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Boehringer Ingelheim to Present 14 Abstracts at the Annual American Thoracic Society International Conference Including Phase 3 Data on Investigational Therapy Nintedanib

Companies mentioned in this article: Boehringer Ingelheim Pharmaceuticals, Inc.

RIDGEFIELD, Conn., April 30, 2014 /PRNewswire/ -- Boehringer Ingelheim announced today that the first results from two highly anticipated Phase 3 trials in idiopathic pulmonary fibrosis (IPF) and in chronic obstructive pulmonary disease (COPD) will be presented at the 2014 American Thoracic Society (ATS) International Conference taking place May 16-21 in San Diego. In addition, 12 abstracts will be presented at the ATS International Conference. The extensive data being presented underscores the company's leadership in pioneering new drug therapies to treat serious lung diseases.

Key data being presented include results from the Phase 3 INPULSIS(TM) trials for nintedanib in the treatment of IPF. The initial results from the Phase 3 data for the fixed-dose combination tiotropium and olodaterol (T+O FDC) for COPD, Spiriva® HandiHaler® (tiotropium bromide inhalation powder) approved as a COPD maintenance treatment, as well as additional investigational treatments for asthma and COPD will also be presented.

"Building on our long-standing heritage and expertise in COPD, Boehringer Ingelheim is committed to expanding into other chronic respiratory diseases. We are particularly excited about our research on nintedanib for idiopathic pulmonary fibrosis, which is a rare, fatal disease with a significant unmet medical need," said Tunde Otulana, M.D., senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim. "The breadth of our data at this year's ATS annual meeting illustrates the depth of our commitment to developing therapies to treat serious lung diseases."

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 of presentation (details below).

Nintedanib (Investigational)
Nintedanib is being investigated to determine its efficacy and safety in treating people with IPF. Its safety and efficacy have not been established and it is not approved.

                  Title              Lead /              Presentation Details

                               Presenting Author
    ---                        -----------------

    Efficacy
     And                 Results
     Safety              Of Two
     Of                  52-
     Nintedanib
     in
     Patients
     with
     Idiopathic
     Pulmonary
     Fibrosis:                                   Late-Breaking Presentation

    Week,
     Phase              L. Richeldi
     III,
     Randomized,
     Placebo-
     Controlled
     Trials
     (INPULSIS(TM))                              Mini Symposium # A95
                                                 Date: Tuesday, May 20, 2014

                                                 Presentation Time: 2:00 - 4:30pm PT


    ---

     Nintedanib
     Attenuates
     Motility
     of Lung
     Fibroblasts
     from
     Patients
     with IPF
     (pre-
     clinical)          L. Wollin                Poster Board # C67
                                                 Date: Sunday, May 18, 2014
                                                  Poster Viewing: 10:45am - 12:30pm
                                                  PT


    ---

Tiotropium + Olodaterol (Investigational)
The first study from the TOviTO® clinical trial program, VIVACITO®, investigated the 24-hour bronchodilator profile of once-daily fixed-dose combinations of tiotropium, a long-acting muscarinic agent (LAMA) and the active ingredient contained in Spiriva® HandiHaler® (tiotropium bromide inhalation powder), plus olodaterol, an investigational long-acting beta2-agonist (LABA), to determine its efficacy and safety in treating COPD patients. Tiotropium plus olodaterol is not currently approved and its efficacy and safety is being evaluated.

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Tiotropium Bromide Inhalation Powder
Tiotropium bromide inhalation powder, which is marketed as SPIRIVA HandiHaler( )in the U.S. by Boehringer Ingelheim, is a once-daily LAMA indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD, including chronic bronchitis and emphysema, and to reduce COPD exacerbations.

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Tiotropium in Asthma (Investigational)
Among the abstracts scheduled for presentation are 52-week results of a study assessing the efficacy and safety of tiotropium delivered via the Respimat® inhaler in Japanese patients with moderate to severe symptomatic asthma. Tiotropium delivered via the Respimat® inhaler is being investigated to determine its efficacy and safety in treating people living with asthma and is not approved for this indication.

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Olodaterol (Investigational)
Two analyses investigating the pharmacokinetics/pharmacodynamics and safety of once-daily olodaterol in COPD patients will be presented. Olodaterol is not currently approved and its efficacy and safety as a bronchodilator maintenance treatment for patients with COPD is being evaluated.

