Adding Inspra® (eplerenone) To StandardTherapy Significantly Reduces Risk Of Cardiovascular Death And HeartFailure Hospitalization In High Risk Patients With Chronic Heart FailureNYHA Class II And Mild Symptoms

Pfizer Inc. (NYSE: PFE) today announced results from a new post-hoc sub-group analysis of the EMPHASIS-HF trial showing statistically significant* reductions in the primary composite endpoint of cardiovascular death and heart failure hospitalization for five pre-defined high risk patient sub-groups with chronic heart failure (CHF) New York Heart Association (NYHA) class II and mild symptoms treated with eplerenone in addition to standard therapy versus those treated with placebo plus standard therapy.1

The results were presented for the first time during a Hot Line Session of The European Society of Cardiology Congress (ESC) in Paris today.

Significant reductions in the risk of the primary endpoint of cardiovascular mortality and heart failure hospitalization were observed in the following five pre-specified high risk sub-groups:

• Patients aged 75 years or older: 78 events (23.6%) among 330 patients on eplerenone and 107 events (32.7%) among 327 patients on placebo (HR 0.66, p=0.004, CI 0.49-0.88)
• Patients with a left ventricular ejection fraction (LVEF) <30%: 180 events (19.3%) among 934 patients on eplerenone and 267 events (27.3%) among 978 patients on placebo (HR 0.65, p<0.0001, CI 0.53-0.78)
• Patients with type 2 diabetes: 99 events (21.6%) among 459 patients on eplerenone and 141 events (35.2%) among 400 patients on placebo (HR 0.54, p<0.0001, CI 0.42-0.70)
• Patients with estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 : 107 events (24.4%) among 439 patients on eplerenone and 163 events (34.5%) among 473 patients on placebo (HR 0.62, p=0.0001, CI 0.49-0.79)
• Patients with systolic blood pressure (SBP) < median, 123 mmHg: 138 events (20.6%) among 669 patients on eplerenone and 201 events (29.4%) among 683 patients on placebo (HR 0.62, p<0.0001, CI 0.51-0.79)

Additionally, in these five sub-groups, the secondary endpoints of all-cause hospitalization and heart failure hospitalization achieved statistically significant (p<0.01) relative risk reductions for the eplerenone group compared to the placebo group.

In May 2010, recruitment to the EMPHASIS-HF trial was halted early after the second pre-specified interim analysis showed that the study´s pre-defined stopping rules had been met and a significant difference (two-sided P<0.001 in favor of eplerenone) in the primary endpoint was evident. The main results of the EMPHASIS-HF study2 were published in New England Journal of Medicine (NEJM) in November 2010.

After halting of recruitment, additional primary endpoints were observed while patients remained on double-blind therapy for a mean seven months of follow-up. Analysis of the data covering the full double-blinded period indicates that the effect of eplerenone on the primary endpoint remained significant over the additional follow-up period (HR 0.66, p< 0.0001 CI 0.57-0.77).

No new safety information emerged from these additional analyses. In each of the high risk sub-groups evaluated, patients receiving eplerenone had a significant increase in the incidence of hyperkalaemia (K+> 5.5 mmol/l). However, there was no significant increase in serious hyperkalemia (K+>6.0 mmol/l), hyperkalaemia leading to drug discontinuation, hospitalization for hyperkalemia, or hospitalization for worsening renal function.

Commenting on the findings, EMPHASIS-HF investigator Professor Bertram Pitt, Division of Cardiology, University of Michigan School of Medicine, U.S. said: "Despite receiving best current treatments, patients with CHF NYHA Class II have a poor prognosis and continue to experience frequent admissions to hospital and reduced life expectancy. The five high risk sub-groups that are the subject of this new post-hoc sub-group analysis are known to be especially vulnerable. The results reported today suggest that adding eplerenone to standard therapy can significantly reduce cardiovascular death and hospitalization in these patients who are of particular concern to clinicians."

Eplerenone is not authorised for use in the five high risk patient sub-groups of the EMPHASIS-HF study population in any market.

References

1. Pitt, B. The effect of eplerenone versus placebo on cardiovascular mortality or heart failure hospitalization in subjects with NYHA class II chronic systolic heart failure (EMPHASIS-HF)- An analysis of the high risk groups in the study population. European Society of Cardiology Congress, Paris 27-31 August 2011. Abstract# 2177

2. Zannad, F; McMurray, J.J.V; and Drexler, H; et al. Eplerenone in patients with systolic heart failure and mild symptoms. New England Journal of Medicine 2010 [10.1056/nejmoa1009492 nejm.org]

About the EMPHASIS-HF trial

EMPHASIS HF (A6141079) is a phase 3B, multinational (2,737 patients from 272 centres in 29 countries), randomized, double-blind placebo-controlled, parallel-group trial. It is conducted in a NYHA II chronic systolic heart failure population, which is a distinct population from the EPHESUS study population (patients with left ventricular dysfunction (LVEF ? 40 %) and clinical evidence of heart failure after recent myocardial infarction). In Europe, the current approved indication for eplerenone is based on the EPHESUS study population.

