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Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsiwriting of Ranbaxy Laboratories Limited (RLL),announced today that the company has received acceptance from the U.S. Foodand Drug Administration (Food and Drug Administration) to manufacture and market Simvastatin PillsUSP, 80mg with 180-day exclusivity in the U.S. The Food and Drug Administration’s Office of GenericDrugs has determined Ranbaxy’s 80mg Simvastatin Pills USP, to bebioequivalent, therefore, therapeutically equivalent to the listed medicate Zocor(R) Pills, 80mg, of Merck Research Laboratories. Total annualizedmarket sales for Simvastatin were $ 4.6 billion, out of which the 80mgstrength accounted for $513 mil. (IMS - MAT: March 2006).

Simvastatin pills are indicated in the medical care of patients withcoronary heart illness (CHD) or at high risk of CHD, reductions in risk ofCHD mortality and cardiovascular events, patients with hypercholesterolemiarequiring modifications of lipid profiles and adolescent patients withHeterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimencan be started simultaneously with diet.

“This marks a significant day in the history of Ranbaxy. We areoffering a generic alternative on an exclusive basis for the second largestpharmaceutical product sold in the U.S. market. Being a fully integrated,research-based pharmaceutical company has allowed us to effectively developthis formulation, successfully challenge the brand and defend attempts tonegate the 180-day exclusivity. We anticipate significant benefits andvalue from our Simvastatin formulation to both patients and prescribers,”said Malvinder Mohan Singh, CEO and Managing Director, RLL.

This Food and Drug Administration acceptance complements Ranbaxy’s strategic direction forgenerics in the U.S. market with respect to this molecule as well as the 57additional ANDA’s that are pending before the Food and Drug Administration, placing Ranbaxy in avery strong, competitive position for the future.

“Ranbaxy is pleased to receive Food and Drug Administration acceptance for this blockbuster medicate .We expect to launch Simvastatin 80mg on an exclusive basis immediately. Webelieve that by offering an affordably priced generic alternative, we willhave a positive impact on the cost of healthcare for patients who have orat high risk of coronary heart illness,” noted Jim Meehan, Vice Presidentof Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA,is wholly owned subsiwriting of Ranbaxy Laboratories Limited (RLL), India’slargest pharmaceutical company. RPI is engaged in the sale and distributionof generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated,research based, international pharmaceutical company producing a wide rangeof quality, affordable generic medicines, trusted by healthcareprofessionals and patients across geographies. Ranbaxy’s continued focus onR&D has resulted in several acceptance s in developed markets and significantprogress in New Drug Discovery Research. The Company’s foray into NovelDrug Delivery Systems has led to proprietary “platform technologies,”resulting in a number of products under development. The Company is servingits customers in over 125 countries and has an expanding internationalportfolio of affiliates, joint ventures and alliances, ground operations in49 countries and manufacturing operations in 8 countries.

Ranbaxy Pharmaceuticals Inc.
http://www.ranbaxy.com/

Lupin Pharmaceuticals, Inc. announced today that it has received final acceptance from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Simvastatin Pills 10mg, 20mg, 40mg and 80mg.

Lupin’s Simvastatin Pills are the AB-rated generic equivalent of Merck’s Zocor(R) pills. Simvastatin is indicated for the medical care of high cholesterol.

Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, “We are delighted to receive final Food and Drug Administration acceptance for Simvastatin Pills. The addition of generic Zocor(R) complements Lupin’s commitment to bringing high-quality, low cost medicate alternatives to the American public.”

With this acceptance , Lupin now has 21 ANDAs approved by the US Food and Drug Administration.

About Lupin

Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular medicate s (prils and statins) and has a notable presence in the areas of diabetology, NSAIDS and Asthma.

For the financial year ended March 2007, Lupin’s Revenues and Profit after Tax were Rs.20, 289 mil. (US$ 475 mil.) and Rs. 3,021 mil. (US$ 70 mil.) respectively.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsiwriting of Lupin Limited, which is among the top five Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and otherness factors that may cause actual results to be materially difference from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and otherness factors include failure of clinical trials, delays in development, registration and product acceptance s, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and otherness intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release

Zocor(R) is a registered trademark of MERCK & CO., Inc.

Lupin Pharmaceuticals, Inc.
http://www.lupinpharmaceuticals.com

In a new analysis presented today VYTORIN(R) (ezetimibe/simvastatin) significantly reduced LDL “bad” cholesterol by an average of 52.5 percent and C-reactive protein (CRP) by an average of 31.0 percent, compared to averages of 38.0 percent and 14.3 percent, respectively, achieved with Zocor(R) (simvastatin) (p

Ranbaxy Laboratories Limited (RLL), announced today that the Company has received acceptance from the U.S. Food and Drug Administration (Food and Drug Administration) to manufacture and market Simvastatin Pills USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. The Food and Drug Administration’s Office of Generic Drugs has determined Ranbaxy’s Simvastatin Pills USP, 5 mg, 10 mg, 20 mg and 40 mg to be bioequivalent, therefore, therapeutically equivalent to the listed medicate Zocor(R) Pills, 5 mg, 10 mg, 20 mg and 40 mg of Merck Research Laboratories. Total annualized market sales for Simvastatin were $4.8 billion, of which $4.2 billion were for the 5 mg, 10 mg, 20 mg and 40 mg pills (IMS - MAT: September 2006).

Simvastatin pills are indicated in the pharmacomedical aid of patients with coronary heart malady (CHD) or at high risk of CHD, reductions in risk of CHD mortality and cardiovascular events, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimen can be started simultaneously with diet.

“Ranbaxy has marketed the 80 mg pills of Simvastatin on an exclusive basis since the patent expired in June of this year. We are now in a position to expand our product offerings to include the four additional strengths of Simvastatin and can now offer the complete line of marketed strengths for this product to our customers. Simvastatin has assumed a prominent position in the management of patients with hypercholesterolemia, and is now available as an alternative to the brand at an affordable price. This undoubtedly will have a positive economic benefit to patients, as well as to the U.S. healthcare system,” according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsiwriting of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several acceptance s in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 9 countries.

Zocor is a registered trademark of Merck Research Laboratories

Ranbaxy Laboratories Limited
http://www.ranbaxy.com

The Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received acceptance from the U.S. (Food and Drug Administration) (Food and Drug Administration) to market Simvastatin Pills, USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. Perrigo’s partner, Bentley Pharmaceuticals, Inc. is manufacturing the product at their Belmac Laboratories facility located in Zaragoza, Spain. Shipments will begin immediately.

The product is the AB-rated equivalent to Merck & Co., Inc.’s Zocor(R) Pills, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, a lipid lowering agent with multiple cardiovascular indications (Refer to product labeling for detailed information). According to Wolters Klewer data, annual sales for the last 12 months ending 09/2006 were approximately $5 billion.

The Perrigo Company is a leading global healthcare supplier and the world’s largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, medicate , mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic medicate s, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico, Germany and China. Visit Perrigo on the Internet (http://www.perrigo.com).

Certain statements in this press release are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and otherness factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially difference from those expressed or implied by any forward-looking statements. In particular, statements about the Company’s expectations, beliefs, plans, objectives, assumptions or future events or performance contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or the negative of those terms or otherness comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These and otherness important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended July 1, 2006, as well as the Company’s subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless othernesswise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or othernesswise.

