C.H. Boehringer Sohn AG & Ko. KG is the parent company of Boehringer Ingelheim, which was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Still headquartered in Ingelheim, it operates globally with 140 affiliates and more than 47,000 employees. The company's key assets of interest are: respiratory diseases, cardiovascular diseases, Parkinson's disease, HIV, thromboembolic diseases, cerebrovascular diseases, oncology, diabetes and hepatitis. 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. Boehringer Ingelheim is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA. The corporate logo of Boehringer Ingelheim depicts a stylized rendition of the central section of the imperial palace of Charlemagne.In October 2012 Boehringer Ingelheim settled a "qui tam" case with the U.S. government for $95 million alleging "off-label" marketing of the drugs Aggrenox, Atrovent, Combivent, and Micardis for uses that weren't approved by the US Food and Drug Administration and were not covered by federal health care programs.In August 2012, Pradaxa claims filed in the federal court were consolidated in a multi-district litigation in the Southern District of Illinois before Chief Judge David R. Herndon. On May 28, 2014,a $650 million settlement was announced on behalf of approximately 3,900 claimants who were injured by the drug Pradaxa made by Boehringer Ingelheim Pharmaceuticals, Inc. The drug is alleged to cause severe bleeding events and/or hemorrhaging to those who were taking the drug. Wikipedia.
News Article | May 16, 2017
— Rising number of chronic kidney diseases (CKD) and dialysis patient pools are the major drivers for the market. Moreover, increasing cases of cancer, HIV‘s and ESRD (End Stage Renal Diseases) are some of the factors enhancing the market growth. However, growing competition from substitute drugs and rising threats from thrombosis and PRCA are the factors inhibiting the market size. By Application, anemia segment leads the Erythropoietin Drugs market during the forecast period. On the other hand, retail pharmacies in end user segment dominated the global market with a huge market share. In terms of geography, Europe commanded the maximum market share and will continue to dominate the market over the forecast period. Some of the key players in the market include Johnson and Johnson, Hospira, Inc., F. Hoffmann-La Roche AG, Amgen Inc, Kyowa Hakko Kirin Co., Ltd, 3SBio Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Intas Pharmaceuticals, Dr. Reddy's Laboratories, Teva Pharmaceutical Industries, JCR Pharmaceuticals, LG Life Science, Novartis AG, Shenyang Sunshine Pharmaceutical, Sihuan Pharmaceutical, Uni-Bio Science, Wanbang Biochemical Pharmaceuticals, Pfizer Inc., Chugai Pharmaceutical and Dragon Pharma. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 6 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments About Stratistics MRC We offer wide spectrum of research and consulting services with in-depth knowledge of different industries. We are known for customized research services, consulting services and Full Time Equivalent (FTE) services in the research world. We explore the market trends and draw our insights with valid assessments and analytical views. We use advanced techniques and tools among the quantitative and qualitative methodologies to identify the market trends. Our research reports and publications are routed to help our clients to design their business models and enhance their business growth in the competitive market scenario. We have a strong team with hand-picked consultants including project managers, implementers, industry experts, researchers, research evaluators and analysts with years of experience in delivering the complex projects. For more information, please visit http://www.strategymrc.com
News Article | July 27, 2017
RIDGEFIELD, Conn., July 27, 2017 /PRNewswire/ -- Boehringer Ingelheim announced today that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of...
