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!

FDA Agreement On Mesoblast's Use Of Singapore Manufacturing Facility For Clinical Trial Production Of Proprietary Mesenchymal Precursor Cells

MELBOURNE, Australia, Feb. 12, 2013 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility. This follows the successful transfer of Mesoblast's MPC manufacturing process from the United States to the Singapore facilities of its contract manufacturer Lonza. As the clinical indications pursued under IND by Mesoblast continue to broaden, particularly using intravenous delivery of MPCs for diseases of excessive inflammation and immunity, the Singapore facility will serve to support strategies for new product delineation. As previously announced, the FDA has agreed that Mesoblast's manufacturing process is acceptable for Phase 3 clinical supplies.  Mesoblast plans to use product manufactured in the Singapore plant in global Phase 3 trials.   Mesoblast Chief Executive Professor Silviu Itescu said: "Having multiple geographic sites to manufacture our MPC products to FDA compliance is an integral part of Mesoblast's corporate strategy for product delineation, and offsets risks of single site dependence. "We anticipate that our operations in Singapore, where we maintain exclusive access to Lonza's manufacturing facilities for allogeneic cells, will expand in line with our growth in global capacity requirements for product supply, new product lines, and partnering strategies."     Mesoblast Limited

Mesoblast Limited is a world leader in the development of biologic products for the broad field of regenerative medicine. Mesoblast's patented Mesenchymal Precursor Cell (MPC) technology is being developed for an extensive range of major clinical diseases, including inflammatory and immunologic conditions, diabetes and its complications, orthopedic spine conditions, and cardiovascular disorders. www.mesoblast.com

CONTACT: Julie Meldrum 
         Global Head of Corporate Communications 
         T: + 61 3 9639 6036 
         E: julie.meldrum@mesoblast.com

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 16,912.11 -70.48 -0.42%
S&P 500 1,969.95 -8.96 -0.45%
NASDAQ 4,442.6980 -2.2110 -0.05%

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