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Novartis NVA237 Phase III data showed rapid, sustained improvement in lung function and symptom relief over one year in COPD patients
GLOW2 study showed NVA237 superior to placebo and similar to open-label tiotropium in increasing lung function, improving COPD symptoms and reducing exacerbations , , Results demonstrated that once-daily NVA237 had rapid onset of action at first dose, sustained 24-hour bronchodilation, and was well tolerated over 52 weeks NVA237 submitted for EU approval under proposed brand name Seebri Breezhaler ; expect US fi

New data among 200 Lucentis abstracts at ARVO show low number of injections with Novartis drug required to achieve and maintain vision gains over 3 years in AMD and DME patients
Data from key studies highlight the value of individualized therapy and reinforce Lucentis (ranibizumab) well-characterized long-term efficacy and safety profile RESTORE extension study in DME patients shows mean of 3.7 and 2.7 Lucentis injections required in years two and three, respectively, to maintain vision gains from core study Swiss retrospective study shows mean 8 letter VA gain sustained in wet AMD patients using individual

Novartis drug pasireotide LAR shows superior efficacy
Patients on pasireotide (SOM230) LAR were 63% more likely to achieve full biochemical control than those on Sandostatin LAR, the current standard of care Acromegaly, a rare endocrine disorder c

Sandoz to acquire Fougera Pharmaceuticals, becoming the number one generic dermatology medicines company globally and in the US
Acquisition of Fougera makes Sandoz, the generics division of Novartis, the number one generic dermatology medicines company globally and in the US, strengthening Sandoz's differentiated products st

Novartis drug Afinitor approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
Kidney tumors affect up to 80% of patients with tuberous sclerosis complex (TSC) and growing tumors may lead to unpredictable life-threatening complications Prior to the approval of Afinitor,

Novartis drug Signifor approved in the EU as the first medication to treat patients with Cushing’s disease
Signifor is first targeted approach for Cushing's disease, a debilitating endocrine disorder caused by an underlying pituitary tumor that triggers excess cortisol , , Majority of patients in

Pharmaceuticals and Alcon performed strongly in the first quarter; overall Group results impacted by expected challenges
Sandoz faced a strong year-ago base with enoxaparin exclusivity and Consumer Health impacted by the suspension of production at the Lincoln, Nebraska manufacturing site Core operating income of US

Novartis drug Jakavi(TM) recommended by CHMP for EU approval to treat patients with the life-threatening blood cancer myelofibrosis
Upon approval, Jakavi(TM) (INC424, ruxolitinib) will be the first EU approved JAK inhibitor developed to treat patients with myelofibrosis, a rare blood cancer Patients with myelofibrosis expe

Novartis updates US label on Gilenya following discussions with the FDA
Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States Prescribing information includes patien

Novartis confirms positive benefit-risk profile of Gilenya following CHMP review and label update recommendation
Revised label agreed between Novartis and the CHMP provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the EU Patients should have ECG before and six hours after the first-dose, with hourly b lood pressure and heart rate measures; Continuous ECG recommended Caution regarding use in patients who may be less tolerant of or are more likely to develop significantly slowed or

Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated
Combination product Valturna to be voluntarily withdrawn from the US market as of July 20, 2012 Basel, Switzerland April 19, 2012 - Novartis announced today that the Tekturna labels have

New extension study data with Novartis drug Gilenya shows patients successfully treated for up to 7 years in relapsing MS
Results from open label phase III extension and 7-year phase II extension studies show sustained low disease activity on clinical and MRI measures in patients continuing on Gilenya (fingolimod) treatment Extension study results demonstrate a safety profile for Gilenya consistent with pivotal trials Data from FIRST study in more than 2,400 patients show overall low incidence of first dose bradycardia and conduction abnormalities

Novartis QVA149 Phase III COPD studies meet primary endpoints
QVA149, a bronchodilator with dual mode of action, is Novartis' third innovation in its Breezhaler Single Dose Dry Powder Inhaler COPD is predicted to be the third leading cause of dea

Novartis launches the Cancer Cell Line Encyclopedia (CCLE) to catalogue world’s cancer cell lines
Collaboration with the Broad Institute yields comprehensive encyclopedia of genetic and molecular information for nearly 1,000 cancer cell lines Basel, March 28, 2012 - Novartis and the Broad Institute have developed a cancer cell line encyclopedia that catalogues the genetic and molecular profiles of almost 1,000 human cancer cell lines used in drug research and development.

Study in JAMA reports significant survival benefit in certain GIST patients taking Novartis drug Glivec for three years after surgery
First large Phase III study to demonstrate significant survival benefits of extending treatment with Glivec for three years compare d to one year following surgery Important finding for treatment of KIT+ GIST patients who are at risk of recurrence following complete resection of primary tumor Basel, March 27, 2012 - The Journal of the American Medical Association (JAMA) today published a Phase III study that showed significant s

Alcon gains exclusive ex-US rights for ocriplasmin, potential first pharmacological treatment for symptomatic vitreomacular adhesion
Symptomatic vitreomacular adhesion (VMA) is a progressive, debilitating eye disease, there is currently no pharmacological treatment available Phase III clinical data demonstrat

Data in NEJM shows Novartis drug Signifor is first therapy to provide rapid, durable benefit for Cushing’s disease patients in Phase III study
Study met primary endpoint showing Signifor (pasireotide) normalized cortisol overproduction , a critical factor in controlling the debilitating endocrine disorder , , Cortisol levels decreased quickly in the majority of patients and levels were normalized in 26.3% of patients treated with pasireotide 900µg twice daily Results showed pasireotide improved key clinical manifestations of the disease, including reductions in bl

Brian McNamara Named Division Head, Novartis OTC
Brian McNamara, who has held several key positions in the Novartis OTC business over the past 7 years, succeeds Naomi Kelman Basel, February 29, 2012 - Novartis named Brian McNamara to the position of Division Head of Novartis OTC (Over-the-Counter), effective immediately.

Two Phase III studies of Novartis drug INC424 published in NEJM show significant clinical benefit for patients with myelofibrosis
Results of the COMFORT-I and COMFORT-II trials show INC424 significantly reduced disease burden in patients with myelofibrosis Myelofibrosis is a life-threatening blood cancer associated with progressive, debilitating symptoms that severely impact quality of life and reduce survival These data provided the basis for worldwide regulatory filings with first actions expected in the second half of 2012 Basel, February 29, 2012 - Th

European Commission approves new label for Novartis drug Glivec
Approval based on Phase III study showing significant recurrence-free and overall survival after three years of adjuvant Glivec in adults with KIT+ GIST Adults with KIT+ GIST are at risk of recurrence following surgical removal of the primary tumor; extended treatment may delay onset of recurrence Basel, February 27, 2012 - Novartis announced today that the European Commission (EC) has approved an update to the Glivec (imatinib

Novartis to revise product information in the European Union for high blood pressure drug Rasilez following assessment by CHMP
CHMP concluded the risk-benefit review of Rasilez* (aliskiren) and confirmed it remains positive for the treatment of essential hypertension CHMP has requested that the Rasilez (aliskiren

FDA requests additional data on Novartis
Basel, February 13, 2012 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) on its application for the expanded use of Menveo (Meningo

Pivotal study published in JAMA confirms potential of Novartis candidate vaccine Bexsero to help protect infants against devastating meningococcal serogroup B disease
Data previously presented at ESPID annual meeting add to the body of evidence showing that Bexsero can help protect all vulnerable age groups Study including more than 1,800 infants showed Bexsero induces robust immune response when given alone or with other routine vaccines in different vaccination schedules Current vaccines do not broadly protect against MenB which is easily misdiagnosed and can kill within 24 hours;

FDA approves Novartis drug Glivec label recommending extending treatment to three years for certain GIST patients after surgery
Phase III results showed 54% reduction in risk of recurrence and 55% reduction in risk of death after three years' adjuvant Glivec in adults with KIT+ GIST Approval builds on vast experience with Glivec, first approved 10 years ago for treatment of adults with metastatic and/or unresectable KIT+ GIST Basel, February 1, 2012 - Novartis announced today that following a priority review, the US Food and Drug Administration (FDA)

Novartis extends commitment to help achieve final elimination of leprosy
New five-year commitment includes donation of treatments worth an estimated USD 22.5 million and is expected to reach an estimated 850,000 patients Novartis will also intensify efforts to buil

Novartis delivers strong underlying financial performance in 2011, expects 2012 sales to be in line with 2011
Fourth quarter sales rose 5% while core operating income grew 17% in constant currencies (cc); full year sales up 12% cc and core operating income up 16% cc Core operating income grew 12% (

