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Last updated on April 18, 2014 at 21:21 EDT

Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference

May 17, 2013

Data on investigational compounds and an approved product will be presented

RIDGEFIELD, Conn., May 17, 2013 /PRNewswire/ — Boehringer Ingelheim will contribute to advancing the scientific discussion in respiratory disease at the American Thoracic Society International Conference (ATS 2013) in Philadelphia, PA, May 17 – 22.( )Data will highlight research conducted with a product approved for the treatment of chronic obstructive pulmonary disease (COPD) [Spiriva® HandiHaler® (tiotropium bromide inhalation powder)], as well as investigational compounds for asthma, idiopathic pulmonary fibrosis (IPF) and COPD.

The breadth of Boehringer Ingelheim data at ATS 2013, one of the largest gatherings of pulmonary clinicians and researchers in the world, reinforces the company’s commitment to lung health and to finding solutions for physicians and patients where unmet needs exist.

Boehringer Ingelheim’s abstracts in respiratory research can be accessed through the ATS website, http://conference.thoracic.org. The data will remain under embargo until the date and time that the data are presented (details below).

Tiotropium (Investigational)
Tiotropium is being investigated to determine its efficacy and safety in treating patients with asthma and is not approved for this indication.

    Title                       Lead      Presentation Details
                                Author
    ---                         ------

    Tiotropium In Asthma: A     K.M. Beeh Poster Board # A35
    Dose-Finding Study In Adult
    Patients With Moderate                Date: Sunday, May 19
    Persistent Asthma                      Poster Viewing: 10:45 a.m. -12:30
                                           p.m. ET
    -----------------                     ----------------------------------

    Tiotropium Is Effective In  D. Halpin Poster Board # B124
    Patients With Severe
    Asthma Without Evidence               Date: Monday, May 20
    Of COPD                                Poster Viewing: 10:45 a.m. -12:30
                                           p.m. ET
    -------                               ----------------------------------

    Tiotropium Decreases The    H.A.M.    Poster Board # H17
    Risk Of Exacerbations In    Kerstjens
    Patients With Symptomatic             Date: Tuesday, May 21
    Asthma Regardless Of                   Poster Viewing: 10:45 a.m. -12:30
                                           p.m. ET
    Baseline Characteristics
    ------------------------

Nintedanib
Nintedanib is being investigated to determine its efficacy and safety in treating patients with IPF and is not approved for this indication.

    Title                      Lead          Presentation Details
                               Author
    ---                        ------

    Patient Journey With       C. Conoscenti Poster Board # 523
    Idiopathic Pulmonary
    Fibrosis (IPF): A                        Date: Sunday, May 19
    Breathtaking Experience                   Poster Viewing: 8:15 a.m. -9:15
                                              a.m. ET
                                              Discussion: 9:15 a.m. -10:45 a.m.
                                              ET
    ---                                      ----------------------------------

    Sustained Inactivation Of  L. Wollin     Poster Board # A32
    Human Lung Fibroblasts By
    Nintedanib                               Date: Monday, May 20
                                              Poster Viewing: 10:45 a.m. -12:30
                                              p.m. ET
    ---                                      ----------------------------------

    Anti-Fibrotic Effects Of   K. Hostettler Poster Board # A28
    Nintedanib (BIBF 1120) In
    Primary Human Lung                       Date: Monday, May 20
    Fibroblasts Derived From                  Poster Viewing: 10:45 a.m. -12:30
                                              p.m. ET
    Patients With Idiopathic
    Pulmonary Fibrosis And
    From Non-Fibrotic Controls
    --------------------------

    Nintedanib Reduced Silica- I. Maillet    Poster Board # 504
    Induced Lung Inflammation
    And Fibrosis In Mice                     Date: Tuesday, May 21
                                              Poster Viewing: 2:00 p.m. -3:00
                                              p.m. ET
                                             Discussion: 3:00 p.m. - 4:30 p.m. ET
    ---                                      ------------------------------------

Olodaterol and tiotropium + olodaterol
Olodaterol and the combination of tiotropium plus olodaterol are being investigated to determine their efficacy and safety in treating patients with COPD and are not approved for this indication.

    Title                     Lead       Presentation Details
                              Author
    ---                       ------

    Effects Of Olodaterol And M. Smit    Poster Board # B41
    Tiotropium On
    Lipopolysaccharide-                  Date: Sunday, May 19
    Induced Airway                        Poster Viewing: 10:45 a.m. -12:30
                                          p.m. ET
    Hyperresponsiveness And
    Inflammation
    ------------

    Evaluation Of The Effects  J. Troost Poster Board # B24
    Of The Long-Acting ß2-
    Agonist Olodaterol On The            Date: Monday, May 20
    QT And QTc Interval In                Poster Viewing: 10:45 a.m. -12:30
                                          p.m. ET
    Healthy Subjects
    ----------------

Tiotropium bromide inhalation powder
Tiotropium bromide inhalation powder, which is marketed as Spiriva® HandiHaler® in the U.S. by Boehringer Ingelheim and Pfizer, Inc., is a once-daily long-acting inhaled muscarinic antagonist (LAMA) indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD, including chronic bronchitis and emphysema, and to reduce exacerbations.

