London UK & Philadelphia US - GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Benlysta™ (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.

'The BLISS-76 results confirm our view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,' said H. Thomas Watkins, President and Chief Executive Officer, HGS. 'We take great pride in the innovation and scientific rigour that has made it possible to bring Benlysta to this point. We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the United States, Europe and other regions. We will continue to work with GSK to advance this drug to the market where it may benefit patients with significant need.'

Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, 'The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in 50 years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients.'

The data from the BLISS-76 study were analysed after 52 weeks, in accordance with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorisation Applications in Europe and other regions. However, the BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialisation agreement entered into in August 2006.

Key Findings from BLISS-76
'We are delighted that the efficacy of treatment with belimumab plus standard of care was superior to placebo plus standard of care in both BLISS-52 and BLISS-76, with overall adverse event rates comparable to placebo plus standard of care,' said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. 'Belimumab met the primary endpoint in both pivotal Phase 3 trials, as specified by the Special Protocol Assessment Agreement with the FDA. We look forward to the full presentation of the BLISS-76 52-week results at an appropriate scientific meeting, hopefully in the first half of 2010.'

Topline BLISS-76 results include:

* Based on an intention-to-treat (ITT) analysis, belimumab 10 mg/kg met its primary efficacy endpoint of superiority versus placebo at Week 52. A statistically significant improvement was shown in patient response rate for belimumab 10 mg/kg plus standard of care, vs. placebo plus standard of care, as measured by the SLE Responder Index at Week 52: 43.2% for 10 mg/kg belimumab, 40.6% for 1 mg/kg belimumab, and 33.8% for placebo (p=0.021 and p=0.10 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo). The 1 mg/kg dose plus standard of care did not achieve a statistically significant improvement in the current study. The SLE Responder Index defines patient response as an improvement in SELENA SLEDAI score of 4 points or greater, with no clinically significant BILAG worsening and no clinically significant worsening in Physician's Global Assessment.
* Results for pre-specified major secondary efficacy endpoints were:
o The proportion of patients with a reduction in SELENA SLEDAI score of at least 4 points by Week 52, was 46.9% for belimumab 10 mg/kg, 42.8% for belimumab 1 mg/kg, and 35.6% for placebo (p=0.0062 and p=0.087 for belimumab 10 mg/kg and 1 mg/kg, respectively vs. placebo).
o Improvement from baseline in Physician's Global Assessment (PGA) at Week 24 was not statistically different between the belimumab and placebo treatment groups. Mean improvement in PGA at Week 52, a pre-specified although not a major secondary endpoint, was 0.49 for belimumab 10 mg/kg, 0.55 for belimumab 1 mg/kg, and 0.46 for placebo (p=0.12 for belimumab 10 mg/kg and p=0.022 for 1 mg/kg, respectively vs. placebo).
o At entry into the BLISS-76 study, approximately 46% of patients were receiving steroids at a prednisone-equivalent dose of at least 7.5 mg per day. Among these patients, the percentage of patients who had their average steroid dose reduced by at least 25% from baseline to 7.5 mg per day or less during the last 12 weeks of study was 16.7% for belimumab 10 mg/kg, 19.2% for belimumab 1 mg/kg, and 12.7% for placebo (not statistically significant vs. placebo).
o Improvement in health-related quality of life at Week 24 as measured by the SF-36 Physical Component Summary (PCS) score was not significantly different among treatment groups. Mean improvement in the SF-36 PCS score at Week 52, a pre-specified although not major secondary endpoint, was 3.41 for belimumab 10 mg/kg, 4.37 for belimumab 1 mg/kg, and 2.85 for placebo (p=0.51 for belimumab 10 mg/kg and p=0.012 for 1 mg/kg, respectively vs. placebo).
* In BLISS-76, belimumab was generally well tolerated, with rates of overall adverse events, serious and/or severe adverse events, all infections, serious and/or severe infections, and discontinuations due to adverse events comparable between treatment groups receiving belimumab plus standard of care and the treatment group receiving placebo plus standard of care. Serious and/or severe adverse events were reported in 26.8% of patients on belimumab and 24.0% of patients on placebo. Infections were reported in 72.1% of patients on belimumab and 67.3% of patients on placebo. Serious and/or severe infections were reported in 7.2% of patients on belimumab and 8.0% of patients on placebo. Serious and/or severe infusion reactions were reported in 1.1% of patients on belimumab and 0.7% of patients on placebo. Discontinuations due to adverse events were 7.2% in the belimumab treatment groups and 7.6% in the placebo treatment group. Malignancies were reported by 2, 3, and 1 subjects in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively. There were three deaths in the study, with 1, 2, and 0 reported in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively.

