Across the globe, people continue to suffer from severe illnesses for which very few effective, well tolerated treatments are available. Research-driven pharmaceutical companies like Bayer are working on innovations intended to benefit these patients. Take pulmonary hypertension, for example. The treatment options for this condition have recently improved to a significant degree.
Exercise is out of the question for Noémi Baert. Even a staircase with 20 steps pushes her to the limit. A walk of just a few hundred meters is more than she can manage. The 13-year-old from Destelbergen in Belgium isn’t even able to carry her own schoolbag. Since the age of six, Noémi has suffered from pulmonary hypertension. This life-threatening illness can affect people of any age.
We are concentrating on innovative active ingredients that represent real breakthroughs in the treatment of a range of illnesses and that address high unmet medical needs. The needs of patients who urgently require new treatment options are always at the forefront of our work.
It usually begins gradually. The patient tires more easily than before, and any exertion leads to shortness of breath. The symptoms remain non-specific as the condition progresses. They can include increasing shortness of breath, a decline in physical strength, chest pains, water retention in the legs, blue lips and fainting. These symptoms are caused by a narrowing of the pulmonary arteries, which can happen for a variety of reasons. As other, comparatively common conditions involve similar symptoms, it may be several years before a patient is diagnosed with pulmonary hypertension. This is the term physicians use to group together the various forms of the disease. Noémi was lucky in one respect, as a cardiologist quickly reached the correct diagnosis. “That helped my daughter to get the right treatment,” says Noémi’s mother, Danielle Verbrugghen.
However, Christian Müller from Arnsberg had to wait many years. His ordeal began in 2004 with a severe pulmonary embolism caused by a vein thrombosis. Müller, who was 36 at the time, spent several months in critical condition in the hospital. Even during his subsequent rehabilitation, he just wasn’t recovering properly. “I wasn’t able to do the exercise section of the program,” recalls Müller, who is trained in wholesale and export trade. The doctors couldn’t pinpoint the cause and, to alleviate the symptoms, they prescribed oxygen treatment. For the next three years, an oxygen machine was Müller’s constant companion. “I couldn’t work anymore and it was impossible to live an independent life,” he says. His parents helped him with day-to-day tasks, but eventually he had to use a wheelchair. When Müller was admitted to the hospital in the spring of 2007 following yet another pulmonary hemorrhage, a doctor there suspected he was suffering from pulmonary hypertension. “He sent me to the cardiac center at Cologne University Hospital for further tests,” Müller explains.
The center is home to cardiologist Professor Stephan Rosenkranz, one of the few experts on pulmonary hypertension in Germany. He is in charge of the center’s pulmonary hypertension outpatient clinic and knows from experience that it can still take a long time before a patient with the condition gets to see a specialist. “Early diagnosis is very important for treating this condition – and the treatment options have greatly increased over the past few years,” he says. A complex diagnostic program has to be performed before treatment can begin. To confirm the diagnosis, it is essential to measure the blood pressure in the pulmonary arteries and examine the right ventricle of the heart using a catheter. Further tests are needed to determine the type of pulmonary hypertension affecting the patient. In Müller’s case, it turned out that his illness was caused by the pulmonary embolism he had suffered back in 2004. In this form of the disease, known as chronic thromboembolic pulmonary hypertension (CTEPH), tiny blood clots in the small pulmonary arteries are responsible for the increased pressure and associated symptoms. CTEPH can occur as a rare complication of acute pulmonary embolism, but the pathogenesis is not completely understood. “In many cases, this form of pulmonary hypertension is potentially curable with special surgery,” says Rosenkranz. That was true for Müller, too. Although he still very much feels the effects of his disease, he can now live without an oxygen machine again.
This type of surgery is not possible for young Noémi, as she suffers from a different form of pulmonary hypertension called pulmonary arterial hypertension. She is helped by various medications that lower the pressure by expanding the pulmonary arteries and relieving the strain on her heart. “There are now several drugs that have this effect. The first member of a distinct substance class has become available in addition. It is also the first active ingredient that can significantly improve the condition of patients with inoperable CTEPH or persistent or recurrent CTEPH after surgery,” Rosenkranz reports. Yet there remains a great need for further research. “We haven’t achieved our goal yet,” he points out, adding that universities and the research-driven pharmaceutical industry still have much work to do. “On the one hand, we must continue to improve existing treatment options. On the other, we need to identify new targets for active ingredients in order to develop new drugs that inhibit excessive cell growth. This cell growth is partly responsible for the narrowing of the pulmonary arteries.”
Developing drugs that can dilate arteries or address the remodeling or increased formation of tissue in the inner lining of the arteries is a core area of research at Bayer HealthCare. Under a co-development and co-commercialization agreement concluded last year, Bayer HealthCare is collaborating with U.S. pharmaceutical company Merck & Co., Inc. (known as MSD outside the U.S. and Canada) in this field.
Bayer scientists are also working on other important approaches to therapy. These include active ingredients for the specific treatment of various cancers, serious cardiovascular conditions such as stroke and heart failure, and certain renal function disorders. A further focus is on the development of novel medicines to treat gynecological diseases. “We are concentrating on innovative active ingredients that represent real breakthroughs in the treatment of a range of illnesses and that address high unmet medical needs. The needs of patients who urgently require new treatment options are always at the forefront of our work. The successful launch of numerous products over the past few years is the result of this long-term focus on innovation,” says Dr. Jörg Möller, head of Global Development at Bayer HealthCare.
The boundaries between “patients” and “consumers” are increasingly fading, with prevention and well-being becoming almost as important as the treatment of diseases.
The Bayer scientists are currently working to seamlessly maintain this innovation flow. This year, the decision could be made to transition five further candidates to Phase III of clinical development. These active ingredients are intended to expand treatment options for various serious illnesses, including a specific form of lymphoma; anemia caused by certain renal disorders; different forms of severe heart failure; and benign tumors of the uterus (myomas). A number of early-stage research projects are proceeding in parallel. “Our work in the field of cardiology, for example, includes new approaches to treating the causes of various vascular diseases, such as pulmonary hypertension,” Bayer scientist Professor Johannes-Peter Stasch reports. In carrying out this work, he and his colleagues are fulfilling one of the greatest desires of Noémi and her mother: “We very much hope that the researchers will continue looking for treatments that will help to stabilize Noémi’s condition.”
Dr. Olivier Brandicourt, Chairman of the Bayer HealthCare Executive Committee, on the subgroup’s strategy
The acquisition of Merck & Co., Inc.’s non-prescription business marked an important milestone for Bayer HealthCare. Alongside strengthening our Consumer Care division, this acquisition also reflects our commitment to Bayer HealthCare’s diversification strategy. Whether it is human or animal health, innovative pharmaceutical products or self-medication, the breadth of our business and portfolio enables us to respond to a rapidly evolving environment. For example, the boundaries between “patients” and “consumers” are increasingly fading, with prevention and well-being becoming almost as important as the treatment of diseases. The know-how and expertise within and across our four divisions enable us to capture our customers’ needs in what we think is the best possible way.
One of the key pillars of our long-term strategy is research and development (R&D) across our businesses, aimed at driving innovation beyond 2020. Some of our current and recently launched products will run out of patent between 2023 and 2025. It is therefore essential that the next wave of innovation follow seamlessly to safeguard growth. Our R&D efforts in this regard focus on the areas in which we excel and have a proven track record of success, for example in cardiology, women’s health and some areas of oncology.
Our strengths throughout our diversified businesses coupled with the required investments will elevate our R&D activities to the next level and ultimately enable us to introduce customer-centric, innovative products to the market.
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