Cornerstone Therapeutics Receives Approval to Acquire Commercial Rights to the Antibiotic Factive

CARY, N.C., Sept. 3 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (NASDAQ:CRTX) , a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that it has received the approval of the United States Bankruptcy Court for the District of Massachusetts for its acquisition of the commercial rights to the antibiotic Factive (gemifloxacin mesylate) in North America and certain countries in Europe from Oscient Pharmaceuticals Corporation (OSCIQ.PK) and expects to promptly close the transaction. At the closing, the Company will purchase the Factive assets for a cash payment of $5,000,000 plus an amount for purchased inventory to be mutually determined prior to closing, quarterly royalty payments based on adjusted net sales for a period of five years and the assumption of certain liabilities, including aggregate cure amounts of $110,000 under certain contracts that were assumed by the Company. Oscient filed its voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code with the United States Bankruptcy Court for the District of Massachusetts on July 13, 2009.

Factive is a fluoroquinolone antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) and community-acquired pneumonia of mild to moderate severity (CAP). According to Wolters Kluwer Health, a third-party provider of prescription data, in 2008, the U.S. oral solid fluoroquinolone market generated approximately 39 million prescriptions. Factive was launched in the U.S. in September of 2004 and is the only fluoroquinolone approved in the U.S. for the five-day treatment of both ABECB and CAP. Approximately 1.1 million prescriptions have been dispensed for Factive since its launch. In 2008, Factive generated approximately $16 million in net revenues. Factive has composition of matter patent protection which extends into 2018, longer than the composition of matter patent protection for any currently marketed fluoroquinolone or other antibiotic widely used to treat respiratory tract infections.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (Nasdaq CM: 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 and key retail pharmacies with its specialty sales force. 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 underpromoted, 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 force, which is focused on the respiratory and related markets; and maintain and strengthen the intellectual property position of the Company's currently marketed products, newly acquired products and product candidates.

Safe Harbor Statement

Statements in this press release regarding the progress and timing of our product development programs and related trials; our future opportunities; our strategy, future operations, financial position, future revenues and projected costs; our management's prospects, plans and objectives; and any other statements about management's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Any statements that are not statements of historical fact (including, without limitation, statements containing the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements.

There are a number of important factors that could cause our actual results or events to differ materially from those indicated by such forward-looking statements, including risks relating to the ability to complete and the expected timeline for completing the transaction with Oscient; our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products, including difficulties relating to the manufacture of Zyflo CR tablets; the possibility that the Food and Drug Administration (the FDA) will take enforcement action against us or one or more of our marketed drugs that do not have FDA-approved marketing applications; patient, physician and third-party payor acceptance of our products as safe and effective therapeutic products; our heavy dependence on the commercial success of a relatively small number of currently marketed products; our ability to maintain regulatory approvals to market and sell our products that do have FDA-approved marketing applications; our ability to enter into additional strategic licensing, collaboration or co-promotion transactions on favorable terms, if at all; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products; difficulties relating to clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to satisfy FDA and other regulatory requirements; our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; 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 26, 2009 and subsequent filings that we make with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release. 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. Our forward-looking statements 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, except that in particular circumstances as specifically indicated we may address the potential impact of our transaction with Chiesi Farmaceutici S.p.A. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

Zyflo CR is a trademark of Cornerstone Therapeutics Inc. Factive is a trademark of LG Life Sciences Ltd.

  Investor Relations Contacts:

  FD

  Evan Smith/Brian Ritchie

  212-850-5600

  evan.smith@fd.com/brian.ritchie@fd.com


  Media Relations Contact:

  FD

  Robert Stanislaro

  212-850-5600

  robert.stanislaro@fd.com


Source: Cornerstone Therapeutics Inc.

CONTACT: Investor Relations, Evan Smith, evan.smith@fd.com, or Brian
Ritchie, brian.ritchie@fd.com, or Media Relations, Robert Stanislaro,
robert.stanislaro@fd.com, all of FD, +1-212-850-5600
 

Posted: September 2009


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