'The lupus community has waited for decades for one positive Phase 3 trial of an investigative drug developed for lupus. Now we have two. Based on the data we now have in hand, we have cause for hope that belimumab may emerge as a significant new treatment for lupus,' said Joan T. Merrill, M.D., a study investigator, Programme Chair, Clinical Pharmacology Research Programme, Oklahoma Medical Research Foundation, Oklahoma City, and Professor, Department of Medicine, University of Oklahoma Health Sciences Centre.

About the Benlysta (belimumab) Phase 3 Development Programme
The Phase 3 development programme for belimumab includes two double-blind, placebo-controlled, multi-centre Phase 3 superiority trials – BLISS-52 and BLISS-76 – to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in seropositive (HEp-2 ANA more than 1:80 and/or anti-dsDNA more than 30 IU/mL) patients with SLE. This is the largest clinical trial programme ever conducted in lupus patients. BLISS-52 randomised and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 randomised and treated 819 patients at 136 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different – 52 weeks for BLISS-52 and 76 weeks for BLISS-76. Data from BLISS-76 were analysed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorisation Applications in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.

The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52 as measured by the SLE Responder Index, which is defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which indicates a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.

In each of the two Phase 3 trials, patients were randomised to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290; BLISS-76, n=273), 1 mg/kg belimumab (BLISS-52, n=288; BLISS-76, n=271), or placebo (BLISS-52, n=287; BLISS-76, n=275). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All patients receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.

About Benlysta (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS®. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defence against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, suggest that belimumab can reduce SLE disease activity.

About the Collaboration with GSK
In August 2006, HGS and GSK entered into a definitive co-development and co-commercialisation agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.

Conference Call
HGS management will hold a conference call to discuss this announcement today at 8:15 AM Eastern. Investors may listen to the call by dialling 800-753-9057 or 913-312-0718, passcode 9331404, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialling 888-203-1112 or 719-457-0820, confirmation code 9331404. Today's conference call also will be webcast and can be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.

About GlaxoSmithKline
GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease. This innovative research is one way GSK – one of the world's leading research-based pharmaceutical and healthcare companies – can deliver on its commitment to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat lupus, hepatitis C, inhalation anthrax and cancer.

The Company's primary focus is rapid progress toward the commercialisation of its two lead drugs, Benlysta™ (belimumab) for lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. Benlysta has successfully met its primary endpoint in two pivotal Phase 3 trials in systemic lupus erythematosus, and the submission of marketing applications in the U.S., Europe and other regions is planned in the first half of 2010. ZALBIN has completed Phase 3 development, and the submission of global marketing applications is planned in fourth quarter 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.

For more information about HGS, please visit the Company's web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

HGS SafeHarbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of Human Genome Sciences' unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, Human Genome Sciences' ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, Human Genome Sciences' dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

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Conference attendees will receive a Passport to Health and Well Being sponsored by UnitedHealth Group, enabling them to embark on an interactive excursion promoting good health and safety with free health and well-being activities and information. Attendees can present their passports to collect stamps upon completing various activities, which in turn will qualify them to receive free prizes. Each passport will have a unique barcode which can be scanned at the Lifeclinic LC500 Health Station, allowing attendees to take various non-invasive biometric tests, and their results can be saved for later tracking and management online. Attendees will be able to securely share their data with their healthcare provider from the Lifeclinic Web site.

'Lifeclinic has a long and trusted relationship with Americans 50 years of age and older. Of the 1 million people who use our automated blood pressure machines and health stations daily, whether at their neighborhood pharmacy or place of employment, a large segment are in the 50-plus age group,' said Lifeclinic's Chief Marketing Officer, Steve Halperin. Halperin added, 'Lifeclinic is committed to serving this community of people, not only in providing them with free access to vital biometric data, but in empowering them to become proactive in the management of their own health and wellness. We want to encourage people to utilize our technology to make good health decisions.'

Featured at the UnitedHealth booth will be the LC500 -- a wellness program-friendly health station that offers automated blood pressure, weight, body fat, BMI and blood oxygen tests, along with glucose meter upload capability. Additional peripheral input ports include IR (infrared) and USB for interfacing with various personal health devices including pedometers. Users can easily navigate through the LC500's interface of test options and health information via a 10.4" color LCD touch screen.

The LC500 is Internet-ready for secure, HIPAA-compliant, open source integration into most network environments and can easily interface with existing wellness applications so that all data gathered by it can be saved. The LC500, along with Lifeclinic's Web-based GroupStat management system, can collect, track and manage real-time biometric data for individuals or in the aggregate to improve the overall outcome of corporate health programs. Users can also manage their own data from any Web browser via the Lifeclinic Web site. Optional features include both a magnetic stripe and barcode reader for store loyalty membership cards or employee identification badges.

About Lifeclinic International, Inc.

Lifeclinic is the world's largest supplier of commercial, automated, blood pressure monitors and health stations. Lifeclinic monitors can be found in over 30,000 pharmacies and 5,000 worksites, wellness centers, medical clinics and health clubs worldwide, performing 500 million blood pressure measurements annually. Lifeclinic monitors, health stations and management systems encourage individuals to take an active role in their healthcare and provide corporate management with tools to help reduce costs while improving the health of individual employees. Visit http://www.lifeclinic.com for more information.

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* First registration study using molecular response as key indicator of patient outcomes; Bcr-Abl biomarker test measures very low levels of residual disease[1],[2]

* Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells[3],[4]

* Complete results to be submitted for presentation at the American Society of Hematology (ASH) meeting in December

Basel - Novartis announced today that Tasigna® (nilotinib) met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Glivec® (imatinib).* Tasigna produced faster and deeper responses than Glivec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study[5],[6].

The Phase III clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients. Designed to detect a difference in major molecular response (MMR) between Tasigna and Glivec after 12 months of treatment, it is also the first registration study in which molecular traces of a key biomarker specific to Ph+ CML have been used as a primary endpoint for regulatory review. The comparison study also met its secondary endpoint, a difference in complete cytogenetic response (CCyR) in favor of Tasigna[5],[6].

"We developed Tasigna to be a potent and selective inhibitor of Bcr-Abl, with the goal of eliminating the underlying cause of Ph+ CML. We now know that Tasigna reduces the level of Bcr-Abl faster and to a lower level than Glivec, with profound implications for improving patients' outcomes," said David Epstein, President and CEO of Novartis Oncology and Novartis Molecular Diagnostics. "Molecular monitoring enables us to evaluate whether patients have achieved this deep level of CML residual disease, reducing the fundamental biomarker of leukemia to nearly undetectable levels."

The blood test used to determine molecular response can detect a single cell containing traces of Bcr-Abl in up to one million normal blood cells[7]. In addition to being simpler and less invasive for patients, the test has a much greater sensitivity than standard cytogenetic tests, which require a sample of bone marrow to be drawn for visual detection of cells containing the Ph chromosome[1]. Molecular monitoring measures the deepest level of CML residual disease[13].

In earlier clinical trials, molecular responses were found to be predictive of better patient outcomes: 100% of Ph+ CML patients who achieved MMR (defined as a thousand-fold or greater reduction in Bcr-Abl relative to standardized baseline level) in the first 12 months of treatment survived without disease progression for at least five years[8]. Follow up of patients in these studies is ongoing.

Details of the ENESTnd findings will be submitted as a late-breaking abstract to the 51st annual meeting of the American Society of Hematology (ASH), to take place in December, in New Orleans, Louisiana, USA.

Previous studies of Tasigna as first-line therapy for patients with newly diagnosed Ph+ CML include the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) study, an ongoing, open-label, single-stage, multicenter Phase II clinical trial; and NCT00129740, an ongoing, open-label, single-center Phase II clinical trial undertaken at M.D. Anderson Cancer Center in Houston, Texas, USA. New data from the GIMEMA study presented earlier this year at the European Hematology Association (EHA) congress show that at 12 months, 85% of patients taking Tasigna achieved MMR. These data indicate a more rapid reduction in disease burden compared to that seen in previous studies with Glivec[9].

Study details

ENESTnd is a Phase III randomized, open-label, multicenter study comparing the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase[5],[6].

ENESTnd is being conducted at 220 global sites, with 846 patients enrolled. Patients were randomized to receive Tasigna 400 mg twice daily (n = 281), Tasigna 300 mg twice daily (n = 282) or Glivec 400 mg daily (n = 283). The primary endpoint was MMR at 12 months; the secondary endpoint was complete cytogenetic response (CCyR) by 12 months. Planned follow-up is for five years[5],[6].

About Ph+ CML

CML is a disease in which the body produces cancerous white blood cells. Almost all patients with CML have an abnormality known as the Philadelphia chromosome, which produces a protein called Bcr-Abl. Bcr-Abl causes malignant white blood cells to proliferate[3]. Worldwide, CML is responsible for approximately 10 to 15% of all adult cases of leukemia[10], with an incidence of one to two cases per 100,000 people per year[11].

About Tasigna[4]

Tasigna has been approved in 73 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Glivec. The effectiveness of Tasigna for this indication is based on confirmed hematologic and unconfirmed cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Tasigna important 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.

The most frequent Grade 3 or 4 adverse events for Tasigna were primarily hematological in nature and included neutropenia and thrombocytopenia. Elevations seen in bilirubin, liver function tests, lipase enzymes and blood sugar, were mostly transient and resolved over time. These cases were easily managed and rarely led to discontinuation of treatment. 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 echocardiogram is recommended prior to initiating therapy with Tasigna and as clinically indicated.

About Glivec[12]

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 US, EU 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 the US and EU, Glivec is now approved for the post-surgery treatment of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors. 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 hematological and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response rates in systemic mastocytosis (SM), HES/CEL, on objective response rates and progression-free survival in unresectable and/or metastatic GIST, on recurrence free survival in adjuvant GIST and on objective response rates in DFSP. Increased survival in controlled trials has been demonstrated only in newly diagnosed chronic phase CML and GIST.

Not all indications are available in every country.

Glivec important 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 and fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well tolerated in all of 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 and 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 "to be submitted," "implications," "predictive," "will," "to take place," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Tasigna or regarding potential future revenues from Tasigna or Glivec. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Tasigna or Glivec 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 for any additional indications or labeling in any market. Nor can there be any guarantee that Tasigna or Glivec will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Tasigna and Glivec could be affected by, among other things, unexpected 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; 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; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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[1] NCCN Practice Guidelines in Oncology - v.1.2010. Chronic Myelogenous Leukemia.
[2] Sessions J. Chronic Myeloid Leukemia in 2007. http://www.amcp.org/data/jmcp/pages%204-7.pdf. Accessed September 2009.
[3] National Cancer Institute. General Information About Chronic Myelogenous Leukemia (PDQ). http://www.cancer.gov/cancertopics/pdq/treatment/CML/patient/. Accessed March 2009.
[4] Tasigna (nilotinib) European Summary of Characteristics. Novartis AG. http://www.tasigna.com/en/tasigna-product-information.jsp#.
[5] Novartis data on file
[6] A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP). http://clinicaltrials.gov/ct2/show?term=ENEST&rank=3. Accessed October 2009.
[7] Kurzrock R, Talpaz M. The molecular pathology of chronic myelogenous leukaemia. Br J Haematol. 1991 Oct; 79 Suppl 1:34-7.
[8] Druker BJ, Guilhot F, O'Brien SG, et al. Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia. N Engl J Med. 2006; 355(23):2408-2517.
[9] Rosti, G et al. Nilotinib for the Frontline Treatment of Ph+ Chronic Myeloid Leukemia. Blood. Published online October 12, 2009. http://bloodjournal.hematologylibrary.org/cgi/content/abstract/blood-2009-07-232595v1
[10] American Cancer Society. Detailed Guide: CML. What are the key statistics about CML? (Sept 2008 revision) Available at: http://www.cancer.org/docroot/CRI/content/
CRI_2_4_1x_What_Are_the_Key_Statistics_About_Chronic_Myeloid_Leukemia_CML.asp?rnav=cri. Accessed April 2009.
[11] Central European Leukemia Study Group. About CML. [Cited 2009 Jan 13] Available from: http://www.cml-info.com/de/healthcare-professionals/about-cml.html.
[12] Glivec® (imatinib) prescribing information. Basel, Switzerland: Novartis International AG; March 2009.
[13] Jabbour E, Cortes J, Kantarjian H, et al. Molecular Monitoring in Chronic Myeloid Leukemia Response to Tyrosine Kinase Inhibitors and Prognostic Implications. Cancer. DOI10.1002/cncr.23427. Published online 17 March 2008.

