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FDA Grants Tigecycline NDA Priority Review Status

Madison, N.J., January 28, 2005 – Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) granted priority review status to the company’s New Drug Application (NDA) for the investigational I.V. antibiotic Tygacil™ (tigecycline). A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.

Tygacil is the first in a new class of antibiotics called glycylcyclines to be submitted for regulatory approval. It was designed to circumvent two major resistance mechanisms that have limited the use of many antibiotics: efflux pumps and ribosomal protection.

“While the number of complicated infections, particularly those resistant to available antibiotics, is on the rise, few antibacterial agents are known to be in development, and there is an urgent need for new treatment options,” says Dr. Robert Ruffolo, President of Wyeth Research. “Tygacil, an expanded broad-spectrum agent, has the potential to help clinicians overcome challenges associated with certain bacterial resistance when selecting an empiric monotherapy.”

Wyeth is seeking market approval for Tygacil as a single agent therapy to treat patients with complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI), caused by gram-negative and gram-positive pathogens, anaerobes, and both methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus (MSSA and MRSA). The Tygacil NDA submission included data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of cIAI and cSSSI. The submission also included in vitro data against both gram-negative and gram-positive bacteria, anaerobes, and certain drug-resistant pathogens.

“The medical community is constantly looking for new ways to treat serious infections and improve patient outcomes,” says Dr. Gary Noskin, Department of Medicine and Division of Infectious Diseases, Feinberg School of Medicine at Northwestern University. “Unfortunately, many antibiotics which are used against a broad range of bacteria are now losing effectiveness.”

Concurrent with its NDA submission in the U.S., Wyeth also submitted a Marketing Authorization Application (MAA) with the European Medicines Agency and additional filings with authorities in Australia and Switzerland on December 15, 2004. This was the first time Wyeth applied simultaneously for U.S. and global approval of a new product. Filing of the NDA with the FDA is an important step in the approval process in the U.S. The FDA sets a goal for completing priority reviews (including judgment on approval) at six months after the NDA submission date.

Treating Serious Infections in Hospitals
More and more patients admitted to hospitals from the community are presenting with antibiotic-resistant bacteria that were previously only found within the hospital environment. This issue is compounded by the fact that few broad-spectrum antibiotic agents are currently in development to fight existing and emerging resistant bacteria. According to an article recently published in the medical journal Clinical Infectious Diseases, just five of 31 anti-infectives in development at the world’s 15 largest pharmaceutical companies are antibacterial agents.

In the U.S., hospital-acquired infections alone afflict approximately 2 million patients and kill nearly 90,000 people annually. About 70 percent of these infections are resistant to at least one drug. Antibiotic resistance leads to increased mortality and morbidity and generates a minimum of $4 billion to $5 billion in costs to U.S. society annually.

Source: Wyeth

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