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Bayer invests in differentiated drug pipeline with over 50 projects focused on high unmet medical needs

Monday, December 4, 2017, 10:00 Hrs  [IST]

Bayer, a global enterprise, presented its Pharmaceuticals Division’s innovation strategy as well as latest research and development (R&D) activities in oncology, cardiovascular diseases, and gynecology. In these areas the company’s R&D strategy is focused on delivering truly differentiated innovations that generate superior value for patients and society.

“With our focused leadership strategy, we are well-prepared to deliver innovations for patients, despite a challenging business environment,” said Dieter Weinand, president of the pharmaceuticals division and member of the management board of Bayer AG. “We have a strong clinical development pipeline with more than 50 projects and a critical mass of promising growth drivers which will continue to deliver meaningful innovations for patients and added value for society.”

“Oncology is one of Bayer’s key pillars for future growth. With four therapies in eight approved indications, an advancing pipeline, and a focused yet diverse development strategy, we are well positioned to further grow our portfolio of cancer treatments in 2018 and beyond,” said Robert LaCaze, executive vice president and head of the oncology strategic business unit at Bayer. “Patients are at the heart of everything we do, which is why we strive each day to develop effective, life-improving therapies and make them available as quickly as possible.”

The company’s launch of a new oncology strategic business unit this year enables an accelerated, integrated approach to the discovery, development, and commercialization of new cancer medications. Bayer focuses its research activities on first-in-class innovations across the following distinct platforms: Oncogenic Signaling, Antibody-Drug Conjugates (ADCs), Targeted Thorium Conjugates (TTCs), and Immuno-Oncology.

In the field of Oncogenic Signaling the company is developing small molecules to target crucial pathways of intracellular tumor signaling that are responsible for the development and survival of cancer in well-defined patient populations (biomarker strategy). In regard to Antibody-Drug Conjugates (ADCs), Bayer is working on antibodies to recognize tumor-specific proteins on cancer cell surfaces, which after binding selectively to cancer cells, release cytotoxins to kill tumor cells. With Targeted Thorium Conjugates (TTCs) drug candidates are being developed using the company’s proprietary platform using high-energy alpha-radiation to kill tumor cells. In Immuno-Oncology it is developing next-generation treatments specifically addressing the needs of patients not responding to current immunotherapies.

Bayer is driving innovation across these development platforms with investment in a robust oncology pipeline and by expanding discovery and development opportunities through a series of strategic agreements with academic centers, other pharmaceutical companies and innovative biotech organizations worldwide.

The company’s novel antibody-based platform of TTCs is expected to deliver alpha radiation selectively to tumor cells while sparing surrounding normal tissues. The approach is to attach alpha particle-emitting thorium-227 to specific antibodies, which deliver their payload directly to the tumor, resulting in lethal DNA double strand breaks. PSMA-TTC, a prostate-specific membrane antigen (PSMA)-targeting thorium conjugate, is expected to go into clinical development next year.

“We are investing in our in-house assets while complementing our innovation strategy with strategic business development that includes in-licensing of promising compounds or smaller acquisitions,” said Dieter Weinand. “We build on internal and external innovation and execute with excellence. This will enable us to deliver superior value for patients and other stakeholders.”

The strategic alliance between Bayer and the Broad Institute of MIT and Harvard, Cambridge, MA, US is an outstanding example of collaboration between industry and an academic research center that aligns complementary strengths to drive medical innovation. Bayer and the Broad Institute have entered into a strategic alliance in the area of oncogenomics and drug discovery which has now been extended for five years until 2023. The goal is to jointly discover and develop therapeutic agents that selectively target cancer genome alterations.

Furthermore, Bayer has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195. Both compounds are being investigated for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors that result in uncontrolled TRK signaling and tumor growth. Follow-up data from a clinical phase I/II study of the oral TRK inhibitor larotrectinib in pediatric patients with advanced solid or primary central nervous system tumors will be presented at the AACR Pediatric Cancer Meeting starting on December 4, 2017 in Atlanta, Georgia (USA).

“The collaborations with the Broad Institute and Loxo Oncology represent new milestones in our endeavor to strengthen our oncology presence and underline our commitment to this therapeutic area,” said Robert LaCaze. “Loxo Oncology’s innovative approach complements Bayer’s oncology pipeline with highly differentiated compounds across different treatment modalities, which are being developed to make a meaningful difference for patients living with various types of cancer.”

Commitment to innovation in cardiovascular diseases
Bayer is an innovation leader in the area of cardiovascular diseases with a long standing commitment. The company’s current cardiovascular portfolio shapes the standard of care today: Bayer is leading in the area of thrombosis, and is in the process of building a robust portfolio for conditions like heart failure and kidney diseases, thereby exploring additional indications adjacent to the classical field of cardiovascular diseases.

“Heart attack and stroke represent a major public health burden and new, more effective treatment options are needed,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceuticals Division and Head of Development. “Millions of people die each year of cardiovascular disease and we are committed to helping patients to access potentially life-saving treatment options and maintain a good quality of life.”

