This Day On The Street
Continue to site
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

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.
CONTACT: Julie Meldrum 
         Global Head of Corporate Communications 
         T: + 61 3 9639 6036 

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
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,815.93 +3.74 0.02%
S&P 500 2,089.09 -0.05 -0.00%
NASDAQ 5,108.22 +5.4120 0.11%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs