07.20.18
Headquarters: Leverkusen, Germany
twitter.com/Bayer
www.bayerpharma.com
Headcount: 99,820
Year Established: 1971
Revenues: $41,943 (+3%)
Pharma Revenues: $20,180 (+3%)
Net Income: $9,696 (+68%)
R&D: $5,395 (+2%)
TOP SELLING DRUGS
Maintaining its position, Bayer’s Pharmaceutical segment saw modest growth in 2017, as pricing pressure, generic competition and health care reforms led to lower growth across all regions. Key growth products Xarelto, Eylea, Stivarga, Xofigo and Adempas performed well with combined sales up 16%. Bayer’s flagship oral anticoagulant Xarelto continued to develop successfully with new indications approved and sales growth in Europe, Japan and China. Bayer also posted further gains for its license revenues – recognized as sales in the U.S. – where Xarelto is marketed by a subsidiary of Johnson & Johnson.
Bayer’s second highest seller, eye drug Eylea grew 16% attributed to expanded volumes in Europe, Canada and Japan.
Xofigo sales were up 23% to $489 million due mainly to its market launch in Japan in 2016 and higher demand in the U.S. Also, sales of cancer drug Stivarga were up 15% to $377 million, benefiting from new approvals in 2017 as a second-line treatment for patients with hepatocellular carcinoma, and pulmonary hypertension treatment Adempas saw $353 million in sales, up 16% mainly as a result of sales growth in the U.S.
Offsetting some of this growth, Kogenate sales suffered due to lower order volumes being placed for the active ingredient by a distribution partner ahead of the planned contract termination at the end of the year. Also, sales of multiple sclerosis drug Betaferon continued to fall primarily as a result of a highly competitive market.
R&D Efforts
Bayer’s Pharmaceutical segment focuses on products for cardiology and women’s healthcare, specialty oncology, hematology and ophthalmology, as well as diagnostic imaging and contrast agents, and in 2017, Bayer managed to transfer ten new molecular entities from its research pipeline into preclinical development.
Bayer picked up several key approvals this past year. In August, the European Commission (EC) expanded the prescribing information for Xarelto to include patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention with stent placement and require oral anticoagulation.
Also, the company’s oral multikinase inhibitor Stivarga picked up an additional indication to treat patients with hepatocellular carcinoma (HCC) who had previously been treated with Nexavar. Stivarga is the first medicine to show a significant improvement in overall survival in second-line treatment of patients with HCC for whom there was previously no further treatment option. The product had been approved for second-line treatment of HCC in the U.S. in April 2017 and in Japan in June 2017.
Additionally, the FDA approved copanlisib under the brand name Aliqopa for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior therapies. Accelerated approval was granted for this indication based on overall response rate. Copanlisib is the only approved PI3K inhibitor with inhibitory activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It’s also the only one to be administered intravenously on an intermittent schedule. In the trial, copanlisib achieved an impressive overall response rate of 59%, with 14% of patients achieving a complete response, and a median duration of response of 12.2 months.
Late Stage Hits & Misses
Bayer has several late-stage assets moving through the pipeline, with some trials ongoing, and others that have been terminated. Bayer and development partner Janssen R&D ended the Phase III NAVIGATE ESUS trial of Xarelto for the secondary prevention of strokes and systemic embolisms in patients who had recently suffered an embolic stroke of unknown origin. Following interim analysis, an independent Data Monitoring Committee recommended that the trial be terminated early since the efficacy of rivaroxaban compared with acetylsalicylic acid (ASA) was similar in the treatment groups and offered limited potential for clinical benefit.
Also, the global Phase III program INHALE, which investigated Amikacin Inhale in intubated and mechanically ventilated patients with Gram-negative pneumonia in addition to standard treatment, did not demonstrate any clinical superiority versus the standard treatment. Neither the primary endpoint nor the secondary endpoints were achieved, and as a result, Bayer terminated its Amikacin Inhale research collaboration with Nektar Therapeutics.
Moreover, following the recommendation of an independent data monitoring committee, Bayer unblinded ahead of schedule a Phase III trial of radium-223 dichloride in combination with abiraterone acetate and prednisone / prednisolone in patients with metastatic castration-resistant prostate cancer, following the observance of an imbalance in terms of more fractures and deaths in the treatment arm.
Moving forward, following positive Phase II data, Bayer launched a Phase III study investigating molidustat in patients with renal anemia. Molidustat is an inhibitor of the enzyme hypoxia-inducible factor-prolyl hydroxylase that stimulates the production of erythropoietin and the formation of red blood cells.
Also, the ASTEROID Phase III program is underway investigating vilaprisan in women with symptomatic uterine fibroids. Vilaprisan is a novel orally dosed, selective progesterone receptor modulator developed by Bayer for enabling long-term treatment of uterine fibroids.
Lastly, a study program is currently investigating the efficacy and safety of rivaroxaban for the treatment and secondary prevention of venous thromboembolism in children. Should this program see successful completion, Bayer would gain extended patent protection for Xarelto in Europe and the U.S. by a further six months.
Early Research Alliances
Several early research alliances aim to uncover new pathways in kidney diseases and oncology. A five-year strategic research alliance with Vanderbilt University Medical Center in Nashville aims to develop new compounds for treating kidney diseases. The goal is to rapidly transfer innovative approaches from the lab to preclinical development.
Additionally, Bayer and PeptiDream Inc., a Japanese biopharmaceutical company, entered a drug discovery agreement covering various therapeutic areas such as oncology and cardiology, as well as classes of drug targets. Using PeptiDream’s Peptide Discovery Platform System technology, the partners will work to identify novel drug discovery candidates for target structures that are difficult to address.