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

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BLUE BELL, Pa. – Only 22 percent of Americans fully trust government agencies to keep personal information secure and private, and the proportion is only slightly better (29 percent) with regard to trust in data protection by financial institutions such as banks, according to research conducted in September by Unisys Corporation (NYSE: UIS).

The findings, part of the latest bi-annual Unisys Security Index, also confirm that most Americans surveyed remain seriously concerned about the security and privacy of their personal information. Nearly two-thirds of Americans are either 'extremely' or 'very" concerned about identity theft and credit and debit card fraud (65% and 64%, respectively).

Americans who are seriously concerned about the security of their online transactions rose to 42 percent, the highest level since the Unisys Security Index began two years ago.

'Government and business organizations recognize the need to protect the private data citizens entrust to them and to protect themselves from fraud through strong identity management solutions,' said Anthony Valletta, former assistant Secretary of Defense for C31 and a Fellow at the Unisys Center for Innovation in Government. 'These risks have been highlighted through a number of incidents in recent months in which private data was put at risk. For example, a recent report by the Government Accountability Office stated that the IRS recorded more than 51,000 cases of apparent taxpayer identity theft and paid out $15 million in fraudulent tax refund claims. This new research from Unisys underlines the need and the public's readiness for technology such as biometrics to address their concerns.'

As concerns grow over data security and identity theft, the majority of Americans (58%) are willing to provide biometric data to merchants and financial institutions to verify and authenticate their identity. Nearly all of those consumers (93%) would be willing to use fingerprint scans, while 79 percent are willing to use iris recognition – an increase of 20 percent and 17 percent, respectively, since consumers were surveyed in November 2008.

'Interestingly, Americans are willing to provide biometric data for identity verification, but we are not seeing the widespread use of biometrics in daily transactions with governments, financial or retail institutions,' said Mark Cohn, vice president of enterprise security, Unisys. 'Adoption of interoperable identity management systems and an investment in shared infrastructure would hasten widespread use of biometrics, taking advantage of the technology that's available today and the public's growing acceptance of biometrics.'

Overall Results of Latest Wave of Security Index

The Unisys Security Index surveys consumer opinion on four areas of security: financial, national, Internet and personal safety. More than 1,000 Americans responded to the latest survey conducted from September 11-13, 2009. The results are tallied on a scale of 0-300, with 300 representing the highest level of perceived concern.

The overall score for the current Unisys Security Index for the United States was 147, indicating a moderate level of overall security concern. The overall score came in unchanged from the last survey taken in March 2009.

The generally moderate concern expressed by consumers appears to reflect a dichotomy between the public perception of these threats and the actual rise of incidents in recent years. For example, Javelin Research and Strategy reported in February 2009 that approximately 1.8 million more U.S. adults fell victim to identity fraud in 2008, compared to 2007. And a May 2009 survey by Actimize found that approximately 81% of financial services organizations expect an increase this year in ATM/debit card fraud.

