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Forest antibiotic approved

Forest Laboratories has won US Food and Drug Administration approval for its antibiotic Teflaro, intended as a new option to help combat infections

Forest Laboratories has won US Food and Drug Administration (FDA) approval for its antibiotic Teflaro (ceftaroline fosamil), which is intended as a new option to help combat infections for which antibiotic resistance is common.

The drug is a broad-spectrum bactericidal cephalosporin that works against both gram-positive and gram-negative microorganisms. The approval covers indications for the treatment of community-acquired bacterial pneumonia, including cases caused by Streptococcus pneumoniae bacteraemia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus, commonly known as MRSA.

Teflaro marks Forest's first product in the antibiotic category and is being handled by the company's new anti-infective franchise.

The company, which expects Teflaro to be available to wholesalers by January, acquired worldwide rights to the drug (excluding Japan) when it bought up the privately held biopharma firm Cerexa in 2007.  Last year, Forest signed an agreement with AstraZeneca (AZ) to co-develop and commercialise the drug in all markets outside the US, Canada and Japan. Japanese rights to the drug are held by Takeda.

The US marketing application for Teflaro included data from pivotal trials in which a total of 1,219 patients were treated with the drug.

In one phase III study enrolling adult patients who were hospitalised with moderate-to-severe CABP, Teflaro-treated patients had a response rate of 69.6 per cent, compared with a response rate of 58.3 per cent for ceftriaxone-treated patients on day four.

In a phase III study of ABSSSI patients, Teflaro-treated patients had a response rate of 74 per cent compared with a response rate of 64.6 per cent for vancomycin plus aztreonam-treated patients on day three.

Pneumonia is the leading cause of death from infectious diseases in the US, while ABSSSI are among the most common infections treated in US hospitals, according to Forest. MRSA, which is the most frequent cause of ABSSSI presenting to US emergency departments, is estimated to cause more than 18,000 deaths in the country each year.

1st November 2010

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