MADISON, N.J., Dec. 16 -- PRNewswire/ AsiaNet
Investigational I.V. Antibiotic Is First in a New Class
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today
that the Company has submitted a global registration dossier for its
investigational antibiotic Tygacil(TM) (tigecycline). This is the first time
Wyeth has applied simultaneously for global approval of a new product. This
registration package included the submission of a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA), as well as a Marketing
Authorization Application (MAA) with the European Medicines Agency and
additional filings with authorities in Canada, Australia, and Switzerland.
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).
"Tygacil is the first glycylcycline, a new class of antibiotic, with the
potential to be a monotherapy option for clinicians treating complicated skin
and skin structure infections and complicated intra-abdominal infections," says
Dr. Robert Ruffolo, President of Wyeth Research. "Complicated infections and
antibiotic resistance are serious concerns around the world, and the hope is
that Tygacil will provide the global medical community with a much needed
treatment alternative."
According to the U.S. Centers for Disease Control and Prevention (CDC),
antibiotic resistance has become so widespread that many significant bacterial
infections in the world are becoming resistant to commonly used antibiotics.
Bacteria that have become resistant to previously effective antimicrobials
include pneumococci, staphylococci, enterococci, E. coli, Enterobacter, and
Acinetobacter.
Treating Serious Infections in Hospitals
Physicians face an increasing clinical challenge because current efforts to
prevent and control antimicrobial resistance in the hospital and community are
inadequate. In fact, 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 a
paper published in the medical journal Clinical Infectious Diseases in April
2004, just five of 31 anti-infectives currently in development at the world's
15 largest pharmaceutical companies are antibacterial agents.
"Increasing antibiotic resistance in hospitals can lead to treatment
failure, poor patient outcomes, and increased cost," says Dr. Sherwood Gorbach,
Professor of Public Health and Medicine, Tufts University School of Medicine.
"In times where the antibiotic pipeline is declining, the filing of new
antibiotics could not be more appropriate."
The submission included data from four pivotal phase III studies examining
the safety and efficacy of Tygacil for the treatment of complicated skin and
skin structure infections and the treatment of complicated intra-abdominal
infections. The filing also included in vitro data against both gram-negative
and gram-positive bacteria, and anaerobes, including drug-resistant pathogens.
The most common adverse events associated with Tygacil in clinical trials were
nausea and vomiting.
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of infectious diseases, women's health care, cardiovascular disease,
central nervous system, inflammation, transplantation, hemophilia, oncology,
vaccines and nutritional products. Wyeth is one of the world's largest
research-driven pharmaceutical and health care products companies. It is a
leader in the discovery, development, manufacturing, and marketing of
pharmaceuticals, vaccines, biotechnology products and nonprescription medicines
that improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort
Dodge Animal Health.
The statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events that
involve risks and uncertainties including, without limitation, risks associated
with the inherent uncertainty of the timing and success of pharmaceutical
research, product development, manufacturing, commercialization, economic
conditions including interest and currency exchange rate fluctuations, changes
in generally accepted accounting principles, the impact of competitive or
generic products, trade-buying patterns, wars or terrorist acts, product
liability and other types of lawsuits, the impact of legislation and regulatory
compliance and obtaining reimbursement, favorable drug pricing, access and
other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's
periodic reports, including current reports on Form 8-K, quarterly reports on
Form 10-Q and the annual report on Form 10-K, filed with the Securities and
Exchange Commission. Actual results may vary materially from the
forward-looking statements. The Company assumes no obligation to publicly
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE: Wyeth Pharmaceuticals
CONTACT: Media - Douglas Petkus,
+1-484-865-5140, or
Natalie de Vane,
+1-484-865-5139; or
Investors - Justin Victoria,
+1-973-660-5340,
all of Wyeth
Web site: http://www.wyeth.com