New Drug Application For Rasilez(R), An Innovative Oral Renin Inhibitor To Treat High Blood Pressure, Accepted For US Regulatory Review

Novartis announced that the US Food and Drug Administration (FDA) accepted its application for Rasilez (aliskiren) as a treatment for high blood pressure. As a renin inhibitor, Rasilez would represent the first new treatment approach for people with high blood pressure in more than a decade. European submission remains on track for 2006.

The US submission included data from more than 6,000 people with high blood pressure. These data showed that when used alone, Rasilez produced significant blood pressure reductions sustained over 24 hours.1

"The sustained 24-hour blood pressure control achieved with once-daily Rasilez is good news for people with high blood pressure," said Dr. James Shannon, MD, Head of Development at Novartis Pharma AG. "This innovative medicine has the potential to redefine future treatment standards, and studies are now underway to evaluate potential long-term benefits beyond blood pressure control."

Throughout the clinical program, Rasilez showed placebo-like tolerability when used alone. When used with ACE inhibitors, calcium channel blockers or a diuretic, Rasilez delivered additional blood pressure reductions, helping people already on therapy to reach their blood pressure goals. Rasilez was well tolerated when used with the most common cardiovascular and anti-diabetic medicines.

"We continue to need new therapeutic approaches to control blood pressure," said Dr. Michael Weber, MD, Professor of Medicine at SUNY Downstate Medical Center in New York. "Renin inhibition has long been considered a logical and highly desired treatment approach. The Rasilez data show that inhibiting renin directly is effective in reducing blood pressure, and in this case, over 24 hours."

Renin inhibition: a unique mechanism of action

Rasilez, developed with Speedel, is a first-of-its-kind treatment in the long search for effective oral renin inhibition. It acts within the renin system, which is central to blood pressure regulation. By suppressing the system's point of activation - renin - Rasilez decreases the activity of the renin system, as measured by plasma renin activity (PRA).

About high blood pressure

High blood pressure - and its consequences - is the world's No. 1 killer and is estimated by the American Heart Association to affect one in four adults - around one billion people globally.2 Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach target blood pressure levels. Many people require three or more medicines to control their blood pressure.3 Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.

The trade name Rasilez is currently pending regulatory, including FDA, approval.

This release contains certain forward-looking statements, relating to the Group's business, which can be identified by the use of forward-looking terminology such as "would", "has the potential to redefine," "potential long-term benefits," or similar expressions, or by express or implied discussions regarding the potential regulatory approval of Rasilez, or potential future revenue from Rasilez. Such statements reflect the current views of the Novartis group of companies with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that any current or future regulatory filings will satisfy the FDA's or other health authorities' requirements, that Rasilez will be approved for any indications in any market, that Rasilez will be brought to market in the US or in any other country, nor that it will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Rasilez could be affected by, among other things, additional analysis of 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; increased government, industry, and general public pricing pressures; 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 AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit www.novartis.com.

References
1. Data on file: Novartis study SPP100 A2308
2. American Heart Association. International Cardiovascular Disease Statistics fact sheet. americanheart.org
3. Datamonitor, Treatment algorithms. Hypertension, 2003

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Humans Differ Genetically More Than Previously Thought

We had thought that 99.9% of our genes are the same, but it seems that the figure is nearer 99.5%, say scientists from the Wellcome Trust Sanger Institute, Cambridge, UK and the Hospital for Sick Children, Toronto, Canada. The difference of 0.4% may not seem like much to most lay people, but for scientists it does. Apparently, huge chunks of the human genome may vary from person-to-person.

You can read about this new study in the journal Nature.

The researchers were aiming to discover how chemicals letters are spread across the whole human genome.

We have strands of DNA that span up to hundreds of thousands of chemical letters. The variations are called CNVs (copy number variants). Some of us may have one copy of a DNA segment, while others have two, three, four, and even more. Sometimes the segments are mixed up differently, depending on the person.

Scientists had only been able to look at tiny changes in DNA that could possible harm us - looking at just one, or very few bases (letters) in the code that programs cells. This study looked at things in a much bigger scale.

After examining the genomes of 270 people, the scientists found located 1,447 CNVs in almost 2,900 genes in about 12% of the whole human genome. In other words, it looks like 12% of our genome can have variations within them, depending on the person. The team found long stretches in the people's codes to be duplicated - some were even missing.

We already know that CNVs are associated with a higher risk of developing Alzheimer's disease, Parkinson's disease, HIV and kidney disease. As more CNVs are traced and mapped, scientists will probably link them to other illnesses and conditions. However, of the variations are in parts of the genome that would not damage our health.

Matthew Hurles, Wellcome Trust Sanger Institute, UK, said "Each one of us has a unique pattern of gains and losses of complete sections of DNA. One of the real surprises of these results was just how much of our DNA varies in copy number. We estimate this to be at least 12% of the genome. The copy number variation that researchers had seen before was simply the tip of the iceberg, while the bulk lay submerged, undetected. We now appreciate the immense contribution of this phenomenon to genetic differences between individuals."

Scientists do not know why copy variations happen. They suspect it occurs during the production of sperm and eggs (when errors are more likely to take place).

"Global variation in copy number in the human genome"

Click here to view article online

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Red Wine May Offset Effects Of High Calorie Diet

Red wine and red grapes contain a chemical, called resveratrol, that can offset some of the effects of gluttony, say researchers from the National Institute on Aging, Harvard Medical School, USA. Resveratrol does not seem to be able to get rid of the obesity, but it can lower glucose levels, help your liver and improve your heart.

You can read about this study in the journal Nature.

Studies had already indicated that resveratrol slows down the aging process in some non-mammalian animals. In this study, the scientists wanted to see what the effects of resveratrol might be on mammals.

They had lab rats which were fed 60% calories coming from fat. The rats were obese, had insulin resistance and cardiovascular diseases. The rats were divided into two groups. One group continued to eat 60% of calories from fat, while the other group had the same diet, but with resveratrol added to it.

The rats receiving resveratrol had lower glucose levels, their hearts became healthier, as did their liver tissue. The scientists also noticed that the rats that consumed resveratrol were more nimble on their feet, compared to the other group.

Even though the resveratrol-fed mice did not lose any weight, their health became as good as that of a mouse on a normal diet. Although the non-resveratrol fed mice continued to have a short lifespan, the resveratrol-fed mice lived as long as mice on a normal diet.

The scientists believe resveratrol may activate SIRT1, a gene associated with longevity.

If what happened to the mice could happen to humans, resveratrol could help prevent obese people from developing Type 2 Diabetes, heart disease, cancer and some other illnesses, say the researchers.

Comment by Editor of Medical News Today

Obesity is something people try to avoid for two reasons. Vanity, and/or health. If we find an ingredient that takes away the health risk, I wonder what most of us would eventually look like.

Would we continue the vanity drive, and then stuff ourselves after committing to a lifetime partner (try to look good only while you are single)?

How many of us would start feasting regularly as soon as the health risk was gone? I suspect I would - that is why I go to the gym everyday; so that I can burn lots of calories and allow myself a few more treats. Would I stop going to the gym? I really don't know.

Would I eat more, or chose that steaming chocolate pudding with lashes of cream, rather than the fruit salad? I think I probably would.

"Resveratrol improves health and survival of mice on a high-calorie diet"

Click here to view abstract online

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Benefits Of Pilates, Evaluation By American Council On Exercise

Check out the group fitness schedule at most health clubs and it's clear that Pilates is still one of the hottest trends in fitness. But is Pilates also a good calorie-burning workout? In an exclusive study, the American Council on Exercise (ACE), America's nonprofit fitness advocate, examined the calorie expenditure of an average Pilates Workout.

Lead researchers Stefanie Spilde and John Porcari, Ph.D. at the University of Wisconsin, La Crosse, recruited 15 healthy women, ages 18 to 26, with at least an intermediate level of Pilates experience. Each subject participated in two 50-minute Pilates mat-training sessions (one beginner, one advanced), following a videotaped routine for consistency.

Each subject first followed a beginner mat Pilates routine, which consisted of five minutes of breath-linked alignment exercises, followed by 40 minutes of basic Pilates exercises that followed the original Method of sequencing. The session ended with five minutes of stretching and realignment. The advanced routine was similar to the beginner routine except that it utilized advanced techniques of positioning and pacing for each exercise. During each session, heart rates and oxygen consumption were measured and recorded, and subjects rated their perceived effort using the 6-20 Borg scale.

