(Registrieren)

Wyeth's Prevenar 13* Receives First Approval

Geschrieben am 14-07-2009

Collegeville, Pennsylvania (ots/PRNewswire) -

- Chile Grants First Approval of Prevenar 13 for the Prevention
of Pneumococcal Disease in Infants and Children-

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the Chilean Ministry of Health, MINSAL (Ministerio de
Salud), has become the first government agency to approve Prevenar
13* Valent, (Pneumococcal Conjugate Vaccine 13 Valent (Diphtheria
CRM(197) Protein)) for infants and young children. Prevenar 13 Valent
is approved for active immunization of children aged 6 weeks through
5 years for the prevention of invasive pneumococcal disease, as well
as pneumonia and otitis media (middle ear infection) caused by 13
pneumococcal serotypes. Pneumococcal disease (PD) is the leading
cause of vaccine-preventable death worldwide in children younger than
5 years of age and is estimated to cause up to one million deaths in
children each year.

Prevenar 13, which builds on the scientific foundation of
Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), is
designed to provide the broadest serotype coverage of any
pneumococcal conjugate vaccine. Prevenar 13 contains 13 serotypes,
seven of which (4, 6B, 9V, 14, 18C, 19F and 23F) are included in
Prevenar and six additional serotypes (1, 3, 5, 6A, 7F and 19A)
associated with the greatest remaining burden of invasive disease.
Notably, serotype 19A is prevalent in many regions of the world and
is often associated with antibiotic resistance.

"The approval of Prevenar 13 in Chile is the first of many
regulatory decisions we anticipate receiving around the world this
year," says Emilio Emini, Ph.D., Executive Vice President, Vaccines
Research and Development, Wyeth Pharmaceuticals. "We believe that
Prevenar 13 is an important milestone in Wyeth's ongoing commitment
to public health in the fight against serious pneumococcal disease
worldwide."

The routine immunization schedule for Prevenar 13 Valent in Chile
is at ages 2, 4, 6, and 12 to 15 months, and the vaccine can be
administered at the same time as other regularly administered
childhood vaccines. Children who have already initiated a vaccination
program with Prevenar* can transition to Prevenar 13* Valent at any
point in their dosing schedule to help protect them from the six
additional disease serotypes included in Prevenar 13 Valent. Children
aged 7 months through 5 years should follow the appropriate dosing
schedule for their age group. There is no information about the
interchangeability of Prevenar or Prevenar 13 Valent with any other
pneumococcal conjugate vaccine that does not contain protein carrier
CRM(197). Wyeth expects Prevenar 13 Valent will be commercially
introduced in Chile later this year.

The Company initiated its global pediatric filings in late 2008
and, to date, has submitted regulatory applications for Prevenar 13
in more than 50 countries spanning six continents and has been
granted priority review in the U.S., Canada, Australia and South
Africa. Prevenar 13 is also being studied in global Phase 3 clinical
trials in adults, with regulatory submissions expected in 2010.

About Pneumococcal Disease

Pneumococcal disease is complex and describes a group of
illnesses, all caused by the bacterium Streptococcus pneumoniae.
Pneumococcal disease affects both children and adults, and includes
invasive infections such as bacteremia/sepsis and meningitis, as well
as pneumonia and otitis media.

Important Safety Information for Prevenar 13*

In clinical studies, the most commonly reported adverse events in
children were injection site reactions, fever, irritability,
decreased appetite, and increased and/or decreased sleep. Risks are
associated with all vaccines, including Prevenar 13. Hypersensitivity
to any vaccine component, including diphtheria toxoid, is a
contraindication to its use. As with any vaccine, Prevenar 13 may not
provide 100% protection against vaccine serotypes or protect against
nonvaccine serotypes.

Important Safety Information for Prevenar*

In clinical studies (n=18,168), 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 Prevenar.
Hypersensitivity to any vaccine component, including diphtheria
toxoid, is a contraindication to its use. Prevenar does not provide
100% protection against vaccine serotypes or protect against
nonvaccine serotypes. The decision to administer Prevenar should be
based on its efficacy in preventing invasive pneumococcal disease.

The frequency of pneumococcal serotypes and serogroups can vary
from country to country, which could influence the effectiveness of
the vaccine in any given country.

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 Prevenar
13 will be commercially successful or will receive regulatory
approval in other markets such as the United States and the European
Union. 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.

* Trademark

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
media, Lili Gordon of Wyeth Pharmaceuticals, +1-484-865-6671, or
Douglas Petkus of Wyeth, +1-973-660-5218; or investors, Justin
Victoria of Wyeth, +1-973-660-5340


Kontaktinformationen:

Leider liegen uns zu diesem Artikel keine separaten Kontaktinformationen gespeichert vor.
Am Ende der Pressemitteilung finden Sie meist die Kontaktdaten des Verfassers.

