Novartis related Press Releases

New data show Menveo to be the first quadrivalent meningococcal vaccine to provide immunogenicity in infants

Maureen Martino — Thu, 10 Jan 2008 08:55:12 -0500

New data show Menveo to be the first quadrivalent meningococcal vaccine to provide immunogenicity in infants

Data in JAMA show Menveo may provide infants protection against four of the most common meningococcal serogroups - A, C, W-135 and Y

Menveo stimulates broad immune response against meningococcal disease in infants from two months old

Basel, January 9, 2008 - Menveo(TM) (MenACWY-CRM), a vaccine in development by Novartis, may protect infants using a schedule beginning at two months of age against four of the most common causes of meningococcal disease. Menveo is the only meningococcal vaccine shown to generate protection against a broad range of serogroups in infants, potentially filling a large unmet medical need.

New data, published in the Journal of the American Medical Association, show that Menveo was well-tolerated and generated high levels of immunogenicity in infants against meningococcal serogroups A, C, W-135 and Y with a standard infant vaccination dosing schedule.

Infants have the highest rate of meningococcal disease, a potentially deadly bacterial infection. However, no currently available quadrivalent vaccine including Menomune® [1] and Menactra® [2] has demonstrated a strong and lasting immune response for this age group.

"These important data show that this new MenACWY vaccine has the potential to protect infants as part of the routine infant vaccine schedule, expanding the potential serogroup coverage of currently available vaccines," said study investigator Andrew Pollard, FRCPCH, PhD, Reader in Paediatric Infection & Immunity, University of Oxford and Honorary Consultant Pediatrician at Children's Hospital in Oxford, England.

"Infants have the highest rate of meningococcal disease, and to date no quadrivalent vaccine has been immunogenic in this high risk age group," said Steve Black, MD, Adjunct Professor of Pediatric Infectious Disease at Stanford University. "These new data are encouraging and offer promise that we will soon have a vaccine to protect all children against a broad range of serogroups that cause meningococcal disease."

These new results build on numerous other clinical trial findings, which support that Menveo generates a strong immune response across all age groups. Novartis plans regulatory submissions for Menveo in the European Union and the United States in 2008.

"Novartis is making great progress toward our goal of protecting all age groups from all causes of meningococcal disease," said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics.

A rare but potentially vaccine-preventable disease, invasive meningococcal disease is an acute, contagious and potentially fatal disease that causes sepsis and meningitis, an infection of membranes around the brain and spinal cord. Each year, approximately 500,000 cases occur around the world, causing about 50,000 deaths. Meningitis symptoms - which can include sudden onset of fever, rash, headache and stiff neck - can progress rapidly. Even with early and appropriate treatment, patients can die, typically within 24-48 hours. Up to 20% of those who survive infection are left with life-long disability, such as deafness, neurological damage or limb loss.

About the trial
The Phase II randomized, open-label trial included 421 infants from the UK and Canada and evaluated multiple schedules including two 3-dose primary schedules, at either 2, 3 and 4 months and 2, 4 and 6 months. Some participants received either an additional dose of MenACWY-CRM or a plain meningococcal polysaccharide at 12 months. One month after the last primary immunization, the percentage of participants with hSBA titers greater than or equal to 1:4 in the 2, 3, 4-month group was 93% or above for all four serogroups. Immunization at 2, 4 and 6 months resulted in a similarly high percentage of participants achieving immune response for serogroups C, W-135 and Y, and 81% for serogroup A. The dose at 12 months generated a strong immune response across all four serogroups, was shown to increase levels of immunity, and is likely to provide sustained protection. The hSBA titer is the human serum bactericidal antibody assay, which measures the body's protective immune response to the meningococcus.

About Menveo
Menveo is currently in multiple Phase III clinical trials involving infants, young children, adolescents and adults. It is based on the same technical expertise Novartis used to produce Menjugate®, a meningococcal serogroup C conjugate vaccine approved outside the United States since 2000 for use in individuals from two months old through adulthood.

The polysaccharide conjugation technique used to produce MenACWY-CRM improves immunization responses compared to older polysaccharide vaccines, which are poorly immunogenic in infants. Currently the only conjugate vaccines approved and available for use in infants protect only against serogroup C; these serogroup C vaccines are not approved in the United States. Menveo will therefore provide the opportunity to protect infants against a broad range of serogroups that cause meningococcal disease.

Novartis is a global leader in providing effective meningococcal vaccines, having distributed more than 26 million doses of Menjugate around the world and producing MenZB, a vaccine against a strain of meningococcus B specific to a recent outbreak in New Zealand. Novartis is also developing a recombinant vaccine to provide broad coverage against multiple strains of serogroup B, which no vaccine currently available can achieve.

About Novartis
Novartis Vaccines and Diagnostics is a division of Novartis focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division's products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operates in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Novartis launches strategic initiative to improve competitiveness in a changing healthcare environmenT

Maureen Martino — Thu, 13 Dec 2007 08:08:19 -0500

Novartis launches strategic initiative to improve competitiveness in a dynamically changing healthcare environment

"Forward" to simplify organizational structures, accelerate and decentralize decision-making processes, redesign the way Novartis operates and provide productivity gains
Targeted initiatives to be implemented during 2008 and 2009 with an expected annual pre-tax cost savings goal of USD 1.6 billion in 2010
Approximately 2,500 full-time positions (2.5% of Group total) planned to be reduced worldwide; many reductions to be achieved through normal staff fluctuation, vacancy management and social programs
Restructuring charge of approximately USD 450 million to be taken in 2007 fourth quarter, to support implementation in a socially responsible manner
Actions to help prepare Novartis Pharmaceuticals for a new growth cycle expected to emerge in second half of 2008

Basel, December 13, 2007 - Novartis is launching a new initiative in a dynamically changing healthcare industry environment that will enhance productivity by streamlining the organization and redesigning the way it operates. This will enable Novartis to more rapidly meet the needs of patients and customers by focusing resources on priority activities that include the research and development of new medicines.

This initiative, called "Forward," is expected to simplify working processes and decision making by eliminating layers, concentrating on core activities and systematically capturing growth opportunities, particularly in emerging markets.

Forward will further enable Novartis to prepare for a new growth cycle in Pharmaceuticals expected to emerge in the second half of 2008. These actions will also generate significant cost savings and realign resources to better address the changing needs of customers.

"Novartis has experienced strong growth over the last decade and strategically focused activities in healthcare, building a portfolio that is focused yet diversified," said Dr. Daniel Vasella, Chairman and CEO of Novartis. "Our portfolio and excellent pipeline of innovative drugs and vaccines provide us with a unique position, both as a platform for growth and to balance risks. We have taken the opportunity given the short-term down-cycle in our pharmaceuticals business to initiate this project. This will simplify our organization and redesign the way we operate. Forward will increase speed and productivity in anticipation of accelerating growth in the second half of 2008."

Novartis benefits from a positive outlook for its strategic portfolio that includes innovative pharmaceuticals, generics, vaccines and diagnostics, and consumer brands. Key growth drivers include the ongoing launches of new medicines following the industry-leading 14 positive regulatory approvals during 2007 in the United States and Europe as well as strong expansion in other businesses, particularly in Vaccines and Diagnostics and Sandoz, the generics division of Novartis.

At the same time, the increasingly challenging industry conditions - including continuous price pressures on drugs, increasing R&D costs, a risk-averse regulatory environment and more aggressive generic competitors - created an impetus for change that led to Forward.

These targeted initiatives include the following:

Organizational structures will be streamlined in corporate functions as well as in the Pharmaceuticals and Consumer Health Divisions, particularly involving general management and administrative areas.
In the Pharmaceuticals Division, the effectiveness of the worldwide sales forces will be improved with a more geographic-tailored marketing approach. Duplication between global, regional and local activities will be eliminated, while certain non-core support activities will be outsourced.
The Consumer Health Division will remove organizational layers to streamline processes and eliminate duplications, while some product supply chains will be restructured to optimize capacity utilization. In certain business units, regional management structures will be modified in order to better focus resources on global or local activities.
The Novartis Institutes for BioMedical Research will focus on disease areas with significant new opportunities and review its research activities globally to take advantage of synergies among disease areas and locations to increase efficiency.
Initiatives are underway to capture savings from the creation of Group-wide shared functions, including procurement and information technology, that will provide greater economies of scale and leverage opportunities in low-cost countries.
Novartis will form a new cross-divisional operation to accelerate growth in small emerging markets, expanding the presence of all Novartis products in regions that include Northern and Sub-Saharan Africa, Central Asia and parts of Southeast Asia.
Implemented in 2008 and 2009, these initiatives are expected to generate a pre-tax annual cost savings of USD 1.6 billion and maximize resources available to support growth and customer-oriented activities. A pre-tax restructuring charge of approximately USD 450 million will be taken in the fourth quarter of 2007.

