A New Leader in Specialised Pharmaceuticals

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Citation
European Cardiovascular Disease 2007 - Issue 1;2007:3(1):1-2
DOI
http://dx.doi.org/10.15420/ecr.2007.0.1.1b

In 2006, Bayer AG acquired Schering AG to combine its pharmaceutical business with Schering AGÔÇÖs business. The newly-created Bayer Schering Pharma AG is ranked among the world┬┤s top 10 speciality pharma companies with leading positions in the fields of womenÔÇÖs healthcare, haematology and cardiology, diagnostic imaging, oncology, primary care and specialised therapeutics. The company - with approximately 40,000 employees - has subsidiaries in over 100 countries worldwide. Its legal domicile is Berlin, Germany.

Bayer Schering Pharma AG combines two successful pharmaceutical companies to form a single, even more powerful enterprise, opening up new opportunities in both diagnostic and therapeutic procedures. The new company looks back on a rich tradition in the field of pharmaceutical research and development, both within Bayer AG and Schering AG.

As early as 1931, Schering launched the first iodine-containing contrast medium Uroselectan, which remained the standard for X-rays of the kidney, bladder and vessels for decades. Numerous innovative contrast media have been developed since then. The combination of an outstanding experience in diagnostic imaging and a strong reputation in therapeutic areas, brings together complementary strengths into a new enterprise, and opens up a broader perspective.

Innovative Products Expand the Range of Diagnostic Imaging

When William Conrad R├Ântgen discovered X-rays in 1895 he opened up a completely new perspective for medicine - the ability to look inside the human body via a non-invasive technique. Over a century later, diagnostic imaging has developed into a highly specialised field of medicine. In addition to the classic X-ray procedure, physicians are today helped by computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, nuclear medicine, single photon emission computed tomography (SPECT) and positron emission tomography (PET), and more recently, fusion scanners, in their efforts to reach fast and precise diagnoses.

Our long-standing experience in the development of contrast media for these modalities has given us a reputation as a global pioneer in diagnostic imaging. As a result, many diseases can be diagnosed earlier and more accurately. With diagnostic imaging representing one of the speciality businesses of the new Bayer Schering Pharma, radiologists can continue to rely on sustained and full access to the familiar, tried and tested contrast media of the former Schering AG:

  • Ultravist┬« for X-ray and CT;
  • Magnevist┬«, the first contrast agent for the entire range of MRI indications;
  • Gadovist┬«, a highly concentrated MRI contrast agent for a broad range of indications;
  • Primovist┬«, the liver-specific MR contrast agent: and
  • Vasovist┬«, the first in a new class of blood pool contrast agents for magnetic resonance angiography (MRA).

Due to Gadovist® unique combination of high concentration and high relaxation properties, it provides excellent contrast. Approved indications for the product include contrast-enhanced MRI of various body regions, i.e. the brain, spine, liver and kidneys, as well as contrast-enhanced MRA. Gadovist-enhanced MRI has also already shown great potential in the diagnosis of heart disease, especially the evaluation of myocardial perfusion. If stress and rest myocardial-perfusion imaging are combined within a single MR session, haemodynamically-significant coronary stenosis can be assessed without the use of ionising radiation. Research presented at the European Congress of Radiology (ECR) by Dr Bernd J Wintersperger of Munich University in Germany, suggests that myocardial-perfusion imaging at 3 Tesla shows a substantial improvement in signal parameters as compared with imaging at 1.5 Tesla, when fast gradient echo (GRE) scanning techniques are employed. This and other improvements may make it easier to detect perfusion deficits.

The novel gadolinium-based product, Vasovist, is the first approved blood pool contrast agent for MRA. The key differentiating characteristic of Vasovist is its reversible binding to human serum albumin, which leads to a much longer intravascular residence time than conventional extracellular agents. Thus, with Vasovist, imaging is possible at very high resolutions, which significantly increases the diagnostic reliability and accuracy of MRA procedures and makes it comparable to the current standard of reference - digital subtraction angiography. Vasovist was approved for use in abdominal and peripheral MRA in the European Union in 2005, then in Canada and Australia, as well as for whole-body MRA in Switzerland in 2006. The product is currently available in 15 European countries. In addition to the approved indications, albumin-binding blood pool agents may have the potential to facilitate the diagnosis of various kinds of diseases or lesions. Vasovist is currently undergoing clinical investigations to explore further the diagnostic value of its blood pool effect outside of MRA.