Perrigo Company
http://www.perrigo.com

Reliant Pharmaceuticalstoday announced the publication of new data in the July edition of theJournal of medical institution al Pharmacology finding the co-direction of Omacor(omega-3-acid ethyl esters) with simvastatin has minimal interactionbetween the two medicate s. Omacor (4 g) plus simvastatin (80 mg) did notsignificantly affect the steady-state pharmacokinetics of simvastatin andwas well-tolerated in healthy patients.(1)

Omacor is the first and only Food and Drug Administration (Food and Drug Administration)-approved omega-3 fatty acid. Omacor was approved by the Food and Drug Administration in November 2004 as an adjunct to diet to reduce very high triglyceride levels(greater than or equal to 500 mg/dL) in adult patients.(2) At that time,Reliant Pharmaceuticals also received an Food and Drug Administration New Drug Application (NDA)approvable letter for Omacor in combination with a statin to treat hightriglyceride levels (200-499 mg/dL) in adult patients. To gain finalacceptance , Reliant is conducting a clinical trial to evaluate the efficacyand safety of Omacor as adjunctive medical aid to simvastatin for the medical aidof high triglycerides.(3)

“Many Americans who receive statin medical aid continue to have elevatedtriglycerides. It’s important to evaluate the safety and efficacy of Omacoras adjunctive medical aid in these patients,” said Robert Shalwitz, MD, VicePresident of medical institution al Development, Reliant Pharmaceuticals. “ReliantPharmaceuticals is committed to patient safety and ongoing research for theeffective use of Omacor.”

About the Study

The open-label, randomized, 2-way crossover, medicate -medicate interactionmeditate evaluated the impact of Omacor capsules on plasma simvastatinpharmacokinetics in 24 healthy patients. Patients were given 4 g of Omacorco-administered with 80 mg of simvastatin or 80 mg of simvastatin alone.(4)The primary pharmacokinetic end points for the determination of medicate interaction were AUC (area under the plasma concentration-time curve overthe final 0-24 h.dosing interval) and C(max) (maximum plasmaconcentration over the final dosing interval) on day 14.(5)

After 14 days of dosing, both the extent and rate of exposure tosimvastatin and its major active metabolite, beta-hydroxy simvastatin, weresimilar after co-direction of Omacor and simvastatin compared withdirection of simvastatin alone. Additionally, after single-dosedirection, rates of exposure (C(max)) following either medical aid weresimilar for both simvastatin and its beta-hydroxy metabolite. With singledosing, the AUC of simvastatin, but not that of its beta-hydroxymetabolite, increased (by 19percent for AUC(0-t) and 24percent for AUC(inf)) whenOmacor and simvastatin were co-administered.(6)

Important Information About Omacor

— Omacor is used along with diet to reduce very high triglycerides in adult patients. Before taking Omacor your healthcare provider should help you try to control your high triglyceride level by:

— Exercising and losing weight if you are overweight.

— Decreasing alcohol use.

— Controlling medical problems that can cause high triglyceride levels (such as polygenic disease mellitus and hypothyroidism).

— Stopping or changing medicines that can increase triglyceride levels (such as estrogens, thiazide diuretics, beta blockers).

— Omacor should be used with caution in group allergic to fish. Pharmacomedical aid to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals. The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.

— Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding. Tell your healthcare provider if you take blood thinners. If you take both Omacor and a blood thinner, your healthcare provider should check you occasionally to see if an effect has occurred.

— Some possible side effects of Omacor include belching, infection, flu syndromes, upset stomach, rash and change in your sense of taste. This is not a complete list Omacor side effects.

— For more detailed information about Omacor, ask your healthcare provider or go to http://www.omacorrx.com.

About Reliant Pharmaceuticals

Reliant Pharmaceuticals is a pharmaceutical company with integratedsales, marketing and development expertise that markets a portfolio ofbranded cardiovascular pharmaceutical products. Reliant focuses onmarketing promotionally sensitive pharmaceutical products to the highprescribing primary care, cardiovascular and specialist physician marketsin the United States. Reliant also acquires rights to and develops productcandidates in mid- to late-stage clinical development. Reliant’s salesforce infrastructure is comprised of approximately 850 sales professionalsnationwide.