Approximately 2,500 full-time positions are expected to be reduced as part of these initiatives from among the nearly 100,000 full-time positions within the Group. Many reductions will be handled though normal fluctuation in staffing levels, which has traditionally averaged about 8% of the Group's annual workforce, as well as vacancy management and social programs. All reductions will be handled in a socially responsible manner with fair and respectful treatment of associates. Novartis will consult with works councils and comply with local labor laws.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "will," and "expect" or similar expressions, or by express or implied discussions regarding potential new cost savings or growth or potential future sales or earnings of the Novartis Group or any of its divisions; or discussions of strategy and plans and expectations and intentions thereto. Such forward-looking statements reflect the current views of Novartis 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 any of the projects described will succeed or that the expected cost savings or growth will be achieved. Similarly, there can be no guarantee that the Novartis Group or any of its divisions will achieve any particular level of revenue or earnings. In particular, management's expectations could be affected by, among other things, sales growth of recently launched products, difficulties or delays in manufacturing products, 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; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; litigation; 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 U.S. 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Novartis further strengthens biologics capabilities in expansion of MorphoSys collaboration

Maureen Martino — Mon, 03 Dec 2007 08:20:49 -0500

Novartis further strengthens biologics capabilities in expansion of MorphoSys collaboration

Collaboration efforts will focus on the discovery and optimization of antibodies against a significant number of molecular targets in a wide range of diseases
Expanded agreement increases the ability of Novartis to generate therapeutic antibodies - the most successful and fastest growing class of biologics

Biologics comprise 25% of Novartis pre-clinical research portfolio, and alliance supports Novartis commitment to being an industry leader in the discovery and development of innovative biologic therapies for patients
Basel, December 2, 2007 - Novartis has expanded its collaboration with the German biotechnology company MorphoSys to create one of the pharmaceutical industry's most comprehensive alliances focused on the discovery and development of antibody-based biologic therapies, the most successful and fastest growing class of biologics.

These treatments are based on monoclonal antibodies and are used to treat diseases that, in some cases, have been more challenging with "small molecule" approaches based on chemical substances.

Under this new 10-year agreement, which may be extended by Novartis for an additional two years, Novartis and MorphoSys will jointly discover and optimize antibodies against a significant number of molecular targets in a wide range of diseases. MorphoSys will also offer increased personnel support for these projects.

In addition, other than rights held by MorphoSys' current collaborations and access for MorphoSys' own internal use, Novartis will have virtually exclusive access to MorphoSys' human antibody libraries and any future improvements made during the collaboration. MorphoSys will also fully transfer a copy of its antibody libraries and technologies to Novartis research sites.

Novartis has been building its position in biologics, consistently growing its capabilities and expertise in the research and development of all biologic therapies, which now represent 25% of the pre-clinical research portfolio. The new Novartis Biologics Unit was created earlier in 2007, establishing a dedicated innovation unit, with a strong biotech culture in the areas of discovery and development unique to biologics, and with full access to the extensive Novartis discovery organization that generates many targets across multiple therapeutic areas.

"This strategic agreement will further leverage MorphoSys antibody technologies with the internal biologics discovery and development capabilities of Novartis so that we can more rapidly and efficiently bring innovative biologic therapies to patients," said Dr. Mark Fishman, President of Novartis Institutes for BioMedical Research. "MorphoSys has been a valued collaborator during the last three years, and we are pleased to expand this alliance."

MorphoSys has developed HuCAL (Human Combinatorial Antibody Library), a technology for the rapid and automated production of specific antibodies that involves more than 12 billion functional and distinct fully human antibodies.

Novartis and MorphoSys began the collaboration in May 2004, and it was first expanded in June 2006 to include a greater number of programs. Multiple active therapeutic antibody programs across various diseases have emerged from this collaboration, and the first US regulatory request to start human clinical trials (an "Investigational New Drug" application) was made within the first three years.

Financial terms of the agreement
Based on a 10-year term, Novartis has committed to making total payments, including FTE support, technology transfer, and annual licensing fees of approximately USD 600 million to MorphoSys. Potential payments could exceed USD 1 billion when including milestones that are contingent upon successful clinical development and market approval of multiple products. MorphoSys may also participate in co-development and assume co-detailing responsibility for selected projects.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "commitment", "designed to", "will", "could", "contingent", "potential", "may", or similar expressions, or by express or implied discussions regarding the potential development of new products as a result of the agreement described in this release, or regarding potential future revenues from products. Such forward-looking statements reflect the current views of the Company 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 any new products will be approved for sale in any market as a result of Novartis' collaboration with MorphoSys. Nor can there be any guarantee that, if approved, any such products will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected research or 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; unexpected manufacturing difficulties; 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 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Tasigna gains European approval for patients with a life-threatening form of leukemia who are resistant or intol

Maureen Martino — Wed, 28 Nov 2007 11:34:09 -0500

Tasigna® gains European approval for patients with a life-threatening form of leukemia who are resistant or intolerant to existing therapies

Tasigna produced response in 49% of patients with Philadelphia chromosome-positive chronic myeloid leukemia resistant or intolerant to existing therapies

Phase III trials launched to explore potential of Tasigna in newly diagnosed CML patients and also those with sub-optimal response to prior treatment

Basel, November 28, 2007 - Tasignaâ (nilotinib) has received European Union approval as a new anti-cancer therapy for patients with a life-threatening form of leukemia who are resistant or intolerant to prior treatment including Glivecâ (imatinib)[*].

The EU approval was supported by data showing that Tasigna produced a positive response in 49% of patients in the chronic phase of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Most patients achieved this response within three months of starting Tasigna treatment.

"The approval of Tasigna gives us the opportunity to help more CML patients and, with Glivec as our first line agent, provide comprehensive treatment options for prescribers," said David Epstein, President and CEO of Novartis Oncology. "Tasigna drives home our commitment to develop compounds to fulfill unmet medical needs by pursuing indications for patients with limited treatment options."

The European Commission decision applies in all 27 EU member states plus Norway and Iceland, and follows recent approvals in the US and Switzerland. Tasigna is now approved in a total of 37 countries, and was also submitted for approval in Japan in June.

CML is one of the four most common types of leukemia, responsible for about 15% of all leukemia cases worldwide[1]. Without treatment, CML typically progresses over three to five years from the initial (chronic) phase through a transition (accelerated) phase to a rapidly fatal form called blast crisis[1]. Tasigna is indicated in the EU for the treatment of adults who are in chronic or accelerated phase Ph+ CML and have resistance or intolerance to prior therapy including Glivec.

Taken twice daily, Tasigna works by inhibiting the proliferation of cells containing an abnormal chromosome in patients with CML. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia chromosome. This protein is recognized as the key driver of the overproduction of cancer-causing white blood cells in patients with Ph+ CML.

Tasigna was designed to target the Bcr-Abl protein more preferentially than Glivec without adding new mechanisms of action.

Earlier this year, a Phase III clinical trial program was launched to compare Tasigna with Glivec for the treatment of newly diagnosed patients with chronic phase Ph+ CML. A study is also underway comparing these two targeted therapies in chronic phase Ph+ CML patients who had sub-optimal responses to previous therapy. Separately, a Phase III program has been launched involving the use of Tasigna in patients with gastrointestinal stromal tumors (GIST) who are resistant or intolerant to prior treatment.

The EU approval of Tasigna was based on a pivotal clinical trial evaluating the rates of cytogenetic response (i.e. reduction or elimination of the Philadelphia chromosome) and confirmed hematologic response (i.e. normalization of white blood cell counts) in Glivec-resistant or -intolerant patients with Ph+ CML in chronic and accelerated phase.

The major cytogenetic response rate with Tasigna was 49% for chronic phase patients and 27% for accelerated phase patients. The complete hematologic response rate was 70% for chronic phase patients who were not already in complete hematologic response at the start of the trial, and the confirmed hematologic response rate was 42% for accelerated phase patients.

The US Food and Drug Administration (FDA) approved Tasigna in October 2007 based on the same pivotal clinical trial that supported the EU filing, but using a different analysis (including shorter duration of follow-up) that produced slightly different response rates.

Tasigna safety information
Because taking Tasigna with food may increase the amount of drug in the blood, Tasigna should not be taken with food and patients should wait at least two hours after a meal before taking Tasigna. In addition, no food should be consumed for at least one hour after the dose is taken.

In countries where it is approved, Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myeloid leukemia in adult patients resistant or intolerant to at least one prior therapy including Glivec. The effectiveness of Tasigna is based on confirmed hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

The most frequent Grade 3 or 4 adverse events for Tasigna were primarily hematological in nature and included neutropenia and thrombocytopenia. Elevations were seen in bilirubin, liver function tests, lipase enzymes and blood sugar, which were mostly transient and resolved over time. These cases were easily managed and rarely led to discontinuation. Pancreatitis was reported in less than 1% of cases. The most frequent non-hematologic drug-related adverse events were rash, pruritus, nausea, fatigue, headache, constipation, and diarrhea. Most of these adverse events were mild to moderate in severity.

