Novartis Files SNDA for Diovan(R) for Treatment of Heart Failure

- First ARB to Seek Indication Beyond Hypertension in the US -



Apr 30, 2001, 01:00 ET from Novartis Pharmaceuticals Corporation

    EAST HANOVER, N.J., April 30 /PRNewswire/ -- Novartis Pharmaceuticals
 Corporation announced it has filed a supplemental new drug application (SNDA)
 for Diovan(R) (valsartan) seeking US Food and Drug Administration (FDA)
 approval for treatment of heart failure.  Diovan is currently indicated for
 first-line treatment of hypertension and is the fastest growing top 10 branded
 prescription antihypertensive in the US today.  Diovan is the first
 angiotensin II receptor blocker (ARB) to seek an indication for heart failure
 in the US.  Filings for the new indication are being initiated with health
 authorities in major international markets.
     "Diovan already helps millions of patients control their hypertension,"
 said Paulo Costa, president and chief executive officer, Novartis
 Pharmaceuticals Corporation.  "This new indication could extend the utility of
 Diovan to some of the many patients who are being treated for heart failure, a
 serious and debilitating form of cardiovascular disease that is difficult to
 treat, but for which Diovan could offer additional clinical benefit."
     The FDA submission is based on the positive findings of the Valsartan
 Heart Failure Trial (Val-HeFT), a landmark study of 5,010 heart failure
 patients at 302 centers in 16 countries.  In Val-HeFT, Diovan significantly
 reduced morbidity by 13.2% (p=0.009) vs usual therapy in heart failure
 patients.  Usual therapy in Val-HeFT included proven heart failure treatments
 such as ACE inhibitors (92.7% of study subjects), beta blockers (34.9%),
 diuretics (85.5%), and digoxin (67.3%).  Morbidity was defined as time to
 first morbid event including death, sudden death with resuscitation,
 hospitalization for heart failure, or administration of intravenous inotropic
 or vasodilator drugs for four hours or more without hospitalization.  The rate
 of all-cause mortality was similar between the two treatment groups.
     In the Valsartan Heart Failure Trial, Diovan significantly reduced heart
 failure hospitalizations by 27.5% compared to usual therapy (p=0.00001).
 Diovan also significantly improved NYHA functional class, ejection fraction,
 heart failure signs and symptoms, and quality of life vs placebo of heart
 failure patients taking usual therapy.  The rate of discontinuations as a
 result of side effects in Val-HeFT was only slightly higher in the valsartan
 group (9.9%) vs the placebo group (7.3%).  Adverse events more frequent with
 Diovan than placebo included dizziness (13% vs 6%), hypotension (6% vs 2%),
 and postural dizziness (2% vs 1%).  The most common adverse events were
 dizziness and hypotension.
     Heart failure, or the progressive weakening of the heart muscle, is the
 fastest growing cardiovascular disease in the world.  High blood pressure is a
 common risk factor for heart failure.  About 75 percent of heart failure
 patients have a prior history of hypertension.
     Nearly five million Americans have heart failure and 1,500 new cases are
 diagnosed every day.  Heart failure is also the leading cause of
 hospitalization in people age 65 and over.  In the US, 2,600 people are
 hospitalized every day because of this condition -- a major reason why costs
 for treating heart failure are expected to exceed $50 billion this year.
     About three million patients worldwide take Diovan for high blood
 pressure.  To explore the potential uses of Diovan beyond hypertension,
 Novartis is conducting the world's largest ongoing clinical trial program
 among the ARBs.  Besides Val-HeFT, other major multinational trials are
 VALIANT (valsartan vs captopril and valsartan plus captopril in 14,500
 post-myocardial infarction patients) and VALUE (valsartan vs amlodipine in
 15,000 high-risk patients with hypertension).  Diovan is also the primary
 agent in a clinical trial assessing optimal blood pressure treatment in adult
 type-2 diabetes patients (ABCD-2V).
     All ARBs carry a warning that the drug should not be used in pregnant
 women due to the risk of injury and even death to the fetus.  For more
 information or a copy of the full prescribing information for Diovan, please
 visit the Novartis website at
 http://www.pharma.us.novartis.com/what/pi.html#cardio and select Diovan.
     Novartis is a member of the American Heart Association (AHA)
 Pharmaceutical Roundtable, a strategic coalition of leading pharmaceutical
 companies who support the AHA's mission by supporting its cardiovascular
 research and educational programs.  Novartis is also a Corporate Member of the
 Heart Failure Society of America.
     Novartis Pharmaceuticals Corporation researches, develops, manufactures
 and markets leading innovative prescription drugs used to treat a number of
 diseases and conditions, including central nervous system disorders, organ
 transplantation, cardiovascular diseases, dermatological diseases, respiratory
 disorders, cancer and arthritis.  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 the Novartis Group (NYSE:   NVS), a world leader in
 healthcare with core businesses in pharmaceuticals, consumer health, generics,
 eye-care, and animal health.  In 2000, the Group's ongoing businesses achieved
 sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF
 4.0 billion (USD 2.4 billion) in R&D.  Headquartered in Basel, Switzerland,
 Novartis employs about 67,600 people and operates in over 140 countries around
 the world.  For further information please consult http://www.novartis.com.
 
