Healthcare Industry News: cIAI
News Release - March 2, 2006
Wyeth Pharmaceuticals' Antibiotic TYGACIL Receives 'Positive Opinion' From European Regulatory AuthorityFinal EU approval expected in second quarter 2006
MADISON, N.J., March 2 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that it has received a "positive opinion" recommending approval for the introduction of its first-in- class antibiotic TYGACILŪ (tigecycline) to the European market by the Committee for Medicinal Products for Human Use (CHMP).
The introduction of TYGACIL to the European market will come at a time when the need for new antibiotic options to combat serious infections is increasing.
"Life-threatening infections are a growing concern globally," says Dr. Joseph Camardo, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "Bacterial infections are becoming more difficult to treat. TYGACIL will provide physicians with an important option for patients."
The "positive opinion" is the final step before formal approval to market TYGACIL in the 25 member states of the European Union, Iceland, Liechtenstein, and Norway. The CHMP recommendation of TYGACIL will now be forwarded to the European Commission (EC) for final approval, which is anticipated in the second quarter of 2006.
TYGACIL has also received approval in six other countries: Brazil, Colombia, Mexico, Peru, Argentina and Ecuador.
Specifically in Europe, TYGACIL will be indicated for the treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections.
TYGACIL received approval for use in the United States by the Food and Drug Administration on June 15, 2005. Since then, TYGACIL has been placed on formulary at more than 1,450 of the largest hospitals in the United States.
In the United States, TYGACIL, the first in a new class of antibiotics called glyclycyclines, has an expanded broad spectrum of in vitro activity against many gram positives, gram negatives, anaerobes, and MRSA.
TYGACIL is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in adults caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis.
TYGACIL is also approved for adults with complicated intra-abdominal infections (cIAI) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.
Important TYGACIL Safety Information
* TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline. * TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. * Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hypophosphatemia). * In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5%) and vomiting (19.7%). * TYGACIL may cause fetal harm when administered to a pregnant woman. * Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening. * The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. * Monotherapy should be used with caution in patients with clinically apparent intestinal perforation. * To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria. * The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established.
For a copy of TYGACIL Prescribing Information, please visit http://www.wyeth.com
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 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
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