Boehringer Ingelheim to Present 29 Abstracts at the Annual American Thoracic Society International Conference

RIDGEFIELD, Conn., May 5, 2015 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that 29 abstracts from the company's respiratory portfolio will be presented at the 2015 American Thoracic Society (ATS) International Conference taking place May 15-20 in Denver, including data on investigational therapies for chronic obstructive pulmonary disease (COPD) and asthma, and on approved products for idiopathic pulmonary fibrosis (IPF) and COPD. Of the 29 accepted abstracts, 19 are on COPD, including key data from the Phase III TONADO™ trials of late-stage, investigational tiotropium/olodaterol Respimat®.  

"We are proud of our long-standing commitment to ongoing innovation in discovering and developing new treatments for serious lung conditions where there is an unmet need," said Danny McBryan, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to sharing our asthma, IPF and late-stage COPD data at ATS, as we continue to advance our portfolio of respiratory products."

Boehringer Ingelheim's abstracts can be accessed through the ATS conference website, http://conference.thoracic.org.  The data will remain under embargo until the date and time of presentation (details below). The breadth of data being presented at the meeting showcases the company's latest contributions to respiratory research.

In addition to the data presentations, Boehringer Ingelheim will provide attending healthcare professionals with several educational opportunities, including an Industry Theater Presentation, "The Role of Bronchodilators in the Long-Term Maintenance Treatment of Patients With COPD: A Review of the Data" (May 18 at 11:45 am MT), and a dinner symposium featuring a panel of experts, "Selection of Long-Term Maintenance Therapy for Patients With COPD" (May 19 at 6:30 pm MT).

Chronic Obstructive Pulmonary Disease (COPD) Presentations 
Sub-analyses from the TONADO™ trials investigating the safety and efficacy of tiotropium/olodaterol RESPIMAT in patients with COPD will be presented.

Tiotropium/olodaterol RESPIMAT is an investigational maintenance treatment for patients with COPD and includes tiotropium, the active ingredient in SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray and Spiriva® HandiHaler® (tiotropium bromide inhalation powder), combined with olodaterol. Tiotropium/olodaterol RESPIMAT is not currently approved and its efficacy and safety is being evaluated. Additional analyses will also be presented from the ANHELTO™ studies of SPIRIVA HandiHaler and olodaterol RESPIMAT versus SPIRIVA HandiHaler alone, as well as the WISDOM™ trial evaluating the stepwise withdrawal of inhaled corticosteroids (ICS) in COPD. Also being presented are further analyses from the TIOSPIR trial comparing SPIRIVA RESPIMAT and SPIRIVA HandiHaler.

Asthma Presentations 
Phase III data from the UniTinA-asthma® program of investigational tiotropium RESPIMAT will also be presented at ATS; specifically data from the PrimoTinA-, MezzoTinA-, and GraziaTinA-asthma® trials in adult patients with severe, moderate and mild symptomatic asthma. Tiotropium RESPIMAT is being studied as a once daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., wheezing, shortness of breath, chest tightness and cough) despite the use of maintenance therapy, including inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA). Tiotropium RESPIMAT is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved in the U.S. for this indication.

Idiopathic Pulmonary Fibrosis (IPF) Presentations 
Boehringer Ingelheim is presenting new analyses from clinical trials of OFEV capsules including pooled subgroup analyses of Phase III trials, safety data beyond 52 weeks from the Phase III INPULSIS® trials, and safety and efficacy data through 76 weeks from the Phase II TOMORROW® trial. 

About Spiriva® HandiHaler® (tiotropium bromide inhalation powder) and SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray

INDICATION 
SPIRIVA HandiHaler and SPIRIVA RESPIMAT are 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.

IMPORTANT SAFETY INFORMATION 
SPIRIVA is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any component of either product.

SPIRIVA 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. Additionally, inhaled medicines, including SPIRIVA, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA 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.

SPIRIVA HandiHaler should be used with caution in patients with severe hypersensitivity to milk proteins.

SPIRIVA 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, prostatic hyperplasia or bladder-neck obstruction occur.

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

Patients with moderate to severe renal impairment (creatinine clearance of </= 50 mL/min for SPIRIVA HandiHaler) and (creatinine clearance of < 60 mL/min for SPIRIVA RESPIMAT) and treated with SPIRIVA should be monitored closely for anticholinergic side effects.

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

The most common adverse reactions >5% incidence and exceeded placebo by >/=1% with SPIRIVA HandiHaler (placebo) were upper respiratory tract infection 41% (37%), dry mouth 16% (3%), sinusitis 11% (9%), pharyngitis 9% (7%), non-specific chest pain 7% (5%), urinary tract infection 7% (5%), dyspepsia 6% (5%), and rhinitis 6% (5%). In addition, the most common reported adverse reaction >/=3% incidence and higher than placebo from the 4-year trial with SPIRIVA HandiHaler (placebo) not included above were headache 5.7% (4.5%), depression 4.4% (3.3%), insomnia 4.4% (3.0%), and arthralgia 4.2% (3.1%).

The most common adverse reactions >3% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) were pharyngitis 11.5% (10.1%), cough 5.8% (5.5%), dry mouth 4.1% (1.6%), and sinusitis 3.1% (2.7%).

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

Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

Please click for full Prescribing Information for SPIRIVA HandiHaler and for SPIRIVA RESPIMAT.

