Cornerstone Therapeutics Signs
Definitive Asset Purchase Agreement to Acquire Commercial Rights
to
the Antibiotic Factive ®
Cary, N.C.,
July 13, 2009 — 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
® (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 thei
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