BASEL, Switzerland, Dec. 1, 2004 (PRIMEZONE) -- First-in-class approval solidifies already established cardio-protective benefits of leading high blood pressure agent Paves the way for further approvals of this indication throughout the EUBasel, December 1, 2004 -- Diovan(R) (valsartan), a powerful, first-line high blood pressure agent, has received its first European marketing authorization from the Medical Products Agency (MPA) of Sweden to treat patients at high-risk following a recent heart attack.
Diovan is the first drug in its class to obtain such an indication, which was based on the positive results of a major international trial proving Diovan to be as effective at preventing death of heart attack survivors as a current standard of care. The approval provides a new treatment for these patients, half of whom are not receiving recommended therapies, and marks a major step toward attaining authorization of Diovan for this new indication throughout the European Union (EU). This indication was nationally approved in the UK earlier this year.
"Combined with Diovan's well established double-digit blood pressure reduction efficacy and proven cardio-protective benefits, the approval in Sweden secures Diovan's place on the forefront of cardiovascular medicine," said Dr. Jorg Reinhardt, Head of Development, Novartis Pharma AG. "We look forward to acquiring similar indications across the European Union to provide heart attack survivors a protective treatment that may be life-saving."
Novartis is pursuing this indication in 13 additional member states of the EU as well as Iceland based on the approval by Sweden through the Mutual Recognition Procedure (MRP). Novartis has also submitted a marketing application at the national level in France, and additional filings have been made in the US and Australia as well as in certain Asian and Latin American countries. Under the MRP, a EU member state is expected to recognize the marketing authorization granted by another member state within 90 days of the start of the process. To date, 23 countries around the world, including the UK and a number of Latin American countries, have approved Diovan to treat post-heart attack patients.
Heart attack remains one of the world's deadliest conditions. Every year, more than three million people from EU countries and 1.2 million Americans suffer a heart attack. High blood pressure is a major risk factor for heart attacks. While progress has been made in treating heart attacks in the emergency room, people who survive the acute (emergency) phase of a heart attack have permanently damaged hearts and are at greatly increased risk for repeat attacks, heart failure or other deadly complications. One in three will die within a year after surviving a first heart attack, and half of all heart attacks are repeat attacks. There is a critical need for new treatments given such a high risk of death.
New approvals based on landmark VALIANT trial The new approval for Diovan is based on the positive results of VALIANT (VALsartan In Acute myocardial iNfarcTion), one of the largest long-term studies ever conducted in people who have survived a heart attack. VALIANT demonstrated that Diovan preserved 99.6% of the benefit of captopril, which is currently a standard of care in these patients, meaning it reduced death to the same degree as the proven treatment. This finding translates into a 25% reduction in premature death by Diovan in patients at high risk following a heart attack. Diovan is the only cardiovascular agent ever demonstrated by a head-to-head trial to have matched the proven benefits of an ACE inhibitor in these patients.
VALIANT was a rigorous comparison of Diovan vs. the ACE inhibitor captopril in 14,703 patients at the highest risk for death following a heart attack for an average of two years. VALIANT also studied the effects of combination treatment with Diovan and captopril. An active-controlled trial, VALIANT compared Diovan to a proven treatment instead of a placebo or sugar pill and was statistically powered to prove whether the effects of Diovan on all-cause mortality were comparable to captopril. The patient population and dosing regimen were intentionally modeled after studies which established the benefits of ACE inhibitors vs. placebo so that a statistical comparison (imputed placebo analysis) could be made of the findings.
VALIANT demonstrated that Diovan is well-tolerated in post-heart attack patients. Adverse events were generally related to the underlying disease.
About Diovan
One of the fastest-growing high blood pressure drugs on the market today, Diovan is a powerful first-line treatment of high blood pressure approved in more than 80 countries and in more than 50 for the treatment of heart failure in patients who also take usual therapy including diuretics, digitalis and either beta blockers or ACE inhibitors, but not both. In the US and Switzerland, among other countries, Diovan is indicated for the treatment of heart failure in patients who cannot tolerate ACE inhibitors. Additional approvals are pending in the European Union for Diovan for the treatment of heart failure.
This new indication for Diovan in Sweden is for the treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular dysfunction after a recent myocardial infarction (heart attack).
Novartis is focused on improving the care of patients with high blood pressure and heart disease through world-class research and unprecedented public health initiatives. The Diovan clinical trial program represents an impressive research commitment across the cardiovascular continuum, involving approximately 50,000 patients. Recently completed Diovan trials include VALUE in high blood pressure patients at risk for cardiovascular complications, VALIANT in post-heart attack patients and Val-HeFT in heart failure patients. Ongoing studies include the NAVIGATOR trial, the largest outcomes trial ever conducted on the prevention of cardiovascular disease and type 2 diabetes in patients with impaired glucose tolerance.
The foregoing release contains forward-looking statements that can be identified by terminology such as "marks a major step toward", "secures . on the forefront", "look forward to", "is pursuing", "is expected", or similar expressions, or by express or implied discussions regarding potential new indications or labeling and marketing approvals for Diovan or regarding potential future sales of Diovan. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan will be approved for any additional indications or labeling in any other market. Nor can there be any guarantee regarding potential future sales of Diovan. In particular, management's expectations regarding commercialization of Diovan could be affected by, among other things, additional analysis of Diovan clinical data; new clinical data; unexpected clinical trial results; 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; industry, government, and general public pricing pressures; and other risks and factors referred to in the Company'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 AG (NYSE:NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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-0- Karen Sutherland Novartis Pharma Communications +41 61 324 7143 (direct) +41 79 593 1085 (mobile) karen.sutherland@pharma.novartis.com John Gilardi Novartis Global Media Relations +41 61 324 3018 (direct) +41 79 596 1408 (mobile) john.gilardi@group.novartis.com