Haemophilus

Cornerstone Therapeutics Signs Definitive Asset Purchase Agreement to Acquire Commercial Rights to the Antibiotic Factive(R)

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.

Keywords: Antibiotics, Antimicrobial Resistance, Bronchitis, Chronic Bronchitis, Community-Acquired, Drug Resistance, Drugs, Factive, Gemifloxacin Mesylate, Infectious Disease, Oscient Pharmaceuticals Inc., Patents Actions, Pharmaceutical Business, Pharmaceutical Company, Pneumonia, Pulmonology, Therapy, Treatment, Cornerstone Therapeutics Inc.

This article was prepared by Anti-Infectives Week editors from staff and other reports. Copyright 2009, Anti-Infectives Week via NewsRx.com.