New Broad-spectrum Antibiotic Tygacil* (tigecycline) Receives Approval For Use In Europe Today

Main Category: MRSA / Drug Resistance
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 04 May 2006 - 0:00 PDT

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Tygacil* (tigecycline) is the first antibiotic in a new class called glycylcyclines approved in Europe. Tygacil is produced by Wyeth and is indicated for use in complicated infections of the skin and soft tissue and complicated intra-abdominal infections acquired either in the hospital or in the community. Tygacil has in vitro activity against many gram-positive and gram-negative bacteria, including multi-drug resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE).1

It is estimated that there have been three million hospital-acquired infections per year in the extended EU, resulting in an alarming 50,000 deaths. Inappropriate use of antibiotics has led to an increasing number of resistant pathogens across Europe; many of these organisms such as MRSA, have developed resistance to multiple antibiotics. Hospital patients, as a result of their often weakened immune systems, are particularly vulnerable to these resistant strains, developing infections that can manifest as infected burns, deep abscesses, surgical wound infections, perforations, or complicated appendicitis, among others. When these clinical complications are added to patients' existing medical conditions they can prove fatal or lead to longer stays in hospital, and therefore a greater burden on health care systems.

Tygacil is one of a limited number of new broad-spectrum antibiotics available in Europe. It is active against many gram-positive bacteria, such as MRSA, and common gram-negative pathogens, such as Escherichia coli. It can be used as empiric monotherapy (before the bacteria are identified) in the treatment of skin or intra-abdominal infections, especially those that may be caused by a mixture of different bacteria.

Professor Mark Wilcox, Clinical Director of Microbiology & Infection Control, Leeds Teaching Hospital, explains, "When a patient develops a serious infection in hospital it takes between 24 and 48 hours to pinpoint the bacteria responsible. It's vital, therefore, in these critical early stages of treatment, to have efficacious broad-spectrum antibiotics available. Tygacil is a useful new alternative broad spectrum antibiotic option."

Tygacil was developed by Wyeth to overcome the two key tetracycline resistance mechanisms, efflux pumps and ribosomal protection, and is unaffected by other bacterial mechanisms of resistance such as extended spectrum beta-lactamases (ESBLs), which have limited the number of antibiotic options available.

David McIntosh, Medical Director of Wyeth Pharmaceuticals comments, "The availability of Tygacil in Europe will provide physicians with an important new alternative in the treatment of complicated skin and intra-abdominal infections." He continues, "Since FDA approval in June 2005, Tygacil has been used in patient care in many US hospitals, and we are very pleased that patients in Europe will now be able to benefit from this new effective antibiotic."

About Tygacil

Tygacil will be launched in individual EU countries during 2006 and 2007, beginning with Germany and Austria. The drug is indicated for complicated infections of the skin and soft tissues and complicated intra-abdominal infections.1

Tygacil received FDA approval in June 2005 and has since received regulatory approval in Brazil, Colombia, Argentina, Mexico, Peru, Ecuador, Kuwait, Qatar, and the Philippines.

The most common adverse events reported in clinical trials with Tygacil were transient nausea (20%) and vomiting (14%). These occurred early and were generally mild or moderate in severity.1

About resistance mechanisms

-- Efflux pumps cause the antibiotic to be quickly pumped out of the bacteria, reducing the antibiotic's efficacy.

-- Ribosomal protection blocks antibiotics from interfering with the bacteria's protein synthesis.

-- This results in the bacteria becoming resistant and causes the antibiotic to become ineffective against the infection.

About Wyeth

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 non-prescription 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.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of 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 non-prescription 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.

References

Opinion of the Committee for Medicinal Products for Human Use on the Granting of a Marketing Authorisation for Tygacil* (tigecycline) - Annex I: Summary of Product Characteristics. London, UK: European Medicines Agency, February 23, 2006.

Hospitals in Europe Link for Infection Control Through Surveillance (HELICES). About HELICS. Available at http://helics.univ-lyon1.fr/about.htm. Accessed February 20, 2006.

Goosens H, Ferech M, Stichele RV, et al, for the ESAC Project Group. Outpatient antibiotic use in Europe and association with resistance; a cross-national database study. Lancet. 2005; 365: 579-587.

Shlaes DM, Gerding DN, John JF Jr, et al. Society for Healthcare Epidemiology of America and Infectious Diseases Society of America Joint Committee on the Prevention of Antimicrobial Resistance: Guidelines for the Prevention of Antimicrobial Resistance in Hospitals. Clin Infec Dis. 1997; 25: 584-599.

5 Cosgrove SE, Carmeli Y. The impact of antimicrobial resistance on health and economic outcomes. Clin Infect Dis. 2003; 36: 1433-1437.

6 Wyeth Europa interpretation of the EMEA-approved Summary of Product Characteristics.

7 Levy SB. Active efflux, a common mechanism for biocide and antibiotic resistance. J App Microbiol. 2002; 92: 65S-71S.

8 Poole K. Mechanisms of bacterial biocide and antibiotic resistance. J App Microbiol. 2002; 92: 55S-64S.

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.

© 2006, Wyeth Pharmaceuticals
http://www.wyeth.com