Primovist is an organ-specific MRI contrast agent with which an exact diagnosis of even small lesions of the liver can be obtained. This contrast agent, which has been approved in most European and Asian countries, is taken up specifically by healthy liver cells, and thus enhances lesion contrast in the liver tissue. Any pathological changes of the organ that exhibit little or no liver-cell function, such as tumours or metastases, can be detected and located. Moreover, Primovist-enhanced MRI can also be employed to characterise focal liver lesions. More recent results suggest that Primovist may also be useful for studying hepatobiliary excretion. This might be of interest in various clinical conditions such as biliary leakage, cholestasis and in patients with liver failure after intensified chemotherapy or bone marrow transplantation. Especially in the latter case, differential diagnosis is extremely difficult - the underlying diseases leading to the liver failure are manifested in very similar clinical symptoms. Furthermore, invasive diagnostic methods, e.g. biopsies, canÔÇÖt be performed in these patients because they usually show concomitant alterations of blood clotting. A non-invasive imaging procedure such as Primovist-enhanced MRI would thus have a high impact on the differential diagnosis of liver disease.

New Compounds for Early and Accurate Diagnosis

Gadofluorines are a new group of macrocyclic, gadolinium-based contrast media that have a distinctively different proposed mechanism of action from all other available contrast agents for MRI. Following intravenous application, gadofluorines bind to proteins with a hydrophilic domain in regions with disturbed endothelial membranes. Anticipated fields of use are imaging of atherosclerosis, inflammatory disorders such as multiple sclerosis (MS), rheumatic disorders and CrohnÔÇÖs disease, tumours, lymph nodes and possibly AlzheimerÔÇÖs disease. The specific visualisation of degeneration and subsequent regeneration of nerves in various experimental disorders of the peripheral and central nervous system, holds great promise for a future clinical application of gadofluorines, in the assessment of nerve injury - and most importantly - of nerve regeneration.

As a leading company in the field of contrast media, Bayer Schering Pharma AG is very much involved in the research and development of new, innovative diagnostic agents, not only for CT and MRI, but also for molecular imaging. In this field, the company focuses on the development of diagnostic agents - known as tracers - which help to detect diseases as early and as accurately as possible.

With these tracers it will be possible to visualise biological processes in vivo at the molecular level, using PET, for example. Being able to diagnose pathological changes at the molecular level at an early stage could make it possible to customise therapies for individual patients with serious diseases.

Working in a strong network with other researching academic and industrial partners helps to identify innovative approaches in this field. In a joint research programme with Stanford University (California, USA), Bayer Schering Pharma AG is working on novel tracers for tumour imaging. In the field of PET imaging the company is collaborating with the Swiss Federal Institute of Technology (ETH), Zurich. It is also pursuing the development of tracers for the early detection of AlzheimerÔÇÖs disease and co-operating with the US company, Avid Radiopharmaceuticals, Inc. Recently, Bayer Schering Pharma AG signed a co-operation contract with Taisho Pharmaceutical Co. Ltd, Nihon Nohyaku Co., Ltd, and the National Institute of Radiological Sciences (NIRS), Japan, on the development of novel tracers for the detection of neurodegenerative diseases such as AlzheimerÔÇÖs disease, ParkinsonÔÇÖs disease and other disorders associated with neuroinflammation.

Essential Add-ons in Diagnostic Imaging

The new Bayer Schering Pharma AG will continue to deliver customer-oriented services and support. This also comprises medical devices and application systems for contrast media, such as automated injectors, MR coils and monitor systems, provided by our subsidiary Medrad Inc., Pittsburgh, USA, the worldwide market leader in this field.Ôûá