News Article | May 23, 2017
Pilot programs demonstrate that digital learning increases physician engagement and empowers patients to self-advocate The Academy of Continued Healthcare Learning (ACHL), ProPatient, and ArcheMedX have launched a series of integrated online learning programs that have successfully educated and empowered both healthcare providers and patients/caregivers to share decision making in addressing the challenges of treating Idiopathic Pulmonary Fibrosis (IPF) and Non-Small Cell Lung Cancer (NSCLC). As scientific discoveries accelerate and our healthcare system becomes more complex, it is critical for clinicians and patients to communicate and collaborate to optimize patient-centric care. While the benefits of shared decision making are well established, it is far from the norm and significant efforts are need to ensure that all stakeholders are comfortable, capable, and committed. “Online learning is a cost-effective way to provide physicians with on-demand access to the latest clinical advances and a trusted channel to educate and empower patients to participate in their care,” said Lisa Keckich, Executive Director at ACHL. She added, “ACHL entered into this partnership to assess whether an integrated educational approach would facilitate shared decision making for complex diseases like IPF and lung cancer. The success of these initiatives demonstrates the power of the ArcheMedX and ProPatient platforms to educate and motivate clinicians and patients to work collaboratively and has established a model we eagerly anticipate extending to additional clinical areas.” Through these interventions clinicians are better prepared to guide their patients through a shared decision making process and patients are better informed and more empowered to participate in their care. Since launching in December 2016, more than a thousand clinicians and patients have participated in the educational program, enhancing multidisciplinary approaches to care and addressing the unique and evolving needs of patients with IPF. 80% of clinicians engaged by the program reported making changes to their shared decision-making practices since participating. Furthermore, 85% of IPF patients reported that the patient education activity helped them better understand IPF. You can learn more about this IPF program here. Since launching in June 2016, thousands of lung cancer clinicians and patients have participated in the educational program, enhancing personalized approaches to care and simplifying important challenges related to diagnosis and treatment. 90% of clinicians engaged by the program reported that they had increased the frequency in which they engage their patients with NSCLC in shared decision-making since participating. 58% of patients feel that they learned from the activity and were better able to understand their diagnosis. You can learn more about this NSCLC program here. *These interventions would not be possible without commercial support. The IPF program is supported by educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Genentech, Inc. and the NSCLC program is supported by an educational grant from Genentech, Inc. ACHL is an-award winning provider of continuing medical education programs. Its mission is to design, develop, and implement quality continuing education activities that have a positive influence on the way healthcare is practiced and ultimately, to improve the quality of care provided to patients. ProPatient is a patient-focused, online educational platform that utilizes interactive video and engaging simulation to provide patients with the opportunity to ask questions of a virtual clinician and role-play different scenarios to improve their skills. ArcheMedX is a healthcare informatics and e-learning technology company that is transforming online education through a data-driven approach to learning. By leveraging nearly five decades of cognitive science and years of applied research, the ArcheMedX team has developed an award-winning e-learning and analytics platform that simplifies the design, delivery, and analysis of online education and training across the healthcare industry. ArcheMedX currently partners with dozens of healthcare organizations (national medical societies, leading academic medical centers, major pharmaceutical firms, and global medical education companies) to power and analyze hundreds of more engaging and interactive learning experiences available across dozens of clinical and non-clinical areas. Learners who participate in ArcheMedX-powered education have been found to improve their knowledge and competence at a level four-to-six times greater than traditional online education. To learn more, visit www.archemedx.com.
News Article | May 24, 2017
Additionally, a pooled analysis from the TOMORROW™, and INPULSIS® trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with Ofev and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, Ofev vs. 3.3%, placebo) and low CV risk (4.5%, Ofev vs. 5.3%, placebo) at baseline. "IPF is a progressive disease that requires ongoing treatment. So, it is important to assess the long-term efficacy and safety of IPF treatments like Ofev to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions," said Imre Noth, M.D., professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. "These new data help to further strengthen the science supporting the efficacy and safety of Ofev for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions." New Insights about IPF Patients A separate analysis presented at ATS examined data from the IPF-PRO patient registry at 18 pulmonary care sites to identify the clinical characteristics of IPF patients who have advanced lung function impairment. Most clinical studies have included IPF patients with mild to moderate lung function impairment, and investigators wanted to understand how patients with more advanced disease differed. Patients with advanced IPF at baseline had greater physical impairment versus patients with mild to moderate disease, including lower six-minute walk distance (320 feet vs. 397 feet). The more advanced IPF patients also had an increased prevalence of hypoxemia (low blood oxygen), both at rest (36.6% vs. 7.4%) and while active (62.4% vs. 20.2%), requiring more supplemental oxygen, as well as a history of pulmonary arterial hypertension, or high blood pressure in the lungs (14.0% vs. 6.4%). In addition, health-related quality of life (HRQL) scores were significantly