Tasigna should be used with caution in patients with uncontrolled or significant cardiac disease (e.g. recent heart attack, congestive heart failure, unstable angina or clinically significant bradycardia), as well as in patients who have or may develop prolongation of QTc. These include patients with abnormally low potassium or magnesium levels, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other drugs that may lead to QT prolongation. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating therapy with Tasigna and as clinically indicated.

About Glivec
Glivec is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in the EU, US and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumors (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In Japan, Glivec is approved for the treatment of patients with Kit (CD117)-positive GIST. In the EU, Glivec is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukemia (HES/CEL).

The effectiveness of Glivec is based on overall hematologic and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in Ph+ ALL, and on objective response rates in GIST and DFSP. There are no controlled trials demonstrating increased survival. Not all indications are available in every country.

Glivec safety information
The majority of patients treated with Glivec in clinical trials experienced adverse events at some time. Most events were of mild to moderate grade and treatment discontinuation was not necessary in the majority of cases.

The safety profile of Glivec was similar in all indications. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well-tolerated in all the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception of a transient liver toxicity in the form of transaminase elevation and hyperbilirubinemia observed when Glivec was combined with high-dose chemotherapy.

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/ necrosis, hip osteonecrosis/avascular necrosis.

Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated. Cardiac screening should be considered in patients with HES/CEL, and patients with MDS/MPD with high level of eosinophils (echocardiogram, serum troponin level).

Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "should", "may" or similar expressions, or by express or implied discussions regarding potential regulatory approvals, new indications or labeling for, or potential future sales of, Glivec or Tasigna. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec or Tasigna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Glivec or Tasigna will be approved for any additional indications or labelling in any market or that Glivec or Tasigna will reach any particular level of sales. In particular, management's expectations regarding Glivec or Tasigna 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; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected delays due to manufacturing; 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 U.S. 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Antisoma Shares Slide as Novartis Corporation (NVS) Sets up Avastin Fight

Maureen Martino — Tue, 20 Nov 2007 11:21:06 -0500

Antisoma Shares Slide as Novartis Corporation Sets up Avastin Fight

LONDON--Nov 20, 2007 -- ASA404 phase III lung cancer trial to include broader range of patients London, UK: 20 November 2007 - Cancer drug developer Antisoma holds its AGM today. At the meeting, CEO Glyn Edwards will provide an update on the Company's key pipeline products and other corporate developments:

"We are making significant advances across our pipeline, and expect to achieve further important milestones during 2008.

ASA404 - update on plans for phase III trial in lung cancer

Our licensing partner, Novartis, plans to start a pivotal phase III trial of ASA404 in non-small cell lung cancer (NSCLC) in early 2008. This trial will now include patients with both major types of NSCLC: squamous and non-squamous. Previous guidance was that the pivotal study would be limited to patients with squamous disease. Discussions with regulatory authorities regarding the trial design are ongoing.

Because more patients are diagnosed with non-squamous than squamous NSCLC, this change more than doubles the population of NSCLC patients addressed directly by the phase III trial. Eligibility for the phase III trial will now be similar to that in our phase II studies, where we showed a substantial survival benefit with ASA404 in a broad population of NSCLC patients.

If the phase III trial is successful, applications to market ASA404 for NSCLC will be filed in 2010 or 2011. The drug also has potential in other cancers. These include prostate cancer, where Antisoma has reported encouraging interim data from a phase II trial and expects to report survival findings next year.

AS1411 - AML phase II trial underway, other trials planned

Our randomised phase II trial of AS1411 in AML (acute myeloid leukaemia) is on track to report initial data in the first half of next year.

The trial compares patients receiving the current standard therapy, cytarabine, with patients receiving cytarabine plus AS1411. We are evaluating two different doses of AS1411, 10 and 40 mg/kg/day. The first report will compare 10 mg/kg/day AS1411 plus cytarabine with cytarabine alone. The primary endpoint is the proportion of patients achieving a complete response (disappearance of leukaemia cells) after treatment.

We are also planning to conduct a phase II trial in renal cancer, an indication where there was promising evidence of anti-cancer activity in phase I. The phase II trial will not now start in the first half of 2008, as previously expected, because we intend to complete additional preclinical and toxicology work before finalising our plans. This aims to identify a safe and optimal approach to repeat dosing of AS1411 for use in the renal cancer trial and other programmes where repeat dosing may be desirable. In parallel with this work, we are making plans for a trial in a third cancer indication, and expect to announce details early next year.

AS1402 and AS1409 - on track with development plans

AS1402 is on track to enter a randomised phase II trial in breast cancer during 2008. Similarly, we expect to meet our objective of initiating our phase I trial of AS1409 before the end of 2007.

United States operation established in Princeton

We have opened an office in Princeton, New Jersey, in order to support our US clinical and regulatory activities. The new office is headed by Dr Chris Smyth, Head of Clinical Operations, who was formerly based at our London office. A number of new, experienced staff have been recruited to meet the needs of our growing clinical trials programme in the US.

Positive outlook

Our pipeline continues to advance, with ASA404 poised to enter phase III and the first phase II data on AS1411 expected soon. By the end of 2007, we expect to have four drugs in clinical trials, and our plans to bring in further drugs for development are progressing well. With last-reported cash of over £60 million and a strong operational base, we are well placed both to maximise the value of our existing assets and to continue the growth of our business."

Enquiries:

Glyn Edwards, CEO Daniel Elger, Director of Communications +44 (0)20 8799 8200 Antisoma plc

Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000 Dietrich Buchanan Communications

Brian Korb +1 646 378 2923 The Trout Group

This Interim Management Statement is published in accordance with the UK Listing Authority's Disclosure and Transparency Rules, in respect of the period from 30 June 2007 to 20 November 2007.

Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company's clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management's current expectations, but actual results may differ materially.

Background on Antisoma

Headquartered in London, UK, Antisoma is a biopharmaceutical company that develops novel products for the treatment of cancer. Antisoma fills its development pipeline by acquiring promising new product candidates from internationally recognised academic or cancer research institutions. Its core activity is the preclinical and clinical development of these drug candidates. Please visit www.antisoma.co.uk for further information about Antisoma.

PRESS RELEASE: New Galvus clinical data reinforces efficacy profile; safety update provided to regulatory agencies

Maureen Martino — Tue, 06 Nov 2007 13:19:17 -0500

New Galvus clinical data reinforces efficacy profile; safety update provided to regulatory agencies

New data accepted for publication show Galvus 50 mg twice-daily dose as effective as a thiazolidinedione (TZD), well tolerated and not causing weight gain

Novartis proposes improving Galvus risk/benefit profile through use of approved 50 mg once-daily and twice-daily doses instead of approved 100 mg once-daily
Basel, November 6, 2007 - New clinical data involving Galvus® (vildagliptin) has been accepted for publication in the journal Diabetes, Obesity and Metabolism showing this new oral medicine was as effective as one of the leading oral type 2 diabetes treatments and well tolerated.

Separately, Novartis provided on November 6 a safety update to European regulators of pooled data showing numerically less frequent liver enzyme elevations in patients who took either 50 mg per day or 50 mg twice daily of Galvus compared to 100 mg once-daily. As a result, Novartis has proposed changes to European prescribing information recommending use of the already-approved 50 mg once-daily and twice-daily doses instead of the 100 mg once-daily dose. Novartis will discuss the data and recommendations with other regulators.

New clinical data reaffirms effectiveness against a TZD
The results of a new clinical study further confirmed the efficacy of Galvus in combination with metformin, a long-standing oral type 2 diabetes treatment. This trial showed Galvus was as effective as pioglitazone, a member of the thiazolidinedione (TZD) class of diabetes medicines, when each was combined with metformin. Galvus was well tolerated and did not cause the weight gain that often occurs in patients taking a TZD.

In the 24-week study of 576 patients with type 2 diabetes, all of whom had inadequately controlled diabetes despite taking the oral medicine metformin, the addition of a 50 mg twice-daily dose of Galvus to metformin treatment reduced blood sugar levels as effectively as adding a 30 mg once-daily dose of pioglitazone to metformin.

Galvus was shown to be weight neutral, while the addition of the TZD was associated with weight gain (up to 1.9 kg after 24 weeks of treatment).

Novartis provides safety update to regulatory agencies
An updated analysis of pooled clinical trial data involving more than 8,000 patients treated with Galvus was finalized following the European Union approval on September 26 and included recently completed studies.

Novartis will discuss these data with the Committee for Medicinal Products for Human Use (CHMP), which is responsible for the review of medicines in Europe, and will seek a revision of prescribing information before Galvus is launched for sale in European markets.

