Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers

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So now some more new strains will emerge and become life-threatening. They

re just shifting the burden elsewhere.

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Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the

Prevention of Pneumococcal Disease in Infants and Toddlers

March 31, 2009 9:30 AM ET

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COLLEGEVILLE, Pennsylvania, March 31 /PRNewswire/ -- Wyeth Pharmaceuticals,

a division of Wyeth WYE, announced today that it has submitted a Biologic

License Application (BLA) to the U.S. Food and Drug Administration (FDA) for

Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria

CRM(197) Protein). Last year, the FDA granted Prevnar 13 Fast Track

designation, which is designed to facilitate review of products that address

serious or potentially life-threatening conditions for which there is an

unmet medical need.

Prevnar 13 is designed to protect against the 13 most prevalent serotypes

associated with pneumococcal disease (PD), the leading cause of

vaccine-preventable death worldwide. Seven of these serotypes (4, 6B, 9V, 14

18C, 19F and 23F) are included in Prevnar®, Pneumococcal 7-valent

Conjugate Vaccine (Diphtheria CRM(197) Protein) - the current global

standard in PD prevention in infants and young children. The six additional

serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest

remaining burden of invasive disease. Both Prevnar 13 and Prevnar use

CRM(197) - an immunological carrier protein with a 20-year history of use in

pediatric vaccines.

" We are pleased that, with this milestone, we are now one step closer to

bringing Prevnar 13 to infants and children, " says Emilio Emini, Ph.D.,

Executive Vice President, Vaccine Research and Development, Wyeth

Pharmaceuticals. " Prevnar, our currently available vaccine, has both proven

clinical efficacy and documented effectiveness, which has resulted in a

significant public health impact. Prevnar 13 builds on the scientific

foundation of Prevnar and, if approved, will provide coverage for the 13

most prevalent pneumococcal serotypes associated with pneumococcal disease,

including serotype 19A, which has emerged as a serious public health threat

in the United States and around the world. "

The Prevnar 13 submission to the FDA includes data from 13 Phase 3 studies,

involving more than 7,000 infants and young children. The Company initiated

its global pediatric filings in late 2008 and, to date, has submitted

regulatory applications for the 13-valent candidate vaccine in more than 40

countries worldwide. Prevnar 13 is also being studied in global Phase 3

clinical trials in adults, with regulatory submissions expected in 2010.

Pneumococcal Disease

Pneumococcal disease is complex and describes a group of illnesses, all of

which are caused by the bacterium Streptococcus pneumoniae. PD affects both

children and adults and includes invasive infections such as

bacteremia/sepsis and meningitis, as well as pneumonia and otitis media

(middle ear infection).

Following the inclusion of Prevnar into the routine pediatric immunization

schedule in the United States, there has been a 98 percent (95% CI: 97%-99%)

reduction in vaccine-type IPD and a 77 percent reduction in all IPD among

children younger than 5 years of age through 2005, compared with a

pre-licensure baseline. In addition, the incidence of disease caused by the

seven conjugate vaccine serotypes declined 55 percent (95% CI: 51%-58%)

among adults 50 years of age or older, an unvaccinated group. The Centers

for Disease Control and Prevention has reported an increase in the incidence

of IPD due to non-vaccine serotypes in children younger than 5 years of age

and in adults 40 years of age and older; it is unknown whether these effects

would be observed in other populations.

Most recently, serotype 19A, which is included in the candidate vaccine, has

been increasing in prevalence in many regions of the world and is frequently

resistant to antibiotics. In fact, serotype 19A has emerged as the

predominant invasive pneumococcal serotype in the United States.

Indication

Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197)

Protein) is indicated for active immunization of infants and toddlers

against serious invasive disease caused by Streptococcus pneumoniae,

including bacteremia (bloodstream infection) and meningitis (infection of

the membranes surrounding the brain and spinal cord) caused by the seven

serotypes in the vaccine. The seven serotypes (strains) of S. Pneumoniae

included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains

that most commonly caused these serious diseases in children prior to the

introduction of Prevnar. The routine vaccination schedule is 2, 4, 6, and 12

to 15 months of age.

Prevnar is also indicated for immunization of infants and toddlers against

otitis media (ear infections) caused by the seven serotypes included in the

vaccine. Protection against ear infections is expected to be less than that

for invasive disease.

As with any vaccine, Prevnar may not protect all individuals receiving the

vaccine from serious invasive disease cause by S. Pneumoniae. This vaccine

should not be used for treatment of active infection.

Important Safety Information for Prevnar

In clinical trials, the most frequently reported adverse events included

injection site reactions, fever (greater than or equal to 38 degrees Celsius

/100.4 degrees Fahrenheit), irritability, drowsiness, restless sleep,

decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar. Hypersensitivity

to any vaccine component, including diphtheria toxoid, is a contraindication

to its use. Prevnar does not protect 100% of children vaccinated.

Immunization with Prevnar does not substitute routine diphtheria

immunization.

About 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. In particular, clinical trial data are subject

to differing interpretations, and the views of regulatory agencies, medical

and scientific experts and others may differ from ours. There can be no

assurance that our regulatory submissions for Prevnar 13 will be accepted

for review by regulatory agencies or that Prevnar 13 will ever receive

regulatory approval or be successfully developed and commercialized. Other

risks and uncertainties that could cause actual results to differ materially

from those expressed or implied by forward-looking statements include, among

others, risks related to our proposed merger with Pfizer, including

satisfaction of the conditions of the proposed merger on the proposed

timeframe or at all, contractual restrictions on the conduct of our business

included in the merger agreement, and the potential for loss of key

personnel, disruption in key business activities or any impact on our

relationships with third parties as a result of the announcement of the

proposed merger; 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; the outcome of government

investigations; 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; global economic conditions; interest and currency

exchange rate fluctuations and volatility in the credit and financial

markets; 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, 2008, which was filed with the Securities and

Exchange Commission on February 27, 2009. 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.