worse in those with advanced lung function impairment. "At Boehringer Ingelheim, we are committed to IPF and broader ILD research and advancements to better understand these devastating diseases," said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "Through ongoing research, we are able to provide the IPF community with the information they need to make informed treatment decisions." Ongoing research is being conducted for the treatment of Ofev in patients with IPF and other interstitial lung diseases. Nintedanib is also being investigated for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD), as well as progressive fibrosing interstitial lung disease (PF-ILD). Additionally, the first following the approval of Ofev for the treatment of IPF is completed and will add evidence to the safety and tolerability of nintedanib in combination with pirfenidone. Results from the 12-week, randomized INJOURNEY trial will be presented at an upcoming international medical congress. The corresponding abstracts can be found within the online program, here: https://cms.psav.com/ats2017/confcal About idiopathic pulmonary fibrosis (IPF) IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition. About the INPULSIS® trials INPULSIS®-1 and -2 are two global Phase III trials which evaluated the efficacy and safety of nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF). The INPULSIS® trials were identical in design, e.g., with matching dosing, inclusion criteria and endpoints. INPULSIS® recruited a range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema. Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS® trials were offered open-label treatment with Ofev® as part of an extension trial to assess the long-term safety and tolerability of Ofev. The INPULSIS®-ON (Clinicaltrial.gov trial identifier: NCT01619085) trial included 734 patients and is currently ongoing. About Ofev® (nintedanib) The U.S. Food and Drug Administration (FDA) approved Ofev for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease. The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW™ trial and the Phase III INPULSIS® trials (INPULSIS®-1 and INPULSIS®-2. All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks. Both INPULSIS® trials were identically designed while the TOMORROW™ study design was similar. What is Ofev? Ofev is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if Ofev is safe and effective in children. What is the most important information I should know about Ofev (nintedanib)? Ofev can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking Ofev, tell your doctor right away. What should I tell my doctor before using Ofev? Before you take Ofev, tell your doctor if you have: Tell your doctor if you: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John's wort. What are the possible side effects of Ofev? Ofev may cause serious side effects. TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure. These are not all the possible side effects of Ofev. For more information, ask your doctor or pharmacist. 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 Boehringer Ingelheim 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 top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives. In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales. For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/ipf-patients-treated-with-ofev-nintedanib-versus-placebo-were-twice-as-likely-to-have-improved-or-stable-lung-function-300462288.html
News Article | May 23, 2017
RIDGEFIELD, Conn., May 23, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced new analyses that provide further evidence that adding SPIRIVA RESPIMAT improved breathing across diverse patient populations who experience uncontrolled asthma symptoms despite the use of another daily...
News Article | June 14, 2017
"Whether I was in centerfield or at bat, my dad was always my biggest fan. He seemed invincible. So when he was finally diagnosed with IPF after battling symptoms like breathlessness and a debilitating cough that persisted for many months, it was devastating to me and my family," said Williams. "Sharing my dad's story is so important because it will help others get the answers they need sooner and easier." IPF is a rare and serious lung disease that causes permanent scarring of the lungs, and makes it difficult to breathe. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. Although considered "rare," IPF affects up to 132,000 Americans, and according to the The Lancet, Hispanics are more likely to suffer from the disease with a 15% higher incidence than the general population.* Also, about 50,000 people in the U.S. are diagnosed every year with IPF – enough to fill a baseball stadium. "Boehringer Ingelheim is proud to partner with baseball legend Bernie Williams who can speak personally about how IPF affected his dad and his family," said Al Masucci, vice president, IPF Business Unit, Boehringer Ingelheim Pharmaceuticals, Inc. "Through the Sin Aliento™ campaign, we hope to educate people to recognize the signs of the disease and take action to see a doctor as early as possible. It is important that a correct medical diagnosis is determined as IPF is often misdiagnosed." The symptoms of IPF are similar to, and often confused with, other more recognizable diseases such chronic obstructive pulmonary disease (COPD), asthma, or congestive heart failure. There are IPF treatments available, including supplemental oxygen, cough management and pulmonary rehabilitation, which can include special exercises or breathing strategies. In 2014, the U.S. Food and Drug Administration (FDA) approved the first drugs specifically indicated for the treatment of IPF. 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 top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives. In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales. For more information, please visit , or follow us on Twitter @BoehringerUS. * Raghu, Ganesh; Chen, Shih-Yin; Yeh, Wei-Shi; Maroni, Brad; Li, Qian; Lee, Yuan-Chi; Collard, Harold R. Idiopahic Pulmonary fibrosis in us medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. The Lancet 2014: 566-572
News Article | June 5, 2017
RIDGEFIELD, Conn., June 5, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that Phase II results from LUME-Meso, a randomized, double-blind, placebo-controlled trial, have been presented as part of an Oral Abstract Session at the 2017 Annual Meeting of the American Society of...