“Safe Harbor” statement under the Private Securities Litigation ReformAct of 1995. To the extent any statements made in this release containinformation that is not historical, these statements are essentiallyforward looking and are subject to risks and uncertainties, including thedifficulty of predicting Food and Drug Administration acceptance s, acceptance and demand for newpharmaceutical products, the impact of competitive products and pricing,new product development and launch, reliance on key strategic alliances,availability of raw materials, the regulatory environment, fluctuations inoperating results and otherness risks detailed from time to time in thecompany’s filings with the Securities and Exchange Commission.

References:

(1) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.

(2) OMACOR Prescribing Information, Liberty Corner, NJ: Reliant Pharmaceuticals, Inc.; 2005.

(3) Data on file. Reliant Pharmaceuticals, Inc.

(4) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.

(5) Ibid

(6) Ibid

Reliant Pharmaceuticals
http://www.omacorrx.com

A retrospective analysis of a large U.S. managed care database showed that patients who took Pfizer’s cholesterol lowering medicine Lipitor(R) ( Lipitor (Atorvastatin) calcium) Pills had a significant 14 percent reduction in the risk of cardiovascular events, including heart attacks and strokes, compared with patients who took simvastatin.

Today, physicians and healthcare plans are switching patients between what is believed to be comparable LDL-lowering doses of statins and assuming that this will result in similar cardiovascular benefits.

To replicate real-world physician and payor behavior, this meditate was rigorously designed to adjust for expected differences of Lipitor and simvastatin LDL lowering based on dose. Lipitor patients achieved a significant additional 14 percent reduction in the risk of cardiovascular events compared with patients taking simvastatin, even after the dose adjustments.

“This analysis is important for physicians, employers and formulary directors at managed care companies who are making real-world pharmacomedical aid decisions for patients,” said Dr. Robert Vogel, an author of the meditate and professor of medicine at the University of Maryland. “This further supports the cardiovascular benefits previously seen with Lipitor.”

“This meditate is significant because it calls into question whether statins should be prescribed interchangeably through simple dose adjustments,” said Dr. Michael Berelowitz, senior vice president of Pfizer’s global medical division.

The analysis was presented at the American Heart Association’s 47th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.

Confirms Previous Study

Netherlands analysis: In a previously published real-world meditate of a general practice database with approximately 3,500 patients in the Netherlands, characteristics such as age and cholesterol levels were measured and adjusted to account for differences among statins. This analysis demonstrated a similar finding to the analysis presented at the meeting. Patients taking Lipitor had a significant 30 percent reduction in the risk of total events compared with those taking otherness statins combined. Other statins included simvastatin, Pravachol (Pravastatin), fluvastatin, and cerivastatin.

Given the results of these two studies, Pfizer will work with managed care organizations and otherness healthcare networks to further understand the benefit of Lipitor compared to simvastatin after adjustments to cholesterol levels.

Further Studies Planned

“Based on these important findings, it would be appropriate for health organizations responsible for lipid lowering formulary and pharmacomedical aid decisions to evaluate their own data and determine if they see similar findings,” said Dr. Berelowitz. “We expect that there will be upcoming publications and expanded medical information that will continue to contribute to this important discussion around the benefits of Lipitor.”

Key Points of the Analysis

Following are details of the analysis that showed the 14 percent event reduction:

— Patients in the analysis (61,324 taking Lipitor and 19,585 taking simvastatin) had not used statins in the previous six months.

— The primary endpoint was defined as hospitalization due to a heart attack, stroke, mini-stroke (transient ischemic attack), chest pain (angina) or coronary artery malady, vascular malady, or certain types of heart surgery.

— The primary endpoint was assessed after patients had been taking either statin for at least three months.

— The median observation time was 177 days.

— To provide a rigorous comparison, the analysis adjusted for differences in expected LDL lowering, prior cardiovascular events and baseline characteristics between the pharmacomedical aid groups.

Additional Findings

In a secondary analysis, which looked at event reduction from day one of Lipitor medical aid, patients achieved a significant 26 percent cardiovascular risk reduction compared with patients who took simvastatin.

