October 08, 2009
Novartis gains exclusive worldwide rights to PTK 0796, in Phase III study as potential first-in-class IV and oral broad-spectrum antibiotic
- PTK 0796 potentially the first broad-spectrum antibiotic given by once-daily infusion or tablet to treat infections caused by drug-resistant bacteria such as MRSA
- Oral form of PTK 0796 could offer a convenient way for patients to continue outpatient antibiotic treatment after leaving hospital
- New antibiotics needed in fight against bacterial resistance, with an estimated 150,000 deaths a year from hospital-acquired infections across US[1] and EU[2]
- Novartis to make upfront payment to Paratek Pharmaceuticals; Paratek eligible for milestones and royalties on future sales
October 06, 2009
Novartis completes shipment of US supply of Fluvirin® seasonal influenza vaccine
- 27 million doses shipped to US market by Novartis - providing more seasonal flu vaccine earlier than in any previous year
- Shipments completed ahead of normal seasonal vaccine delivery schedules to allow for earlier vaccination
- First shipments of A(H1N1) vaccine delivered to US government less than four months after the pandemic declaration by the WHO
- A/Brisbane/59/2007, IVR-148 (H1N1)
- A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus)
- B/Brisbane/60/2008[2]
- Children between 6 months and 18 years of age
- Pregnant women
- People 50 years of age and older
- People of any age with certain chronic health conditions, such as asthma, diabetes or heart disease
- People in nursing homes and other long-term care facilities,
- Household contacts of person at high risk for complications from influenza,
- Household contacts and out-of-home caregivers of children less than 6 months of age
- Healthcare workers[9]
October 05, 2009
Sandoz launches somatropin, the first-ever Japanese biosimilar, increasing access to key medicines in second largest global market
- Human growth hormone somatropin launch follows precedent-setting approval in June
- Paves way for entry of biosimilars in Japan, increasing access to affordable, high-quality biopharmaceuticals in world's second largest pharmaceuticals market
- European data indicates that biosimilars can save payors billions of dollars
September 30, 2009
Two-year Phase III study shows Novartis oral MS therapy FTY720 significantly reduces relapses and disability progression
- FREEDOMS study shows FTY720 reduced relapse rates by 54-60% compared to placebo, and disability progression by 30-32%[1]
- Results build on Phase III TRANSFORMS one-year study showing FTY720 reduced relapses significantly more than interferon beta-1a, a standard of care[2]
- Phase III efficacy and safety data confirm positive benefit-risk profile for lower 0.5 mg dose[1] and support planned submissions in US and EU at end of 2009
- Future development of FTY720 in relapsing forms of MS to focus on lower 0.5 mg dose
September 25, 2009
Novartis bronchodilator QAB149 recommended for approval in European Union to treat patients with chronic obstructive pulmonary disease
- QAB149 is set to become the first COPD therapy in the EU that combines 24-hour bronchodilation[1],[2] from a once-daily dose with onset of action within five minutes[3]
- A Phase III study vs. tiotropium showed significant lung function benefit[1], improvements in COPD symptoms[4] and significantly more days free of 'relief' medication use[5]
- COPD affects 210 million people globally[6], up to 82 million in Europe[7],[8], and is projected to become the third leading cause of death worldwide[9]
September 25, 2009
Novartis A(H1N1) Pandemic Influenza vaccine Focetria® receives positive opinion from CHMP
- Significant milestone in bringing pandemic influenza vaccines to market in Europe
- Novartis delivers first shipments of A(H1N1) vaccine to governments in Europe just three months after the WHO declaration of the pandemic
- Focetria formulated with MF59® adjuvant which can boost the body's immune response and increase protective antibody levels with less antigen than needed with non-adjuvanted vaccines
September 24, 2009
Sandoz completes acquisition of EBEWE Pharma, improving global patient access to affordable injectable cancer medicines
- Acquisition of EBEWE Pharma provides strong platform for future growth of differentiated generics business
- New global center of excellence for injectable cancer medicines broadens portfolio of affordable medicines for patients
- Sandoz to focus on quick and seamless integration for customers and employees
September 17, 2009
Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
- Valturna combines in a single pill valsartan, an angiotensin receptor blocker, with aliskiren, the only approved direct renin inhibitor
- Valturna is the first therapy to target two points within the renin angiotensin aldosterone system (RAAS), which plays a key role in regulating blood pressure
- Valturna offers significantly greater blood pressure reduction than either valsartan or aliskiren alone[1]
September 15, 2009
Novartis investigational bronchodilator QAB149 improves lung function and reduces breathlessness compared to tiotropium in patients with COPD
- New data show a higher proportion of patients treated with QAB149 achieved clinically relevant improvements in symptoms of breathlessness compared to tiotropium[1]
- Patients taking QAB149 experienced 20 percent more days free of 'relief' medication, used to treat acute episodes of severe breathlessness, compared to tiotropium[2]
- The Phase III data reinforce that once-daily QAB149 combines relevant 24-hour bronchodilation[3],[4] with an onset of action within five minutes[5]
September 03, 2009
Novartis MF59® adjuvanted cell culture-based vaccine shows strong immune response in A(H1N1) clinical trials
- First pilot trial of investigational A(H1N1) vaccine with 100 subjects indicates strong, potentially protective, immune response in 80% of subjects after one dose, more than 90% after two doses.
- MF59® adjuvanted cell culture-based A(H1N1) vaccine was well tolerated, pain at the injection site the most frequent adverse event.
- Larger pivotal trials with both cell culture and traditional egg based vaccines under way to include more than 6000 adults and children.