An analysis of the data showed that the intensity of the beginning Pilates routine was lower than the recommended guidelines for improving cardio respiratory fitness. The average percentage of maximal heart rate was 54 percent, which is below the ACSM recommendation of 64 percent to 94 percent. The advanced Pilates routine elicited a higher aerobic response, with 62 percent of maximal heart rate and 43 percent of VO2 max. This would be the equivalent to the energy requirements of walking 3.5 to 4 miles per hour.

The study concluded that the cardiovascular benefits of Pilates appear to be limited. Even though participants feel as though they're working hard-and from a muscular standpoint, they are-they are not achieving significant aerobic or calorie-burning benefits from their efforts.

"Pilates has a long list of benefits including improved body mechanics, balance, coordination, strength and flexibility," said Dr. Cedric X. Bryant, chief exercise physiologist for ACE. "While the ACE study shows that a Pilates session burns a relatively small amount of calories, it is still a valuable addition to any exercise routine offering the essential elements of building a strong core and increasing flexibility."

Complete study results appear in the November/December 2005 edition of ACE Fitness Matters magazine or on our Web site at
acefitness.org/getfit/PilatesStudy2006.pdf.

About ACE

The American Council on Exercise (ACE), America's Authority on Fitness, is a nonprofit organization dedicated to promoting the benefits of physical activity and protecting consumers against unsafe and ineffective fitness products and instruction. As the nation's "workout watchdog," ACE sponsors university-based exercise science research and testing that targets fitness products and trends. ACE sets standards for fitness professionals and is the world's largest nonprofit fitness certifying organization. For more information on ACE and its programs, call (800) 825-3636 or log onto the ACE Web site at
http://www.acefitness.org.

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Autism Rates Drop After Mercury Removed From Childhood Vaccines

Journal of American Physicians and Surgeons shows that since mercury was removed from childhood vaccines, the alarming increase in reported rates of autism and other neurological disorders (NDs) in children not only stopped, but actually dropped sharply - by as much as 35%.

Using the government's own databases, independent researchers analyzed reports of childhood NDs, including autism, before and after removal of mercury-based preservatives. Authors David A. Geier, B.A. and Mark R. Geier, M.D., Ph.D. analyze data from the CDC's Vaccine Adverse Event Reporting System (VAERS) and the California Department of Developmental Services (CDDS) in "Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines."

The numbers from California show that reported autism rates hit a high of 800 in May 2003. If that trend had continued, the reports would have skyrocketed to more than 1000 by the beginning of 2006. But in fact, the Geiers report that the number actually went down to only 620, a real decrease of 22%, and a decrease from the projections of 35%.

This analysis directly contradicts 2004 recommendations of the Institute of Medicine which examined vaccine safety data from the National Immunization Program (NIP) of the CDC. While not willing to either rule out or to corroborate a relationship between mercury and autism, the IOM soft-pedaled its findings, and decided no more studies were needed. The authors write: "The IOM stated that the evidence favored rejection of a causal relationship between thimerosal and autism, that such a relationship was not biologically plausible, and that no further studies should be conducted to evaluate it."

As more and more vaccines were added to the mandatory schedule of vaccines for children, the dose of the mercury-based preservative thimerosal rose, so that the cumulative dose injected into babies exceeded the toxic threshold set by many government agencies. Mercury is known to damage nerve cells in very low concentrations.

The concern about vaccines may actually be underrated, as it is generally acknowledged that the voluntary reporting of such disorders has resulted in vast underreporting of new cases. For example, the Iowa state legislature banned thimerosal from all vaccines administered there after it documented a 700-fold increase in that state alone. California followed suit, and 32 states are considering doing so.

Up until about 1989 pre-school children got only 3 vaccines (polio, DPT, MMR). By 1999 the CDC recommended a total of 22 vaccines to be given before children reach the 1st grade, including Hepatitis B, which is given to newborns within the first 24 hours of birth. Many of these vaccines contained mercury. In the 1990s approximately 40 million children were injected with mercury-containing vaccines.

The cumulative amount of mercury being given to children in this number of vaccines would be an amount 187 times the EPA daily exposure limit.

