Innovation for health – Bayer HealthCare
Bayer HealthCare is a health care company with global research activities that develops products in the areas of Pharmaceuticals, Consumer Care, Diabetes Care and Animal Health. These four areas account for two thirds of Bayer’s R&D expenses. Three current examples can be found in the table below.
Sustainable innovations at Bayer HealthCare
The anticoagulant Xarelto™
The orally administered anticoagulant Xarelto™ (containing rivaroxaban) targets the blood clotting process and inhibits the activity of the Factor Xa enzyme, which plays a key role in the formation of a thrombosis. The product is already the most thoroughly investigated Factor Xa inhibitor in clinical development, and the study program is planned to include more than 65,000 patients overall.
Fighting tumors with Alpharadin
Scientists at Bayer HealthCare are now testing a new active ingredient that is designed to more accurately target bone metastasis in advanced prostate cancer: alpharadin, an alpha radiation substance, can be easily administered intravenously and finds its way into the skeleton within 10 minutes owing to its similarity to calcium.
Riociguat for pulmonary hypertension
Riociguat is an innovative, orally administered substance currently being investigated in Phase III trials as a potential new treatment approach for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), two life-threatening forms of pulmonary hypertension. Riociguat is the first member of a novel class of medicines that stimulate the enzyme soluble guanylate cyclase (sGC).
Our research follows a long-term strategy of developing therapeutic options for currently unmet medical needs. To achieve this, we undertake to use innovative technologies responsibly. This also applies to the development of drug products to treat diseases that are both severe and very rare – also known as “orphan diseases.” Among these are the hereditary disease cystic fibrosis, which we treat with an innovative development from Bayer called the ciprofloxacin inhaler. This preparation was classified by the Food and Drug Administration (FDA) [ 109
] as an orphan drug.
Advances in the field of biomedical research are opening up completely new possibilities for us, but at the same time they raise questions about the responsible use of new technologies and the findings they enable. This applies, for example, to pharmacogenetics, stem cell research and regenerative medicine. We address concerns and suggestions, and undertake to act ethically. Stem cells provide a beacon of hope in medicine, as they can be transformed into various cell and tissue types. Bayer HealthCare is not currently conducting research projects with embryonic stem cells and has not done so in the past. However, we are convinced that research – particularly with adult stem cells – in the field of regenerative medicine should be promoted. Scientific discoveries in this area could lead to new therapeutic solutions for serious and life-threatening diseases.
We strengthen our own research infrastructure with a global network of external partners from science and industry, thus safeguarding the long-term success of our product pipeline.
Orphan Drug Designation for Bayer medicines
The U.S. Food and Drug Administration (FDA) classified Bayer Health Care’s development candidate regorafenib as an “orphan drug” (drug for rare diseases) in February 2011. The drug for treating patients with gastrointestinal stromal tumors (GIST) is currently undergoing Phase III clinical testing. The FDA
classification “orphan drug” is designed to promote the development of drugs for diagnosing, preventing and treating rare diseases that affect less than 200,000 people in the United States. The classification as an orphan drug guarantees the drug exclusive access to the U.S. market for a period of seven years. In March 2010, the FDA also classified the ciprofloxacin dry powder inhaler for the treatment of chronic lung infections with Pseudomonas aeruginosa in cystic fibrosis patients as an orphan drug. This is currently in Phase II of development. More information on our clinical trials [ 110 ]
can be found on the Internet.
Stringent drug safety requirements
Clear and binding requirements apply not just to the research of new pharmaceuticals, but also to their manufacture and commercialization.
We continuously evaluate the benefit-risk profile of our pharmaceutical and medical products from their development until their registration and throughout their life cycles. Within the framework of the safety risk management process at Bayer HealthCare, experts from various disciplines form so-called Safety Management Teams (SMTs). These teams jointly evaluate the available data and other information on a product so as to identify possible safety risks at an early stage, build up a base of data and undertake measures to reduce these risks.
Examples of such measures include the revision of pack inserts, targeted information programs and training measures for physicians and patients. The comprehensive risk management plans are among the core tasks of the SMTs. Should further risks become known following the regulatory approval of a product, we immediately take steps to minimize them. In this connection, we employ the same process and update each respective risk management plan.