The recent analysis further characterized a known imbalance in liver enzyme levels, which now appears more visibly in the higher Galvus once-daily dosing regimen. The results showed 0.86% of Galvus patients taking the 100 mg once-daily dose, 0.34% of those taking the 50 mg twice-daily dose and 0.21% of those taking the 50 mg once-daily dose had elevations of the liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of greater than three times the upper limit of normal (3xULN).

At a 50 mg daily dosage, the incidence rate was comparable to the 0.20% in the pooled comparator group of about 4,400 patients taking metformin, a TZD, a sulfonylurea or a placebo. The placebo rate was 0.40%, and this was numerically higher than the Galvus 50 mg twice-daily dose. Elevated levels of these enzymes can indicate liver cell damage.

Novartis will continue working with the CHMP and other agencies to review these results and to revise prescribing information for Galvus, which is a member of a new drug class known as DPP-4 inhibitors. The currently approved European information recommends a 50 mg once-daily dose for use in combination with a sulfonylurea as well as a 50 mg twice-daily or 100 mg once-daily dose for combination use with either metformin or a TZD.

Galvus is currently available in Brazil and Mexico as both a 50 mg and 100 mg daily dose. In February 2007, Novartis received an "approvable letter" from the US Food and Drug Administration (FDA) and is in discussions with the agency.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "proposes", "will", "approvable", or similar expressions, or by express or implied discussions regarding the potential launch of Galvus for sale in European markets, potential future approvals of Galvus in other countries, including the US, and potential future revenues from Galvus. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Galvus to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Galvus will be launched for sale in any European market, or that Galvus will be approved in the US or in any other markets. Nor can there be any guarantee that Galvus will achieve any particular levels of revenue. In particular, management's expectations regarding Galvus 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; 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Novartis International Says U.S. Approves Tasigna Cancer Drug

Maureen Martino — Tue, 30 Oct 2007 09:55:49 -0400

Novartis International Says U.S. Approves Tasigna Cancer Drug

BASEL, SWITZERLAND -- Oct 29, 2007 -- Tasigna® (nilotinib) has been approved in the US as a new anti-cancer therapy for certain patients with a life-threatening form of leukemia who are resistant or intolerant to prior treatment including Glivec® (imatinib)*, an established treatment standard and a leading Novartis medicine.

Novartis will make Tasigna available throughout the US within days following this approval by the Food and Drug Administration (FDA) to meet the treatment needs of these patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

CML is one of the four most common types of leukemia, a form of blood cancer, and affects around 4,500 people in the US each year[1].

"Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy," said David Epstein, President and CEO of Novartis Oncology. "This approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+ CML patients."

Taken twice daily, Tasigna works by inhibiting the proliferation of cells containing an abnormal chromosome. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia chromosome. This protein is recognized as the key cause and driver of the overproduction of cancer-causing white blood cells in patients with Ph+ CML.

Tasigna was specifically designed to target the Bcr-Abl protein more preferentially than Glivec without adding new mechanisms of action. At six months follow-up, Tasigna reduced or eliminated cells carrying the abnormal Philadelphia chromosome in 40% of patients in chronic phase of the disease.

Applying experience gained from the development of Glivec, which remains the most frequently prescribed treatment for patients with CML, a team of Novartis scientists created Tasigna in August 2002, just a year after the launch of Glivec. In preclinical studies, the medicine was able to overcome resistance resulting from Bcr- Abl kinase mutations in 32 of 33 cell lines commonly associated with Ph+ CML. Patients with a variety of these mutations also responded to treatment with Tasigna.

The first worldwide approval for Tasigna came in Switzerland in July 2007. European Union approval is expected by the end of this year after the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in Europe, issued a positive opinion in September. Tasigna was also submitted for approval in Japan in June.

Without treatment, CML typically progresses over three to five years from the initial (chronic) phase through a transition period (accelerated phase) to a rapidly fatal form (blast crisis)[2]. Recent landmark clinical trial results for Glivec show that nearly 90% of newly diagnosed chronic-phase Ph+ CML adult patients treated with Glivec were alive after five years[3], but some develop resistance or cannot tolerate this therapy.

The FDA approved Tasigna for treatment of chronic-phase and accelerated-phase Ph+ CML in adult patients resistant or intolerant to prior treatment, that included Glivec. This approval is based on an open-label multicenter clinical trial evaluating the drug's safety and rates of cytogenetic response (i.e. reduction or elimination of the Philadelphia chromosome) and hematologic response (i.e. normalization of white blood cell counts) in Glivec-resistant or -intolerant patients with Ph+ CML in chronic phase (n=280) and accelerated phase (n=105).

In clinical trials, the primary endpoint for patients in chronic phase was unconfirmed major cytogenetic response (MCyR). After a minimum follow-up of six months (median treatment duration 8.7 months), Tasigna produced MCyR in 40% of 232 chronic phase patients evaluated for efficacy. The complete cytogenetic response in these patients was 28%.

For patients in accelerated phase, the primary endpoint was confirmed hematological response (HR). Complete HR was reported in 18% of patients in accelerated phase. (Accelerated phase patients had a minimum follow-up of four months and a median treatment duration of 6.4 months).

The highest prior Glivec dose was at least 600 mg/day in 77% of patients, with 44% of patients receiving doses of 800 mg/day or higher. In addition, 24 different mutations in Bcr-Abl were noted in 19% of chronic phase and 25% of accelerated phase CML patients who were evaluated for mutations.

Tasigna safety information

Because taking Tasigna with food may increase the amount of drug in the blood, Tasigna should not be taken with food and patients should wait at least two hours after a meal before taking Tasigna. In addition, no food should be consumed for at least one hour after the dose is taken.

In countries where it is approved, Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia in adult patients resistant or intolerant to at least one prior therapy including Glivec. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

The most frequent Grade 3 or 4 adverse events for Tasigna were primarily hematological in nature and included neutropenia and thrombocytopenia. Elevations were seen in bilirubin, liver function tests, lipase enzymes and blood sugar, which were mostly transient and resolved over time. These cases were easily managed and rarely led to discontinuation. Pancreatitis was reported in less than 1% of cases. The most frequent non-hematologic drug-related adverse events were rash, pruritus, nausea, fatigue, headache, constipation, and diarrhea. Most of these adverse events were mild to moderate in severity.

Tasigna should be used with caution in patients with uncontrolled or significant cardiac disease (e.g. recent heart attack, congestive heart failure, unstable angina or clinically significant bradycardia), as well as in patients who have or may develop prolongation of QTc. These include patients with abnormally low potassium or magnesium levels, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other drugs that may lead to QT prolongation. Low levels of potassium or magnesium must be corrected prior to Tasigna administration.

Studies have also shown virtually no non-hematologic cross-intolerance between Glivec and Tasigna. (Cross-intolerance occurs when patients cannot tolerate two different drugs because of the same side effects). Causes of non-hematologic intolerance to Glivec included Grade 3 or 4 rash/skin toxicity, fluid retention, gastrointestinal intolerance, liver toxicity, and myalgia/arthralgia.

About Glivec

Glivec is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in the EU, US and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumors (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In Japan, Glivec is approved for the treatment of patients with Kit (CD117)-positive GIST. In the EU, Glivec is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukemia (HES/CEL).

The effectiveness of Glivec is based on overall hematologic and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in Ph+ ALL, and on objective response rates in GIST and DFSP. There are no controlled trials demonstrating increased survival. Not all indications are available in every country.

Glivec contraindications, warnings and adverse events The majority of patients treated with Glivec in clinical trials experienced adverse events at some time. Most events were of mild to moderate grade and treatment discontinuation was not necessary in the majority of cases.

The safety profile of Glivec was similar in all indications. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well-tolerated in all the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception of a transient liver toxicity in the form of transaminase elevation and hyperbilirubinemia observed when Glivec was combined with high-dose chemotherapy.

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/ necrosis, hip osteonecrosis/avascular necrosis.

Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated. Cardiac screening should be considered in patients with HES/CEL, and patients with MDS/MPD with high level of eosinophils (echocardiogram, serum troponin level).

Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "should," "can," "expected," "may" or similar expressions, or by express or implied discussions regarding potential regulatory approvals, new indications or labeling for, or potential future sales of, Glivec or Tasigna. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec or Tasigna to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Tasigna will be approved in the EU, Japan or any additional market; that that Glivec or Tasigna will be approved for any additional indications or labelling in any market; or that Glivec or Tasigna will reach any particular level of sales. In particular, management's expectations regarding Glivec or Tasigna 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; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected delays due to manufacturing; 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 U.S. 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 - News) is a world leader in offering medicines to protect health, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

1. American Cancer Society. Overview: Leukemia - Chronic Myeloid (CML). http://www.cancer.org/docroot/CRI/content/CRI_2_2_1x_ How_Many_People_Get_Chronic_Myeloid_Leukemia.asp?rnav=cri. Last accessed October, 2007.

