STIOLTO™ RESPIMAT® Now Available in the United States for the Treatment of COPD

RIDGEFIELD, Conn., June 30, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. announced today that STIOLTO™ RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is now available by prescription at pharmacies across the United States.

In May 2015, the U.S. Food and Drug Administration (FDA) approved STIOLTO RESPIMAT for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). STIOLTO RESPIMAT is not indicated to treat asthma or acute deterioration of COPD.

“For more than 40 years, Boehringer Ingelheim has been an industry leader in the discovery and development of new treatment options for the COPD community. In fact, we began our scientific research of COPD when there were no available options, and now offer six therapies for people living with this chronic disease,” said Kathleen M. Dowd, senior vice president, Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. “We are proud to offer patients STIOLTO RESPIMAT, which has proven to be more effective in improving lung function than either tiotropium or olodaterol alone, with a comparable safety profile.”

 

Boehringer Ingelheim will offer a savings card that will allow most eligible patients to get STIOLTO RESPIMAT at no cost for 12 consecutive months, depending on their insurance provider. The savings card will be available in the STIOLTO RESPIMAT patient brochure, as well as on www.STIOLTO.com.

Boehringer Ingelheim is committed to helping patients access our medicines through philanthropic programs. Through the Boehringer Ingelheim Cares Foundation Patient Assistance Program, we help eligible patients who cannot afford our medicines to obtain them free of charge. For more information, visit www.bipatientassistance.com or call 1-800-556-8317.

COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease. More than 15 million Americans have been told by a healthcare provider that they have COPD, and as many as 45 percent of the total estimated COPD cases in the U.S. remain undiagnosed.

About the RESPIMAT® Inhaler

STIOLTO is administered via RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, including approved and investigational therapies. RESPIMAT is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication.

The RESPIMAT inhaler delivers medication independent of inspiratory effort. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds). For more information about STIOLTO RESPIMAT, please visit
www.STIOLTO.com.

About Stiolto™ Respimat® (tiotropium bromide and olodaterol) Inhalation Spray

INDICATION
Stiolto™ Respimat® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

IMPORTANT SAFETY INFORMATION
People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include swelling of the lips, tongue or throat, itching or rash.

Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs. Get emergency medical care if your breathing problems worsen quickly. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins, and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.

STIOLTO can cause serious allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and get immediate medical help.

STIOLTO can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar, or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can increase the pressure in your eyes which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine, and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

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.

Read the step-by-step Patient Instructions for Use for using STIOLTO RESPIMAT before you use your inhaler.

Please see full Prescribing Information, including Medication Guide.

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

INDICATION
Spiriva® HandiHaler® (tiotropium bromide inhalation powder) and SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray are prescription medicines used once daily (maintenance medicines) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema.

SPIRIVA HandiHaler and SPIRIVA RESPIMAT also reduce the likelihood of flare-ups (COPD exacerbations).

IMPORTANT SAFETY INFORMATION
Do not use SPIRIVA HandiHaler or SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and get immediate medical help.

Before using SPIRIVA HandiHaler, tell your doctor if you have a severe allergy to milk proteins.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, stop taking your medicine, use your rescue inhaler and call your doctor right away or go to the nearest emergency room.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA HandiHaler or SPIRIVA RESPIMAT can increase side effects.

Do not take SPIRIVA HandiHaler and SPIRIVA RESPIMAT together.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

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

The most common side effects with SPIRIVA HandiHaler include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate and blurred vision.

The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.

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

Do not spray SPIRIVA RESPIMAT into your eyes as this may cause blurring of vision and pupil dilation.

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.

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

About Striverdi® Respimat® (olodaterol) Inhalation Spray

Indication
Striverdi® Respimat® (olodaterol) Inhalation Spray is a prescription medicine used long term, inhaled one time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). Long‐acting beta2‐agonist (LABA) medicines, such as STRIVERDI RESPIMAT, help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine (short‐acting beta2‐agonist) with you to treat sudden symptoms.

Do not use STRIVERDI RESPIMAT if you have asthma. STRIVERDI RESPIMAT is approved to treat COPD only.

IMPORTANT SAFETY INFORMATION
People with asthma who take long-acting beta2-agonist (LABA) medicines, such as STRIVERDI RESPIMAT, have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.

STRIVERDI RESPIMAT has been approved for chronic obstructive pulmonary disease (COPD) only. STRIVERDI RESPIMAT is NOT to be used in asthma.

Do not use STRIVERDI RESPIMAT more often or at higher doses than prescribed for you by your doctor.

Do not use STRIVERDI RESPIMAT with other LABAs.

Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine and it does not make your breathing problems better.

Tell your doctor about all of your health conditions before using STRIVERDI RESPIMAT, including if you have a heart condition, high blood pressure, thyroid problems, diabetes, or if you suffer from seizures.

Tell your doctor about all the medicines you take, including prescription and non‐prescription medicines, vitamins, and herbal supplements.

STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm, or high blood sugar.

STRIVERDI RESPIMAT can cause serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your doctor or get emergency medical care if you get any symptoms of a serious allergic reaction.

The most common side effects are runny nose, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

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.

Read the step-by-step Patient Instructions for Use for using STRIVERDI RESPIMAT before you use your inhaler.

Please see full Prescribing Information, including Medication Guide.

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.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

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.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.