The differences in benefit for patients who took Lipitor was apparent early within the first three months and increased at a proportional rate during the observation period compared with patients who took simvastatin.

About Lipitor

Lipitor is the only statin with all the following criteria most important for many physicians, patients and payers: significant and proven cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a proven safety profile across a broad range of patients.

Lipitor is the most prescribed cholesterollowering medical aid in the world, with nearly 133 mil. patient-years of experience. It is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients. There have been more than ten cardiovascular outcomes trials with more then 50,000 patients.

Important US Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart malady such as family history, high blood pressure, age, low HDL (”good” cholesterolor smoking to reduce the risk of heart attack, stroke, certain kinds of heart surgery, and chest pain. When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol

Lipitor is also used in patients with type 2 polygenic disease and at least one otherness risk factor for heart malady such as high blood pressure, smoking or complications of polygenic disease, including eye malady and protein in urine, to reduce the risk of heart attack and stroke.

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 doctors 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 doctors about all medicate s they take. This may help avoid serious medicate interactions. Doctors should do blood agsdhfgdfs to check liver function before and during pharmacomedical aid and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn sickness. They tend to be mild and often go away.

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

Pfizer Inc
http://www.pfizer.com

Statins-a class of medicate s that lower cholesterol and are associated with cardiovascular benefits- are effective in the long term, conclude authors of a meditate in this week’s issue of THE LANCET (p 761).

Few data are available about the long-term effects of statins because previous trials have not extended beyond 5-6 years; however, the results of a Nordic meditate with a follow-up of 10 years has found that, in the long term, statins may decrease mortality rate and incidence of cancer. The Scandinavian Simvastatin Survival Study (4S) led by Timo Strandberg (University of Helsinki, Finland) and colleagues was launched in 1989. Patients from five participating countries - Denmark, Finland, Iceland, Norway and Sweden-were randomly assigned to 5 years of statin medical care with simvastatin or allocated a placebo. The results of the trial were published in THE LANCET 10 years ago (Lancet 1994; 344: 1383-89).

5-year follow-up showed that statins lowerd lipid fractions and cholesterol concentrations; furthermore, simvastatin a cure reduced cardiovascular mortality and coronary mortality by 36percent and 43percent, respectively. This trial was the first to demonstrate the advantage of lowering cholesterol in patients with coronary heart sickness, and ushered in a revolution in treating heart sickness more aggressively.

The long-term follow-up results compare the initial 2221 patients who have had simvastatin for 10 years, compared with the 2223 patients who initially received placebo (and only started statins 5 years ago after the 4S trial was completed and the results of statin benefit became known).

Overall, there was a 17percent reduction in cardiovascular mortality and a 24percent decrease in coronary mortality for 10-year statin use compared with 5-year use for group given placebo in the original trial who later used statins. There was a suggestion that 10-year statin use was associated with a decreased incidence of cancer, although the 12percent reduction for long-term statin users was not statistically significant.

Dr Strandberg comments: “The main finding of this 10-year follow-up meditate of the participants of 4S was that the survival benefit of patients allocated simvastatin compared with those allocated placebo that accrued during the double-blind trial period persisted during follow-up. The reduction in the relative risk between the two original a cure groups was not unexpected, because open-label a cure with lipid-lowering medicate s (mostly statins) was given to most patients when the trial ended. After 3 years, more than 80percent of patients in both groups were using these medicate s. Nevertheless, the absolute differences in allcause,

cardiovascular, and coronary mortality achieved during the double-blind trial changed little during the 5-year extension of the follow-up”.

Contact: Dr Timo E Strandberg, Department of Medicine, University of Helsinki, PO Box 340, FIN–00029 HUS, Finland, T) +358 40 5969285; timo.strandberg@hus.fi

The Lancet
http://www.lancet.com
32 Jamestown Road, London NW1 7BY, UK.