2. Faderl S; Talpaz M; Estrov Z; O'Brien S; Kurzrock R; Kantarjian HM. The biology of chronic myeloid leukemia. N Engl J Med. 341:164-72, 1999

3. Druker, B. et al. Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia. N Engl J Med 2006;355:2408- 17.

* Known as Gleevec® (imatinib mesylate) in the US, Canada and Israel.

Contact: Novartis Media Relations

John Gilardi Novartis Global Media Relations +41 61 324 3018 (direct) +41 79 596 1408 (mobile) Email Contact

Geoff Cook Novartis Oncology +1 862 778 2675 (direct) +1 973 652 7927 (mobile) Email Contact

Source: Novartis International AG

PRESS RELEASE: Novartis Corporation Voltaren Gel Receives US Regulatory Approval

Maureen Martino — Mon, 22 Oct 2007 10:48:54 -0400

Novartis Corporation Voltaren Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis

PARSIPPANY, N.J., Oct. 22 -- Voltaren(R) Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.

The US Food and Drug Administration (FDA) granted the approval to Novartis for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.

Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body's most commonly affected joints. It is the first prescription topical osteoarthritis treatment to have proven its effectiveness in both the knees and joints of the hands through clinical trials. Voltaren Gel delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment.

"Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favorable safety profile. The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offering patients an alternative to oral therapies," said Roy Altman, MD, Professor of Medicine in the Division of Rheumatology and Immunology at UCLA in Los Angeles and Past President of the Osteoarthritis Research Society International. "Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects."

The efficacy and safety of Voltaren Gel were studied in more than 900 patients with knee or hand osteoarthritis. The US approval was based on several studies, including the results of two randomized, double-blind, placebo-controlled efficacy studies and a 12-month safety study.

Voltaren Gel was shown to significantly reduce pain in hand and knee osteoarthritis, with pain relief sustained through the end of treatment. After six weeks of treatment in an efficacy study of patients with osteoarthritis of the hand, results showed that pain levels were reduced by nearly half (46%). In a 12-week study in patients with osteoarthritis of the knee, Voltaren Gel showed a 51% reduction in pain.

"Voltaren Gel represents an important clinical milestone - it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands," said Jorge Insuasty, MD, Senior Vice President, Research and Development, Novartis Consumer Health, Inc. "Patients now have the option to effectively treat osteoarthritis pain directly at the source with favorable tolerability."

Approximately 21 million people in the US have osteoarthritis,(1) and the aging population in the US means 72 million more will be at risk for developing the condition by 2030.(2) Osteoarthritis is a chronic, painful condition that often leads to working limitations and reduced overall health.(3)

About osteoarthritis

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints - such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint.(3) The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking.

Arthritis and related conditions, such as osteoarthritis, cost the US economy nearly $128 billion per year in medical care and indirect expenses, including lost wages and production.(4)

Despite the high prevalence of osteoarthritis, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in the affected patients.

About Voltaren Gel

Voltaren Gel provides 1% diclofenac sodium in a topical gel formulation. It is a non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel delivers highly effective pain relief with a favorable safety profile as its systemic absorption is 94% less than comparable oral diclofenac treatment.

Important safety information

The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

The use of Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac.

Voltaren Gel should not be administered to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Voltaren Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Voltaren Gel should not be used in combination with other oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.

Voltaren Gel joins other available Voltaren prescription medications in the US as well as the Novartis global portfolio of Voltaren Emulgel products. For full prescribing information, visit www.voltarengel.com or call 1-800-452- 0051.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "often leads to," "may be," "can be," or similar expressions, or by express or implied discussions regarding potential future revenues from Voltaren Gel. Such forward-looking statements reflect the current views of the Company 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 Voltaren Gel will achieve any particular levels of revenue in the future. In particular, management's expectations regarding commercialization of Voltaren Gel could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data, competition in general, increased government, industry and general public pricing pressures, unexpected regulatory actions or delays or government regulation generally, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. 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 is a world leader in offering medicines to protect health, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit our website at http://www.novartis.com.

PRESS RELEASE: Novartis delivers record earnings in first nine months of 2007

Maureen Martino — Thu, 18 Oct 2007 10:32:28 -0400

Novartis delivers record earnings in first nine months of 2007 thanks to strong operational performance and divestment gains

Strong operational performance for Group continuing operations:

Nine-month net sales up 13% to USD 28.1 billion (+9% local currencies) driven by all divisions, particularly Vaccines and Diagnostics and Sandoz
Operating income rises 9% to USD 6.5 billion, excluding a one-time incremental environmental provision of USD 590 million to cover worldwide remediation plans
14 positive US and EU regulatory decisions so far in 2007; launches underway for Tekturna/Rasilez, Exforge, Lucentis, Galvus, Exelon Patch, Aclasta/Reclast and Tasigna
To expand management experience and provide fresh impetus, Joe Jimenez becomes CEO of Pharmaceuticals and Thomas Ebeling named as CEO of Consumer Health
Group net income for first nine months doubles to USD 11.1 billion thanks to after-tax gains of USD 5.2 billion from Medical Nutrition and Gerber divestments
Novartis now focused solely on healthcare
Group on track for record operating and net income from continuing operations in 2007 (excluding environmental provision)
Elimination of 1,260 positions in US Pharma marketing and sales organization to adapt to new product portfolio, generating annual savings of USD 230 million

Basel, October 18, 2007 - Commenting on the results, Dr. Daniel Vasella, Chairman and CEO of Novartis said: "Following the successful divestments of the Medical Nutrition and Gerber businesses we are now strategically focused on healthcare products. Despite the anticipated weak quarter in Pharmaceuticals, we showed a strong operational performance driven by our other businesses. I am especially pleased that Vaccines and Diagnostics and Sandoz grew dynamically and improved profitability. This demonstrates that our focused diversification at least partially balances the risks recently seen in the pharmaceutical industry with heightened FDA demands and a more aggressive and risk-taking generics industry in the US. After losing several products to generics, Pharmaceuticals succeeded in launching many new medicines, including Lucentis, Exforge, Tekturna/Rasilez, Exelon Patch, Tasigna, Galvus and Aclasta/Reclast, creating the foundation for a new growth phase that will be visible starting in the second half of 2008. Our overall objective to bring new medicines to patients is reflected in the 14 positive US and European regulatory decisions already received in 2007. The announced changes at the divisional leadership level will not just broaden management experience but also bring fresh impetus and efficiency after a long and strong growth period."

Group
All divisions - particularly Vaccines and Diagnostics and Sandoz - supported the expansion in Group net sales from continuing operations. Higher net sales volumes represented seven percentage points of growth, while acquisitions provided two percentage points and currency translation four percentage points. Price changes had no impact.

Pharmaceuticals
Europe, Latin America and key emerging markets all delivered strong growth, with the Oncology and Neuroscience franchises growing at double-digit rates and many of the top 10 brands maintaining No.1 leadership positions in their therapeutic areas. Diovan (USD 3.7 billion, +17% lc) and Gleevec/Glivec (USD 2.2 billion, +14% lc) both generated good growth, while the new brands Tekturna/Rasilez, Exforge, Exjade, Lucentis, and Xolair expanded rapidly. US net sales fell 3% as growth from many brands were offset by the Zelnorm suspension in March as well as generic competition for Lotrel, Lamisil and Famvir.

Vaccines and Diagnostics
Strong deliveries of vaccines for seasonal influenza to the US as well as vaccines for tick-borne encephalitis and pediatric vaccine components drove growth. On a comparable basis, net sales rose 49% (including net sales from Chiron before April 2006 acquisition).

Sandoz
Dynamic performance thanks mainly to the US and supported by recent launches of difficult-to-make generics, strong growth of the base portfolio and the Lotrel authorized generic. Several other countries contributed to growth, benefiting from initiatives in emerging growth markets and Western Europe.

Consumer Health continuing operations
OTC and Animal Health each delivered double-digit gains thanks to a focus on strategic brands, new product launches and expansion in emerging markets and Japan. CIBA Vision net sales rose as contact lens deliveries were resumed in 2007 following recent product shortages.

Operating income - Nine months to Septermber 30

Group
Excluding the Corporate expense of USD 590 million to increase environmental provisions, operating income from continuing operations rose 9%.

Pharmaceuticals
Major investments in new product launches and late-stage clinical trials as well as lost US operating income from Lotrel, Zelnorm and Lamisil were among the factors leading to an only modest increase in operating income and a decline in the operating margin to 28.9 % of net sales. R&D investments were up 20% and represented 20.4% of net sales, up 1.9 percentage points from the 2006 period. Marketing & Sales expenses as a percentage of net sales rose 0.9 percentage points to support the new brands Exjade, Lucentis, Exforge, Tekturna/Rasilez and Aclasta/Reclast. Cost of Goods Sold was negatively impacted by an intangible asset impairment charge of USD 320 million following the start of US generic competition for Famvir. However, Other Income & Expense improved from one-time gains mainly related to the sale of equity investments and a launch provision reversal for Tekturna/Rasilez. Excluding exceptional items and the amortization of intangible assets in both periods, adjusted operating income rose 5% and the operating margin was 31.6%.

