Cornerstone Therapeutics Signs Definitive Asset Purchase Agreement to Acquire Commercial...

Mon Jul 13, 2009 5:35pm EDT
 
[-] Text [+]
Cornerstone Therapeutics Signs Definitive Asset Purchase Agreement to Acquire
Commercial Rights to the Antibiotic Factive(R)


CARY, N.C., July 13 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc.
(Nasdaq CM: 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 signed a
definitive asset purchase agreement with Oscient Pharmaceuticals Corporation
(Nasdaq CM: OSCI) to acquire the commercial rights to the antibiotic
Factive(R) (gemifloxacin mesylate) in North America and certain countries in
Europe.  The completion of the acquisition is subject to customary closing
conditions, approval of the United States Bankruptcy Court for the District of
Massachusetts, where Oscient filed its voluntary petition for relief under
Chapter 11 of the United States Bankruptcy Code on July 13, 2009 and the
conduct of a Bankruptcy Court supervised auction process in which Oscient will
seek competing bids to achieve the highest price possible for the FACTIVE
assets.. Pursuant to the agreement, it is anticipated that the auction process
will be completed and the Bankruptcy Court will render its decision within the
next sixty days

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.
 According to a Datamonitor report, there is an increased trend in prescribing
the fluoroquinolone class, even as first line empiric treatment, due to the
atypical strains associated with ABECB and CAP.  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.

"This transaction is reflective of our strategy to acquire, develop and
commercialize prescription products for the respiratory market," said Craig
Collard, President and CEO of Cornerstone.  "Factive is a high-quality,
patent-protected product with strong brand recognition.  We believe that this
product fits well within our existing portfolio and that our
respiratory-focused sales force will be able to drive prescription growth of
Factive in the U.S. market.  Moreover, we remain positioned to evaluate
additional drugs to add to our growing portfolio of products."   

It is estimated that chronic bronchitis affects approximately 9 million adults
in the U.S.   Patients with chronic bronchitis are prone to frequent
exacerbations, characterized by increased cough and other symptoms of
respiratory distress. Longitudinal studies have estimated that 1 to 4
exacerbations occur each year in patients with chronic bronchitis. 
Exacerbations are estimated to account for approximately 12 million physician
visits per year in the U.S.   Antibiotic therapy, the standard treatment for
ABECB, is typically effective in reducing the course of illness for patients. 
Fluoroquinolones are frequently used to treat ABECB due to their activity
versus  Haemophilus influenzae and Moraxella catarrhalis,  two of the most
common causes of these infections. 

Of the estimated 4 to 5 million cases per year of CAP, nearly 1 million cases
occur in patients over the age of 65.  CAP cases result in approximately 10
million physician visits and as many as 1 million hospitalizations annually. 
Antibiotics are the mainstay of treatment for most patients with pneumonia. 
Over the last decade, though, resistance to penicillins and macrolides has
increased significantly, and in many cases, fluoroquinolones are now
recommended as a first line of therapy due to their efficacy against a wide
range of respiratory pathogens, including many antibiotic resistant strains. 
The most recent treatment guidelines from the Infectious Diseases Society of
America and the American Thoracic Society recommend fluoroquinolones as a
first-line treatment for certain higher-risk patients with CAP.

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 and key retail pharmacies with
its specialty sales force.  The Company also has a late-stage clinical
pipeline with five 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 proposed transaction with
Oscient; the benefits of the proposed transaction; 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((R)) 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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (the SEC) on May 7, 2009 and other
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 future
acquisitions, mergers, dispositions, business development transactions, joint
ventures or investments that we may make, except that in particular
circumstances as specifically indicated we may address the potential impact of
our proposed transaction with Chiesi Farmaceutici SpA.  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((R)) is a registered trademark of Cornerstone Therapeutics Inc. 
Factive((R)) is a registered 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.

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

 

Featured Broker sponsored link

Editor's Choice

A selection of our best photos from the past 24 hours.  Slideshow 

Most Popular on Reuters

  • Articles
  • Video