CHMP recommends EU approval to update Novartis drug Glivec label to include three year treatment for GIST patients after surgery
Opinion based on Phase III study showing 66% recurrence-free and 92% overall survival at five years after three years' adjuvant Glivec in adults with KIT+ GIST Glivec has helped transform treatment and outcomes in patients with KIT+ GIST since its first approval in the metastatic setting almost 10 years ago Basel, January 20, 2012 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the

Novartis drug Signifor recommended by CHMP for EU approval to treat patients with Cushing’s disease
If approved, Signifor (SOM230, pasireotide) would be the first approved medication targeting Cushing's disease In clinical trials, pasireotide suppresses overproduction of cortisol caused by a

Sandoz initiates two more Phase III biosimilar trials, reinforcing long-term global leadership commitment
Phase III clinical study for filgrastim biosimilar (Neupogen ) is expected to support expansion to the US market Phase III study for Sandoz pegfilgrastim (Neulasta ) represents next ma

Novartis receives approval for Lucentis and launches Galvus in China
Lucentis (ranibizumab) approved in China to treat wet age-related macular degeneration, a major cause of blindness and severe vision loss in people over 50 Oral type 2 diabetes treatment Galvu

Novartis to restructure US business
Novartis to restructure US business to strengthen competitive position in light of loss of Diovan patent and announces charge for Rasilez /Tekturna.

Novartis recalls certain over-the-counter products in the US
The recall is precautionary following consumer complaints of chipped and broken pills and inconsistent bottle packaging line clearance practices possibly resulting in mixed tablets There hav

Novartis announces termination of ALTITUDE study with Rasilez / Tekturna in high-risk patients with diabetes and renal impairment
ALTITUDE study involved patients with type 2 diabetes and renal impairment who are at high risk of cardiovascular and renal events Committee overseeing study identified higher adverse events w

Novartis drug Gilenya showed positive clinical outcomes
Once-daily oral MS medicine showed a 48% relative reduction in annualized relapse rate, meeting primary endpoint in Phase III placebo-controlled study Significant reduction in brain volume loss demonstrated, reinforcing strong efficacy benefit in key secondary endpoint Basel, December 15, 2011 - Novartis announced today new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS) treated with Gilenya (fingolimod) had a statistically significant 48% reduction in annualized relapse rates (ARR) at 24 months compared to placebo.

Novartis pivotal study of Exjade shows significant reduction of iron overload in patients with non-transfusion-dependent thalassemia
Trial shows Exjade, an iron chelator, is significantly better than placebo at reducing liver iron concentration in patients with NTDT Non-transfusion-dependent thalassemia (NTDT) is a genetic blood disorder in which patients may accumulate excess iron in the body Data will serve as basis for first regulatory filings in US and Europe by year end Basel, December 13, 2011 - Results from THALASSA, the first pivotal

New Phase III data shows Novartis JAK inhibitor INC424 significantly reduced disease burden in patients with myelofibrosis
COMFORT-II data showed INC424 provided clinically relevant and statistically significant improvements in symptoms at all evaluations vs.

Two Novartis Phase III studies show twice as many Ph+ CML patients achieve deeper levels of response with Tasigna compared to Glivec
ENESTcmr data show 23% of patients switched to Tasigna achieved undetectable levels of Bcr-Abl within 12 months compared to 11% who continued on Glivec Three-year ENESTnd data show 32% of newly diagnosed patients on Tasigna reached deepest levels of molecular response measured versus 15% on Glivec ENESTnd study also shows significantly fewer patients progressed to advanced stages of CML with Tasigna after three years,

New data confirms Novartis drug Afinitor significantly extends time women with advanced breast cancer live without tumor growth
Longer-term BOLERO-2 data reveal treatment with everolimus combined with hormonal therapy improved time to disease progression to 7.4 versus 3.2 months with hormonal therapy alone These results presented at SABCS provide further evidence that everolimus may represent a major advance for women with ER+HER2- breast cancer Published in NEJM today are previously-reported positive results of BOLERO-2, which serve as the basis for first

Novartis highlights advances for patients with breast cancer and hematological diseases with over 160 SABCS and ASH abstracts
Tasigna Phase III trials in Ph+ CML including 36-month follow-up data in newly diagnosed patients Exjade pivotal study results investigating iron chelation in patients with non-transfusi

Novartis gains European Commission approval for Rasitrio , a Rasilez-based triple combination pill to treat high blood pressure
Pivotal phase III data showed significantly greater blood pressure reductions with Rasitrio compared to dual combinations of each of its individual components Up to 85 percent of patients may