                                      Lead / Presenting Author          Presentation Details
                        Title
                        -----

    Pharmacokinetics/
     Pharmacodynamics and Safety
     Analysis Of A Single Dose Of
     Olodaterol Administered Via
     The Respimat(R) Soft
     Mist(TM) Inhaler In Patients
     With Mild And Moderate Liver
     Impairment                   L. Groenke                   Poster Board # 406
                                                               Date: Monday, May 19, 2014
                                                               Poster Viewing: 2:00 - 3:00pm PT
                                                               Discussion: 3:00 - 4:30pm PT
    ---                                                        ----------------------------

    PK/PD and Safety Analysis of                                Poster Board # A102 Date: Wednesday,
     a Single Dose of Olodaterol                                May 21, 2014
     (30 µg Administered via the
     Respimat(R) Soft Mist(TM)
     inhaler) in Patients with
     Severe Renal Impairment      L. Groenke
                                                               Poster Viewing: 10:45am - 12:30pm PT
    ---                                                        ------------------------------------

About Nintedanib (Investigational)
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF). It targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis -- the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).

About Tiotropium+Olodaterol (Investigational)
Tiotropium + olodaterol is a fixed-dose long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) combination currently under investigation as a once-daily maintenance treatment in patients with chronic obstructive pulmonary disease (COPD). Boehringer Ingelheim is studying T+O FDC delivered via the Respimat® inhaler in a large Phase 3 clinical trial program, TOviTO®, which consists of several studies, including the pivotal TONADO® 1&2 trials investigating the effect of T+O FDC on lung function and quality of life in patients with COPD.

About Tiotropium in Asthma (Investigational)
Tiotropium is a long-acting anticholinergic 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 Phase 3 clinical trial program, UniTinA-asthma®, to evaluate its potential across a range of asthma patients. The UniTinA-asthma® Phase 3 clinical trial program is designed to help address the unmet medical needs of appropriate patients who remain symptomatic despite current therapies.

About Olodaterol (Investigational)
Olodaterol is an investigational long-acting beta2-agonist (LABA) currently being evaluated 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 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 improve lung function in patients with 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)
SPIRIVA HandiHaler is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of SPIRIVA capsules.

SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.

Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA HandiHaler. Additionally, inhaled medicines, including SPIRIVA HandiHaler, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA HandiHaler should be stopped and other treatments considered.

Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA HandiHaler.

Use with caution in patients with severe hypersensitivity to milk proteins.

SPIRIVA HandiHaler should be used with caution in patients with narrow?angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow?angle glaucoma, or prostatic hyperplasia or bladder?neck obstruction occur.

Since dizziness and blurred vision may occur with the use of SPIRIVA HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

As SPIRIVA HandiHaler is a predominantly renally excreted drug, SPIRIVA HandiHaler use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of less than or equal to 50 mL/min).

SPIRIVA HandiHaler has been used concomitantly with short?acting and long?acting sympathomimetic (beta?agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.

SPIRIVA HandiHaler may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic?containing drugs.

The most common adverse reactions in the 1?year placebo?controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non?specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4?year trial not included above were headache, constipation, depression, insomnia, and arthralgia.

SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.

SPIRIVA capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.

Please refer to the Instructions for Use for additional information on the use of SPIRIVA HandiHaler.

Indication
SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) is indicated for the long?term, once?daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

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

About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately fatal lung disease for which there are no FDA-approved drugs. The incidence of IPF can vary considerably and there is some evidence that the patient population is increasing. IPF is characterized by progressive scarring of lung tissue and loss of lung function over time. Development of scarred tissue is called fibrosis. Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen. As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.

About Asthma
Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction. When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

As of December 2012, an estimated 300 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow by an additional 100 million people worldwide by 2025.

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease in many patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic.

About COPD
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease can make it harder to breathe because less air is able to flow in and out of the lungs. Over 26 million Americans are estimated to have COPD and almost half are not diagnosed. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States.

Common symptoms of COPD include shortness of breath and coughing with or without mucus.

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 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

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

Contact:
Boehringer Ingelheim
Pharmaceuticals, Inc.
Jennifer Forsyth
Public Relations
203-791-5889
jennifer.forsyth@boehringer-ingleheim.com

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.