Between 1989 and 2003, there has been an explosion of autism. The incidence of autism (and other related disorders) went from about 1 in 2,500 children to 1 in every 166. Currently there are more than a half million children in the U.S. that have autism. This disorder has devastated families.

In 1999, on the recommendation of the American Academy of Pediatrics and U.S. Public Health Service, thimerosal was removed from most childhood vaccines as a "precautionary" measure - i.e. without admitting to any causal link between thimerosal and autism.

The Geiers conclude that mercury continues to be a concern, as it is still added to some of the most commonly-used vaccines, such as those for flu:

"Despite its removal from many childhood vaccines, thimerosal is still routinely added to some formulations of influenza vaccine administered to U.S. infants, as well as to several other vaccines (e.g. tetanus-diphtheria and monovalent tetanus) administered to older children and adults. In 2004, the Institute of Medicine (IOM) of the U.S. National Academy of Sciences (NAS) retreated from the stated 1999 goal of the AAP and the PHS to remove thimerosal from U.S. vaccines as soon as possible.As a result, assessing the safety of TCVs [thimerosal-containing vaccines] is a matter of significant importance."

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Middle Aged Men Can Live Long If They Want

If you are a middle-aged man and you want to live a long time, all you need is a good lifestyle - some good genes would also help. Make sure you don't become obese, remember to exercise regularly, keep your blood pressure down, avoid the boozy lifestyle and keep away from foods high in refined sugars, say experts from the Pacific Health Research Institute, Hawaii, USA.

You can read about this new study in the Journal of the American Medical Association (JAMA).

If you look after yourself in this way your chances of reaching 85, and being healthy at that age, are five times greater than for men who stray off the beaten track.

The researchers looked at data on 5,820 Japanese/American males - they had been monitored for four decades. The men were initially monitored in 1965 - at that time they had an average age of 54 and were all healthy.

They were followed up in 2005. The scientists found that the following, either in isolation, or in combination, significantly influenced whether the men lived a long life, and also whether their extra years were healthy ones:

-- obesity
-- alcohol consumption (3+ drinks a day is too much)
-- high blood sugar
-- hypertension (high blood pressure)
-- high level of triglycerides

All the factors listed here contributed towards a reduced lifespan and a higher chance of being unhealthy during old age.

They found that a man who had drunk a lot, was fat, had high blood pressure, smoked and had high levels of sugar and triglycerides in his blood would have a 78% chance of never living till the age of 85. His chances of reaching 90 were just 6%.

However, a man who had drunk either nothing or moderately, had not been overweight, exercised regularly, did not smoke, had normal blood pressure, normal blood sugar levels and normal levels of triglycerides, had a 69% chance of reaching 85 - and also being healthy at that age.

Dr. Bradley Willcox, study leader, was surprised at how starkly the different lifestyles influenced longevity and health. He said that smoking is the major factor here, closely followed by high blood sugar during middle age. The scientists also found that a middle-aged man's grip strength was closely linked to his lifespan - the stronger his grip, the longer he is likely to live. As grip strength is linked to physical fitness, middle-aged men should make sure they do regular physical exercise, they said.

Other factors influence how healthy men are likely to be when they are old - the higher the academic level of a man, the healthier he is likely to be when he is old. Married men live longer than single men, but do not enjoy better health during old age (perhaps they live longer because their wives help them remember to go to their doctors, get their medications, and take them. Also, spouses can become carers).

The study covered the mid sixties to the turn of the century, before many drugs came onto the market.

Midlife Risk Factors and Healthy Survival in Men

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Gut Microbes Give Us Clues To Obesity Cause And Treatment

US scientists have discovered that "gut microbes" - bacteria that live in our digestive tract - could be powerful clues to the cause and treatment of obesity.

This remarkable news was published in Nature this week and conducted at Washington University School of Medicine in St. Louis.

The clue lies in the relative abundance of two major families of intestinal bacteria: Firmicutes and Bacteroidetes. These make up 90 per cent of the bacteria in the gut of humans, and, coincidentally, white mice.

Researchers in the first of two parallel studies found that as obese people lose weight, the balance between the Firmicutes and the Bacteroidetes changes - the latter increasing in abundance as an overweight person gets slimmer. (It would seem that the microbes ending in "cute" are perhaps not as lovable as their name implies!).

