November 17, 2009
Novartis Influenza A(H1N1) 2009 vaccine US interim data show lower doses of antigen may suffice to generate a protective immune response against A(H1N1)
- Interim clinical data from approximately 4,000 individuals suggest that half a dose of the currently US-approved Novartis unadjuvanted Influenza A(H1N1) 2009 vaccine met immunogenicity criteria in adults and the elderly
- Data also show that Novartis MF59® adjuvant was well tolerated and could potentially quadruple the Novartis A(H1N1) 2009 influenza vaccine supply
- MF59® adjuvant has an established safety profile supported by clinical data from more than 33,000 study participants and 12 years of real life safety data with more than 45 million doses of influenza vaccine administered since 1997 in Europe
November 13, 2009
Novartis receives approval in Switzerland for Celtura®, a cell culture-based Influenza A(H1N1) pandemic vaccine
- Swissmedic approval allows Novartis to begin shipments of Celtura to Switzerland, providing supplies of A(H1N1) vaccine immediately
- Approvals in Germany and Switzerland demonstrate expanded adoption of new cell culture technology -- an important milestone in replacing 50 year-old egg-based influenza vaccine production with modern biotechnology
- Clinical trials in more than 1,900 individuals across all age groups demonstrate that the vaccine was well tolerated and elicited a strong immune response
November 12, 2009
Novartis launches Prevacid®24HR over-the-counter for full 24-hour frequent heartburn treatment
- Prevacid®24HR prevents acid production that causes frequent heartburn pain for a full 24 hours with one pill a day
- Prevacid®24HR provides America's 50 million frequent heartburn sufferers[1] with convenient and easy accessibility to this effective heartburn treatment
- First new over-the-counter treatment for frequent heartburn sufferers in six years
- About 75% of frequent heartburn sufferers experienced some sleep problems as a result of their heartburn - either problems falling asleep or staying asleep.
- Living with frequent heartburn pain can affect personal relationships, including social activities with family and friends, quality time with children and spouses, and even sexual relationships.
- For 52% of sufferers, discomfort from frequent heartburn has some impact on their work, including their ability to focus in meetings and their overall ability to be productive.
November 05, 2009
Novartis receives regulatory approval in Germany for Celtura®, a cell culture-based Influenza A(H1N1) pandemic vaccine
- Approval marks an important milestone in the process of replacing 50 year-old egg-based flu vaccine production with modern biotechnology
- Clinical trials in more than 1,850 individuals across all age groups show strong efficacy, that can induce immune responses associated with protection against influenza in individuals from 3 to 50 years of age
- Novartis continues to pursue registration of Celtura in other major countries
November 04, 2009
Novartis to expand its human vaccines presence in China through proposed acquisition of a majority stake in Zhejiang Tianyuan
- Tianyuan a privately-held vaccines company providing a competitive product portfolio and pipeline in China, where Novartis has a limited vaccines presence
- Tianyuan and Novartis to collaborate on building a vaccines industry leader targeting unmet medical needs in China, the world's third-largest vaccines market
- Acquisition of 85% stake in Tianyuan for approximately USD 125 million will require Chinese regulatory and government approvals
November 03, 2009
Novartis announces USD 1 billion investment to build largest pharmaceutical R&D institute in China
- Novartis Institute of BioMedical Research in Shanghai, an integral part of the Novartis global R&D network worldwide, to rank third largest for Novartis worldwide
- Additional USD 250 million invested in advanced technical R&D and manufacturing facility opening in Changshu, furthering economic development of Jiangsu province and Suzhou city
October 29, 2009
Novartis on track to deliver Influenza A (H1N1) vaccine for the US
- Novartis on track to produce 90 million units of bulk antigen in line with commitment to US Department of Health and Human Services, despite very low yields of initial seed virus
- 90 million units of bulk antigen expected to result in 60 million vaccine doses due to required overage and overfills in the filling process of multi-dose vials and pre-filled syringes
- To date, Novartis has shipped more than 7.5 million doses of Influenza A (H1N1) vaccines in multi-dose vials and pre-filled syringes ready to use, and expects to reach 25 to 30 million doses by the end of November
- Novartis also initiated deliveries against the 90 million doses of proprietary adjuvant, which could be used to double the amount of vaccine doses produced
October 28, 2009
Novartis biological drug Ilaris® approved in EU to treat children and adults with CAPS, a rare debilitating auto-inflammatory disease
- First drug approved in EU for patients as young as four years old with cryopyrin-associated periodic syndrome (CAPS)[1]
- Approval based on positive data showing Ilaris produced rapid and sustained remission of CAPS symptoms in up to 97% of patients[2]
- Ilaris is a monoclonal antibody that selectively targets and blocks interleukin-1 beta (IL-1ß), the trigger for inflammation and tissue damage in CAPS patients[1],[2],[3]
- Studies ongoing in groups of patients with other diseases involving IL-1ß such as COPD, type 2 diabetes and gout - one of the most painful forms of arthritis
October 23, 2009
Novartis receives approval in the European Union for Exforge HCT®, a new 3-in-1 treatment for high blood pressure
- Exforge HCT combines the efficacy of three widely prescribed blood pressure treatments, valsartan, amlodipine and hydrochlorothiazide, in a single pill
- Up to 85% of patients may need multiple medications to help control their blood pressure[1],[2], underscoring the need for more effective combination treatments
- Single-pill combinations reduce daily pill burden and simplify treatment schedules[3]
October 22, 2009
Novartis delivers strong new product momentum and operational performance in first nine months of 2009
- Strong underlying growth in first nine months of 2009 from healthcare portfolio:
- Net sales of USD 31.3 billion rise 8% in local currencies (lc), led by double-digit expansion in Pharmaceuticals
- Operating income of USD 7.3 billion up 1%, but advances 11% in constant currencies and excluding exceptional items
- Net income of USD 6.1 billion down 8% due to negative currency impact, Alcon-related financing costs and USD 189 million of associated companies charges; but net income in constant currencies rises 2%
- Basic EPS: USD 2.69 in first nine months of 2009 vs. USD 2.93 in 2008
- Free cash flow before dividends advances 20% to USD 6.1 billion
- Progress in innovation: 2009 approvals for Afinitor (US/EU), Ilaris (US) and H1N1 pandemic flu vaccines; positive Phase III data for QAB149 (COPD) and FTY720 (MS)
- Novartis on track for record sales and earnings in constant currencies in 2009
