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

AMRI Announces Development And Manufacturing Deal With Biota Holdings Limited

Stocks in this article: AMRI BTA

ALBANY, N.Y., April 17, 2012 /PRNewswire/ -- AMRI (NYSE: AMRI), a leading global contract research and manufacturing organization, was selected by Biota Holdings Limited (ASX: BTA), a leading anti-infective drug development company based in Australia, to further develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor. AMRI will provide these services to support a New Drug Application for laninamivir to the United States Food and Drug Administration (FDA).

(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO )

Biota is working to establish the U.S. manufacturing of laninamivir, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for FDA approval of the drug.

AMRI's role will initially involve the development and manufacture of the active pharmaceutical ingredient for use in clinical trials. In the future there is the potential for AMRI to be selected as the commercial manufacturer of the product.

"The agreement with Biota demonstrates AMRI's global reputation as a preferred partner for delivering best-in-class drug discovery, development and manufacturing services," said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D. "We look forward to working with Biota to accelerate the advanced development of laninamivir."

In March 2011, the Office of Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services awarded Biota a five-year contract estimated to be worth $231 million for the advanced development of laninamivir. The drug is already approved for sale in Japan and was launched as Inavir by Daiichi Sankyo in October 2010. It is not currently approved for sale in other markets.

About AMRI

AMRI is a global contract research and manufacturing organization with more than twenty years experience providing customers fully integrated drug discovery, development, and manufacturing services. AMRI supplies a broad range of services and technologies that support the discovery and development of pharmaceutical products and the manufacturing of API and drug product for existing and experimental new drugs. With locations in the United States, Europe, and Asia, AMRI maintains geographic proximity and flexible cost models. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.

About Laninamivir

Laninamivir is an influenza antiviral, known as a long acting neuraminidase inhibitor (LANI) and a unique treatment for influenza. Unlike vaccines, neuraminidase inhibitors offer the ability to treat an influenza infection, but may also be used preventatively. Current or first-generation neuraminidase inhibitors require twice daily dosing. LANI compounds offer the potential of a single administration for treatment and once a week for prevention. This represents a significant advantage compared with existing influenza antiviral treatments.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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!

Markets

DOW 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

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