Vaccines and Diagnostics
The strong expansion, particularly in seasonal influenza vaccines, led to operating income of USD 179 million. Adjusting for legal settlement gains of USD 83 million as well as for restructuring charges and acquisition-related amortization of intangible assets resulted in adjusted operating income of USD 323 million.

Sandoz
Advancing sharply faster than net sales growth, operating income benefited from ongoing improvements in sales volumes thanks to new product launches and efficiency improvements throughout the division, with the operating margin rising to 15.2%. Excluding exceptional items and the amortization of intangible assets in both periods, adjusted operating income rose 19% and the adjusted operating margin was 20.8%.

Consumer Health continuing operations
On the back of a solid performance, significant investments were made throughout the division in R&D and marketing to support new product launches and geographic expansion.

Third quarter

Net sales

Group
Sandoz, Vaccines and Diagnostics and Consumer Health all delivered strong growth, helping to offset the decline in Pharmaceuticals in the US market. The expansion in Group net sales from continuing operations came from five percentage points of higher sales volumes, while acquisitions added one percentage point and currency translation had a positive impact of four percentage points. Net price changes led to a decline of one percentage point.

Pharmaceuticals
Strong growth in key regions - particularly in Europe, Latin America and emerging growth markets - was offset by the loss of Zelnorm, Lotrel, Lamisil and Famvir in the US, where net sales declined 17%. The leading brands Diovan (USD 1.3 billion, +14% lc), Gleevec/Glivec (USD 783 million, +14% lc), Sandostatin and Femara were supported by increasing contributions from new products including Tekturna/Rasilez, Exforge, Exjade, Lucentis, and Xolair, had combined net sales of about USD 300 million in the quarter.

Vaccines and Diagnostics
Seasonal influenza vaccine deliveries occurred earlier for the 2007/2008 flu season and were sharply higher for the current season than in the year-ago period. Diagnostics delivered growth from market share expansion in Europe and the West Nile Virus test.

Sandoz
Dynamic expansion driven by recently launched products in the US increasing at a fast pace. Key US contributors were authorized versions of Lotrel and ondansetron (Zofran®)[1] as well as generics of the difficult-to-make products metoprolol succinate ER (Toprol-XL®)[1] and cefdinir (Omnicef®)[1]. Other top regions were Eastern Europe, Asia and Latin America.

Consumer Health continuing operations
OTC and Animal Health both delivered robust growth, leading to the overall double-digit expansion. The start of the "cough and cold" season in the US underpinned OTC, while new product launches in Europe and recent entry in Japan further supported the performance. Animal Health benefited from the integration of Sankyo Lifetech.

Operating income - Third quarter

Group
Operating income from continuing operations rose 3% when excluding the USD 590 million one-time increase in Corporate environmental liability provisions.

Pharmaceuticals
Operating income was heavily impacted by the loss of contributions from Zelnorm, Lotrel and Lamisil in the US and the USD 320 million impairment charge for Famvir as well as investments in new launches and late-stage development compounds. Marketing & Sales investments rose 1.1 percentage points as a percentage of net sales over the 2006 quarter to support investments in Tekturna/Rasilez, Exforge and Aclasta/Reclast. R&D expenses were up 1.2 percentage points as a percentage of net sales for late-stage trials, including QAB149, FTY720, Galvus, AGO178 and MFF258. Other Income & Expense contributed 2.9 percentage points, thanks to USD 166 million in gains from the sale of Tanox shares and product divestments. Excluding exceptional items and the amortization of intangible assets in both periods, operating income fell 3% and the operating margin was 31.4%.

Vaccines and Diagnostics
Underlying operating income of USD 246 million reflected the dynamic increase in sales of seasonal influenza vaccines to the US and shipments occurring earlier than in 2006. Reported operating income includes USD 74 million in restructuring and acquisition-related amortization charges.

Sandoz
Excellent underlying improvement thanks to ongoing volume growth and new product launches. Operational improvements in manufacturing and efficiencies in Marketing & Sales further supported growth. Excluding exceptional items and amortization of intangible assets in both periods, operating income rose 28% and the adjusted operating margin was 19.2%.

Consumer Health continuing operations
Investments for several new product launches and expansion into emerging markets and Japan led to operating income growing at a slower rate than net sales.

Corporate

First nine months

Income from associated companies
In the third quarter, income from associated companies was USD 116 million, up 32% from USD 88 million in the year-ago period. The Roche investment contributed USD 113 million, representing an anticipated share of USD 144 million from Roche's 2007 third quarter net income, which was offset by USD 31 million for amortization of intangible assets. In the first nine months, income was USD 308 million compared to USD 193 million in the 2006 period, which included one-time charges for the Chiron acquisition.

Financial income, net
Net financial income in the third quarter was USD 43 million compared to a loss of USD 4 million in the 2006 third quarter, reflecting good currency management in challenging conditions and additional returns from increased liquidity due to divestitures. In the first nine months, net financial income was USD 110 million, more than double the income from the 2006 period.

Taxes
Group continuing operations for the first nine months of 2007 had a tax rate of 11.0%, down from 15.1% in the prior-year period due to factors that included reduced profits in the US, the environmental liability provision, a reduction of the German corporate tax rate from 37.5% to 28.5% and the deferred tax impact of legal restructurings for the Chiron acquisition. Many of these one-time factors occurred in the 2007 third quarter, leading to a tax rate of 2.3% for the period.

Net income from discontinued operations
Net income from discontinued operations was USD 5.4 billion, which reflects the pre-tax divestment gain of USD 5.8 billion (USD 5.2 billion after taxes) from the sale of Medical Nutrition and Gerber as well as net income before their divestment.

Balance sheet
The Group's equity rose to USD 49.5 billion at September 30, 2007, from USD 41.3 billion at December 31, 2006. The increase reflected nine-month net income of USD 11.1 billion, actuarial gains from employee benefit plans of USD 0.9 billion, share-based compensation of USD 0.4 billion and USD 1.4 billion in currency translation gains that more than offset the dividend payment of USD 2.6 billion and net share repurchases of USD 3.3 billion.

Thanks to the divestment proceeds, net liquidity rose to USD 7.3 billion from net debt of USD 0.7 billion at the end of 2006. The debt/equity ratio improved to 0.15:1 compared to 0.18:1 at the end of 2006. Utilizing these proceeds and the Group's strong free cash flow, Novartis plans to complete the repurchase of up to USD 4 billion of shares by the next Annual General Meeting in February 2008. Shares worth USD 3.0 billion were repurchased in the first nine months of 2007, including USD 2.2 billion during the third quarter, via a second trading line on the SWX Swiss Exchange.

Novartis is one of the few non-financial services companies worldwide to have attained the highest credit ratings from Standard & Poor's, Moody's and Fitch, the three benchmark rating agencies. S&P has rated Novartis as AAA for long-term maturities and as A1+ for short-term maturities. Moody's has rated the Group as Aaa and P1, respectively, while Fitch has rated Novartis as AAA for long-term maturities and as F1+ for short-term maturities.

Cash flow
For the first nine months, cash flow from continuing operating activities rose USD 0.3 billion to USD 6.2 billion. Net cash used in financing activities from continuing operating activities was USD 6.2 billion, mainly the result of the USD 2.6 billion dividend payment and USD 3.1 billion for the net purchase of treasury shares. For continuing operations in the first nine months, free cash flow after dividends was USD 1.7 billion, down from USD 2.4 billion in the 2006 period mainly due to the higher dividend and higher working capital requirements to support the business expansion.

Increase of provisions for worldwide environmental liabilities
Novartis has increased its provisions for worldwide environmental liabilities linked mostly to previously owned businesses by USD 590 million following a review completed in the 2007 third quarter. This increase in Corporate provisions includes the creation of a Swiss foundation with capital of CHF 200 million to finance the Novartis-related share of any potential remediation costs including landfills in the Basel region (including Switzerland, France and Germany). Assessments are expected to be completed shortly in coordination with various governments, which are responsible for the supervision and decision-making process for any remediation actions. This new foundation underscores the commitment of Novartis to sustainable and appropriate solutions.

Laying the foundation for future growth
The Pharmaceuticals division is proceeding with a reorganization of its Development organization, aiming to strengthen project focus, integrating decision making at the therapeutic franchise level and simplifying the development governance.

In a second initiative, Novartis Biologics is being established as a focused unit to accelerate and optimize the potential of research and development of innovative biologic medicines. This unit will unify and expand the expertise within Novartis by bringing together the key elements necessary for fast and high-quality R&D activities and to help attract top talent. Biologics comprise 25% of the pre-clinical research pipeline at Novartis and are increasingly a priority in R&D activities.

