European Committee Issued Positive Opinions to Extend Indication for PREVENAR to Include Pneumonia and Otitis Media

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has received two positive opinions recommending approval for an extension of the indication for PREVENAR™ (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) to the European market by the Committee for Medicinal Products for Human Use (CHMP).

MADISON, NJ, USA | Mar 01, 2007 |
  Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has received two positive opinions recommending approval for an extension of the indication for PREVENAR™ (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) to the European market by the Committee for Medicinal Products for Human Use (CHMP). The opinions recommend extending the indications of PREVENAR to include active immunization against pneumonia and acute otitis media (middle ear infection) caused by vaccine serotypes. PREVENAR is currently approved for active immunization of children from 2 months to 5 years of age against sepsis, meningitis, bacteraemic pneumonia and bacteraemia caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. Pneumococcal disease is a significant concern to children’s health, estimated to result in more than one million deaths each year in young children around the world.

“S. pneumoniae is the leading cause of bacterial pneumonia in humans beyond the first few weeks of life and is a major cause of death and illness worldwide,” says Peter Paradiso, Vice President, Scientific Affairs, Wyeth Vaccines. “It also is an important cause of acute otitis media, which if left untreated, may lead to more serious diseases such as mastoiditis and meningitis. We welcome the CHMP’s recommendation for both new indications in the EU which, if approved, will underscore the value of PREVENAR in helping to protect infants and young children from common pediatric illnesses caused by S. pneumoniae.”

PREVENAR is the first and only conjugate vaccine shown to be effective in reducing the incidence of pneumococcal disease (PD) in infants and toddlers. The CHMP recommendations of PREVENAR will now be forwarded to the European Commission (EC) for final approval, which is anticipated in the second quarter of 2007.

Many health authorities have recognized the importance of protecting infants and young children against pneumococcal disease. PREVENAR is a part of the routine national childhood immunization schedule in 16 countries worldwide, including Belgium, France, Germany, Greece, Italy, Netherlands and the United Kingdom (UK).

About Pneumonia
Pneumococcal pneumonia is an infection of the lungs caused by the bacterium Streptococcus pneumoniae. There are many causes of pneumonia, including bacteria, viruses and other pathogens. When S. pneumoniae invades the lungs, the body’s immune system responds, generating an inflammatory response. White blood cells, fluid and cellular debris then fill the air spaces of the lower respiratory tract causing physical symptoms such as coughing, fever and shortness of breath.

In prelicensure clinical trials, PREVENAR was found to be 97.4 percent (95% CI: 82.7–99.9) efficacious in preventing serotype-specific invasive pneumococcal infections in infants who were fully vaccinated and 89.1 percent (95% CI: 73.7–95.85) efficacious for all cases of invasive pneumococcal disease regardless of serogroup. Importantly, in this clinical study, PREVENAR was effective in reducing the incidence of radiographically-confirmed pneumonia in children younger than two years of age by 23.4 percent (95% CI: 5.2–38.1).

About Otitis Media
Acute otitis media (AOM) is a common childhood disease with important ramifications to the overall health of infants and young children. The peak incidence of AOM occurs at 6 to 18 months of age, but it can also occur in older children. Complications of AOM include persistent middle ear effusion, chronic otitis media, transient hearing loss, or speech delays.

PREVENAR has been shown to have an impact on AOM; in a clinical study, PREVENAR reduced vaccine serotype cases of AOM by 57 percent (95% CI: 44–67), cases of culture-confirmed pneumococcal AOM by 34 percent (95% CI: 21–45) and all cases of AOM by 6 percent (95% CI: -4-16).

In the United States, a study found that following the introduction of PREVENAR, otitis media outpatient visit rates declined by 20 percent in children aged less than two years, representing 246 fewer otitis media visits per 1,000 children in the United States.

About Pneumococcal Disease
Pneumococcal disease describes a group of illnesses caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. This bacterial pathogen, which affects both children and adults, is a major cause of death and illness worldwide. In fact, according to the World Health Organization (WHO), pneumococcal disease is the number one vaccine-preventable cause of death in children younger than 5 years of age worldwide.

Important Safety Information about PREVENAR

In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (>38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea and rash.

Risks are associated with all vaccines, including PREVENAR. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. PREVENAR does not provide 100 percent protection against vaccine serotypes or protect against nonvaccine serotypes.

Wyeth Pharmaceuticals
Wyeth Pharmaceuticals 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 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 based on current expectations of future events and 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 the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our 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; data generated on our 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.” 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.

SOURCE: Wyeth Pharmaceuticals

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