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.
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"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."
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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.
