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Photo: Novartis Receives FDA Approval for Valturna(R), a Single-Pill Combination of valsartan and aliskiren, to Treat High Blood Pressure

September 17, 2009

EAST HANOVER, N.J., Sept. 17 /PRNewswire/ — The US Food and Drug Administration (FDA) has approved Valturna(R) (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

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“This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. “It offers an important additional treatment option for physicians and hypertension patients, many of whom are not at their blood pressure goal. Valturna builds upon our strong cardiovascular franchise and is consistent with our long-term commitment to developing effective and innovative therapies. It further strengthens our growing portfolio of single-pill combinations to treat high blood pressure.”

Valturna combines in a single pill valsartan, the active ingredient in Diovan(R), the number one selling branded high blood pressure medicine worldwide, and aliskiren, the active ingredient in Tekturna(R), the only approved direct renin inhibitor (DRI). Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone.

“When it comes to diagnosing and treating high blood pressure, there is a real need for innovative therapies that help patients get to a healthier blood pressure range,” said John Flack, M.D., Valturna investigator, and Chairman of the Department of Internal Medicine, Wayne State University, Detroit. “Now for the first time, we have a treatment option in one pill that targets two key points of the RAAS, which may be overactive in many hypertensive patients.”

This approval was primarily based on a pivotal eight-week randomized, double-blind, placebo-controlled clinical trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. The initial doses of aliskiren and valsartan were 150 mg and 160 mg, respectively, and were increased at four weeks to 300 mg and 320 mg, respectively. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the eight-week primary endpoint. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo (p<0.05 for aliskiren/valsartan vs monotherapies or placebo).

The single-pill combination Valturna targets the RAAS in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II, an important end product of the RAAS that causes blood vessels to tighten and narrow. The aliskiren component reduces angiotensin II levels by directly inhibiting renin, an enzyme produced by the kidneys that starts a process which leads to formation of angiotensin II. An overactive RAAS is an important contributor to high blood pressure in many patients. By targeting two key points within the RAAS, Valturna helps blood vessels relax and widen so blood pressure is lowered.

Research suggests that up to 85% of hypertensive patients may need multiple medications to help control their blood pressure, underscoring the need for effective combination treatments.

High blood pressure affects approximately 74 million, or nearly one in three, US adults. Although high blood pressure can be easily diagnosed and often successfully managed, approximately 36% of US adults treated with antihypertensive medication do not have their blood pressure controlled. If left untreated, high blood pressure can lead to stroke, heart attack, heart failure, kidney failure and vision problems.

Valturna, Tekturna and Diovan are not approved to treat or prevent stroke, heart attack, heart failure, kidney failure or eye problems resulting from high blood pressure.

History of Diovan(R) (valsartan) tablets and Tekturna(R) (aliskiren) tablets

Diovan, which marked its 10th anniversary in 2007, is the number one selling branded high blood pressure medicine worldwide. Diovan’s extensive clinical trials program demonstrates the longstanding commitment of Novartis to research.

Tekturna is a direct renin inhibitor in the first new approved class of high blood pressure medicine in more than a decade. Tekturna was approved by the FDA in March 2007 for the treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna in combination with maximal doses of angiotensin-converting enzyme (ACE) inhibitors has not been adequately studied.

The long-term potential of the direct renin inhibitor Tekturna is being evaluated in an extensive clinical program known as ASPIRE HIGHER.

Novartis and Hypertension Management

For decades Novartis has been a leader and innovator in hypertension management, offering a range of innovative therapies designed to help patients with different needs achieve their blood pressure goals. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

Valturna is available in two strengths as tablets containing aliskiren and valsartan: 150 mg/160 mg and 300 mg/320 mg.

Valturna is a prescription medication for adults containing two medicines in one tablet that work together to lower blood pressure when one is not enough. Valturna may also be used as the first medicine if your doctor decides you are likely to need more than one. Tekturna and Diovan may be used to treat high blood pressure. Tekturna may be used alone or in combination with other high blood pressure medicines. Tekturna has not been adequately studied in combination with the maximum doses of a class of medicines called ACE inhibitors.

Important Safety Information

IMPORTANT WARNING: Valturna, Tekturna, or Diovan may harm an unborn baby, causing injury and death. If you get pregnant, stop taking Valturna, Tekturna, or Diovan and call your doctor right away. If you plan to become pregnant, talk to your doctor about other medicines to treat your high blood pressure before taking Valturna, Tekturna, or Diovan.

Tell your doctor about all of your medical conditions, including kidney or liver problems. Also, tell your doctor about all medicines you take, including those to treat fungal infections, atorvastatin, cyclosporine, and potassium-containing medicines, supplements, or salt substitutes containing potassium.

If you develop an allergic reaction involving swelling of the face, lips, throat and/or tongue that may cause difficulty in breathing or swallowing, stop taking Valturna or Tekturna and contact your doctor immediately.

Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. Call your doctor right away.

The most serious side effects with Diovan are low blood pressure (hypotension) and kidney problems. Other side effects with Diovan have generally been mild. The most common side effects with Diovan are viral infection, fatigue, and abdominal pain. In clinical studies, the most common side effects experienced by more patients taking Valturna than patients taking a sugar pill was tiredness, sore throat, runny nose, diarrhea, upper respiratory tract infection, urinary tract infection, flu or flu-like symptoms, and dizziness, and for Tekturna, it was diarrhea. Other less common reactions to Tekturna include skin rash, and cough.

Click here for full Prescribing Information for Diovan.

Click here for full Prescribing Information for Tekturna.

Click here for full Prescribing Information for Valturna.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “commitment,” “may,” “can,” “risk,” “potential,” “dedicated,” or similar expressions, or by express or implied discussions regarding potential additional marketing approvals for Valturna, potential new indications or labeling for Tekturna, or regarding potential future revenues from Valturna, Tekturna or Diovan. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Valturna will be approved for sale in any additional markets. Nor can there be any guarantee that Tekturna will be approved for any additional indications or labeling in any market. Neither can there be any guarantee that Valturna, Tekturna or Diovan will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding these products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; 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 Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which 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, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in 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 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

SOURCE Novartis Pharmaceuticals Corporation


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