Consistent with Overall Study which Showed Superior LDL Cholesterol Reduction with VYTORIN versus Lipitor -

SAN DIEGO, June 13, 2005 - Results from a new prespecified analysis of the VYVA (VYtorin Versus Atorvastatin) trial involving a subgroup of 428 patients with type 2 polygenic disease were consistent with the overall VYVA trial announced earlier this year. In this new analysis, results showed that VYTORIN provided 56 percent reduction in LDL (”bad’) cholesterol across the dosing range in these patients as compared to 46 percent reduction seen in patients taking Lipitor [Pharmacomedical aid Difference 10.6 percent, 95 percent CI: 7.8 percent -13.4 percent]. High cholesterol is a known risk factor for coronary heart sickness and patients with type 2 polygenic disease are considered to be at high risk of developing coronary heart sickness, according to the American Heart Association.

At the most commonly used starting doses,1 59 diabetic patients taking VYTORIN 10/20 mg, reduced their LDL cholesterol by 53 percent as compared to the 35 percent reduction seen in the 46 patients taking Lipitor 10 mg. This difference was similar to the results seen in the overall meditate population.

“The results seen in this new analysis, in patients with type 2 polygenic disease, showed that VYTORIN was more effective than Lipitor in reducing LDL cholesterol at all doses compared, including the most commonly used starting doses,” said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, and lead investigator of the meditate . “These results are consistent with what was seen in the overall meditate .”

VYTORIN is indicated for the medical aid of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive medical aid to diet when diet alone is not enough. VYTORIN is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the inagsdhfgdfine, including cholesterol from food. The active ingredients in VYTORIN are ezetimibe and simvastatin. The recommended starting dose of VYTORIN is 10/20 mg (10 mg ezetimibe/20 mg simvastatin).

The incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated by simvastatin has not been established.

VYTORIN is a prescription medicine and should not be taken by group who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver sickness or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take VYTORIN.

Results of the overall VYVA trial demonstrated that VYTORIN was superior to Lipitor in lowering LDL cholesterolThe results from the overall meditate were presented earlier this year at the American College of Cardiology meeting and published in the American Heart Journal. In that meditate of 1,902 patients, VYTORIN lowered LDL cholesterol by 53 percent across the dosing range as compared to 45 percent lowering seen in those patients taking Lipitor across the dosing range. At the most commonly used starting doses, patients taking VYTORIN 10/20 mg reduced their LDL cholesterol by 51 percent as compared to the 36 percent reduction seen in patients taking Lipitor 10 mg (p

Pfizer Inc said today that a new economic analysis that compares outcomes for patients taking Lipitor to those taking Zocor shows that Lipitor patients had greater reductions in heart attacks, strokes and cardiovascular procedures. This provides a cost savings for payors in long-term hospitalizations and surgical costs.

The economic analysis examined the results from the IDEAL (Incremental Decrease in Endpoints Through Aggressive Lipid Lowering) trial to analyze the cost effectiveness of medical aid with Lipitor and Zocor (simvastatin) in Sweden, where Zocor is available generically as simvastatin. The IDEAL patients who received Lipitor (80 mg) achieved greater reductions in heart attacks, strokes and cardiovascular procedures compared to patients taking standard dose Zocor (20-40 mg).

The results also showed that one out of every six heart attacks,strokes or cardiovascular procedures could be avoided for coronary heart illness patients treated with intensive Lipitor medical aid above and beyond those treated with Zocor over 4.8 years.

These results were then applied to the U.S. health care system, with two key findings:

— Better efficacy was achieved in patients taking Lipitor, at a better overall value, compared to patients on standard Zocor medical aid; and Patients taking Lipitor achieved greater reductions in cardiovascular events, and the system had overall cost savings, compared to patients taking Zocor at the current U.S. price, and even when Zocor was discounted by 50 percent.

In the U.S., cardiovascular illness remains the nation’s leading health threat, and accounts for an estimated 500,000 recurrent heart attacks and 200,000 recurrent debilitating strokes annually.