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

About OFEV® (nintedanib) capsules

Indication and Usage 
OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS 
Elevated Liver Enzymes

• The safety and efficacy of OFEV has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Treatment with OFEV is not recommended in patients with moderate or severe hepatic impairment.
• In clinical trials, administration of OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, and GGT) and bilirubin. Liver enzyme increases were reversible with dose modification or interruption and not associated with clinical signs or symptoms of liver injury. The majority (94%) of patients with ALT and/or AST elevations had elevations <5 times ULN. The majority (95%) of patients with bilirubin elevations had elevations <2 times ULN.
• Conduct liver function tests (ALT, AST, and bilirubin) prior to treatment with OFEV, monthly for 3 months, and every 3 months thereafter, and as clinically indicated. Dosage modifications, interruption, or discontinuation may be necessary for liver enzyme elevations.

Gastrointestinal Disorders 
Diarrhea

• Diarrhea was the most frequent gastrointestinal event reported in 62% versus 18% of patients treated with OFEV and placebo, respectively. In most patients, the event was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhea led to permanent dose reduction in 11% of patients treated with OFEV compared to 0 placebo-treated patients. Diarrhea led to discontinuation of OFEV in 5% of the patients compared to <1% of placebo-treated patients.
• Dosage modifications or treatment interruptions may be necessary in patients with adverse reactions of diarrhea. Treat diarrhea at first signs with adequate hydration and antidiarrheal medication (e.g., loperamide), and consider treatment interruption if diarrhea continues. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe diarrhea persists despite symptomatic treatment, discontinue treatment with OFEV.

Nausea and Vomiting

• Nausea was reported in 24% versus 7% and vomiting was reported in 12% versus 3% of patients treated with OFEV and placebo, respectively. In most patients, these events were of mild to moderate intensity. Nausea led to discontinuation of OFEV in 2% of patients. Vomiting led to discontinuation of OFEV in 1% of the patients.
• For nausea or vomiting that persists despite appropriate supportive care including anti-emetic therapy, dose reduction or treatment interruption may be required. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe nausea or vomiting does not resolve, discontinue treatment with OFEV.

Embryofetal Toxicity

• OFEV is Pregnancy category D. It can cause fetal harm when administered to a pregnant woman. If OFEV is used during pregnancy, or if the patient becomes pregnant while taking OFEV, the patient should be advised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with OFEV and to use adequate contraception during treatment and at least 3 months after the last dose of OFEV.

Arterial Thromboembolic Events

• Arterial thromboembolic events have been reported in patients taking OFEV. In clinical trials, arterial thromboembolic events were reported in 2.5% of patients treated with OFEV and 0.8% of placebo-treated patients. Myocardial infarction was the most common adverse reaction under arterial thromboembolic events, occurring in 1.5% of OFEV-treated patients compared to 0.4% of placebo-treated patients. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.

Risk of Bleeding

• Based on the mechanism of action (VEGFR inhibition), OFEV may increase the risk of bleeding. In clinical trials, bleeding events were reported in 10% of patients treated with OFEV and in 7% of patients treated with placebo. Use OFEV in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk.

Gastrointestinal Perforation

• Based on the mechanism of action, OFEV may increase the risk of gastrointestinal perforation. In clinical trials, gastrointestinal perforation was reported in 0.3% of patients treated with OFEV, compared to 0 cases in the placebo-treated patients. Use caution when treating patients who have had recent abdominal surgery. Discontinue therapy with OFEV in patients who develop gastrointestinal perforation. Only use OFEV in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk.

ADVERSE REACTIONS

• Adverse reactions reported in >/=5% of patients treated with OFEV and more commonly than in patients treated with placebo included diarrhea (62% vs. 18%), nausea (24% vs.7%), abdominal pain (15% vs 6%), liver enzyme elevation (14% vs 3%), vomiting (12% vs 3%), decreased appetite (11% vs 5%), weight decreased (10% vs 3%), headache (8% vs 5%), and hypertension (5% vs 4%).
• The most frequent serious adverse reactions reported in patients treated with OFEV, more than placebo, were bronchitis (1.2% vs. 0.8%) and myocardial infarction (1.5% vs. 0.4%). The most common adverse events leading to death in patients treated with OFEV, more than placebo, were pneumonia (0.7% vs. 0.6%), lung neoplasm malignant (0.3% vs. 0%), and myocardial infarction (0.3% vs. 0.2%). In the predefined category of major adverse cardiovascular events (MACE) including MI, fatal events were reported in 0.6% of OFEV-treated patients and 1.8% of placebo-treated patients.

DRUG INTERACTIONS 
P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers

• Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of potent P-gp and CYP3A4 inhibitors (e.g., erythromycin) with OFEV may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of OFEV. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with OFEV. Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%. Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with OFEV should be avoided as these drugs may decrease exposure to nintedanib.

Anticoagulants

• Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.

USE IN SPECIFIC POPULATIONS 
Nursing Mothers

• Excretion of nintedanib and/or its metabolites into human milk is probable. Because of the potential for serious adverse reactions in nursing infants from OFEV, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Hepatic Impairment

• Monitor for adverse reactions and consider dose modification or discontinuation of OFEV as needed for patients with mild hepatic impairment (Child Pugh A). Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with OFEV is not recommended.

Smokers

• Smoking was associated with decreased exposure to OFEV, which may alter the efficacy profile of OFEV. Encourage patients to stop smoking prior to treatment with OFEV and to avoid smoking when using OFEV.

Please click here for full Prescribing Information, including Patient Information.

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.

Leading Respiratory Forward 
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

Corporate Social Responsibility 
Boehringer Ingelheim is committed to developing innovative medicines that improve lives and to providing valuable services and support to patients, families and communities.  To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

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, visit: http://us.boehringer-ingelheim.com

Contact:
Boehringer Ingelheim
Pharmaceuticals, Inc.
Name: Christopher Wahlers
Public Relations
Phone: 203-798-4375
Email: [email protected]

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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