Bayer is advancing its efforts to address unmet need in stroke prevention, arterial and venous thromboembolism as well as the field of cardiovascular diseases through expanding indications for its Factor Xa inhibitor rivaroxaban. Bayer has submitted an application to the European Medicines Agency (EMA) for the marketing authorization of the vascular dose of the Factor Xa inhibitor in combination with aspirin for the treatment of patients with coronary artery disease (CAD) or peripheral artery disease (PAD). The submission was based on results of the Phase III COMPASS study, which showed that the vascular dose of rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg once daily reduced the risk of the composite outcome of stroke, cardiovascular death and heart attack by an unprecedented 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD. A filing in the US is expected by the end of 2017.

In parallel, Bayer is working on the next generation of anti-coagulants including Factor XI (FXI) approaches. FXI inhibition may have potential as an antithrombotic therapy with a favourable bleeding profile and offers a potential additional pathway for treating patients for whom there are currently no suitable therapeutic options available. With the FXI antisense oligonucleotide (FXI ASO), in-licensed from IONIS Pharmaceuticals, and the anti-FXIa Antibody, Bayer has two projects in this area currently in clinical Phase II development as well as a small molecule FXIa-inhibitor in preclinical development.

Heart failure is another high medical need indication in the area of cardiovascular diseases Bayer is addressing with several projects across all stages of its clinical development portfolio. Globally, over 26 million people suffer from heart failure, which shows a growing incidence primarily due to a reduction in mortality from myocardial infarction and an ageing population. Vericiguat, an investigational stimulator of the soluble guanylate cyclase (sGC) that the company is developing in collaboration with Merck & Co. / MSD Sharp & Dohme, is the most advanced and currently investigated in a Phase III clinical program in patients with chronic heart failure and reduced injection fraction. With its partial adenosine A1-agonist, neladenoson bialanate, and a chymase inhibitor Bayer also has two additional investigational heart failure agents currently in Phase II clinical development, with further assets in early clinical and preclinical phase.

Diabetic kidney disease is another detrimental cardiovascular disease, which occurs in 20% to 30% of all diabetics. The prevalence of diabetes has extended epidemic magnitudes, with 425 million people affected worldwide. Finerenone is a novel oral non-steroidal mineralocorticoid receptor (MR) antagonist Bayer is currently investigating in Phase III clinical development. It is aimed to block the deleterious effects of MR-overactivation.

Bayer is also exploring new investigational agents targeting adjacent indications such as obstructive sleep apnea. Sleep apnea is a serious sleep disorder in which breathing repeatedly stops and starts. Breathing pauses can last between 20 to 40 seconds and may occur 30 times or more an hour. As a result, the quality of sleep is poor, which makes the affected patients tired during the day. Sleep apnea is a leading cause of excessive daytime sleepiness. Without treatment, obstructive sleep apnea can cause or aggravate cardiovascular disorders. A new TASK channel blocker from Bayer which blocks the TASK1/3 potassium ion channel which resulted in restored activity of upper airway muscles in preclinical models recently entered clinical Phase I development for patients with obstructive sleep apnea.

Bayer’s gynecological research efforts focus on finding new treatment options for gynecological diseases with a high medical need such as uterine fibroids and endometriosis, which affect a large number of women in society. Uterine fibroids are the most common benign gynecological tumors of women of reproductive age. They are frequently characterized by heavy menstrual bleeding, pain and bulk symptoms. Uterine fibroids are a leading cause of hysterectomy (removal of the uterus) and their impact on a woman’s life can be significant. Approximately 5–10 percent of women of reproductive age have symptoms of uterine fibroids and require treatment. Endometriosis is characterized by the presence and growth of functioning endometrial tissue (inner lining of the uterus) in places other than the uterus that often results in severe pain and infertility.

“While uterine fibroids and endometriosis impact women in their everyday life, current medical treatment options are not satisfactory,” said Dr. Joerg Moeller. “It is our ambitious goal that our research and development efforts in this area result in medical therapies that control symptoms or fight causes and thereby significantly improve the quality of life for women with such conditions.”

Bayer’s gynecology pipeline includes several investigational compounds in various stages of preclinical as well as clinical development. Vilaprisan is a novel oral, selective progesterone receptor modulator (SPRM) from Bayer and is currently investigated in a Phase III clinical study program ASTEROID in women suffering from uterine fibroids. Vilaprisan may allow for effective long-term treatment of uterine fibroids.

In addition, six investigational compounds are currently in early clinical development for endometriosis such as the non-hormonal AKR1C3 Inhibitor. In preclinical models the AKR1C3 Inhibitor demonstrated efficient reduction of local steroid biosynthesis and a modulation of the prostaglandin pattern. A strong reduction of lesion size and a reduction of inflammation were observed with no effects on ovarian function and no changes in systemic estrogen levels.


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