Neu! Bewerten Sie unsere Artikel in der rechten Navigationsleiste und finden
Sie außerdem den meist aufgerufenen Artikel in dieser Rubrik.

Sie suche nach weiteren Pressenachrichten?
Mehr zu diesem Thema finden Sie auf folgender Übersichtsseite. Desweiteren finden Sie dort auch Nachrichten aus anderen Genres.

http://www.bankkaufmann.com/topics.html

Weitere Informationen erhalten Sie per E-Mail unter der Adresse: info@bankkaufmann.com.

@-symbol Internet Media UG (haftungsbeschränkt)
Schulstr. 18
D-91245 Simmelsdorf

E-Mail: media(at)at-symbol.de

214176

weitere Artikel:
  • Elemica integriert wichtige Geschäftsprozesse und über 100 Lieferkettenpartner für das weltweit führende Spezialchemieunternehmen LANXESS Exton, Pennsylvania und Frankfurt (ots/PRNewswire) - - Durch eine einzige Verbindung zu Elemica kann die Infrastruktur vereinfacht und die Kommunikation beschleunigt werden Das branchenführende eBusiness-Lieferketten-Netzwerk Elemica gab bekannt, dass LANXESS, eines der weltweit führenden Spezialchemieunternehmen, dank des Geschäftsprozessnetzwerks Elemica Business Process Network seine Infrastruktur rationalisieren und die Verbindung zu Hunderten von Partnern entlang der Lieferkette vereinfachen konnte. LANXESS und die Handelspartner mehr...

  • Zwischen Luxus und Trostlosigkeit: Mehr als 50 Karstadt-Häuser in der Einzelkritik Frankfurt/Main (ots) - Das Wirtschaftsmagazin Der Handel (Deutscher Fachverlag, Frankfurt am Main) wollte die Nöte des insolventen Warenhausbetreibers Karstadt genau untersuchen - und besuchte dafür mehr als 50 Filialen quer durch die Bundesrepublik . Die Standorte wurden nach Kriterien wie Lage, Architektur, Atmosphäre, Sortiment und Kompetenz des Personals überprüft. Das Ergebnis nach rund 3.000 Kilometer Autofahrt und über 40 Städte: Die Filialen sind alles andere als homogen und schwanken zwischen Luxus und Trostlosigkeit. Vielerorts mehr...

  • Rheinische Post: Opel-Belegschaft lehnt Magna-Angebot ab Düsseldorf (ots) - Die Opel-Arbeitnehmer distanzieren sich überraschend von Magna. "Der europäische Gesamtbetriebsrat von General Motors hat das aktuelle Übernahme-Konzept von Magna einstimmig abgelehnt", sagte der Chef der IG Metall in NRW, Oliver Burkhard, der in Düsseldorf erscheinenden "Rheinischen Post" (Mittwochausgabe). Der bislang als Favorit für die Übernahme von Opel geltende Autozulieferer hatte die Belegschaftsvertreter bei einem gemeinsamen Treffen am Donnerstag mit neuen Forderungen zur geplanten Übernahme konfrontiert, mehr...

  • Zum dritten Mal: famila gewinnt Umweltpreis Kiel (ots) - Die famila-Handelsmarkt Kiel GmbH & Co. KG erhält in diesem Jahr zum dritten Mal den "Umweltpreis der Wirtschaft" der Studien- und Fördergesellschaft der Schleswig-Holsteinischen Wirtschaft e. V. famila wird für das im November 2008 eröffnete famila-Warenhaus Kiel-Wik mit einzigartigem Energiekonzept ausgezeichnet. Die Verleihung findet heute im Beisein von Ministerpräsident Peter Harry Carstensen im Kieler Schloss statt. Auszeichnung für das energieeffiziente famila-Warenhaus Kiel-Wik Der Preis wird jährlich an Unternehmen mehr...

  • Improving Transfusion Safety: Fenwal, Verax Biomedical Sign Agreement for Rapid, Point-of-Care Bacteria Test Lake Zurich, Illinois (ots/PRNewswire) - Fenwal Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today it has signed a five-year exclusive worldwide agreement with Verax Biomedical Incorporated to market, sell and distribute Verax's unique PanGenera(R) Detection (PGD) technology, a rapid diagnostic test used to detect bacterial contaminants in donated blood platelets. The Verax PGD(R) test is the only rapid test for the detection of bacteria cleared by the mehr...

Mehr zu dem Thema Aktuelle Wirtschaftsnews

Der meistgelesene Artikel zu dem Thema:

DBV löst Berechtigungsscheine von knapp 344 Mio. EUR ein

durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Exzellent
Sehr gut
gut
normal
schlecht