October 20, 2009
New Phase II data show ACZ885 gave better pain relief and flare prevention for patients with chronic gout than an injectable corticosteroid
- ACZ885 provided pain relief and reduced risk of flares by 94% versus an injectable corticosteroid in hard-to-treat patients unable to use common gout medicines[1]
- Gout is one of the most painful forms of arthritis involving acute attacks of inflammation that can damage joints and bone[2],[3]
- ACZ885 blocks action of inflammatory protein interleukin-1 beta which plays key role in causing painful gout flares[4],[5],[6]
October 20, 2009
Novartis drug Tasigna® meets primary endpoint in pivotal trial against Glivec® as first-line treatment in chronic myeloid leukemia patients
- Tasigna produced faster and deeper responses compared to Glivec as first-line treatment in Philadelphia chromosome-positive chronic myeloid leukemia
- First registration study using molecular response as key indicator of patient outcomes; Bcr-Abl biomarker test measures very low levels of residual disease[1],[2]
- Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells[3],[4]
- Complete results to be submitted for presentation at the American Society of Hematology (ASH) meeting in December
October 19, 2009
Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD
- US Food and Drug Administration (FDA) has requested additional information on dosing proposed for QAB149
- Novartis will continue to work with the FDA to gain US approval for QAB149
October 19, 2009
Leading Dengue and TB scientists discuss new clinical research approaches and models of excellence for clinical research and trials in endemic regions
- According to public health officials, low income countries carry more than 90% of the global disease burden and have less than 10% of funds from public and private sources to deal with them[1]
- NEHCRI is a unique role model for clinical TB and Dengue research in endemic regions, utilizing local input to build capacity and develop health infrastructure to treat patients that are most in need
- The global prevalence of Dengue has risen by 11 times since 1970[2], and globally, the WHO estimated 9.27 million incidents of TB in 2007, almost 1 million of which occurred in Indonesia[3]
October 12, 2009
Novartis enters into agreement for exclusive US and Canadian rights to Fanapt(TM), an FDA-approved oral therapy for schizophrenia
- Fanapt (iloperidone), an antipsychotic therapy, is indicated in US for the acute treatment of schizophrenia in adults, set for US launch in early 2010
- Addition of Fanapt will strengthen Novartis psychiatry portfolio and build on history in schizophrenia
- Schizophrenia is a chronic, severe and disabling psychiatric disorder estimated to affect more than two million adults in the US and nearly 250,000 Canadians
- Rights to Fanapt acquired from Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million; Vanda eligible for milestones and sales royalties
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]
