Data from the ASPIRE study (Aliskiren Study in Post-MI patients to Reduce rEmodelling) were presented at the American College of Cardiology (ACC) Congress in Atlanta. Results from the study showed that the addition of aliskiren did not provide the anticipated effect of limiting adverse changes to the heart’s left ventricle, which is the organ’s main pumping chamber that can often reduce its ability to pump blood efficiently[1].

The 36-week study involving 820 patients, all of whom had evidence of impaired left ventricular function, assessed changes in left ventricular end systolic volume (LVESV) through echocardiograms from baseline to the study end. A small numerical reduction in cardiac volume (LVESV, -0.99 mL) was seen in patients receiving aliskiren and standard therapy compared to those given standard therapy only; however, this was not statistically significant[1].

The combined rates of cardiovascular death, hospitalization for heart failure, recurrent heart attack, stroke and resuscitated sudden death were similar in the aliskiren group and the group given standard therapy. In patients receiving aliskiren in addition to standard therapy there was a higher rate of hyperkalemia, hypotension and kidney dysfunction when compared to the group receiving standard therapy alone[1].

Based on the results of this trial, Novartis does not plan to pursue an outcome trial for post-MI patients. ASPIRE is one of 14 trials in the 35,000 patient ASPIRE HIGHER clinical trial program that is designed to evaluate potential benefit of aliskiren beyond blood pressure reduction.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “can,” “plan,” “potential,” or similar expressions, or by express or implied discussions regarding the outcome of the ASPIRE HIGHER clinical trial program, regarding potential new indications or labeling for aliskiren or regarding potential future revenues from aliskiren as a result. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with aliskiren to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees regarding the potential outcome of the ASPIRE HIGHER clinical trial program.  Nor can there be any guarantee that aliskiren will be submitted or approved for any additional indications or labeling in any market. Neither can there be any guarantee that any such additional indications or labeling will result in aliskiren achieving any particular levels of revenue in the future. In particular, management’s expectations regarding aliskiren could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group’s continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

References

[1]    Solomon S, et al. Effect of the Direct Renin Inhibitor Aliskiren on Left Ventricular Remodelling Following Myocardial Infarction with Left Ventricular Dysfunction: ASPIRE. Late Breaker presentation at American College of Cardiology 59th Annual Scientific Sessions 2010

# # #

Novartis Media Relations

e-mail: media.relations@novartis.com

Novartis Investor Relations

“The new data presented at ACC demonstrate that Lipitor 80 mg may help prevent cardiovascular events in these high-risk patients.”

“Nearly 26 million Americans suffer from CKD, which is often associated with co-morbidities – such as heart disease, metabolic syndrome or obesity – that can increase risk for heart attack and stroke,” said Dr. Prakash Deedwania, professor of Medicine, UCSF School of Medicine, San Francisco, CA and Chief, Cardiology Section, VACCHCS/UCSF Program, Fresno, CA. “The new data presented at ACC demonstrate that Lipitor 80 mg may help prevent cardiovascular events in these high-risk patients.”

According to the new analyses, for patients with both CHD and CKD, being obese or having metabolic syndrome may further increase their risk for cardiovascular events.

In one sub-analysis, which looked at the 1,859 patients in TNT who had CHD, CKD and metabolic syndrome, Lipitor 80 mg was associated with a 35 percent reduction in the risk of major cardiovascular events compared with Lipitor 10 mg. In a separate sub-analysis of the 954 patients in TNT with CHD, CKD and obesity, Lipitor 80 mg was associated with a 33 percent reduction in the risk of major cardiovascular events compared with Lipitor 10 mg. For both sub-analyses, major cardiovascular events included a combined endpoint of death from heart disease, non-fatal heart attack, resuscitated cardiac arrest and fatal or non-fatal stroke.

The safety of Lipitor in these patient sub-sets was consistent with that in the overall TNT trial. Lipitor is not approved for the treatment of CKD, obesity or metabolic syndrome.

About the TNT Study

The original TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. After an eight week run-in on Lipitor 10 mg, patients were randomized to receive either Lipitor 10 mg or Lipitor 80 mg. Primary study results were published in The New England Journal of Medicine in 2005.

The primary endpoint of the original TNT study was the time to occurrence of a first major cardiovascular event, defined as death from heart disease, non-fatal heart attack, resuscitated cardiac arrest, or fatal or non-fatal stroke.

Lipitor 80 mg is not a starting dose. Lipitor is not approved in all countries to reduce the risk of cardiovascular events in patients with existing heart disease.

Throughout the TNT study, Lipitor was generally well tolerated.

About Obesity and Metabolic Syndrome

Obesity, defined as having a body mass index of 30 or higher, affects more than one-third of the U.S. adult population, according to the latest National Health and Nutrition Examination Survey. Obesity is now recognized by the American Heart Association (AHA) as a major risk factor for CHD, which can lead to heart attack. Obesity is also associated with metabolic syndrome, which the AHA defines as the presence of three or more related health factors, including insulin resistance, high waist circumference, low HDL cholesterol levels and high blood pressure and triglycerides. Patients with metabolic syndrome are at increased risk for CHD and other diseases related to plaque build-ups in artery walls.

About Chronic Kidney Disease

Patients with CKD do not effectively filter toxins from the blood. When CKD progresses to kidney failure, either dialysis or a kidney transplant is needed. CKD has been recognized as an important independent predictor of cardiovascular risk, and patients with CKD are more likely to die from a cardiovascular event than to reach end-stage renal disease.

Important U.S. Prescribing Information

Lipitor is a prescription medicine that is used along with a low-fat diet. 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 www.Lipitor.com.

The ABCB1 gene contains the genetic code for a protein (P-glycoprotein) that plays an important role in how the body absorbs many medications, including antiplatelet drugs. Genetic variants in ABCB1 may reduce response to antiplatelet therapy.

In this sub-study, the TRITON-TIMI 38 investigators analyzed clinical outcomes among 2,943 patients tested for the “C3435T” variant in the ABCB1 gene. More than one out of four (27 percent) patients in the analysis were found to have two C3435T variants in their chromosomes.(1) Clopidogrel-treated patients who had two C3435T variants (n=414) had a 66 percent increased risk of experiencing the primary composite endpoint of cardiovascular death, heart attack or stroke compared to clopidogrel-treated patients without the variant (12.9 percent vs. 8.2 percent, HR=1.66; p=0.033). The overall ABCB1 genetic analysis, which included clopidogrel patients with two, one or no C3435T variants, also showed a significant increase in the primary endpoint for patients with two variants (p=0.0064).

In contrast, Effient-treated patients with two C3435T variants (n=390) did not have a statistically significant increased risk of experiencing the primary composite endpoint compared to Effient-treated patients without the variant (11 percent vs. 9.7 percent, HR=1.12; p=0.64), and the differences in the overall ABCB1 analysis were likewise not significant (p=0.40).

“These data are important because they suggest that multiple genetic variations may impact a patient’s response to antiplatelet medications, and that these effects appear to differ from medication to medication,” said Jessica Mega, M.D., M.P.H., associate physician at Brigham and Women’s Hospital and investigator at the TIMI Study Group. “Understanding the full scope of these genetic variations may help determine which drug to prescribe as part of the dual antiplatelet therapy a patient receives after an angioplasty with a stent.”

In this subanalysis, there was no association between C3435T genotype and bleeding in either treatment group. In the overall TRITON-TIMI study population, Effient produced higher rates of clinically significant bleeding than clopidogrel.

Study Methodology

TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of Effient versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during a median period of at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either Effient 60 mg or the FDA-approved loading dose of clopidogrel 300 mg, followed by a daily maintenance dose of either Effient 10 mg or clopidogrel 75 mg. All patients also received a daily dose of aspirin (75 mg to 325 mg).

This analysis was designed to examine whether specific genetic variations could affect patient response to antiplatelet therapy. The pharmacogenetic analyses examined DNA samples from 2,943 patients from the TRITON-TIMI 38 clinical trial.

The genetic subanalysis was not powered to make efficacy comparisons between clopidogrel and prasugrel based on genetic variations.

About Effient

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) co-developed Effient, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Effient helps keep blood platelets from clumping together and developing a blockage in an artery. Effient is approved by the U.S. Food and Drug Administration for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with ACS who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

About Acute Coronary Syndromes

ACS, which includes heart attack and unstable angina (chest pain), affects more than 1.5 million people in the United States annually, many of whom are managed with PCI.(2) In 2009, an estimated 785,000 people in the United States will have a new heart attack, and about 470,000 will have a recurrent attack.(3) ACS results in significant morbidity and mortality, accounting for half of all deaths due to cardiovascular disease, and costs Americans more than $150 billion annually, nearly 60 percent of which results from rehospitalization.(4)

Important Safety Information about Effient

Antiplatelet medicines, including Effient, can increase a patient’s risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or “mini-stroke” (transient ischemic attack or TIA).

If patients are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (e.g., warfarin) or taking NSAIDs (e.g., ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.

If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient.

Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or death.

Patients should get medical attention right away if they develop any of the following unexpected symptoms: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots. These symptoms may be signs of a rare but potentially life-threatening condition called TTP, which has been reported with other medicines in this class that are like Effient, sometimes after a short time (less than 2 weeks).

For more information about Effient, please see the Full Prescribing Information, including Boxed Warning (http://pi.lilly.com/us/effient.pdf), and Medication Guide (http://pi.lilly.com/us/effient-ppi.pdf). You may also learn more about Effient at www.Effient.com.

About Daiichi Sankyo

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. Areas of primary focus for Daiichi Sankyo research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis and bacterial infections. For more information, visit www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains certain forward-looking statements about Effient for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention and reflects Daiichi Sankyo’s and Lilly’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filing with the United States Securities and Exchange Commission and Daiichi Sankyo’s filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.

Effient(R) is a registered trademark of Eli Lilly and Company.

Plavix(R) is a registered trademark of Sanofi-Aventis Corp.

P-LLY

1. Marzolini, C, et al, Polymorphisms in human MDR1 (P-glycoprotein): Recent advances and clinical relevance. Clinical Pharmacology & Therapeutics, 2004;75(1):13-33.

2. American Heart Association. Heart Disease and Stroke Statistics – 2008 Update. Dallas, TX. American Heart Association. (Pg. 14).

3. American Heart Association Heart Disease and Stroke Statistics – 2009 Updated. Dallas, TX. American Heart Association. (Pg. 2)

4. Kolansky, D, Acute coronary syndromes: Morbidity, mortality, and pharmacoeconomic burden. Amer J of Manag Care, 2009;15:S36-S41. http://www.ajmc.com/media/pdf/A213_09mar_KolanskyS36to41.pdf. Accessed Feb. 12, 2010.

SOURCE Eli Lilly and Company

“The positive 30-day results reaffirm my belief that a device that bioresorbs, or disappears, into the body after restoring blood flow is the next logical step in the treatment of cardiovascular disease,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “The continuing positive results of the ABSORB trial and the clinical benefits demonstrated to date by Abbott’s bioresorbable technology show promise that a bioresorbable scaffold is on its way to becoming a clinical reality and will be the next revolution in interventional cardiology.”

This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support. Abbott is the only company with long-term, three-year clinical data on a complete patient set evaluating the safety and performance of a fully bioresorbable drug eluting scaffold.

“The encouraging 30-day results show that Abbott’s BVS is able to restore blood flow with no cases of blood clots or repeat procedure, suggesting that there could be important clinical benefits for patients,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “If Abbott’s bioresorbable technology continues to perform well in clinical trials, it has the potential to become the new standard of care for patients with coronary artery disease.”

Abbott’s investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration therapy, is what makes Abbott’s BVS unique in the field of cardiology.

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12, 18 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months.

Abbott’s bioresorbable technology delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web site at www.abbott.com.

(1) MACE is a composite measure of key efficacy and safety endpoints and includes cardiac death, heart attack (myocardial infarction) and ischemia-driven target lesion revascularization.

SOURCE Abbott

In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The complete response letter does not contain requests related to the December 2009 observations from the FDA’s pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.

“This is a significant step forward in our ability to bring this important therapy to patients,” said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

The NDA for BYDUREON was submitted in May 2009 and accepted by the FDA in July 2009. It is based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA.

Amylin to Host Investor Conference Call

Amylin will host a conference call to discuss the complete response letter for BYDUREON on Monday, March 15 at 8:30 a.m. ET/5:30 a.m. PT. Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals, will lead the call.

The call will be webcast live through Amylin’s corporate Web site and a recording will be made available following the close of the call. To access the webcast, please log on to www.amylin.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 291-9234 (U.S./Canada) or (617) 614-3923 (international), conference access code 12781062. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (888) 286-8010 (U.S./Canada) or (617) 801-6888 (international), conference access code 34108583.

About Diabetes

Diabetes affects more than 24 million people in the U.S. and an estimated 285 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)

About BYETTA(R) (exenatide) injection

BYETTA is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight-loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction. See important safety information below. Additional information about BYETTA is at www.BYETTA.com.

Important Safety Information for BYETTA(R) (exenatide) injection

Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems, and should be used with caution in people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Severe allergic reactions can happen with BYETTA.

The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For additional important safety information about BYETTA, please see the full Prescribing Information (http://pi.lilly.com/us/byetta-pi.pdf) and Medication Guide (http://pi.lilly.com/us/byetta-ppi.pdf).

About Amylin, Lilly and Alkermes

Amylin, Lilly and Alkermes are working together to develop BYDUREON, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes’ proprietary Medisorb(R) technology for long-acting medications. BYDUREON is not currently approved by any regulatory agencies.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin’s research and development activities leverage the Company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California.

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs.

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients’ lives. Alkermes’ robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.

This press release contains forward-looking statements about Amylin, Lilly and Alkermes. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYDUREON may not be approved by the FDA in a timely manner or at all; the companies’ response to the complete response letter may not be submitted in a timely manner and/or the information provided in such a response may not satisfy the FDA; the FDA may request additional information prior to approval; BYETTA and/or the approval of BYDUREON and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical issues; clinical trials not being completed in a timely manner, not confirming previous results, not being predictive of real world use or not achieving the intended clinical endpoints; label expansion requests or NDA filings, such as the NDA filing for BYDUREON mentioned in this press release, not receiving regulatory approval; the commercial launch of BYDUREON being delayed; or manufacturing and supply issues. The potential for BYETTA and/or BYDUREON may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the development and commercialization of pharmaceutical products including those inherent in the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. These and additional risks and uncertainties are described more fully in Amylin’s, Lilly’s and Alkermes’ most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements.

BYDUREON(TM) and BYETTA(R) are trademarks of Amylin Pharmaceuticals, Inc., and Medisorb(R) is a registered trademark of Alkermes, Inc.

P-LLY

(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010. Accessed March 12, 2010.

(ii) Diabetes Statistics. American Diabetes Association. Available at http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed March 12, 2010.

(iii) Direct and Indirect Costs of Diabetes in the United States. American Diabetes Association. Available at: http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html. Accessed March 12, 2010.

(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.

SOURCE Amylin Pharmaceuticals, Inc.

“Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints”

“Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints,” said Hal Barron, M.D., head, Global Development and chief medical officer at Roche.

These findings do not impact Avastin’s approved uses or its broad development program in other tumor types.

About Prostate Cancer

Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate cancer and approximately 27,000 died from the disease in the United States.

About CALGB 90401

CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate Avastin plus docetaxel chemotherapy and prednisone, compared to docetaxel chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the NCI under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB.

The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival, prostate-specific antigen response rate and safety.

Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.

About Avastin

Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF). VEGF plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.

Boxed WARNINGS and Additional Important Safety Information

People treated with Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine or large intestine. In clinical trials, this side effect occurred in more people who received Avastin than in the comparison group (0.3 percent to 2.4 percent). In some cases, GI perforation resulted in fatality.

Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of having surgery and wound healing problems following surgery has not been determined.

Severe bleeding: Treatment with Avastin can result in serious bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin.

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine, which led to kidney problems, was seen in less than 1 percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in 5 percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2 percent of people.

Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.

Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Genentech, Inc.
Media Contact:
Charlotte Arnold, 650-467-6800
Advocacy Contact:
Kristin Reed, 650-467-9831
Investor Contacts:
Kathee Littrell, 650-225-1034
Karl Mahler, 011 41 61 687 85 03

“We are pleased that these data suggest PREFLUCEL elicits a strong immune response and may prevent influenza disease in vaccinated individuals”

The Phase III clinical study found a 78 percent overall protection rate against culture-confirmed influenza from influenza strains that matched those in the vaccine and a 71 percent rate of prevention of influenza from all circulating strains. The study was conducted during the 2008/2009 influenza season in the United States in more than 7,000 healthy clinical trial participants ages 18 to 49.

“We are pleased that these data suggest PREFLUCEL elicits a strong immune response and may prevent influenza disease in vaccinated individuals,” said Hartmut J. Ehrlich, M.D., vice president of Global Research and Development for Baxter’s BioScience business. “This is a landmark study assessing the efficacy of a cell culture-based, non-adjuvanted and preservative-free vaccine in the prevention of seasonal influenza.”

In the double-blind, placebo-controlled trial, the highly sensitive nasopharyngeal fluid test was used to detect the presence of influenza infection in any of the 7,243 trial participants who presented with clinical symptoms suggestive of influenza disease at least 21 days after vaccination.

The study also assessed the immunogenicity of PREFLUCEL by determining the rates of seroprotection and seroconversion, as well as geometric mean titer increases, in vaccinated study participants. Immunogenicity results met all of the requirements for each of these criteria set forth by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). For licensure of new influenza vaccines, CHMP mandates that at least one of these criteria are met for each of the three strains (H1N1*, H3N2, B) included in the vaccine. The findings were also consistent with immunogenicity data from Baxter’s previous studies of PREFLUCEL in adults and the elderly.

The Phase III study also indicates that PREFLUCEL’s safety profile is similar to that of licensed egg-derived seasonal influenza vaccines. The most common side effects observed in the study were injection site reactions, myalgia, fatigue, headache and malaise.

Baxter and DVC plan to complete the PREFLUCEL Phase III clinical trial program in adults and elderly individuals in early 2010. Work on this vaccine is being completed as part of a U.S. Department of Health and Human Services (HHS) Office of Public Health and Emergency Preparedness contract awarded to DVC in May 2006. DVC is working in collaboration with Baxter to develop seasonal and pandemic influenza vaccines. Under this contract, DVC is managing the project and clinical trials. Baxter is manufacturing the vaccines and will serve as the FDA license-holder should the product be licensed in the United States.

* For this Phase III clinical trial, PREFLUCEL trivalent vaccine contained a 2008/2009 seasonal influenza H1N1 strain, which differs from the 2009 pandemic influenza H1N1 strain.

ACKNOWLEDGEMENTS:

1. This project has been funded in whole or in part with Federal (United States Government) funds from the Office for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number HHS0100200600013C.

2. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L. 105-78; 100% of the total of this project’s costs are financed with Federal (United States Government) money.

3. The content of this publication does not necessarily reflect the views or policies of the United States Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

About DVC

DynPort Vaccine Company LLC (DVC) manages product development programs and provides consulting, technical and program management services to U.S. government agencies and companies in the biotechnology and pharmaceutical industries. DVC is part of CSC’s North American Public Sector business unit’s Government Health Services Division. CSC’s expertise in providing health services to government agencies has grown over the last five decades to offer commercial best practices integrated to meet federal, state and local healthcare requirements. Services range from optimizing claims processing to operating disease surveillance systems to vaccine development and management. CSC’s ideas and solutions are improving the quality of healthcare with better information for better decisions to save lives and money. For more information, visit www.csc.com/dvc.

About CSC

CSC is a global leader in providing technology-enabled solutions and services through three primary lines of business. These include Business Solutions and Services, the Managed Services Sector and the North American Public Sector. CSC’s advanced capabilities include systems design and integration, information technology and business process outsourcing, applications software development, Web and application hosting, mission support and management consulting. Headquartered in Falls Church, Va., CSC has approximately 92,000 employees and reported revenue of $16.0 billion for the 12 months ended Jan. 1, 2010. For more information, visit the company’s Web site at www.csc.com.

Further information about this trial is posted at www.clinicaltrials.gov.

The safety and efficacy of this product has not been established. This product is currently under clinical investigation and has not been licensed by the FDA.

This release includes forward-looking statements concerning the company’s vaccine products, including with respect to clinical trials, licensures, and the advantages of the vaccine products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; additional clinical results demonstrating the safety and efficacy of the products; market acceptance of vaccines developed with Vero cell technology; continued public commitment to addressing pandemic threats; and other risks identified in the company’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.

Contacts

Baxter International Inc.
Media Contacts
Andrew Lewis, 847-948-2815
Laura Jacobs, 847-948-3026
or
Investor Contact
Mary Kay Ladone, 847-948-3371

“Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus”

The objectives of the SAVOR-TIMI 53 trial are to test the hypothesis of whether treatment with ONGLYZA compared with placebo when added to a patients’ current standard of care will result in a reduction in the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke and to exclude an unacceptable cardiovascular toxicity. The SAVOR-TIMI 53 trial was in part designed to fulfill a post-marketing requirement for the U.S. Food and Drug Administration (FDA), as well as to help answer the important question of potential benefit beyond glucose lowering. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.

Eugene Braunwald, M.D., Chairman, and Deepak L. Bhatt M.D., MPH, Senior Investigator of the TIMI Study Group, in conjunction with Itamar Raz, M.D., Head of the Diabetes Unit at the Hadassah University Medical Center, Jerusalem, will serve as principal investigators and conduct the trial for Bristol-Myers Squibb and AstraZeneca.

“One of the objectives of the SAVOR-TIMI 53 study is to test superiority of treatment with ONGLYZA versus placebo when added to current therapy, as well as exclude unacceptable cardiovascular risk,” said Eugene Braunwald, M.D., Chairman of the TIMI Study Group.

ONGLYZA has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the United States and European Union. ONGLYZA was approved by the U.S. FDA in July 2009. ONGLYZA (saxagliptin) is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications – metformin, sulfonylureas or thiazolidinediones (TZD) – or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA has not been studied in combination with insulin.

IMPORTANT INFORMATION ABOUT ONGLYZA

Indication and Important Limitations of Use

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

ONGLYZA has not been studied in combination with insulin.

Important Safety Information

• Use With Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA.
• Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug.

Most common adverse reactions (regardless of investigator assessment of causality) reported in ≥5 percent of patients treated with ONGLYZA (saxagliptin) and more commonly than in patients treated with control were upper respiratory tract infection (7.7 percent, 7.6 percent), headache (7.5 percent, 5.2 percent), nasopharyngitis (6.9 percent, 4.0 percent) and urinary tract infection (6.8 percent, 6.1 percent). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1 percent, 8.1 percent and 4.3 percent, respectively.

Drug Interactions: Because ketoconazole, a strong CYP 3A4/5 inhibitor, increased saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP 3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance ≤50 mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter.

Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ONGLYZA is administered to a nursing woman.

Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have not been established.

Please see accompanying US Full Prescribing Information or visit www.bms.com.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

About TIMI Study Group

Since its inception in 1984 the principal goal of the TIMI Study Group (TIMI) has been to conduct high quality clinical trials that enhance the care of patients with coronary artery disease. TIMI has been involved in a wide array of phase 1 to phase 4 trials as well as registries. These have ranged in size from less than 30 to more than 25,000 subjects. The interventions studied include fibrinolytic, antithrombotic, anti-platelet, anti-ischemic and lipid lowering agents as well as percutaneous coronary intervention.

About Hadassah University Medical Center, Jerusalem, Israel

The Hadassah University Medical Center is a leading provider of medical and health services in Israel, known for its pioneering vision and enduring commitment to patient-centered care and groundbreaking research.

The Diabetes Unit at Hadassah Medical Organization is made up of a multidisciplinary team of physicians and scientists, recognized experts in the field of diabetes both at the basic science and clinical levels. The Diabetes Unit team is currently leading several clinical studies worldwide. For more information please visit: Hadassah Diabetes Center

ONGLYZA is a trademark of the Bristol-Myers Squibb Company.

Contacts

Media:
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
AstraZeneca
Jim Minnick, 302-886-5135
jim.minnick@astrazeneca.com
or
Investors:
Bristol-Myers Squibb
John Elicker, 609-252-4611
john.elicker@bms.com
or
AstraZeneca
Karl Hard, +44-20-7304-5322
karl.j.hard@astrazeneca.com
or
AstraZeneca
Clive Morris, + 44-20-7304-5084
clive.morris@astrazeneca.com

Primary data from the NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial, initiated in 2001, were presented today at the American College of Cardiology Annual Meeting in Atlanta, USA[1] and simultaneously published online in the New England Journal of Medicine[2],[3]. The study assessed whether valsartan or the oral anti-diabetic agent nateglinide could delay progression to diabetes or reduce the incidence of cardiovascular events in people with IGT and cardiovascular disease or risk factors.

“Obesity and hypertension are global health epidemics, and many of these patients have problems with impaired glucose tolerance. From numerous studies, we know that patients with IGT have an increased risk for type 2 diabetes and cardiovascular disease,” said Dr. Robert Califf, Vice Chancellor for Clinical Research at Duke University School of Medicine and Director of the Duke Translational Medicine Institute, Durham, NC, USA. “It is critical that we continue to search for pharmacologic interventions that may reduce the incidence of diabetes and cardiovascular disease while emphasizing to our patients that weight loss, as little as 5%, may improve outcomes.”

Patients in the study with IGT and cardiovascular disease or other risk factors, who received valsartan for at least five years in addition to background therapy and a study-specific lifestyle-modification program, achieved a statistically significant 14% reduction in their risk of developing new-onset diabetes compared to those in the non-valsartan group[1],[2].

Valsartan therapy did not show a reduction in the risk of cardiovascular events in this well-managed group of patients[1],[2], while nateglinide-based therapy did not show a reduction in the incidence of new-onset diabetes or of cardiovascular events in this study population[1],[3].

Trevor Mundel, M.D., Global Head of Development at Novartis Pharma AG said: “As a global leader in cardiovascular and metabolic health, Novartis is committed to advancing public health and policy pertaining to diabetes. We are very pleased with the findings of the NAVIGATOR study as they add to the large body of scientific information on valsartan.”

The worldwide prevalence of diabetes is expected to increase by 50% (i.e. from 285 to 439 million patients) by 2030 [4]. IGT is a defined stage in the development of diabetes[5], and it has been suggested that up to 70% of people with impaired fasting glucose (IFG) and IGT are likely to develop type 2 diabetes over their lifetime[6]. Current guidance from the American Diabetes Association, American College of Endocrinology/American Association of Clinical Endocrinologists and the World Health Organization recommends a variety of interventions for the management of pre-diabetes, based on lifestyle modification[7],[8],[9].

“Lifestyle modification remains the primary intervention for the prevention of diabetes. The NAVIGATOR study shows that valsartan, when added to a lifestyle-modification program, can delay progression to diabetes in people who are at high cardiovascular risk and have impaired glucose tolerance,” said Dr Rury Holman, Professor of Diabetic Medicine at the Oxford Centre for Diabetes, Endocrinology & Metabolism, University of Oxford, United Kingdom.

Novartis plans to discuss the results of this study with the U.S. Food and Drug Administration with a view to applying for a label change for valsartan. Valsartan is currently indicated for the treatment of high blood pressure for the treatment of heart failure, and reducing the risk of cardiovascular mortality in patients who have suffered a heart attack (myocardial infarction). Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Neither valsartan nor nateglinide is currently indicated for the treatment of patients with IGT.

About the study

NAVIGATOR was a prospective, multinational, randomized, double-blind, placebo-controlled, two-by-two factorial design trial being conducted in 39 countries at nearly 800 sites. The 9,306 patients enrolled in the trial had IGT and were either older than age 50 with diagnosed cardiovascular disease or older than age 55 with at least one risk factor for cardiovascular disease, such as high blood pressure, family history of heart disease, high cholesterol or smoking. In addition to background therapy and a study-specific lifestyle modification program, patients were randomized to receive either valsartan, nateglinide, valsartan and nateglinide together, or placebo[2],[3]

NAVIGATOR had three co-primary endpoints. The first endpoint was confirmed progression to overt diabetes, defined according to standard WHO/ADA criteria. The second (‘core’ cardiovascular) endpoint was a composite of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure. The third (‘extended’ cardiovascular) endpoint consisted of the core cardiovascular endpoint plus revascularization and hospitalization for unstable angina. The median follow-up time (for vital status) was 6.5 years[2].

The primary NAVIGATOR results for valsartan were as follows:[1],[2]

• Statistically significant reduction in the risk of progression to diabetes of 14% (HR 0.86, 95% CI 0.80-0.92; p<0.001) compared to non-valsartan treatment
• No statistically significant reduction of the ‘core’ (HR 0.99, 95% CI 0.86-1.14; p=0.42) and ‘extended’ (HR 0.96, 95% CI 0.86-1.07; p=0.22) CV endpoints

The primary results for nateglinide were as follows:[1],[3] 

• No reduction compared to non-nateglinide treatment in terms of progression to diabetes (HR 1.07, 95% CI 1.00-1.15, p=0.98)
• No statistically significant reductions of the ‘core’ (HR 0.94, 95% CI 0.82-1.09, p=0.22) and ‘extended’ (HR 0.93, 95% CI 0.83-1.03, p=0.08) CV endpoints 

Valsartan was dosed up to 160 mg once daily. During the course of the study, 556 participants (12%) in the valsartan group and 531 (11%) in the non-valsartan group discontinued the study drug due to an adverse event. The most common adverse event seen in the valsartan group was hypotension. Nateglinide was dosed up to 60 mg three times daily. During the course of the study, 520 participants (11%) in the nateglinide group and 485 (10%) in the non-nateglinide group discontinued study drug due to an adverse event. The most common adverse events seen in the nateglinide group were hypotension-related events and hypoglycemia[2],[3]

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “risk,” “continue to search,” “may,” “committed,” “expected,” “likely,” “can,” “plans,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for valsartan or regarding potential future revenues from valsartan as a result. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with valsartan to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that valsartan will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that any such additional indications or labeling will result in valsartan achieving any particular levels of revenue in the future. In particular, management’s expectations regarding valsartan could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group’s continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

References

[1] Califf RM. Late-breaking presentation at the ACC Congress 2010; Abstract No: 3010-12.

[2] McMurray J, et al. N Engl J Med 2010; in press.

[3] Holman RR, et al. N Engl J Med 2010; in press.

[4] International Diabetes Federation. Diabetes Atlas. 4th ed. Available at: www.diabetesatlas.org/content/diabetes-and-impaired-glucose-tolerance. Last accessed 5 Mar 2010.

[5] International Expert Committee. Diabetes Care 2003;26:3160-7.

[6] Nathan DM, et al. Diabetes Care 2007;30(3):753-9.

[7] American Diabetes Association. Diabetes Care 2010;33(Suppl 1):S11-61.

[8] American Association of Clinical Endocrinologists. Endocr Pract 2008;14(7):933-46.

[9] World Health Organization. Fact sheet No: 312 – Diabetes. Available at: www.who.int/mediacentre/factsheets/fs312/en/. Last accessed 5 Mar 2010.

# # #

Novartis Media Relations

e-mail: media.relations@novartis.com

Novartis Investor Relations

“Sunitinib has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease”

“Sunitinib has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer Oncology is committed to the rigorous evaluation of investigational therapies in breast cancer, which despite recent advancements, continues to claim far too many lives each year.”

There were more adverse events, including serious adverse events, in the investigational arm than in the comparator arm of each study. A continuing analysis of efficacy and safety data will be completed and presented at a medical meeting in the near future.

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced / metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sutent has played a significant role in advancing the treatment landscape and remains standard of care in its approved indications. To date, more than 82,000 patients globally have been treated with sunitinib in the clinical setting and in trials across multiple tumors.

Pfizer remains committed to the development program for sunitinib and is continuing to study its potential role in the treatment of other solid tumors including advanced non-small cell lung cancer, advanced castration-resistant prostate cancer, advanced hepatocellular carcinoma, and as adjuvant therapy for renal cell carcinoma, in Phase 3 trials.

Pfizer Oncology is dedicated to further understanding and developing agents to better match specific patients with treatments and increase benefits from selected therapies.

About Advanced Breast Cancer

Breast cancer is the most common cancer and the leading cause of cancer-related death among women globally. Compared to early stage breast cancer, effective therapy for advanced breast cancer, which includes inoperable locally advanced and metastatic disease, remains a clinical challenge in the oncology community. Additional treatment options are desperately needed to address this continuing unmet medical need.

About Sutent (®) (sunitinib malate)

Sutent is an oral multi-kinase inhibitor approved for the treatment of GIST after disease progression on or intolerance to imatinib mesylate and advanced / metastatic RCC.

Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important Sutent (®) (sunitinib malate) Safety Information

Women of childbearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on Sutent.

Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.

Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

The most common adverse reactions in GIST and RCC clinical trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.

For more information on Sutent and Pfizer Oncology, including full prescribing information for Sutent (sunitinib malate), please visit www.pfizer.com.

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 200 clinical trials underway.

By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time.

For more information please visit www.Pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of March 11, 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 about certain potential additional indications for Sutent, including their 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 additional indications for Sutent as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such additional indications; and competitive developments.

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.

Contacts

Pfizer Inc.
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Chris Loder
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or
Investors:
Suzanne Harnett
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M: (646) 256-9250