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Biopharmaceuticals FDA

 News Release - October 10, 2011

FDA Approves Combivent(R) Respimat(R) (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease

Active ingredients of dual-action Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol now delivered by new propellant-free inhaler

RIDGEFIELD, Conn., Oct. 10, 2011 -- (Healthcare Sales & Marketing Network) -- Boehringer Ingelheim Pharmaceuticals, Inc. announced Friday that the U.S. Food and Drug Administration (FDA) approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.

COMBIVENT RESPIMAT and COMBIVENT MDI are indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

In a 12-week, randomized, double-blind, placebo and active-controlled clinical trial, COMBIVENT RESPIMAT was shown to be clinically comparable to COMBIVENT MDI, in terms of FEV1. FEV1 is the maximal amount of air that can be forcefully exhaled in one second. In the study, treatment was administered to patients with COPD four times a day.

COMBIVENT MDI and COMBIVENT RESPIMAT are the only short-acting bronchodilator products that offer two different medicines in a single inhaler. Clinical studies in patients with COPD have shown that the combination of ipratropium bromide and albuterol sulfate provides patients significantly greater improvement in lung function than either component alone.

COMBIVENT RESPIMAT uses a new type of inhaler with a propellant-free delivery mechanism to produce an slow-moving mist. COMBIVENT RESPIMAT requires one inhalation per dose as compared to COMBIVENT MDI, which requires two inhalations per dose. COMBIVENT RESPIMAT also offers a dose indicator to inform patients of the amount of remaining medication in the inhaler.

"COMBIVENT RESPIMAT is a testament to our company's dedication and focus on making meaningful developments in respiratory medicine," said Greg Behar, President and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "Leveraging our extensive respiratory therapeutic experience and a long history of bringing innovative medicines to patients, we continue to expand our strong clinical program examining the potential of several late-stage investigational compounds also delivered by the RESPIMAT inhaler."

COMBIVENT RESPIMAT was developed in response to the Montreal Protocol, an international treaty requiring the phase-out of inhalers that use chlorofluorocarbons (CFCs) as propellants, such as COMBIVENT MDI. COMBIVENT RESPIMAT uses a spring mechanism to release the medication, rather than a propellant, so it does not release CFCs or hydrofluoroalkane (HFA) propellants.

COMBIVENT RESPIMAT will be available to patients by prescription starting in mid-2012. To allow adequate time to transition, COMBIVENT MDI will be available until late 2013. As of January 1, 2014, COMBIVENT RESPIMAT will be the only COMBIVENT product available.

"Boehringer Ingelheim invested more than 10 years developing COMBIVENT RESPIMAT," said Christopher Corsico, M.D., MPH, Senior Vice President, Medicine and Regulatory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to ensuring patients and healthcare professionals are accurately instructed on how to use the new type of inhaler, before COMBIVENT MDI is no longer on the market."

About COPD

Chronic obstructive pulmonary disease (COPD) is also known as chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 24 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes and more people each year than breast cancer and diabetes combined.

Common symptoms of COPD include coughing, with or without mucus, or shortness of breath. These symptoms are often confused with normal signs of aging. As COPD progresses, symptoms tend to get worse and more damage occurs in the lungs. Breathing gradually becomes more difficult until people with COPD feel like they are inhaling and exhaling through a small straw.

About COMBIVENT® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol (MDI) and COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT are indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

Important Safety Information

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT are contraindicated in patients hypersensitive to any of components of the drug product or to atropine or its derivatives. COMBIVENT Inhalation Aerosol is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut.

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the COMBIVENT therapy should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister of COMBIVENT Inhalation Aerosol.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after administration of ipratropium bromide or albuterol sulfate. If such a reaction occurs, therapy with COMBIVENT should be stopped at once and alternative treatment should be considered.

The albuterol sulfate contained in COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT, like other beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. If these symptoms occur, COMBIVENT may need to be discontinued. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol. In addition, beta adrenergic agents have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT should be used with caution in patients with cardiovascular disorders; especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Do Not Exceed Recommended Dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT contain albuterol sulfate, a beta-adrenergic sympathomimetic amine and, therefore, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Beta adrenergic agents may produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Ipratropium bromide, a component of COMBIVENT Inhalation Aerosol and COMBIVENT RESPIMAT, is an anticholinergic and may cause urinary retention. Therefore, caution is advised when administering either medication to patients with prostatic hyperplasia or bladder-neck obstruction. Ipratropium bromide, also may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle Glaucoma. Therefore, COMBIVENT should be used with caution in patients with narrow angle Glaucoma.

Caution patients to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow angle Glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately. Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of COMBIVENT; patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.

There is potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of COMBIVENT with other anticholinergic containing drugs as this may lead to an increase in anticholinergic adverse effects.

Caution is advised in co-administration of other beta-adrenergic agents, beta-receptor blocking agents, and non-potassium sparing diuretics. Extreme caution should be used in the co-administration of COMBIVENT and monoamine oxidase inhibitors or tricyclic antidepressants.

In clinical trials, the most common adverse reactions reported for COMBIVENT were bronchitis, upper respiratory tract infection, headache, dyspnea, cough, pain, respiratory disorder, sinusitis, pharyngitis and nausea, nasopharyngitis.

For full prescribing information for COMBIVENT RESPIMAT, please visit

For full prescribing information for COMBIVENT MDI, please visit

Boehringer Ingelheim: Leading Respiratory Forward

Treatment of airway diseases has long been a major area of focus for Boehringer Ingelheim and significant resources are dedicated to research in this field. Boehringer Ingelheim has been a leader in developing therapies for chronic obstructive pulmonary disease for more than 20 years. More recently, the Company has also branched out into developing treatment options for asthma, lung cancer, IPF and other respiratory indications.

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 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24% of net sales in its largest business segment, Prescription Medicines, on research and development.

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Source: Boehringer Ingelheim

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