Pfizer Announces European Union Approval of a New Form of Lipitor (atorvastatin) for Use in Children

New York, July 6, 2010 (ots/PRNewswire) - Pfizer Inc. announced it has
received European Commission approval of a new chewable form of
Lipitor (atorvastatin calcium) suitable for use in children aged 10
or older with high levels of LDL ("bad") cholesterol and high
triglycerides due to the inherited disorder familial
hypercholesterolemia and other primary causes, which can increase the
risk of heart disease and premature death. This pediatric indication
has also been approved for the currently available tablet form of
Lipitor.

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The Decision to approve the use of atorvastatin in these
pediatric patients in Europe is based on the results of a pediatric
investigation plan (PIP) filed by Pfizer with the European Medicines
Agency (EMA) in November 2009. Investigations into pediatric use are
required by recent European pediatric regulations(1) in an effort to
encourage pharmaceutical companies to increase understanding of the
use of medicines in children. Pfizer hopes to improve treatment
options for such pediatric patients, reflecting its ongoing support
for patients at risk of cardiovascular disease.

To support the investments necessary to conduct clinical trials
in children, the EU created certain incentives, including the
availability of a six-month extension to an existing patent
extension, also known as a supplementary protection certificate
(SPC). As previously announced in November 2009, Pfizer intends to
apply for the additional six months of patent protection in European
countries where it has an SPC. A country-by-country process will be
required to secure this patent term extension.

Based on the results of Pfizer-sponsored trials, in March, the
EMA's Committee for Medicinal Products for Human Use (CHMP)
recommended that a pediatric-appropriate formulation of Lipitor
(chewable tablets) be approved for the treatment of
hypercholesterolaemia in adolescents and children aged 10 years or
older, and the approval of this indication for the currently
available presentations of Lipitor (film-coated tablets). The
European Commission Decision formalizes these recommendations, which
must now be implemented in all EU member states.

As a result of an earlier pediatric clinical development program,
Lipitor has been approved for use in children (aged 10 to 17 years)
with heterozygous familial hypercholesterolemia in the United States
since 2002.

Important U.S. Prescribing Information

LIPITOR is a prescription medicine that is used along with a
low-fat diet, and when diet and exercise are not enough. It lowers
the LDL ("bad" cholesterol) and triglycerides in your blood. It can
raise your HDL ("good" cholesterol) as well. LIPITOR can lower the
risk for heart attack, stroke, certain types of heart surgery, and
chest pain in patients who have heart disease or risk factors for
heart disease such as age, smoking, high blood pressure, low HDL, or
family history of early heart disease.

LIPITOR can lower the risk for heart attack or stroke in patients
with diabetes and risk factors such as diabetic eye or kidney
problems, smoking, or high blood pressure.

LIPITOR is not for everyone. It is not for those with liver
problems. And it is not for women who are nursing, pregnant or may
become pregnant.

Patients taking LIPITOR should tell their doctor if they feel any
new muscle pain or weakness. This could be a sign of rare but serious
muscle side effects. Patients should tell their doctor about all
medications they take. This may help avoid serious drug interactions.
Doctors should do blood tests to check your liver function before and
during treatment and may adjust the dose. Common side effects are
diarrhea, upset stomach, muscle and joint pain, and changes in some
blood tests.

For additional product information, visit http://www.Lipitor.com.

Pfizer Inc: Working Together for a Healthier World(TM)

At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery, development
and manufacturing of medicines for people and animals. Our
diversified global health care portfolio includes human and animal
biologic and small molecule medicines and vaccines, as well as
nutritional products and many of the world's best-known consumer
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time. Consistent
with our responsibility as the world's leading biopharmaceutical
company, we also collaborate with health care providers, governments
and local communities to support and expand access to reliable,
affordable health care around the world. For more than 150 years,
Pfizer has worked to make a difference for all who rely on us. To
learn more about our commitments, please visit us at
http://www.pfizer.com.

DISCLOSURE NOTICE:

The information contained in this release is as of July 6, 2010.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future
events or developments.

This release contains forward-looking information that involves
substantial risks and uncertainties. These include, among other
things, the Company's ability to satisfy the procedural requirements
of the EU Paediatric Medicines Regulation relating to the application
for the additional six months of patent/SPC protection in certain EU
countries.

A further list and description of risks and uncertainties can be
found in Pfizer's Annual Report on Form 10-K for the fiscal year
ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

1. Regulation (EC) No 1901/2006 of the European Parliament and of
the Council on medicinal products for paediatric use, amended by
Regulation (EC) No 1902/2006.

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

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