The second study was conducted in a neighbouring lab using white mice. Here, researchers discovered that the bacteria in the guts of obese white mice were more efficient at extracting calories from complex carbohydrates than the bacteria in the guts of slimmer mice.

Also, in an earlier study, they had shown that the guts of obese mice had the same depletion of Bacteroidetes as found in the guts of the obese humans.

This means that you could have two guys eating the same amount of food (i.e. consuming the same calories) each day, and doing the same amount of exercise (i.e. burning equal number of calories) but over the course of several years, one gradually gets fatter and the other stays the same. Why? Because the one who stays the same has more Bacteroidetes in his gut, extracting fewer calories from the same amount of food.

The poor guy who gets fatter has a more efficient calorie grabber in his gut, and the excess gets stored as fat - putting him at higher risk of eventually becoming obese.

Trillions of "friendly" gut bacteria digest the food we eat by breaking down complex molecules like polysaccharides (complex carbs found in fruit, vegetables and grains) into simple sugars for energy. The excess is converted to fat for longer term storage. However, these studies suggest that the simple equation (calorie value of food intake) - (energy we use) equals (the fat we store), is different for different people.

These studies form part of a growing body of research revealing fascinating new insights into what we are made of and what makes us tick.

We used to think that the human body was a collection of cells with the same DNA imprint - like a unique bar code for each person. However, within us, in our guts, lie communities of microbes that outnumber our cells by 10 to 1, and, according to the researchers behind these two studies, "they may contain 100 times more genes than our own human genome".

The researchers suggest that intestinal bacteria could become "biomarkers, mediators and potential therapeutic targets" in the fight against obesity.

"An obesity-associated gut microbiome with increased capacity for energy harvest."
Peter J. Turnbaugh, Ruth E. Ley, Michael A. Mahowald, Vincent Magrini, Elaine R. Mardis, and Jeffrey I. Gordon.
Nature 444, 1027-131 (21 December 2006) | doi:10.1038/nature05414

Introduction to the Microbiology of Bacteria (Leeds University, UK).

Review of Genome-wide Analysis of Gut Bacteria - research, applications and resources (Horizon Press).

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FDA Approves Higher Dose Formulations Of Diovan HCT(R) (valsartan/hydrochlorothiazide) For Treatment Of High Blood Pressure

The U.S. Food and Drug Administration (FDA) approved two new, higher dose formulations of the high blood pressure medication Diovan HCT(R) (valsartan/hydrochlorothiazide): 320/12.5 mg and 320/25 mg. The approval of the higher strengths of Diovan HCT provides more options to help physicians more effectively manage their patients' high blood pressure. The new formulations of Diovan HCT will be commercially available by early June 2006.

Diovan HCT is a combination of the efficacious blood pressure medicine Diovan(R) (valsartan), the most prescribed agent in the ARB (angiotensin receptor blocker) class, and the diuretic hydrochlorothiazide (HCTZ). The majority of high blood pressure patients will require a combination of two therapies, like Diovan HCT, to achieve blood pressure goals. Diovan HCT provides greater blood pressure-lowering benefits to patients who require more than either the diuretic or Diovan alone. Previously, Diovan HCT was available in 80/12.5 mg, 160/12.5 mg, and 160/25 mg tablets.

"Millions of patients already rely on Diovan and Diovan HCT to help them get to goal and maintain healthier blood pressure levels," said Alex Gorsky, head of pharma, North America and chief executive officer, Novartis Pharmaceuticals Corporation. "The approval and availability of these new formulations means that, with Diovan HCT, physicians will have the widest and most flexible range of dosing options in the ARB class."

High blood pressure is a public health crisis, affecting more than 65 million Americans or one in three adults. The risk of cardiovascular disease doubles with every increase of 20/10 mmHg above a healthy blood pressure of 115/75 mmHg. High blood pressure medications not only lower blood pressure, but also reduce the risk of suffering a stroke or heart attack. Overall 70 percent of people with high blood pressure do not have their condition controlled. Moreover, about half of those taking medication for their condition do not have it successfully managed, underscoring the need for more powerful treatments.

Details of Data Supporting Approval

Data supporting approval showed the new higher doses of Diovan HCT provided significantly greater reductions in blood pressure compared to either therapy alone. Diovan HCT 320/25 mg lowered systolic/diastolic blood pressure 25/17 mmHg compared to 6/7 mmHg with placebo alone.