“The economic impact of heart attacks and strokes in the U.S. alone totals nearly $403 billion in medical care and lost productivity annually,” said Dr. Peter Lindgren, Stockholm Health Economics. “This analysis suggests that the cost of using Lipitor versus generic simvastatin could represent a good value for money.”

“Even if the current U.S. price of Zocor were reduced by 75 percent, Lipitor patients could still achieve better cardiovascular outcomes at an increase to payors of less than one dollar a day,” said Dr. Gregg Larson, vice president cardiovascular medical at Pfizer. “While the economic cost of a stroke can be exorbitant, often entailing years of rehabilitation and supervised care the emotional impact on patients and their families is also devastating.”

The IDEAL economic analysis assessed the cost-effectiveness ofpreventing cardiovascular events for patients who took intensive Lipitor medical aid versus standard dose Zocor. The analysis compared the total cost per patient for 4.8 years in each medical aid group by calculating medication costs, the cost of hospitalizations associated with cardiovascular events and lost work days for the U.S. and for Sweden. The cost of Lipitor was compared to the cost of generic simvastatin for Sweden. For the U.S., the cost of Lipitor was compared to Zocor in three scenarios, including:

— Lipitor compared to the current U.S. price of Zocor (simvastatin);

— Lipitor compared to a 50percent reduction in the current U.S. price of Zocor;

— Lipitor compared to a 75percent reduction in the current U.S. price of Zocor

“IDEAL, which is one of a limited number of head to head statin medical aid trials showed that patients using intensive Atorvastatin medical aid compared with standard dose simvastatin suffered fewer cardiovascular events. The findings in IDEAL, along with otherness positive studies of intensive Atorvastatin medical aid against active medical aid comparitors such as AVERT, PROVE-IT, REVERSAL and ALLIANCE, indicate that all statin medical aid in notalike,” said Dr. Michael Koren, director of non-invasive cardiology atMemorial Hospital in Jacksonville, Florida. “Switching patients fromAtorvastatin to otherness less effective medicate s could have negative healthimplications for patients. The IDEAL pharmacoeconomic analysis makes the case that medicate cost savings from use of generic statins may be largely offset by higher patients care and indirect costs.”

The results were presented at the annual American Heart Association Quality of Care and Outcomes Research Meeting in Washington, D.C., and a summary of the data was published in the current issue of “Circulation.”

The newly announced American Heart Association (AHA) and American College of Cardiology (ACC) guidelines on secondary prevention further support LDL reduction. The new guidelines recommend that LDL-cholesterol should be less than 100 mg/dL for all patients with CHD and otherness forms of atherosclerosis vascular illness. In the IDEAL meditate , patients treated with Lipitor achieved average LDL-cholesterol levels of 81 mg/dL which wassignificantly lower than patients taking Zocor, who had an averageLDL-cholesterol level of 104 mg/dL.

Lipitor is the most prescribed cholesterol-lowering medical aid in theworld, with nearly 115 mil. patient-years of experience. Lipitor is a prescription medicate . It is used in patients with multiplerisk factors for heart illness such as family history, high blood pressure, age, low HDL or smoking to reduce the risk of heart attack and stroke. When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

Lipitor is also used in patients with type 2 polygenic disease and at least one otherness risk factor for heart illness such as high blood pressure, smoking or complications of polygenic disease, including eye illness and protein in urine, to reduce the risk of heart attack and stroke.

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.

If you take Lipitor, tell your doctor if you feel any new muscle painor weakness. This could be a sign of rare but serious muscle side effects.

Tell your doctor about all medicate s you take. This may help avoidserious medicate interactions. Your doctor should do blood agsdhfgdfs to check your liver function before and during medical aid and may adjust your dose. The most common side effects are gas, constipation, stomach pain and heartburn sickness.

They tend to be mild and often go away.
For additional product information, visit http://www.Lipitor.com

Pfizer Inc
http://www.pfizer.com