News Article | September 19, 2017
Clear the Air: Opening Up About COPD presents portraits of three real people, Bob Moss, Tina Lisenby and Mary Savord, who show strength, conviction and determination as they take control of their COPD treatment plan – which they hope will inspire others to do the same. "I know all too well the impact and frustrations of living with COPD after witnessing my mother's struggle," said LeVine. "My goal in the film was to bring empathy to a narrative that recognizes the possibilities, while still acknowledging the realities people living with COPD face every day. I hope people will be inspired by Bob, Tina and Mary, as they share their stories from diagnosis and, ultimately, the path they took to take control of their COPD care." Clear the Air: Opening Up About COPD chronicles each person's story from the difficulty of adjusting to the challenges of living with COPD to working with their healthcare providers, family and friends to successfully navigate their lives with COPD. "In my experience, some people don't always have empathy for others living with COPD, and unfortunately, patients' toughest critics are often themselves," said Dr. Breion Tafoya, Pulmonologist at Dickinson Pulmonology Clinic, who is Mary's doctor and featured in the film. "I'm really proud to be part of this film, which shows how three people are living their lives with COPD. The reality is, once you have COPD, you always have it, so it's important to be proactive about finding the right care and learning how to live with the disease." For the many people living with COPD, their care incorporates a treatment plan, which could include smoking cessation, healthy eating, pulmonary rehabilitation, and daily medicines, such as STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray. STIOLTO RESPIMAT is a prescription medicine used long term, two puffs once a day, in controlling symptoms in adults with COPD. STIOLTO RESPIMAT works by helping the muscles around the airways in the 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 and is not to be used for asthma. "We are incredibly proud to premier this authentic cinematic reflection of three very different people living with COPD who share intimate details about their struggles and successes," said Jean-Michel Boers, president, Human Pharma, Boehringer Ingelheim Pharmaceuticals, Inc. "We know that COPD has both a physical and emotional impact on people, and this film captures the realities of COPD and the inspiring triumphs of Bob, Mary and Tina. We hope this film will be a source of inspiration and education for others." The film can be viewed at ClearTheAirCOPD.com, along with additional short videos featuring the film's cast, and information to help patients learn more about their own COPD symptoms. The goal is to motivate and empower people with COPD to take control of their care and talk with their doctor about a treatment plan that works for them. People with asthma, who take long-acting beta -agonist medicines such as olodaterol, one of the medicines in STIOLTO RESPIMAT, have an increased risk of death from asthma. STIOLTO RESPIMAT should not be used to treat asthma and should not be used for treating sudden symptoms of COPD. People should not use STIOLTO RESPIMAT if they are allergic to tiotropium, ipratropium, olodaterol, or any ingredient in STIOLTO RESPIMAT. As with other inhaled medicines, STIOLTO RESPIMAT can cause serious side effects, including sudden shortness of breath that may be life threatening. The most common side effects are runny nose, cough and back pain. Please see complete Important Safety Information below. Meet the Cast of Clear the Air: Opening Up About COPD Bob, a retired industrial worker and a U.S. veteran, was diagnosed with COPD in 2011. Despite a short history of smoking, his doctors believe his COPD resulted from many years of exposure to pollution and fumes. Bob lives on the island of Kauai in Hawaii with his wife, Kathy, who he met when looking for a singer to join his traveling country band. Since retiring and moving to Hawaii, Bob enjoys fishing, woodworking and playing the guitar. Tina, a retired university admissions officer from South Carolina, was first diagnosed with COPD in 2009. Unlike the 20-30 percent of smokers who develop COPD, Tina never smoked. She was diagnosed with the disease after being exposed to second-hand smoke by family and friends her entire life. Her brother Marc, her last living immediate relative, lives in nearby Georgia and visits often, despite her insistence that she can get by on her own. Tina remains active in her community where she plays piano at her church and leads the local pulmonary support group. Mary was diagnosed with COPD in 2001 and lives on her own in the Upper Peninsula of Michigan. Prior to learning that she had COPD, Mary had been a regular smoker. Since her diagnosis, Mary changed her lifestyle; she quit smoking, cooks fresh foods – including fruits and vegetables – and regularly attends her pulmonary rehab and support groups. Mary enjoys her