In the US, immediate actions are underway to strengthen and streamline the pharmaceuticals organization. These include a reduction of about 240 positions in headquarters functions, while the US sales force will be reduced by approximately 510 Novartis and 510 third-party representatives. The majority of these reductions will be accomplished by not filling vacant positions, while all reductions will be handled in a socially responsible manner. This initiative will lead to cost savings of approximately USD 230 million in 2008.

On a Group-wide level, the organization will be delayered and simplified; decision making will be decentralized wherever appropriate and shared functions centralized, such as in procurement and IT infrastructure. Over a period of two years, this will result in significant savings. These actions will enhance the Group's competitiveness and its ability to move rapidly to best meet the needs of patients and customers in a rapidly evolving environment.

Management changes
To expand experience at the top management level and to provide fresh impetus, Thomas Ebeling will now lead the Consumer Health Division and Joe Jimenez will lead the Pharmaceuticals Division. Thomas Ebeling, who has done an excellent job in managing Pharmaceuticals to high levels of performance, will now take over the challenge of developing the Consumer Health business into a world-class leader and a more significant part of the Group's broad healthcare portfolio. Joe Jimenez will, in turn, take over responsibility of transforming Pharmaceuticals as the business adapts to new market conditions. These changes are effective immediately.

Group outlook
(Continuing operations, excludes exceptional divestment gains and environmental provision increase. Barring any unforeseen events)

Novartis has made significant progress during 2007 to focus on its strategic healthcare portfolio as well as gain regulatory approvals and launch new medicines. Strong growth prospects for the Group's portfolio are expected to underpin a new growth phase starting to become visible in the second half of 2008 and positioning Novartis for further years of record results.

The Pharmaceuticals Division's net sales are negatively impacted during 2007 and the first half of 2008 by the suspension of Zelnorm as well as US generic competition for Lotrel, Lamisil, Famvir and Trileptal. Combined annual US net sales in 2006 for these products were approximately USD 3.1 billion. As a result, Novartis expects mid-single-digit growth in 2007 net sales for Group continuing operations and low-single-digit growth in the Pharmaceuticals Division, both in local currencies.

Novartis reaffirms expectations for record operating and net income from continuing operations in 2007 (excluding exceptional divestment gains and Corporate environmental provision increase).

Pharmaceuticals product performance and pipeline update
Novartis has a highly competitive industry position thanks to the ongoing dynamic growth of Diovan and Gleevec/Glivec as well as approvals for several new brands and one of the most respected pipelines with 139 projects in clinical development.

A total of 14 positive regulatory decisions have been achieved to date in 2007 in the US and Europe. These include US/EU approvals for Tekturna/Rasilez and Exforge (hypertension), Exelon Patch (Alzheimer's) and Aclasta/Reclast (osteoporosis). EU approvals were also received for Lucentis (age-related macular degeneration) and Tyzeka/Sebivo (hepatitis B).

During the third quarter, European regulators approved Galvus as a new oral therapy for patients with type 2 diabetes, while European approval is expected by the end of the year for Eucreas as a single-tablet combination of Galvus and metformin.

Following a positive opinion in September from European regulators, European Union approval is expected by the end of the year for Tasigna, a new therapy for chronic myeloid leukemia patients not responding to Gleevec/Glivec. Swiss approval was also granted this year. A decision on the US submission is expected by the end of 2007.

Several late-stage development compounds are on target toward regulatory submissions. These include FTY720 (multiple sclerosis), QAB149 (respiratory diseases), AGO178 (depression), RAD001 (cancer), ABF656 (hepatitis C) and SOM 230 (Cushing's disease).

Pharmaceuticals products
Note: All net sales growth figures refer to year-to-date worldwide performance in local currencies

Diovan (USD 3.7 billion, +17% lc) maintained its strong growth profile as the world's No. 1 branded high blood pressure medicine thanks to double-digit net sales growth in the US, Japan and Latin America. Diovan has achieved a 40% share of its market segment in the US among angiotensin receptor blockers (ARBs) and has been growing faster than the US anti-hypertensive market. Co-Diovan/Diovan HCT, a single-tablet combination with a diuretic, is now the No. 1 branded antihypertension combination therapy in the US and has benefited worldwide from increasing use of multiple therapies to help patients reach treatment goals.

Gleevec/Glivec (USD 2.2 billion, +14% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), expanded net sales based on improved survival rates for patients, expansion of the GIST market and use in rare diseases. Competition has also expanded the CML market, but it had little impact on underlying demand. During the third quarter, the FDA approved updated labeling that includes five years of data demonstrating an estimated overall survival rate of 89.4% in CML patients, confirming the generally well-tolerated safety profile in these patients.

Zometa (USD 954 million, -2% lc), an intravenous bisphosphonate therapy for patients with cancer that has spread to the bones, has been affected by overall slowing growth for this class of medicines due to patients receiving less frequent treatments and for a shorter course of therapy. However, use in patients with lung and prostate cancers continues to rise.

Sandostatin (USD 749 million, +8% lc), for patients with acromegaly and various tumors, has delivered consistent growth amid increasing use of the long-acting-release Sandostatin LAR version, which accounts for about 85% of the brand's worldwide net sales. New competition in acromegaly is expected to start in the US in the 2007 fourth quarter.

Neoral/Sandimmun (USD 700 million, -1% lc), for organ transplantation, has maintained stable worldwide net sales despite ongoing generic competition in the US thanks to its pharmacokinetic profile and reliability.

Femara (USD 679 million, +27% lc), an oral treatment for women with hormone-sensitive breast cancer, delivered ongoing dynamic growth primarily thanks to expanded use in the early adjuvant indication in the US and Europe as well as from the 2006 launch in Japan. Femara has been outpacing competitors and gaining market share in the aromatase inhibitor segment due to its unique clinical benefits. More than 50 countries have approved Femara for the early adjuvant treatment of women immediately following breast cancer surgery.

Lotrel (USD 660 million, -34% lc, only in US) has been negatively affected since May 2007 following the "at risk" launch of a generic copy by Teva Pharmaceuticals despite a valid US patent until 2017. Sandoz has launched an authorized generic version of this high blood pressure medicine. A trial date has not been set for the ongoing lawsuit against Teva, which risks potentially significant damages if Novartis prevails.

Trileptal (USD 594 million, +10% lc), a treatment for epilepsy seizures, has continued to generate growth but is now facing US generic competition.

Lamisil (USD 529 million, -31% lc), a treatment for fungal nail infections, was negatively impacted by the start of US generics in July. Generic competition also affected sales in Europe and Japan.

Exelon (USD 461 million, +14%), for mild to moderate forms of Alzheimer's disease and dementia associated with Parkinson's disease, maintained excellent growth. Exelon Patch was launched in the US and approved in Europe in the third quarter. The constant delivery of Exelon through the patch showed equivalent efficacy at the target dose to the highest doses of capsules but with three times fewer reports of nausea or vomiting.

Exjade (USD 255million, +167% lc) has delivered dynamic growth - particularly in Europe and the Middle East - since its first launch in 2005 based on its status as the first once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusion. Over 85 countries have approved Exjade, which is used to treat iron overload in patients with various blood disorders that require blood transfusion support. In June, it was submitted in Japan for approval a year ahead of schedule.

Lucentis (USD 223 million), for the eye disease "wet" age-related macular degeneration (AMD), was launched in the first European markets after approval in January and has experienced rapid growth, especially in Germany, France and Switzerland. Lucentis is the only treatment proven in clinical trials to maintain and improve vision in these patients, the leading cause of blindness in people over age 50. Genentech holds the US rights.

Xolair (USD 100 million), for moderate to severe allergic asthma, did particularly well in France, Spain and Greece. Novartis co-promotes Xolair with Genentech in the US and shares a portion of operating income. Xolair had nine-month US net sales of USD 352 million.

Zelnorm/Zelmac (USD 83 million, -80% lc), for irritable bowel syndrome and chronic constipation, continued to be negatively affected by the suspension of marketing and sales in March 2007 in the US while complying with the FDA's request to review cardiovascular safety data. It has also been suspended or withdrawn in several other countries. A treatment access program was started in the US to provide Zelnorm to appropriate patients. Novartis continues to believe that Zelnorm/Zelmac offers important benefits to appropriate patients, and discussions continue with health authorities.

Prexige (USD 81 million), an oral COX-2 inhibitor for osteoarthritic pain, is available in 30 countries. It was recently withdrawn in Australia and Canada, and suspended in Turkey, based on post-marketing reports of serious liver side effects associated with long-term use of high doses. In September, a 100 mg dose received a "not approvable" letter from the FDA despite it being one of the most studied COX-2 inhibitors with a favorable benefit/risk profile. Novartis believes Prexige continues to be a valuable therapy option for appropriate patients, particularly those at risk of serious gastrointestinal complications, and will continue discussions with the FDA and other health authorities.