'As financial institutions move to near real time transactions, the existing vulnerabilities are being exploited at an alarming rate,' said Patricia Titus, chief information security officer, Unisys Federal Systems. 'Not only are the criminals becoming more sophisticated in how they launch attacks, but the unsuspecting consumers become the weakest link – allowing easy exploitation of their private financial data.'

Financial security was the predominant concern of those surveyed in March 2009, but those worries were displaced in last month's survey by an increase in national security concerns, as well as fears surrounding national health epidemics such as the H1N1 flu outbreak.

In September, 64% of Americans (up from 58% in March) expressed serious concern about national security threats such as the war on terrorism. In addition, nearly 47% of those surveyed (up from 41% in March) are seriously concerned about the threat of a health epidemic.

'American consumers are not as concerned with financial security as they were months ago and are now more focused on national security,' said Cohn. 'As consumers perceive that the economic crisis has leveled off, companies and governments may need to reprioritize accordingly to elevate risk management strategies that address longstanding but shifting concern about war and terrorism as well as growing concern about public health.'

Additional findings from the latest U.S. results of the Unisys Security Index include:

* Americans are divided with regard to concern about computer security; 40 percent are seriously concerned about this issue, while 25 percent are not concerned at all.
* While most Americans feel comfortable about their personal safety, one-third (32%) are seriously concerned about this threat, which is an increase of five percent since 1H09.
* Households earning more than $75,000 in annual income are more willing to provide biometric data than are adults with smaller household incomes.

About the Unisys Security Index

The Unisys Security Index is a bi-annual global study that provides insights into the attitudes of consumers on a wide range of security related issues. Lieberman Research Group conducted the survey in Brazil, Europe and the U.S.; Newspoll conducted the research in Asia-Pacific. The Unisys Security Index surveys more than 8,500 people in nine countries: Australia, Belgium, Brazil, Germany, the Netherlands, New Zealand, Spain, the United Kingdom and the United States. The study measures consumer perceptions on a scale of zero to 300, with 300 representing the highest level of perceived concern. For more information, visit www.unisyssecurityindex.com.

About Unisys

Unisys is a worldwide information technology company. We provide a portfolio of IT services, software, and technology that solves critical problems for clients. We specialize in helping clients secure their operations, increase the efficiency and utilization of their data centers, enhance support to their end users and constituents, and modernize their enterprise applications. To provide these services and solutions, we bring together offerings and capabilities in outsourcing services, systems integration and consulting services, infrastructure services, maintenance services, and high-end server technology. With more than 26,000 employees, Unisys serves commercial organizations and government agencies throughout the world. For more information, visit www.unisys.com.

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Two-year data from the LITHE study, being presented at the American College of Rheumatology, show that, with long-term use, patients with rheumatoid arthritis treated with ACTEMRA (tocilizumab, known as RoACTEMRA within the EU) plus methotrexate (MTX) suffered 81% less damage to their joints compared to those treated with MTX, the current standard therapy, alone1. For patients, this means that their joint damage is significantly reduced, and that they can therefore continue to enjoy their lives without the evolving disability usually associated with the disease.

Furthermore, data from two long-term extension studies2 also being presented at the meeting demonstrate that the percentage of ACTEMRA patients achieving remission from their disease (DAS28 less than 2.6) increased steadily over a 3-year period, from 27% at 24 weeks to 62% at 180 weeks (3.4 years).

The unprecedented remission rates seen with ACTEMRA were primarily the result of the profound effect on swollen and tender joints across a range of patient populations:

* Patients with no previous biologic therapy: After 96 weeks (1.8 years) of treatment with ACTEMRA, close to 50% of the patients had one or less swollen joint
* Patients with inadequate response to one or more tumour necrosis factor (TNF) inhibitors: Among those patients 34% had one or less swollen joint after treatment with ACTEMRA
* Patients who were MTX-naive and were treated with ACTEMRA as monotherapy: 55% had one or less swollen joint and 35% had one or less tender joints after 96 weeks.