independence, which pushes her to make sure she takes the steps she needs to manage her COPD and her overall health. Abbey LeVine is an Emmy®-nominated Executive Producer and Director whose work over the last two decades has been viewed by millions of people on major television networks, in theaters and online. Throughout her career, LeVine has worked on a variety of documentary films and television programs where she has captured the personal perspectives of people in real-life settings, from celebrities to everyday working Americans. She was recognized for her work in this area for Dr. Phil with an Emmy® nomination. LeVine is personally invested in the Clear the Air: Opening Up About COPD film as her mother is living with COPD. She knows there is a growing population of people with COPD and wanted to gain a better understanding of a patient's journey. About COPD Chronic obstructive pulmonary disease (COPD) is a term that includes 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, especially with physical activities. 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. INDICATION for STIOLTO RESPIMAT 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 beta -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 beta -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 rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. 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 or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. 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 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 cause new or worsening eye problems including narrow-angle glaucoma, and 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 urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. 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 STIOLTO RESPIMAT before you use your inhaler. Please see accompanying , , and , including boxed WARNING. 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 145 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 their 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 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales. For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
Morwick T.,Boehringer Ingelheim Pharmaceuticals
Expert Opinion on Therapeutic Patents | Year: 2010
Importance of the field: Pim kinases have recently emerged as targets of interest in oncology and immune regulation. Ongoing studies have identified a role for these proteins in cell survival and proliferation, both functionally and mechanistically, and overexpression has been observed in a number of human cancers and inflammatory states. Areas covered in this review: This report reviews the patent literature for Pim kinase inhibitors identified from a search of the Thomson patent databases from 1970 through July 2009. Full analyses are provided for publications reporting Pim kinases as primary targets, and a cursory description is given for those disclosing Pim as one of a limited number of secondary targets. What the reader will gain: Readers will gain an overview of the various inhibitor series including coverage, potency, selectivity, protein binding features and therapeutic focus, and an appreciation for which scaffolds and structural features have been most highly exploited. Take home message: A greater understanding of pathological mechanisms for Pim kinases has stimulated the recent development of a variety of inhibitor classes with one compound advancing into the clinic earlier this year. Ongoing studies will help define applications for these inhibitors in the treatment of Pim-associated human diseases. © 2010 Informa UK Ltd.
Cerny M.A.,Boehringer Ingelheim Pharmaceuticals
Current Topics in Medicinal Chemistry | Year: 2013
Owing to the high degree of similarity between aldosterone synthase (CYP11B2) and cortisol synthase (CYP11B1), the design of selective inhibitors of one or the other of these two enzymes was, at one time, thought to be impossible. Through development of novel enzyme screening assays and significant medicinal chemistry efforts, highly potent inhibitors of CYP11B2 have been identified with selectivities approaching 1000-fold between the two enzymes. Many of these molecules also possess selectivity against other steroidogenic cytochromes P450 (e.g. CYP17A1 and CYP19A1) as well as hepatic drug metabolizing P450s. Though not as well developed or explored, inhibitors of CYP11B1, with selectivities approaching 50-fold, have also been identified. The therapeutic benefits of affecting the renin-angiotensin-aldosterone system have been well established with the therapeutically useful angiotensin-converting enzymes inhibitors, angiotensin receptor blockers, and mineralocorticoid receptor antagonists. Data regarding the additional benefits of an aldosterone synthase inhibitor (ASi) are beginning to emerge from animal models and human clinical trials. Despite great promise and much progress, additional challenges still exist in the path towards development of a therapeutically useful ASi. © 2013 Bentham Science Publishers.