Cornerstone Therapeutics Receives Approval to Acquire Commercial Rights to the Antibiotic Factive(R)
03 Septiembre 2009 - 7:01AM
PR Newswire (US)
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 / Media Relations Contact: FD Robert
Stanislaro 212-850-5600 DATASOURCE: Cornerstone Therapeutics Inc.
CONTACT: Investor Relations, Evan Smith, , or Brian Ritchie, , or
Media Relations, Robert Stanislaro, , all of FD, +1-212-850-5600
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