     The foregoing press statement contains forward-looking statements that can
 be identified by terminology such as "file," "potential," "submission," "new
 indication," or similar expressions.  Such forward-looking statements involve
 known and unknown risks, uncertainties and other factors that may cause the
 actual results to be materially different from any future results,
 performance, or achievements expressed or implied by such statements.  In
 particular, management's expectations relating to Diovan could be affected by,
 among other things, uncertainties relating to clinical trials and product
 development; unexpected regulatory delays or government regulation generally;
 the company's ability to obtain or maintain patent and other proprietary
 intellectual property protection; and competition in general.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X51092853
 
 

SOURCE Novartis Pharmaceuticals Corporation
    EAST HANOVER, N.J., April 30 /PRNewswire/ -- Novartis Pharmaceuticals
 Corporation announced it has filed a supplemental new drug application (SNDA)
 for Diovan(R) (valsartan) seeking US Food and Drug Administration (FDA)
 approval for treatment of heart failure.  Diovan is currently indicated for
 first-line treatment of hypertension and is the fastest growing top 10 branded
 prescription antihypertensive in the US today.  Diovan is the first
 angiotensin II receptor blocker (ARB) to seek an indication for heart failure
 in the US.  Filings for the new indication are being initiated with health
 authorities in major international markets.
     "Diovan already helps millions of patients control their hypertension,"
 said Paulo Costa, president and chief executive officer, Novartis
 Pharmaceuticals Corporation.  "This new indication could extend the utility of
 Diovan to some of the many patients who are being treated for heart failure, a
 serious and debilitating form of cardiovascular disease that is difficult to
 treat, but for which Diovan could offer additional clinical benefit."
     The FDA submission is based on the positive findings of the Valsartan
 Heart Failure Trial (Val-HeFT), a landmark study of 5,010 heart failure
 patients at 302 centers in 16 countries.  In Val-HeFT, Diovan significantly
 reduced morbidity by 13.2% (p=0.009) vs usual therapy in heart failure
 patients.  Usual therapy in Val-HeFT included proven heart failure treatments
 such as ACE inhibitors (92.7% of study subjects), beta blockers (34.9%),
 diuretics (85.5%), and digoxin (67.3%).  Morbidity was defined as time to
 first morbid event including death, sudden death with resuscitation,
 hospitalization for heart failure, or administration of intravenous inotropic
 or vasodilator drugs for four hours or more without hospitalization.  The rate
 of all-cause mortality was similar between the two treatment groups.
     In the Valsartan Heart Failure Trial, Diovan significantly reduced heart
 failure hospitalizations by 27.5% compared to usual therapy (p=0.00001).
 Diovan also significantly improved NYHA functional class, ejection fraction,
 heart failure signs and symptoms, and quality of life vs placebo of heart
 failure patients taking usual therapy.  The rate of discontinuations as a
 result of side effects in Val-HeFT was only slightly higher in the valsartan
 group (9.9%) vs the placebo group (7.3%).  Adverse events more frequent with
 Diovan than placebo included dizziness (13% vs 6%), hypotension (6% vs 2%),
 and postural dizziness (2% vs 1%).  The most common adverse events were
 dizziness and hypotension.
     Heart failure, or the progressive weakening of the heart muscle, is the
