning that patients typically receive treatment for only 1 to 2 months, unlike the life-long care required for many of the enzyme replacement therapies. It is the only drug approved for GvHD. And lastly, because the disease is most often lethal absent successful intervention, and treatment with Prochymal has been shown to be both clinically and -- clinically meaningful and improve survival.

2 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 16,939.63 -20.94 -0.12%
S&P 500 1,974.72 -3.62 -0.18%
NASDAQ 4,435.04 -14.5240 -0.33%

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