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

Cornerstone Therapeutics Announces Development Of Generic For Tussionex®

CARY, N.C., Aug. 5 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (Nasdaq: CRTX) ("Cornerstone" or the "Company"), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that its product candidate CRTX-067 is an ANDA filing for a generic 10 mg chlorpheniramine polistirex/8 mg hydrocodone polistirex suspension product that will be a generic substitute for the product currently sold under the Tussionex brand name by UCB, Inc.

"This product offers substantial revenues in 2011 and exciting growth potential," said Craig A. Collard, Cornerstone's President and Chief Executive Officer.  "Resolving the uncertainty around 067 underlines Cornerstone's commitment to focus on the development of its cough and cold franchise.  We continue to expect that the expedited review of 067 will result in FDA approval in early 2011."

This announcement immediately follows the announcement of the Company's decision to cease manufacturing and distribution of marketed unapproved drugs, and to focus its growth strategy exclusively on products with long-term revenue potential, intellectual property and NDA or ANDA approvals.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (Nasdaq: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets.  The Company currently promotes multiple marketed products in the United States to respiratory-focused physicians, key retail pharmacies and hospitals with its specialty sales forces.  The Company also has a late-stage clinical pipeline with a recent regulatory submission filing and four additional regulatory approval submissions targeted within the next three years.  Key elements of the Company's strategy are to in-license or acquire rights to under-promoted, patent-protected, branded respiratory or related pharmaceutical products, or late-stage product candidates; implement life cycle management strategies to maximize the potential value and competitive position of the Company's currently marketed products, newly acquired products and product candidates that are currently in development; grow product revenue through the Company's specialty sales forces; and maintain and strengthen the intellectual property position of the Company's currently marketed products, newly acquired products and product candidates.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including statements regarding the progress and timing of approvals of our product candidates, our product development programs and related trials, our strategy and our future operations and opportunities, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including our development programs, the results of preclinical studies and clinical trials with respect to our products under development, our ability to enter into collaboration or other license arrangements with respect to our technology on commercially reasonable terms or at all, our ability to obtain and maintain protection for the intellectual property we own or license from third parties, our ability to satisfy FDA and other regulatory requirements and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 4, 2010 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release, should not be relied upon as representing our views as of any other date and do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise.

Tussionex® is a registered trademark of UCB Manufacturing, Inc.

SOURCE Cornerstone Therapeutics Inc.

Copyright 2009 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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
Submit an article to us!
SYM TRADE IT LAST %CHG
CRTX $0.00 0.00%
AAPL $126.43 -1.80%
FB $77.62 -1.50%
GOOG $532.96 -1.40%
TSLA $230.76 0.11%

Markets

DOW 17,974.38 -96.02 -0.53%
S&P 500 2,093.18 -21.31 -1.01%
NASDAQ 4,940.8380 -76.0910 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs