Pharmaceutical News and Articles

Updated European guidelines highlight benefits of Rasilez, the only approved direct renin inhibitor, in treating high blood pressure

• Updated European Society of Hypertension (ESH) guidelines recognize that Rasilez® monotherapy is effective at lowering blood pressure in a single daily dose1

• Rasilez is also effective in combination with either a diuretic, a calcium channel blocker (CCB) or an angiotensin receptor blocker (ARB)2

• Guidelines acknowledge that Rasilez has effects on top of standard care on two indicators of heart failure severity and kidney disease1,2

Basel, October 26, 2009 — Updated European Society of Hypertension (ESH) guidelines recognize the benefits of Rasilez® (aliskiren) for the treatment of high blood pressure. Rasilez, a first-in-class direct renin inhibitor (DRI), works at the point of activation of the renin angiotensin aldosterone system (RAAS), directly inhibiting the activity of renin, an enzyme that triggers a process that may lead to high blood pressure and organ damage2,3.

The updated European Guidelines on Hypertension Management, appraised by an ESH task force, recognize that Rasilez effectively lowers high blood pressure in patients when given in monotherapy at a single daily dose, and is also effective when used in combination with either a thiazide diuretic, a calcium antagonist or an angiotensin receptor antagonist. In addition, the guidelines acknowledge that Rasilez has substantially increased its database within the last two years, including data indicating the drug’s effects on two indicators of heart failure severity and kidney disease; B-type natriuretic peptide (BNP) and urinary albumin:creatinine ratio (UACR)1,2. The guidelines recognize Rasilez’s ability to reduce BNP levels on top of standard therapy in patients with mild stable heart failure and also acknowledge Rasilez’s effects on reducing UACR in patients with hypertension, type 2 diabetes mellitus, and nephropathy, on top of standard care1,2.

“There is a serious unmet need in the treatment of high blood pressure and we are very pleased the updated ESH guidelines recognize the benefits of Rasilez as an effective treatment option,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “An extensive and ongoing cardio-renal outcomes program - ASPIRE HIGHER - will continue to explore Rasilez’s long-term benefits and potential to protect against subclinical organ damage beyond existing antihypertensive therapies.”

The heart and kidney protection potential of Rasilez, in addition to its blood pressure lowering ability, is currently being investigated further in the landmark ASPIRE HIGHER program, the largest ongoing cardio-renal outcomes program worldwide involving more than 35,000 patients in 14 trials. Findings from four of the 14 studies in the ASPIRE HIGHER program, the AVOID, ALOFT, ALLAY and AGELESS studies, have already been reported to date showing that treatment with Rasilez has the potential for cardio-renal protection4-7.

About Rasilez/Tekturna Rasilez, known as Tekturna in the US, is the only drug that works by directly targeting renin to decrease the activity of the RAAS2. Renin is an enzyme produced by the kidneys that starts a process that narrows blood vessels and, when inappropriately activated, may lead to high blood pressure. Rasilez reduces plasma renin activity (PRA) and helps blood vessels relax and widen so blood pressure is lowered.

Rasilez/Tekturna is approved in over 70 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez. In July 2009, Rasilez also received approval in Japan. Tekturna HCT, the first single-pill combination involving Tekturna, was approved in the US in January 2008 for second-line treatment of high blood pressure, and more recently for first-line use. The single-pill combination Rasilez HCT was approved in the European Union in January 2009. In September 2009, Valturna, a single-pill combination of Tekturna and Diovan (valsartan), was approved in the US. Other single-pill combinations with Rasilez are currently in development including a single-pill combination with amlodipine.

The core of the Novartis portfolio is its cardiovascular and metabolic medications for the treatment of high blood pressure and diabetes. These include Diovan® (valsartan), the number one selling blood pressure medication worldwide8; Exforge® (valsartan/ amlodipine), a single pill combining two leading medicines for high blood pressure; Exforge HCT® (amlodipine/valsartan/HCT); and Rasilez® (aliskiren), the first and only approved direct renin inhibitor, and two single pill combinations of Rasilez, Rasilez HCT (aliskiren/HCT) and Valturna (aliskiren/valsartan). For the treatment of type 2 diabetes, these include Galvus® (vildagliptin, a DPP-4 inhibitor) and Eucreas® (vildagliptin and metformin).

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” “potential,” “may,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Rasilez/Tekturna or regarding potential future revenues from Rasilez/Tekturna. 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 Rasilez/Tekturna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Rasilez/Tekturna will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that Rasilez/Tekturna will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Rasilez/Tekturna 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 each of these areas. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 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. Mancia G, et al. Reappraisal of European Guidelines on Hypertension Management: A European Society of Hypertension Taskforce Document J of Hypertens November 2009:27:000?. 2. Rasilez Summary of Product Characteristics (SmPC) for European Union. 3. Azizi M, Webb R, Nussberger J, Hollenberg NK. Renin Inhibition with Aliskiren: Where Are we Now, and Where Are we Going? J Hypertens 2006;24:243?. 4. Parving H-H, et al. Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy. N Eng J Med June 5, 2008;358:2433-46. 5. McMurray JJ, et al. Effects of the Oral Direct Inhibitor Aliskiren in Patients with Symptomatic Heart Failure. Circulation - Heart Failure. 2008;1:17-24. 6. Solomon S, et al. Effect of the Direct Renin Inhibitor Aliskiren, Either Alone or in Combination With Losartan, Compared to Losartan, on Left Ventricular Mass in Patients With Hypertension and Left Ventricular Hypertrophy: The Aliskiren Left Ventricular Assessment of Hypertrophy (ALLAY) Trial. Circulation.2009:119: 530-537. 7. Duprez DA et al. The AGELESS Study: The Effect of Aliskiren vs Ramipril Alone or in Combination with Hydrochlorothiazide and Amlodipine in Patients ≥ 65 Years of Age with Systolic Hypertension. Oral Presentation at the American Heart Association 2008 Scientific Sessions. 8. IMS Midas Worldwide Sales Data. May 2009.

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