More Clinical Data Required To Support European Approval Of CAP Indication For TYGACIL

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 24 Apr 2008 - 0:00 PDT

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Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) (tigecycline). This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth's action is based on its understanding of the Committee for Medicinal Products for Human Use (CHMP) assessment that the TYGACIL CAP pivotal clinical trials did not include a sufficient number of severely ill CAP patients to alleviate reviewer concerns regarding efficacy in this subpopulation. TYGACIL is currently approved in Europe for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections in adults.

"We are disappointed that we were not able to allay the concerns of the CHMP, and are evaluating the appropriate next steps to take in Europe," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "In October 2007, the U.S. Food and Drug Administration (FDA) accepted the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of TYGACIL for the proposed CAP indication."

The FDA is currently reviewing this application and a decision is expected during the second quarter of 2008. TYGACIL has been approved for use in patients with CAP in the Philippines and Thailand. Regulatory applications are also pending in Australia, Brazil, Canada, Switzerland and India.

Indications

TYGACIL(R) (tigecycline) is indicated for the treatment of adults with:

-- Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis

-- Complicated intra-abdominal infections 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 group (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Important Safety Information

-- 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

-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-

threatening -- 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, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL

-- The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established

-- 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

-- The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established

-- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis

-- Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective

-- 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

-- Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin

-- Monotherapy should be used with caution in patients with clinically apparent intestinal perforation

-- In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response

-- The following drugs should not be administered simultaneously through the same Y-site as TYGACIL: amphotericin B and diazepam

Please see Prescribing Information.

Wyeth Pharmaceuticals:

Wyeth Pharmaceuticals, a division of Wyeth has leading products in the areas of women's health care, infectious disease, gastrointestinal health, 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, nutritionals 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.

The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost- containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Wyeth Pharmaceuticals
http://www.wyeth.com