The blood-pressure lowering effect of the high doses of Diovan HCT was maintained throughout long-term follow-up studies lasting up to one year (without placebo control), and was the same regardless of age or gender, and for black and non-black patients.


The overall incidence of adverse events with Diovan HCT was comparable to placebo. Further, giving Diovan in combination with HCTZ lowered the incidence of hypokalemia (low blood potassium) associated with HCTZ. Hypokalemia can cause cardiac arrhythmia, muscle pain and/or weakness, general discomfort, irritability, extreme thirst, frequent urination and confusion.

Data To Be Presented At ASH

Much of the data supporting approval of the higher dose formulations of Diovan HCT will be presented at the upcoming American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition May 16-20, 2006, in New York, NY. In total, more than 30 studies related to Diovan, Diovan HCT and other Novartis medications for treating high blood pressure will be presented. The presentations will include clinical data on the efficacy of Rasilez(R) (aliskiren) and Exforge(R) (amlodipine besylate/valsartan), both investigational agents for which Novartis recently submitted new drug applications to the FDA for their use in treating high blood pressure.

"The breadth and depth of data to be presented at ASH underscore Novartis' innovation and leadership in the hypertension category," Mr. Gorsky added. "We continue to strongly support a robust research program to fully develop Diovan and Diovan HCT, as well as investigate new therapies such as Rasilez and Exforge."

About Diovan and Diovan HCT

Diovan and Diovan HCT should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child. If you get pregnant or plan to get pregnant, call your doctor right away. Do not take Diovan or Diovan HCT if you are allergic to any of the ingredients in these products.

Do not take Diovan HCT if you have a history of reduced urine output, or have allergic reactions to certain drugs known as sulfonamides. If you're taking Diovan HCT, tell your doctor about all your medical conditions and medicines you take, including: liver or kidney problems, lupus or if you take lithium.

In clinical studies with Diovan and Diovan HCT, side effects have generally been mild. The most serious side effects with both Diovan and Diovan HCT are low blood pressure (hypotension) and kidney problems, and additionally with Diovan HCT, skin rash. The only side effect that was more frequent with Diovan HCT than placebo was nasopharyngitis (2.4% vs 1%). In individual studies, a dose-related increase in the incidence of dizziness was observed Diovan HCT-treated patients.

Diovan HCT is not for the initial treatment of high blood pressure. Diovan HCT may be the right medication for you if Diovan or certain other blood pressure medicines alone have not worked.

For more information or full prescribing information for Diovan or Diovan HCT, go to "Prescribing Info/Quick Download" at http://www.pharma.us.novartis.com.

The foregoing release contains forward-looking statements that can be identified by terminology such as "studies showed," "appeared to," "strongly support," or by discussions regarding potential new indications or labelling for Diovan and/or Diovan HCT, or regarding the long-term impact of a patient's use of Diovan and/or Diovan HCT. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan and/or Diovan HCT to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan and/or Diovan HCT will be approved for any additional indications or labelling in any market. In particular, management's expectations regarding Diovan and/or Diovan HCT could be affected by, among other things, additional analysis of Diovan and/or Diovan HCT 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; increased government 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 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 Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis
http://www.novartis.com
http://www.pharma.us.novartis.com

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Once-Yearly Reclast(R) Demonstrates Highly Significant Fracture Risk Reductions In The Treatment Of Postmenopausal Osteoporosis, New Study Shows

New Phase III data presented for the first time demonstrated that the investigational treatment Reclast(R)^ (zoledronic acid) 5 mg was highly effective in reducing the incidence of bone fracture in women with postmenopausal osteoporosis across the most common fracture sites -- hip, spine and non-spine^^ -- with sustained effect over three years.(1) Further data demonstrated that postmenopausal osteoporosis patients currently taking oral alendronate can be directly switched to Reclast and maintain beneficial bone effects for a full 12 months after a single dose.(2) These studies were presented today at the annual meeting of the American Society of Bone and Mineral Research (ASBMR) in Philadelphia.

