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
July 11, 2008
Novartis enters strategic partnership with Lonza to accelerate growth of biologics pipeline
- Alliance enables Novartis to rapidly scale up development and production for rich biological pipeline, which accounts for a quarter of its development portfolio
- Strong Novartis R&D capabilities coupled with Lonza's leadership in process development and manufacturing, provides ideal long-term partnership
July 10, 2008
Novartis buys additional 51.7% stake in Speedel and announces plans to acquire remaining shares in a mandatory public tender offer
- Novartis and Speedel have a long-standing collaboration based on financial support for Speedel creation in 1998 and development of Tekturna/Rasilez
- Speedel pipeline provides access to many R&D projects targeting cardiovascular disease, including a range of direct renin inhibitors
- Ownership of Speedel provides greater flexibility and speed in development of Tekturna/Rasilez and also ends royalty and manufacturing fee payments
- After acquiring a 51.7% stake directly from major Speedel shareholders for CHF 130 per share in cash, Novartis now holds 61.4% of Speedel
- Novartis will commence a mandatory tender offer to acquire the remaining Speedel shares at the same price
July 08, 2008
Novartis completes acquisition of 25% stake in Alcon from Nestlé, first step toward majority ownership of the world leader in eye care
- Strong strategic fit with Novartis thanks to Alcon's pharmaceutical, surgical and consumer eye care products businesses