    Title                                         Lead                     Presentation Details
                                                  Author
    ---                                           ------

    The Impact Of GOLD 1 And                      F. Maltais               Poster Board # F21
    2 COPD On Self-Reported
    Functional Limitations,                                                Date: Sunday, May 19
    Activity, And Correlations                                              Poster Viewing: 10:45 a.m. -12:30
                                                                            p.m. ET
    With Symptom-Limited
    Exercise Compared With
    Age- And Gender-Matched
    Control Subjects (440)
    ---------------------

    Effect Of Tiotropium On                       P. Calverley             Poster Board # 812
    Nighttime Awakening And
    Daily Rescue Medication                                                Date: Monday, May 20
    Use In Patients With COPD                                               Poster Viewing: 8:15 a.m. -9:15
                                                                            a.m. ET
                                                                            Discussion: 9:15 a.m. -10:45 a.m.
                                                                            ET
    ---                                                                    ----------------------------------

     Four-Year Predictive Ability
    Of The New GOLD L. Goossens               Poster Board # 901
    Date: Monday, May
      COPD
    Severity Grading Using
    UPLIFT Data                               20
    Poster Viewing: 2:00 p.m. -3:00
                                                                             p.m. ET
    Discussion: 3:00 p.m. -
                                                                             4:30 p.m. ET
    ---------------------------------------------              ----------- ------------------------------------

    Cluster Analysis In Patients                  P. Gagnon                Poster Board # 101
    With GOLD 1 COPD
                                                                           Date: Tuesday, May 21
                                                                            Poster Viewing: 8:15 a.m. -9:45
                                                                            a.m. ET
                                                                            Discussion: 9:15 a.m. -10:45 a.m.
                                                                            ET
    ---                                                                    ----------------------------------

    A Propensity-Matched                          C. Kozma                 Poster Board # J93
    Retrospective Analysis To
    Identify Predictors Of                                                 Date: Tuesday, May 21
    Rehospitalization For                                                   Poster Viewing: 10:45 a.m. -12:30
                                                                            p.m. ET
    Patients With Chronic
    Obstructive Pulmonary
    Disease (COPD)
    -------------

    Efficacy Of Tiotropium In A                   M. Decramer              Poster Board # 111
    4 Years Study Analyzed
    According To New GOLD                                                  Date: Tuesday, May 21
    ABCD Severity Grading                                                   Poster Viewing: 8:15 a.m. -9:15
                                                                            a.m. ET
                                                                            Discussion: 9:15 a.m. -10:45 a.m.
                                                                            ET
    ---                                                                    ----------------------------------

    Gender-Related Differences                    N. Roche                 Poster Board # D5
    In The Expression Of COPD:
    A Matched Case-Control                                                 Date: Wednesday, May 22
    Study                                                                   Poster Viewing: 10:45 a.m. -12:30
                                                                            p.m. ET
    -----                                                                  ----------------------------------

    Variations In Mortality Risk                  P.R. Burgel              Poster Board # D70
    Among COPD Patients In
    Clinical Trials: Data From                                             Date: Wednesday, May 22
    The UPLIFT Study                                                        Poster Viewing: 10:45 a.m. -12:30
                                                                            p.m. ET
    ----------------                                                       ----------------------------------

About Tiotropium
Tiotropium is a long-acting anticholingeric bronchodilator currently being studied as a once-daily treatment in asthma patients who remain symptomatic despite use of maintenance therapy, including inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). Boehringer Ingelheim is developing the drug in a robust Phase 3 clinical trial program, UniTinA-asthma(TM), to evaluate its potential across a wide range of asthma patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic. The UniTinA-asthma Phase 3 clinical trial program is designed to help address the unmet needs of appropriate patients who remain symptomatic despite current therapies.

About Nintedanib
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for IPF. It targets three growth factors: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis. By blocking these signaling pathways that are involved in fibrotic processes, it is hypothesized that there may be potential to reduce disease progression, and thereby slow the decline of lung function. Nintedanib is also in clinical development and under evaluation as a possible treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.

About Olodaterol
Olodaterol is an investigational long-acting beta2-agonist (LABA) currently being studied as a once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Olodaterol’s efficacy as a once-daily bronchodilator in patients with COPD is being investigated in a robust clinical trial program, which has been conducted in a patient population representative of those seen in clinical practice.

About Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing airways. COPD includes chronic bronchitis, emphysema or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups (exacerbations), which are worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation or flare-up is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath and wheezing that requires medicine beyond your rescue medicine.

Important Safety Information for Spiriva® HandiHaler® (tiotropium bromide inhalation powder)

Do not use SPIRIVA HandiHaler if you are allergic to tiotropium or ipratropium (e.g., Atrovent®) or any of the ingredients in SPIRIVA. If your breathing suddenly worsens, your face, throat, lips or tongue swells, you get hives, itching or rash, stop taking SPIRIVA and seek immediate medical help.

Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device.

If you have vision changes or eye pain or if you have difficulty passing urine or painful urination, stop taking Spiriva® HandiHaler® (tiotropium bromide inhalation powder) and call your doctor right away.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not let the powder from the SPIRIVA capsule get into your eyes.

Dizziness and blurred vision may occur with SPIRIVA. Should you experience these symptoms, you should use caution when engaging in activities such as driving a car or operating appliances or other machines.

Read the Patient Information and the step-by-step Instructions for Use for SPIRIVA before you use your inhaler.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.

Click here for full Spiriva Prescribing Information, Patient Information and Instructions for Use.

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.


Source: PR Newswire