Postmenopausal osteoporosis (osteoporosis) is a serious condition affecting millions of women worldwide.(3) An estimated one out of every two women over age 50 with osteoporosis will suffer an osteoporotic fracture in her lifetime.(4) Of those women age 65 years or older who fracture a hip, 21% will die within one year.(5) Reclast is the only once-yearly bisphosphonate treatment being studied for the treatment of osteoporosis.

An interim analysis encompassing 99% of the data from the now completed three-year HORIZON Pivotal Fracture Trial showed that patients treated with Reclast experienced a 70% risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in hip fractures (p=0.0032) over three years compared to placebo. This met the study's two primary endpoints. Additionally, the study met all secondary endpoints including risk reduction in clinical spine fractures and non-spine fractures.

In the study, the overall incidence of adverse events experienced with Reclast was comparable to placebo. The most common adverse events associated with Reclast were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache, and bone pain, the majority of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Reclast. Analysis of key safety parameters, including kidney and jaw safety, found Reclast to be comparable to placebo.(1)

"The efficacy and safety data show that for the first time women may have the option of a once yearly treatment for osteoporosis," stated Dr. Dennis Black, the study steering committee chair from University of California, San Francisco. "The results show that Reclast effectively protects women against fractures including those of the hip, which can be devastating."


Additional Phase III data presented at the meeting from a study of 225 women with osteoporosis demonstrated that patients treated with weekly Fosamax therapy can directly switch to Reclast. In the study, the beneficial effects of alendronate on bone mineral density levels in postmenopausal women were maintained for 12 months after a single infusion of Reclast, and, at 12 months, bone mineral density values for patients randomized to receive Reclast were similar to bone mineral density values for patients randomized to continued treatment with alendronate, meeting the study's primary endpoint. In patients taking Reclast, bone turnover remained within the normal pre-menopausal range at 12 months after an infusion.(2) The most common adverse events reported in this study were similar to those observed in the pivotal fracture trial.(1,2,6)

Furthermore, two separate studies of women being treated for osteoporosis have shown that a majority preferred a once-yearly infusion to a once-weekly pill.(7,8)

"We believe once-yearly Reclast may offer advantages for the millions of women suffering from osteoporosis and potentially provide the most comprehensive protection across the most common osteoporotic fracture sites," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.

Reclast In Post-Menopausal Osteoporosis: Study Designs

The Health Outcomes and Reduced Incidence with Zoledronic acid Once yearly (HORIZON) Pivotal Fracture Trial is a multi-national, multi-center, randomized, placebo-controlled trial of 7,736 women. The study evaluated the potential of a once-yearly infusion of Reclast to decrease the risk of fracture in postmenopausal women with osteoporosis. Primary endpoints were incidence of new vertebral fractures and hip fractures at three years compared to placebo. All study participants received elemental calcium (1000 to 1500 mg per day) and vitamin D (400 to 1200 IU per day).

The second Phase III Reclast study presented at ASBMR investigated the safety and efficacy of treating patients with Reclast who were previously taking Fosamax. This randomized, double-blind, double-dummy, multi-center trial compared a single infusion of 5 mg Reclast vs. continuation of therapy with oral alendronate weekly for 52 weeks. The study included postmenopausal women with low bone mineral density (n=225). The women must have been treated with Fosamax for at least one year prior to randomization. The primary endpoint of the study was percent change in lumbar spine bone mineral density from baseline to one year.

About Reclast

Reclast is being studied worldwide in a series of multi-national and multi-center clinical trials program called HORIZON. This clinical development program studies a once-yearly dosing with Reclast for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and the treatment of osteogenesis imperfecta in children. Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centers worldwide. The HORIZON program is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases.

Zoledronic acid 5mg, under the brand name Aclasta(R), has been approved in approximately 50 countries worldwide, including the EU and Canada, for the treatment of Paget's disease. The U.S. Food and Drug Administration (FDA) issued an "approvable letter" for Reclast for the treatment of Paget's disease of the bone in February 2006. The FDA requested additional data from the ongoing clinical trial program in osteoporosis. Novartis is working with the FDA to gain approval for this indication. Zoledronic acid, the active ingredient of Reclast, is also available under the brand name Zometa(R) for use in other indications.

