September 03, 2008
Rasilez® , first-in-class direct renin inhibitor, lowers high blood pressure more effectively than diuretic in obese patients
- Data presented at European Society of Cardiology congress confirm Rasilez is effective in difficult-to-treat patients with obesity, heart failure and diabetes[1],[2],[3]
- Data from ALOFT study shows Rasilez reduces marker of heart failure severity when added to optimal therapy in chronic heart failure patients with diabetes[2]
- Findings important as 70% of patients with high blood pressure are overweight or obese[4] and 23 million people worldwide have chronic heart failure[5]
- Heart and kidney protection potential of Rasilez independent of blood pressure lowering ability being further studied in ASPIRE HIGHER clinical program
September 03, 2008
Sandoz receives FDA approval for Omnitrope® Pen 10 with liquid cartridge
- New 10mg strength offers increased treatment flexibility and more convenient dosage form
- Comparable quality, safety and efficacy combined with significant cost savings
- Approval further demonstrates Sandoz leadership in high quality follow-on biologics
August 29, 2008
Novartis decides not to pursue further development of Aurograb(TM)
- Aurograb(TM) decision reached after Phase II results show lack of efficacy as an add -on therapy for life-threatening bacterial infections
- USD 235 million impairment charge to be taken in 2008 third quarter results
- Mycograb(TM) continues in Phase III trials for treatment of severe fungal infections
August 27, 2008
Glivec receives FDA priority review as first therapy to reduce recurrence of gastrointestinal stromal tumors after surgery
- Clinical data showing unprecedented 89% reduction in risk of GIST relapse with use of Glivec after surgery are basis for FDA, EMEA, Swissmedic filings
- Historically, one in two patients experienced recurrence of GIST after surgery
- Regulatory submissions reflect continued commitment to bringing new therapeutic approaches to patients with rare diseases
August 27, 2008
NICE final guidance recommends Lucentis® as cost-effective treatment for wet AMD, a leading cause of blindness
- Lucentis is only approved therapy to demonstrate improvement in vision and vision-related function in vast majority of wet AMD patients
- NICE decision secures access to innovative medication for eligible patients with wet AMD in England and Wales
August 07, 2008
Novartis begins shipment to US of Fluvirin® Influenza Virus Vaccine with three new strains for the 2008-2009 influenza season
- Delivery of Fluvirin supports planning and scheduling of public health influenza vaccination efforts
- At least 20 million doses available by the end of September, when widespread vaccination campaigns usually begin
- Additional manufacturing capacity recently approved by FDA for Fluvirin pre-filled syringes
August 04, 2008
Single-pill combinations Diovan HCT® and Exforge® approved in US as first-line treatments for high blood pressure
- Approvals consistent with current US treatment guidelines to start appropriate patients on combination therapies[1]
- Up to 80% of patients may need multiple medications to help them reach blood pressure goals[2]
- Single-pill combinations offer effective, convenient medications which could help patients reach treatment goals faster[3]
- High blood pressure is one of the most important but treatable risk factors for cardiovascular disease - the world's leading cause of death[4]
July 28, 2008
Exforge® helps nearly twice as many patients control their high blood pressure compared to amlodipine alone
- New data show that patients on Exforge with baseline blood pressure >=180 mmHg experienced significant reductions of up to 40 mmHg to help reach target levels[1]
- Significant blood pressure reductions seen with Exforge across difficult-to-treat groups such as the elderly, obese and people with diabetes[1]
- High blood pressure is a leading but treatable risk factor for cardiovascular disease - the world's leading cause of death[2]
July 25, 2008
Once-yearly Aclasta® recommended in EU to treat male osteoporosis and reduce risk of new fractures in patients after hip fracture
- Male indication important as osteoporosis often neglected in men - estimated one in five men aged over 50 may suffer an osteoporosis-related fracture[1]
- Positive opinion also expands once-yearly Aclasta indication to include osteoporosis patients who recently suffered a low-trauma hip fracture
- EU label to include data showing 35% reduction in new fractures and 28% reduction of all-cause mortality[2] in post-hip fracture patients treated with Aclasta
- Recommendation comes shortly after similar change to US label for Reclast[3][*]
July 17, 2008
Novartis gains momentum with strong performance in first half of 2008 from portfolio focused on growth areas of healthcare
- First-half results for continuing operations led by improving Pharmaceuticals performance ahead of expectations and expansion in Vaccines and Diagnostics
- Net sales rise 11% (+2% in local currencies) to USD 20.6 billion
- Operating income advances 12% to USD 4.9 billion on business expansion, productivity gains and currency benefits
- Net income up 13% to USD 4.6 billion; basic EPS rises 17% to USD 2.01
- Dynamic growth from new products - including Tekturna/Rasilez, Exforge, Lucentis, Exelon Patch and Aclasta/Reclast - provides USD 1.3 billion in first-half net sales
- Key R&D projects on track for 2008 submissions, particularly Afinitor (RAD001) for advanced kidney cancer and Menveo meningococcal meningitis vaccine
- 25% stake in Alcon, the world leader in eye care, purchased in July; strategic acquisitions strengthen portfolio and complement internal growth drivers
- Novartis on track for record sales and earnings in 2008 from continuing operations