The Bayer HealthCare Compliance Management System also plays a key role in added safety. It describes measures aimed at permanently and continuously satisfying regulatory requirements for quality assurance in human and veterinary medicine. The observation of technical compliance standards is verified through systematic internal inspection both for all functions summarized as “global clinical development” and for production. These audits also cover contracted institutes and suppliers. Risks are systematically identified and assessed with the help of a risk management system. If process deviations, violations of the rules or quality deficiencies are established, these are analyzed on a case-by-case basis, and preventive or corrective measures undertaken. Countries and regions continuously receive support in observing pharmaceutical compliance.
The results of our risk management process and the activities derived from it help to ensure the safety of our patients and the correct use of our products, thus ensuring an optimal medical benefit-risk ratio.
Particular challenges posed by possible product risks
As a global company with a diverse business portfolio, the Bayer Group is exposed to numerous legal risks, especially in the area of product liability.
As of April 16, 2011, there were about 8,000 lawsuits pending in the United States involving Bayer’s oral contraceptives Yasmin™ and YAZ™. The lawsuits claim that Yasmin™ and/or YAZ™ – or Ocella™ and/or Gianvi™, generic versions of Yasmin™ and YAZ™ marketed in the United States by Barr Laboratories, Inc. – had caused harm to the health of users, and in isolated cases even death. Pursuant to agreements in 2008 and 2010, Bayer manages product liability litigation for Ocella™ and Gianvi™, Bayer retains product liability for Ocella™ product supplied by Bayer with certain exceptions, and the parties have allocated potential future product liability relating to Gianvi™ product supplied by Bayer. Plaintiffs seek compensatory and punitive damages, claiming, in particular, that Bayer knew, or should have known, of these risks and should be held liable for having failed to disclose them or adequately warn users of Yasmin™ and/or YAZ™. Bayer has also been served with three putative class actions claiming economic loss, one of them also claiming personal injuries. One of these class actions, brought in federal court on behalf of all private health insurers in the United States, was dismissed with prejudice. All cases pending in U.S. federal courts have been consolidated in a multidistrict litigation (MDL) proceeding for common pre-trial management. In addition, 13 Canadian class actions have been served upon Bayer as of February 1, 2011. Additional lawsuits are anticipated. Bayer believes that it has meritorious defenses and intends to defend itself vigorously. Based on the information currently available, Bayer has taken accounting measures for anticipated defense costs.
Further examples of particular challenges in this context, such as Trasylol™, are given in our Annual Report 2010
Analysis of pharmaceuticals in the environment
Within the scope of its product stewardship, Bayer HealthCare aims to pursue an adequate, risk-based and responsible approach to the issue of “pharmaceuticals in the environment.” Following the use of pharmaceuticals by patients, trace amounts of these pharmaceuticals or degradation products are excreted and in many cases can thus enter wastewater. Wastewater treatment facilities reduce or degrade these substances. However, some substances are not completely removed and can thus enter natural bodies of water. A special working group conducts tests on ecotoxicity and on the dispersal and degradation behavior of our pharmaceuticals so as to keep trace elements in the soil and groundwater as low as possible and enable risks to be closely monitored.
Bayer also participates in important research projects. One activity being undertaken with various cooperation partners, including from the water resources industry, is the European PILLS (Pharmaceutical Input and Elimination from Local Sources) [ 113 ]
project, which is scheduled to run from 2007 to 2011. The PILLS partnership focuses on wastewater treatment. As it seems efficient to undertake measures at point sources where there is a high concentration of residues in wastewater, the collaboration focuses on the development of local treatment facilities for hospitals and nursing homes. Bayer HealthCare is represented on the scientific advisory committee of PILLS. The company contributes its expertise in the assessment of the ecological risks of pharmaceutical trace amounts and in the treatment of wastewater resulting from the company’s own production activities.
Bayer sets standards in quality for veterinary pharmaceuticals
Bayer HealthCare has marketed products for livestock and companion animals for more than 100 years. The company today offers over 100 different products for animal health and parasite control. These products minimize the risk of transmission of possible pathogens to humans.
At Animal Health, safety and quality standards apply that are comparable to those in human medicine. Here, we focus particularly on the environmental compatibility of our products.
Through training measures and information materials, we provide veterinarians and private consumers with targeted details on the responsible use of our products. In this context, we support the initiative of EPRUMA, the European Platform for the Responsible Use of Medicines in Animals [ 114 ]
, and provide assistance in minimizing the risk of infectious disease among animals and thus reducing the consumption of antibiotics.
Assuming responsibility in the marketing of medicines