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Boehringer Ingelheim Pharmaceuticals, Inc. to Present Latest Data from Robust Respiratory Portfolio at American College of Chest Physicians (ACCP) Annual Meeting


10/25/2013 6:43:35 AM

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RIDGEFIELD, Conn., Oct. 24, 2013 /PRNewswire/ -- Boehringer Ingelheim today announced the upcoming presentation of data from 11 abstracts, including 6 oral presentations, across the company's respiratory portfolio at the 2013 American College of Chest Physicians (ACCP) annual meeting, CHEST 2013, taking place October 26 31 in Chicago. These data exemplify Boehringer Ingelheim's continued commitment to lung health and to discovering new therapies for patients and physicians where unmet needs exist.

These data will highlight ongoing research from the company's development programs for asthma and chronic obstructive pulmonary disease (COPD), and provide additional information on the once-daily COPD maintenance therapy, Spiriva® HandiHaler® (tiotropium bromide inhalation powder). Data from the TIOSPIR (Tiotropium Safety and Performance in Respimat) trial, one of the largest international COPD trials conducted to date, will also be presented.

Tiotropium in Asthma
The CHEST program includes a session titled "Tiotropium and Asthma", which will feature four oral presentations from from the tiotropium development program for adults with severe persistent asthma, including one Phase 2 study and analyses from the PrimoTinA-asthma® Phase 3 trials. The presentations focus on new analyses and data, including expanded analyses of safety and exacerbation data. The PrimoTinA-asthma® studies are designed to evaluate once-daily tiotropium delivered via the Respimat® inhaler as add-on therapy to inhaled corticosteroid/long-acting beta agonists (ICS/LABA) in symptomatic patients with severe persistent asthma. Tiotropium delivered via the Respimat® inhaler is being investigated to determine its efficacy and safety in treating patients with asthma and is not approved for this indication.

Title*

Presenting Author

Presentation Details

Improvements in lung function with tiotropium as add-on controller therapy to ICS+LABA for patients with symptomatic severe asthma

D. E. Doherty

Session: Tiotropium and Asthma (Slides; ID 10747)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT

Once-daily tiotropium is well tolerated as add-on to standard treatment for patients with symptomatic asthma despite receiving inhaled corticosteroids and long-acting beta 2 agonists

J. Bernstein

Session: Tiotropium and Asthma (Slides; ID 10747)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT

Once-daily tiotropium reduces risk of exacerbations and asthma worsening in patients with symptomatic asthma despite treatment with inhaled corticosteroids and long-acting beta 2 agonists

D. Tashkin

Session: Tiotropium and Asthma (Slides; ID 10747)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT

Tiotropium as add-on therapy to ICS+LABA in patients with symptomatic severe asthma: spirometric assessment over 24 hours

J. Corren

Session: Tiotropium and Asthma (Slides; ID 10747)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT


*Data will remain under embargo until 12:00am CT on Monday, October 28

Olodaterol
Among the abstracts scheduled for presentation are results from a Phase 3 analysis assessing the effects of once-daily olodaterol on exercise endurance in COPD patients. Olodaterol is not currently approved and is being investigated to determine the drug's efficacy and safety as a bronchodilator maintenance treatment for patients with COPD.

Title*

Presenting Author

Presentation Details

Evaluation of the effects of olodaterol on exercise endurance in patients with COPD: results from two 6-week studies

F. Maltais

Session: New Treatments for COPD (Slides; ID 10730)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT

The 24-hour FEV1 time profile of olodaterol once daily (QD) via Respimat® and formoterol twice daily (BID) via Aerolizer® in patients with COPD: results from two 6-week studies

G. J. Feldman

Session: New Treatments for COPD (Slides; ID 10730)

Date: Monday, October 28

Time: 1:45pm 3:15pm CT

Efficacy of olodaterol once daily (QD) via Respimat® in GOLD 2/3 COPD patients not receiving background therapy: pooled data from 48-week studies

G. T. Ferguson

Poster Board # 2485

Session: COPD Safety of Treatment (Poster; ID 10702)

Date: Wednesday, October 30

Time: 1:30pm 2:30pm CT

Pooled cardiac safety analysis of 48-week administration of olodaterol once daily (QD) via Respimat® versus placebo and formoterol twice daily (BID) in patients with COPD

P. Sachs

Poster Board # 2479

Session: COPD Safety of Treatment (Poster; ID 10702)

Date: Wednesday, October 30

Time: 1:30pm 2:30pm CT

Pooled safety analysis of olodaterol QD via Respimat® versus placebo and formoterol BID in patients with COPD: independently adjudicated respiratory-related severe adverse events

D. Niewoehner

Poster Board # 2470

Session: COPD Safety of Treatment (Poster; ID 10702)

Date: Wednesday, October 30

Time: 1:30pm 2:30pm CT


*Data will remain under embargo until 12:00am CT on Monday, October 28

Tiotropium Bromide Inhalation Powder
New data from the TIOSPIR trial comparing the safety and efficacy of once-daily tiotropium delivered via two inhalers Respimat® and HandiHaler® was accepted as a late-breaker presentation. The abstracts below present data from the TIOSPIR trial and a separate post-hoc analysis of sex differences in physical activity in individuals with untreated mild-to-moderate COPD.

Spiriva® HandiHaler® (tiotropium bromide inhalation powder) 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.

Tiotropium delivered via the Respimat® inhaler is under clinical development and is not yet approved in the United States.

Title*

Presenting Author

Presentation Details

The Tiotropium Safety

and Performance in Respimat

(TIOSPIR) trial: bronchodilator

efficacy in a spirometry substudy

A. Anzueto

Session: COPD Original Investigations (Slides; ID 11134)

Date: Wednesday, October 30

Time: 2:45pm 4:15pm CT

Sex differences in physical

activity levels and dyspnea in

mild-to-moderate COPD

J. Guenette

Poster Board # 2455

Session: COPD Diagnosis & Evaluation (Poster; ID 10703)

Date: Wednesday, October 30

Time: 1:30pm 2:30pm CT


*Data will remain under embargo until 12:00am CT on Monday, October 28

About Tiotropium in Asthma
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®, to evaluate its potential across a wide range of asthma patients. 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 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 each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. 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).

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 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.

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

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.

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.

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 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.



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