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FDA Approves Factive (Gemifloxacin) for Treatment Of Respiratory Tract Infections

Oral fluoroquinolone antibiotic kills the increasingly resistant strep pneumoniae bacteria, the most common cause of lower respiratory tract infections

SOUTH SAN FRANCISCO, CA -- April 7, 2003 -- GeneSoft Pharmaceuticals, Inc., an emerging pharmaceutical company based in South San Francisco, today announced that the Food and Drug Administration (FDA) has approved FactiveŽ (gemifloxacin), for the treatment of mild-to-moderate community-acquired pneumonia (CAP), and acute bacterial exacerbation of chronic bronchitis (AECB).

"The approval of Factive is especially important because the growing resistance of bacteria like strep pneumonia is rendering many current drugs ineffective to treat serious respiratory tract infections," according to Dr. Gary Patou, President of GeneSoft. "Factive will provide doctors with a powerful treatment option at a time when up to 40% of the strains of streptococcus pneumoniae may be resistant to both penicillin and erythromycin."

As many as 13 million people suffer from acute exacerbation of chronic bronchitis in the United States with mortality rates in hospitalized patients as high as 30%. There are as many as 4 million cases of community-acquired pneumonia, with 64,000 people dying every year from the disease. It is the leading cause of death due to infections.

Factive has been widely tested in global clinical trials in nearly 10,000 people. AECB trials have shown that 5 days of Factive is as effective as other marketed products whether it is a beta lactam, a macrolide, or another fluoroquinolone. In CAP trials Factive given for 7 days is effective treatment for patients.

Like other antibiotics, Factive should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. They do not treat viral infections. The most common side effects include diarrhea, rash, nausea, and headache. Rash is generally mild to moderate in nature and is more likely to occur if taken for longer than the recommended course.

Today's FDA approval follows a recommendation last month by the Anti-Infective Drugs Advisory Committee (AIDAC) to approve Factive. On March 4th, the AIDAC voted 18-0 with one abstention to recommend Factive for mild-to-moderate CAP and voted 15-3 with one abstention for Factive for AECB.

Factive is GeneSoft's lead product, a fluoroquinolone antibiotic to which the company owns all the marketing and regulatory approval rights in North America and Europe.

"The FDA approval of Factive is a major advance in the treatment of respiratory infections and a huge step for GeneSoft," said to David Singer, Chairman and Chief Executive Officer of GeneSoft. "Factive is just the first of several novel antibiotics in our development pipeline to treat patients with resistant bacteria."

GeneSoft licensed Factive from the Korean pharmaceutical company LG Life Sciences. Factive was originally developed by GLAXOSMITHKLINE (NYSE: GSK). PAREXEL International (Nasdaq: PRXL) is the US Regulatory Agent for Factive.

The quinolone class is a 16 billion dollar a year market in the U.S. alone, the fastest growing class of antibiotics. GeneSoft's pipeline includes other novel mode-of-action medications for the treatment of a wide range of infectious diseases, including those from biological warfare threats. The company is currently developing drugs for anthrax, small pox and malaria in partnership with the U.S. military.

GeneSoft Pharmaceuticals, Inc.

GeneSoft is an emerging pharmaceutical company based in South San Francisco that has a deep product portfolio of novel anti-infective agents. GeneSoft's strong research and development capabilities have yielded a broad clinical and pre-clinical pipeline. Factive (gemifloxacin) is GeneSoft's lead product, a quinolone antibiotic to which the company owns exclusive marketing rights in North America and Europe. GeneSoft also has two distinct novel mode-of-action classes of antibiotics currently under development, with programs in Phase I trials and late pre-clinical development.

SOURCE: GeneSoft Pharmaceuticals, Inc

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