August 22, 2014 10:14 AM ET

Pharmaceuticals

Company Overview of F. Hoffmann-La Roche Ltd

Company Overview

F. Hoffmann-La Roche Ltd. provides in-vitro diagnostics and drugs for cancer and transplantation. The company specializes in medicines for oncology, virology, inflammation, metabolism, CNS, clinical chemistry, immunology, urinalysis, blood screening, genetics, infectious diseases, and microbiology. Its products include cancer treatments, such as Avastin, Herceptin, and MabThera that are also effective in the treatment of rheumatoid arthritis, anemia, and osteoporosis. The company also researches, develops, and produces molecular diagnostic reagents, test systems, and test kits. In addition, it provides automated instruments, software, consumables, and IT solutions used in in-vitro diagnostic...

Konzern-Hauptsitz

Grenzacherstrasse 124

Basel,  4070

Switzerland

Founded in 1896

Phone:

41 61 688 11 11

Fax:

41 61 691 93 91

Key Executives for F. Hoffmann-La Roche Ltd

Chief Executive Officer
Age: 47
Head of Roche Basel Site
Compensation as of Fiscal Year 2014.

F. Hoffmann-La Roche Ltd Key Developments

F. Hoffmann-La Roche Ltd Announces New Data from LUTE / VERSE Phase IIb Studies Investigating Lebrikizumab in Patients with Severe Uncontrolled Asthma

F. Hoffmann-La Roche Ltd. has announced new data from the LUTE /VERSE Phase IIb studies investigating lebrikizumab in patients with severe uncontrolled asthma. The data showed that asthma attacks were reduced by 60% in lebrikizumab-treated patients with a high level of the biomarker periostin, compared to only 5% in patients with a low level of periostin. The data also showed that in patients with high periostin levels, lebrikizumab improved lung function as measured by FEV1, which reflects an increase in the maximum amount of air that can be forcibly exhaled in one second. Lebrikizumab was generally well-tolerated and the safety profile was consistent with previous study results. The new data released at AAAAI build upon previous positive phase II data, which were based on lebrikizumab treatment in patients who were uncontrolled despite inhaled corticosteroids. The LUTE /VERSE studies enrolled a more severe asthma population, as these patients were receiving high dose inhaled corticosteroids in addition to a second asthma controller therapy. Based on the results, lebrikizumab is currently being evaluated in adult patients with severe uncontrolled asthma in two phase III studies called LAVOLTA I and LAVOLTA II. Lebrikizumab is currently under investigation in seven ongoing or planned clinical studies, including one for idiopathic pulmonary fibrosis (IPF). LUTE and VERSE were replicate, multicenter, double-blind studies that randomized patients with severe uncontrolled asthma despite treatment with inhaled glucocorticosteroids (ICS) and a second controller to receive lebrikizumab 37.5 mg, 125 mg, 250 mg or placebo subcutaneously every four weeks. The LUTE /VERSE studies, initially phase III, were converted to phase IIb upon identification of a process-related impurity requiring changes to the lebrikizumab manufacturing process. The primary endpoint was the rate of exacerbations during the placebo-controlled period. The data was evaluated separately in patients with high periostin levels and low periostin levels. Data showed that asthma attacks were reduced by 60% in lebrikizumab-treated patients with a high level of the biomarker periostin (=50 ng/mL; p=.01 all doses combined), compared to only 5% in patients with a low level of periostin (=50 ng/mL; p=.87 all doses combined). Specifically, exacerbation rates were reduced by 22, 77 and 81% in periostin-high patients in the lebrikizumab 250 mg, 125 mg and 37.5 mg groups, respectively. Change from baseline in FEV1 was a key secondary endpoint. At 12 weeks in the periostin-high group (=50 ng/mL serum periostin level), there was a 9.1% increase in FEV1 in the pooled lebrikizumab arms over placebo (p=0.02), compared with a 2.6% increase over placebo in the periostin-low group (p=.26). Data showed FEV1 was increased by 6.8, 10.7 and 10.1% in the periostin-high patients in the lebrikizumab 37.5 mg, 125 mg and 250 mg groups, respectively, compared with placebo. The overall frequency of adverse events was 70% in the lebrikizumab arm (all dose levels combined) versus 63% in the placebo group. The frequencies of serious adverse events (lebrikizumab, 2%; placebo 1.7%) were similar. There were no deaths reported in the studies. Overall, no clinically important safety signals were identified.

F. Hoffmann-La Roche Ltd Receives CE Mark for New Version of HIV Diagnostic Test

F. Hoffmann-La Roche Ltd. has announced that its dual-target HIV-1 qualitative test, v2.0, has received CE Mark certifications, allowing it to be sold for clinical use in the European Union and those countries accepting CE Marked products. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure. This dual target design allows for more reliable results to confidently and effectively diagnose HIV-1 infection. The new dual-target HIV-1 qualitative test, v2.0 works with both plasma and dried blood spot (DBS) collection cards to facilitate PCR testing, and more importantly make sample collection and transportation easy, even from the smallest infant in the most rural area. The DBS collection card and the need for more sensitive and accurate information to diagnose babies early in their life and patients across many African countries is instrumental to facilitate healthcare required for the region. The HIV-1 dual target qualitative test and DBS cards eliminates need for refrigeration, drastically reduces the volume of blood to be stored or transported, and the stress for the mother and the child is dramatically improved. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or dried blood spots using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer for automated amplification and detection.

F. Hoffmann-La Roche Ltd Announces Earnings Results for the Year 2013

F. Hoffmann-La Roche Ltd. announced earnings results for the year 2013. The company has reported that net income for 2013 was CHF 11.37 billion, or CHF 14.27 per share, compared to CHF 9.66 billion, or CHF 13.49 per share, for 2012. Group sales for 2013 were CHF 46.78 billion, compared to CHF 45.50 billion for 2012. Core operating profit for 2013 was CHF 17.90 billion, compared to CHF 17.16 billion for 2012.

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