The primary objective of this trial is to evaluate the efficacy and safety of eplerenone plus standard heart failure (HF) therapy - including an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blockers (ARB), plus a beta"´blocker "´ versus placebo plus standard HF therapy on the cumulative incidence of cardiovascular (CV) mortality and HF hospitalization (a composite primary endpoint). The mean follow-up time was 21.1 months.

Patients were to be randomized (1:1) to receive eplerenone 25 mg once daily (OD) or matching placebo. At four weeks, the dose of study drug could be increased to 50 mg OD (two 25mg tablets of eplerenone or two matching placebo tablets once daily) based on serum potassium level. The trial was designed to enroll 3100 patients and to continue until a total of 813 adjudicated primary endpoint events were reported.

The EMPHASIS-HF trial demonstrated a statistically significant 37% relative risk reduction for patients with chronic systolic heart failure and mild symptoms treated with eplerenone (p<0.0001) plus standard therapy compared to placebo plus standard therapy in the primary composite endpoint of death from CV causes or HF hospitalization. There were also statistically significant reductions in the other major secondary endpoints of all-cause mortality, CV mortality, all-cause hospitalization and HF hospitalization. These landmark results were simultaneously published in the New England Journal of Medicine at the time of first presentation at the American Heart Association (AHA) Scientific Sessions in November 2010.

In May 2010, Pfizer announced that it would halt recruitment to the EMPHASIS-HF trial early on the recommendations of the trial´s independent Executive Steering Committee (ESC). The recommendations followed a second interim analysis by the independent Data Safety Monitoring Committee (DSMC) of the EMPHASIS-HF trial confirming the study had reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules.

The study was funded by Pfizer.

About INSPRA®

INSPRA® (eplerenone) is a steroid nucleus-based mineralcorticoid receptor (MR) antagonist with a higher degree of selectivity than spironolactone. Eplerenone is thought to be a more selective blocker at the mineralcorticoid receptor since there is evidence that some of the effects result from a blockade of cortisol stimulation of the MR-receptor.

Important Prescribing Information

In the United States, Inspra® (eplerenone) is indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction less than or equal to 40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI). Eplerenone is also indicated for the treatment of hypertension. Eplerenone may be used alone or in combination with other antihypertensive agents.

Eplerenone is contraindicated in all patients with serum potassium greater than 5.5 mEq/L at initiation, creatinine clearance less than or equal to 30 mL/min, or concomitant administration of strong CYP3A4 inhibitors. Eplerenone is also contraindicated for the treatment of hypertension in patients with type 2 diabetes with microalbuminuria, serum creatinine greater than 2.0 mg/dL in males or greater than 1.8 mg/dL in females, creatinine clearance less than 50 mL/min, or concomitant administration of potassium supplements or potassium sparing diuretics.

Serum potassium should be measured before initiating eplerenone therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter, especially in patients at risk for the development of hyperkalemia such as elderly patients with renal insufficiency and patients with type 2 diabetes and microalbuminuria.

Most common adverse reactions (greater than 2% and more frequent than with placebo) in patients with CHF Post-MI: hyperkalemia and increased creatinine. Most common adverse reactions (greater than or equal to 2% and more frequent than with placebo) in hypertensive patients: dizziness, diarrhea, coughing, fatigue and flu-like symptoms.

In the EU, eplerenone is indicated to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ?40%) and clinical evidence of heart failure after recent myocardial infarction.

In Japan, eplerenone is approved for the treatment of hypertension.

For additional product information in the US, visit: http://media.pfizer.com/files/products/uspi_inspra.pdf

UK prescribing information is available at: http://www.medicines.org.uk/EMC/medicine/16746/SPC/Inspra+25mg+%26+50+mg+film-coated+tablets/

Other countries should refer to local prescribing information.

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DISCLOSURE NOTICE: The information contained in this release is as of August 29, 2011. 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 about a potential additional indication for Inspra, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development.; decisions by regulatory authorities regarding whether and when to approve any supplemental drug applications that may be filed for this additional indication for Inspra as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such additional indication; and competitive developments. -8-

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, 2010 and in its reports on Form 10-Q and Form 8-K.

* The p values for the primary endpoint for the 5 high risk sub groups were: p?0.0001 (history of DM, LVEF <30%, SBP < median123mmHg, and eGFR < 60 ml/min/1.73m2 ); and p= 0.004 (age ?75 years ).