"These data confirm that tocilizumab is very effective at inhibiting the damage to joints which is characteristic of rheumatoid arthritis,' says Professor Josef Smolen, University of Vienna, Austria. 'This impressive effect on joints, coupled with the previously shown ability of tocilizumab to provide relief from the signs and symptoms of RA gives it an important role within clinical practice. Successful remission with tocilizumab may help to restore a patient's sense of freedom, without painful flare-ups or fear of long-term disability."

The long-term safety profile of ACTEMRA is well characterised in 2.4 year data3, being presented at the ACR, from the most comprehensive registration trial programme for any RA biologic, with almost 4,000 patients participating in the programme. Analysis from the Phase III programme (including five pivotal trials and two long-term extension studies) show that adverse events and severe adverse events remained stable over extended periods of time.

About the studies
About the LITHE study

The LITHE study, a randomised, double-blind, placebo-controlled trial was designed to evaluate the efficacy of TCZ plus MTX in preventing structural joint damage and improving physical function over two years. LITHE was an international study, including 15 countries and 1196 patients with moderate to severe RA who had an inadequate response to MTX. In this randomised study, patients received either ACTEMRA (4 mg/kg or 8 mg/kg, one infusion every four weeks) in combination with MTX or MTX alone. Results from the 24-month analysis showed that at 104 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8mg + MTX, 4mg +MTX, and MTX alone groups were: 0.37, 0.58 and 1.96 respectively.
About the long-term extension studies

Patients participating in the most comprehensive trial programme for any biologic in RA including four pivotal studies (OPTION, TOWARD, RADIATE, AMBITION), were entered into two long-term extension studies (GROWTH95, GROWTH96), which examined safety and efficacy of ACTEMRA across a number of different patient populations: DMARD insufficient response (IR), anti-TNF-IR and monotherapy. Over 3,986 patients were included in the 2.4 year safety, and 3.5 year efficacy analyses. Long-term extension studies have shown low discontinuation rates due to side-effects (5.8/100 patient years).
About ACTEMRA

ACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. ACTEMRA is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of ACTEMRA, all of which met their primary endpoints. ACTEMRA was first approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. ACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or TNF inhibitors. It is also approved for use in several other countries, including India, Brazil, Switzerland and Australia.

The overall safety profile of ACTEMRA is consistent across all global clinical studies. The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries or any observed impact on liver function. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.
About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80'000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References:
1. LITHE: Tocilizumab inhibits radiographic progression and improves physical function in rheumatoid arthritis (RA) patients (Pts) at 2 years with increasing clinical efficacy over time. Fleischmann, R et al. Oral presentation at ACR, 18th October 2009
2. Long-term efficacy of tocilizumab in rheumatoid arthritis for up to 3.5 years. Smolen J et al. Oral presentation at ACR, 18th October 2009
3. Long-term safety and tolerability of tocilizumab treatment in patients with rheumatoid arthritis and a mean treatment duration of 2.4 years. Van Vollenhoven, R et al. Poster presentation at ACR, 20th October 2009

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HealthierCompany's Senior Director of US Operations, Holly Iftner said, "Being recognized in this manner by the Country of Malaysia is a testament to our global commitment to positively impacting employee and individual health through Health Risk Appraisal". Iftner, based in Atlanta, GA, leads the US Company, HealthierCompany LLC, owned by Genseq Ltd.

"Our team is proud to have our Health Risk Appraisal recognized as the Best of E Health by APICTA" said Dr. Waqas Awan, Senior Scientist of Genseq Sdn Bhd and HealthierCompany. "We pride ourselves on remaining on the forefront of bioinformatics and health technology and receiving this award is a tribute to that." The presentation, led by Dr. Awan, included HealthDrive, the company's Health Risk Appraisal and HealthDrive Portable, a product that is currently under development. HealthDrive Portable is a secure, convenient method for individuals to store, update and share their medical history with their Physician and is estimated for release in the first quarter of 2010.

Genseq, Ltd. specializes in Health Risk Appraisal (HRA), the science of predicting health risks and diseases from an individual's family health history, medical history, diet, lifestyle, metabolism and other environmental factors. The company offers its online HRA service to corporations worldwide via the website, www.healthiercompany.com

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