Exforge (USD 52 million), a single tablet combining the angiotensin receptor blocker valsartan (Diovan) and the calcium channel blocker amlodipine, has outpaced the US and European launches of other high blood pressure combination medicines due to its unique combination that involves two of the most prescribed high blood pressure medicines.

Tekturna/Rasilez (USD 20 million), the first new type of high blood pressure medicine in more than a decade, has performed well in a competitive US marketplace following its approval and launch in March. European Union approval was received in August, and initial launches are underway. Known as Tekturna in the US and as Rasilez in other markets, key drivers have been broad clinical data showing its efficacy and safety, recognition of the need for new high blood pressure medicines and increasing US formulary reimbursement coverage. This medicine was discovered by Novartis and developed in collaboration with Speedel.

Aclasta/Reclast was launched in September in the US as a 15-minute, once-yearly infusion for women with postmenopausal osteoporosis. Approved in the EU in October, the initial launches were started in Germany and the UK. The New England Journal of Medicine published in September the results of the first-ever clinical study involving more than 2,100 men and women with osteoporosis who had suffered a hip fracture, showing that Aclasta/Reclast reduces the risk of further fractures and death in the studied population.

Research & Development update

Tasigna (nilotinib) received a positive opinion recommending European approval and Swiss approval in the third quarter as a therapy for patients with a certain form of chronic myeloid leukemia (CML) resistant or intolerant to treatment with Gleevec/Glivec (imatinib). A decision on the US submission is expected in 2007, while a submission for Japanese approval was completed this year. Phase III studies are underway in newly diagnosed CML patients and patients responding sub-optimally to other therapies. A registration study is also underway in gastrointestinal stromal tumors (GIST). Tasigna and Gleevec/Glivec inhibit Bcr-Abl, the cause of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Tasigna was designed to be a more selective inhibitor of Bcr-Abl and its mutations.

Galvus (vildagliptin), a new oral once-daily treatment for type 2 diabetes, received European Union approval in September, while a single-tablet combination with the oral anti-diabetes medicine metformin with the brand name Eucreas also received a positive regulatory opinion in September recommending European Union approval. In the US, Novartis is continuing discussions with the FDA on steps needed for approval after having received an "approvable letter" in February 2007 that included a request for additional data from clinical trials.

FTY720 (fingolimod) has completed enrollment in the pivotal Phase III trials for relapsing forms of multiple sclerosis (MS). These are the FREEDOMS trial, a two-year placebo-controlled trial measuring reductions in relapse frequency and disability progression in MS patients and the one-year TRANFORMS trial comparing FTY720 with interferon beta-1a (Avonex®). The extension of a Phase II trial has shown sustained clinical benefits, indicating FTY720 could provide an important new option for the estimated 2.5 million people worldwide with this disabling neurological disease. Submission is on track for 2009.

RAD001 (everolimus), a once-daily oral inhibitor of the mTOR pathway that has demonstrated broad clinical activity in multiple tumors, achieved an important milestone in the third quarter by completing enrollment in the metastatic renal cell carcinoma registration trial. Registration trials are also underway in chemotherapy-refractory pancreatic islet cell tumors (pICT) in the first- and second-line setting and for chemo-refractory carcinoid tumors. RAD001 acts by directly inhibiting tumor cell growth and metabolism as well as the formation of new blood vessels (angiogenesis). First submissions could be as early as 2008.

QAB149 (indacaterol), a once-daily long-acting beta-agonist with 24-hour bronchodilation and a fast onset of action, has completed enrollment in a pivotal Phase III monotherapy trial in chronic obstructive pulmonary disease (COPD). QAB149 is being developed with other respiratory medicines and development compounds for COPD and asthma.

ABF656 (Albuferon®) (albumin interferon alpha-2b) has completed enrollment and initial dosing ahead of schedule in ACHIEVE 1, the first of two pivotal Phase III trials for this long-acting interferon for use in combination with ribavirin in treatment-naïve patients with the liver disease chronic hepatitis C. Phase II results suggest it may offer efficacy at least comparable to peginterferon alfa-2a, with improved dosing convenience, comparable safety and possibly less impairment of quality of life. Novartis and Human Genome Sciences will co-promote Albuferon in the US, while Novartis will have exclusive rights in the rest of the world. The first regulatory submission is planned for 2009.

Disclaimer
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 "outlook", "expected", "will", "on track", "set", "intends", "prospects", "expectations", "anticipated", "potential", "may", "planned", "potentially", "believes", "pending", "promising", "pipeline", "approvable", "plans", "could", "can", or similar expressions, or by express or implied discussions regarding potential future revenues from any particular products, or potential future sales or earnings of the Novartis Group or any of its divisions or business units; potential new products, or potential new indications for existing products, or regarding potential future revenues from any such products; or by discussions of strategy, plans, expectations or intentions. Such statements reflect the current views of management with respect to future events and are subject to certain known and unknown risks, uncertainties, assumptions 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 any particular products will reach any particular sales levels. Neither can there be any guarantees that the Novartis Group, or any of its divisions or business units, will achieve any particular financial results. Nor can there be any guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for existing products in any market, or that they will achieve any particular revenue levels. In particular, management's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; the Group's ability to obtain or maintain patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; and other risks and factors referred to in the Novartis Group'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 described herein as 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

PRESS RELEASE: Thompson Scientific Publishes "Who Is Making The Biggest Splash"

Maureen Martino — Thu, 18 Oct 2007 10:00:41 -0400

Thompson Scientific Publishes "Who Is Making The Biggest Splash"

A QUARTERLY REVIEW OF SCIENTIFIC LITERATURE ON DRUGS AND THERAPIES FROM APRIL – JUNE 2007

Novartis Takes Top Spot, Previously Held by GlaxoSmithKline Since June 2006

Philadelphia, PA USA, London UK, October 16, 2007 -- Thomson Scientific, part of The Thomson Corporation and leading provider of information solutions to the worldwide research and business communities, today announced the availability of its most recent quarterly review of scientific literature on drugs and therapies. "Who is Making the Biggest Splash?" was created to provide an objective assessment of how this tremendous volume of research is being received within the clinical community and to give expert measured insight into organizations that helped to shape professional opinions. In this quarterly review, Thomson Scientific has assessed the quantity and quality of the materials published by pharmaceutical companies, research institutions and other non-commercial from April – June 2007 to identify which organization has made the biggest splash.

Novartis gained pole position in this quarter's analysis, knocking GlaxoSmithKline out of the top spot for the first time since June 2006. Researchers affiliated with the firm issued 82 articles, abstracts or scientific posters between April and June 2007, more than the 73 identified in the previous quarter. The company maintained its solid Thomson Source Score of 76. Three of the other organizations at the top of the list (AstraZeneca, GlaxoSmithKline, and Eli Lilly) this quarter also ranked in the top five last quarter.

"The international pharmaceutical industry is among the most active sponsors of scientific research, so it is understandable that our findings confirm that scientific articles affiliated with, or sponsored by, pharmaceutical companies provide a robust level of information for readers of scientific journals," said Larry Liberti, VP, General Manager, Thomson Pharmaceutical Services. "Our one-of-a-kind report finds that many pharmaceutical companies have good grounds for saying what they say – and judging by their source score, say it well."

Other key findings include:

GlaxoSmithKline drops to fourth, with 18 less sources than Novartis.
Big Pharma features prominently, representing all entries except for the two US National Institutes of Health.
There was a notable change from previous quarters where at least one discovery or biotechnology company was represented in the top ten.
No companies in the top 15 exceed a Thomson Source Score of 80%.
The top six entries are among the world's leading pharmaceutical companies.

Findings are based on information compiled from Thomson Pharma® and the Thomson Message Mapping SystemSM, which provides data to the pharmaceutical industry in real-time, evaluating specific drugs and therapies against competitors as new studies are being published, helping pharmaceutical companies to measure the overall impact of published scientific information.

For a full copy of the report with analysis, please visit: http://www.thomsonpharma.com/media/pdfs/tpqr/making-a-splash-apr2007.pdf

About The Thomson Corporation
The Thomson Corporation ( www.thomson.com) is a global leader in providing essential electronic workflow solutions to business and professional customers. With operational headquarters in Stamford, Conn., Thomson provides value-added information, software tools and applications to professionals in the fields of law, tax, accounting, financial services, scientific research and healthcare. The Corporation's common shares are listed on the New York and Toronto stock exchanges (NYSE: TOC; TSX: TOC).

Thomson Scientific is a business of The Thomson Corporation. Its information solutions assist professionals at every stage of research and development—from discovery to analysis to product development and distribution. Thomson Scientific information solutions can be found at scientific.thomson.com.