 fastest growing cardiovascular disease in the world.  High blood pressure is a
 common risk factor for heart failure.  About 75 percent of heart failure
 patients have a prior history of hypertension.
     Nearly five million Americans have heart failure and 1,500 new cases are
 diagnosed every day.  Heart failure is also the leading cause of
 hospitalization in people age 65 and over.  In the US, 2,600 people are
 hospitalized every day because of this condition -- a major reason why costs
 for treating heart failure are expected to exceed $50 billion this year.
     About three million patients worldwide take Diovan for high blood
 pressure.  To explore the potential uses of Diovan beyond hypertension,
 Novartis is conducting the world's largest ongoing clinical trial program
 among the ARBs.  Besides Val-HeFT, other major multinational trials are
 VALIANT (valsartan vs captopril and valsartan plus captopril in 14,500
 post-myocardial infarction patients) and VALUE (valsartan vs amlodipine in
 15,000 high-risk patients with hypertension).  Diovan is also the primary
 agent in a clinical trial assessing optimal blood pressure treatment in adult
 type-2 diabetes patients (ABCD-2V).
     All ARBs carry a warning that the drug should not be used in pregnant
 women due to the risk of injury and even death to the fetus.  For more
 information or a copy of the full prescribing information for Diovan, please
 visit the Novartis website at
 http://www.pharma.us.novartis.com/what/pi.html#cardio and select Diovan.
     Novartis is a member of the American Heart Association (AHA)
 Pharmaceutical Roundtable, a strategic coalition of leading pharmaceutical
 companies who support the AHA's mission by supporting its cardiovascular
 research and educational programs.  Novartis is also a Corporate Member of the
 Heart Failure Society of America.
     Novartis Pharmaceuticals Corporation researches, develops, manufactures
 and markets leading innovative prescription drugs used to treat a number of
 diseases and conditions, including central nervous system disorders, organ
 transplantation, cardiovascular diseases, dermatological diseases, respiratory
 disorders, cancer and arthritis.  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 the Novartis Group (NYSE:   NVS), a world leader in
 healthcare with core businesses in pharmaceuticals, consumer health, generics,
 eye-care, and animal health.  In 2000, the Group's ongoing businesses achieved
 sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF
 4.0 billion (USD 2.4 billion) in R&D.  Headquartered in Basel, Switzerland,
 Novartis employs about 67,600 people and operates in over 140 countries around
 the world.  For further information please consult http://www.novartis.com.
 
     The foregoing press statement contains forward-looking statements that can
 be identified by terminology such as "file," "potential," "submission," "new
 indication," or similar expressions.  Such forward-looking statements involve
 known and unknown risks, uncertainties and other factors that may cause the
 actual results to be materially different from any future results,
 performance, or achievements expressed or implied by such statements.  In
 particular, management's expectations relating to Diovan could be affected by,
 among other things, uncertainties relating to clinical trials and product
 development; unexpected regulatory delays or government regulation generally;
 the company's ability to obtain or maintain patent and other proprietary
 intellectual property protection; and competition in general.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X51092853
 
 SOURCE  Novartis Pharmaceuticals Corporation