About Postmenopausal Osteoporosis

Postmenopausal osteoporosis (PMO) is a serious condition affecting millions of women worldwide. Osteoporosis currently affects an estimated 50.7 million people in the UK, France, Germany, Italy, Spain, the USA and Japan.(3) Incidence of hip fracture in women is projected to rise by 240% worldwide by 2050, as populations grow and age.(9)

Disclaimer

The foregoing release contains forward-looking statements that can be identified by the use of terminology such as "may," "believe," "potentially," "potential," or similar expressions, or by express or implied discussions regarding potential regulatory filings, approvals or future sales for Reclast. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Reclast to be materially different from any future results, performance or achievements expressed or implied by such statements. There is no guarantee that Reclast will be approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication in any market. Neither can there be any guarantee regarding potential future sales of Reclast. In particular, management's ability to ensure satisfaction of any health authorities' requirements is not guaranteed and management's expectations regarding commercialization of Reclast could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including new clinical data and additional analysis of existing clinical data; 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; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the Securities and Exchange Commission of the United States. 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 Pharmaceuticals Corporation develops, manufactures, markets and sells 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, gastrointestinal 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 (NYSE: NVS) -. a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References

1. Black DM, et al. Effect of once-yearly infusion of Zoledronic Acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.

2. McClung M, et al. Single infusion of zoledronic acid 5 mg provides sustained benefits in BMD and biomarkers at 12 months in postmenopausal women with low bone mineral density and prior alendronate therapy. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.

3. Decision Resources Inc. -- Dbase 9; Kanis JA, 2000 & Melton LJ, 1995.

4. National Institutes of Health Osteoporosis and Related Bone Diseases -- National Resource Center. Osteoporosis Overview. Department of Health and Human Services. Available at http://www.niams.nih.gov/bone/hi/overview.htm.

5. US Congress, Office of Technology Assessment, Hip Fracture Outcomes in People Age 50 and Over -- Background Paper, OTA-BP-H-120 (Washington, DC: US Government Printing Office, July 1994).

6. Recker R, et al. Bone histomorphetry demonstrates normal bone remodelling in postmenopausal women with osteoporosis/osteopenia switched from oral alendronate to IV zoledronic acid. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.

7. Lindsay R, et al. A single zoledronic acid 5 mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Presented at Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), 15-18 March 2006, Vienna, Austria.

8. Omizio M, et al. A single infusion is preferred to oral weekly treatment in post-menopausal women with low bone mineral density previously treated with alendronate. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.

9. Gullberg B, et al. World-wide projections for hip fracture. Osteoporosis Int 1997; 7:407-13.

Novartis Pharmaceuticals Corporation
http://www.novartis.com

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Tykerb Helps Stall Advanced Breast Cancer, Says Glaxo

Tykerb, an experimental drug, helps stall advanced breast cancer, said makers GlaxoSmithkline at the American Society of Clinical Oncology, Atlanta, USA. Glaxo said women who had not benefited from Herceptin, another breast cancer drug, benefited when receiving Tykerb.

Tyberb, taken along with Xeloda was shown to be twice as effective in slowing down an aggressive type of breast cancer as Xeloda alone.

Tykerb, a pill, blocks proteins that encourage the development and spread of cancer.

Even though Tykerb is still an experimental drug, it is a potential rival to Herceptin, which belongs to Genentech and its parent company, Roche.

About 400,000 women are diagnosed with breast cancer globally each year. After lung cancer, it is the second leading cause of female cancer-related deaths in most developed countries.

In a study of 321 women, all with advanced breast cancer who tested positive for HER2, 160 who received Tykerb with Xeloda had no cancer growth for 36.9 weeks. The other 161 women who were on Xeloda alone experienced no cancer growth for just 19.7 weeks. The trial was stopped so that the women who were not taking Tykerb could do so if they wished.

HER2 is a protein which makes breast cancer more aggressive.

Glaxo is planning to apply for FDA approval for Tykerb later on this year.

Tykerb and Herceptin work in different ways. Herceptin does not enter the cancer cell to block HER2, it binds to the outside of the cell. Tykerb, on the other hand, enters the cancer cell and blocks the protein. Tykerb was also created to block EGFR.

So far, the heart failure side-effect found among some patients taking Herceptin has not so far been detected with Tykerb.

Tykerb is taken once a day as a pill. Herceptin is taken once a month as an infusion.

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