Also, an exclusive alliance with Loxo Oncology aims to develop and commercialize larotrectinib (LOXO-101) and LOXO-195 for the treatment of cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.
In recent news, Bayer and the University of Texas MD Anderson Cancer Center signed a five-year collaboration aimed at accelerating the development of new targeted treatments based on patient or tumor characteristics for which current therapies have not shown clinical efficacy. Bayer will contribute early stage as well as clinical assets from its development pipeline for further clinical development at MD Anderson Cancer Center. MD Anderson will apply its translational and clinical expertise to help accelerate ongoing and future clinical trials.
twitter.com/Bayer
www.bayerpharma.com
Headcount: 99,820
Year Established: 1971
Revenues: $41,943 (+3%)
Pharma Revenues: $20,180 (+3%)
Net Income: $9,696 (+68%)
R&D: $5,395 (+2%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Xarelto | atrial fibrillation | $3,951 | 13% |
Eylea | macular degeneration | $2,252 | 16% |
Mirena | women’s health | $1,349 | 8% |
Kogenate | hemophilia | $1,158 | -17% |
Nexavar | oncolgy | $999 | -4% |
Betaferon | multiple sclerosis | $780 | -11% |
Yaz | women’s health | $776 | -4% |
Adalat | hypertension | $776 | 4% |
Aspirin | Cardio cardiovascular | $696 | 8% |
Glucobay | diabetes | $674 | 9% |
Maintaining its position, Bayer’s Pharmaceutical segment saw modest growth in 2017, as pricing pressure, generic competition and health care reforms led to lower growth across all regions. Key growth products Xarelto, Eylea, Stivarga, Xofigo and Adempas performed well with combined sales up 16%. Bayer’s flagship oral anticoagulant Xarelto continued to develop successfully with new indications approved and sales growth in Europe, Japan and China. Bayer also posted further gains for its license revenues – recognized as sales in the U.S. – where Xarelto is marketed by a subsidiary of Johnson & Johnson.
Bayer’s second highest seller, eye drug Eylea grew 16% attributed to expanded volumes in Europe, Canada and Japan.
Xofigo sales were up 23% to $489 million due mainly to its market launch in Japan in 2016 and higher demand in the U.S. Also, sales of cancer drug Stivarga were up 15% to $377 million, benefiting from new approvals in 2017 as a second-line treatment for patients with hepatocellular carcinoma, and pulmonary hypertension treatment Adempas saw $353 million in sales, up 16% mainly as a result of sales growth in the U.S.
Offsetting some of this growth, Kogenate sales suffered due to lower order volumes being placed for the active ingredient by a distribution partner ahead of the planned contract termination at the end of the year. Also, sales of multiple sclerosis drug Betaferon continued to fall primarily as a result of a highly competitive market.
R&D Efforts
Bayer’s Pharmaceutical segment focuses on products for cardiology and women’s healthcare, specialty oncology, hematology and ophthalmology, as well as diagnostic imaging and contrast agents, and in 2017, Bayer managed to transfer ten new molecular entities from its research pipeline into preclinical development.
Bayer picked up several key approvals this past year. In August, the European Commission (EC) expanded the prescribing information for Xarelto to include patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention with stent placement and require oral anticoagulation.
Also, the company’s oral multikinase inhibitor Stivarga picked up an additional indication to treat patients with hepatocellular carcinoma (HCC) who had previously been treated with Nexavar. Stivarga is the first medicine to show a significant improvement in overall survival in second-line treatment of patients with HCC for whom there was previously no further treatment option. The product had been approved for second-line treatment of HCC in the U.S. in April 2017 and in Japan in June 2017.
Additionally, the FDA approved copanlisib under the brand name Aliqopa for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior therapies. Accelerated approval was granted for this indication based on overall response rate. Copanlisib is the only approved PI3K inhibitor with inhibitory activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It’s also the only one to be administered intravenously on an intermittent schedule. In the trial, copanlisib achieved an impressive overall response rate of 59%, with 14% of patients achieving a complete response, and a median duration of response of 12.2 months.
Late Stage Hits & Misses
Bayer has several late-stage assets moving through the pipeline, with some trials ongoing, and others that have been terminated. Bayer and development partner Janssen R&D ended the Phase III NAVIGATE ESUS trial of Xarelto for the secondary prevention of strokes and systemic embolisms in patients who had recently suffered an embolic stroke of unknown origin. Following interim analysis, an independent Data Monitoring Committee recommended that the trial be terminated early since the efficacy of rivaroxaban compared with acetylsalicylic acid (ASA) was similar in the treatment groups and offered limited potential for clinical benefit.
Also, the global Phase III program INHALE, which investigated Amikacin Inhale in intubated and mechanically ventilated patients with Gram-negative pneumonia in addition to standard treatment, did not demonstrate any clinical superiority versus the standard treatment. Neither the primary endpoint nor the secondary endpoints were achieved, and as a result, Bayer terminated its Amikacin Inhale research collaboration with Nektar Therapeutics.
Moreover, following the recommendation of an independent data monitoring committee, Bayer unblinded ahead of schedule a Phase III trial of radium-223 dichloride in combination with abiraterone acetate and prednisone / prednisolone in patients with metastatic castration-resistant prostate cancer, following the observance of an imbalance in terms of more fractures and deaths in the treatment arm.
Moving forward, following positive Phase II data, Bayer launched a Phase III study investigating molidustat in patients with renal anemia. Molidustat is an inhibitor of the enzyme hypoxia-inducible factor-prolyl hydroxylase that stimulates the production of erythropoietin and the formation of red blood cells.
Also, the ASTEROID Phase III program is underway investigating vilaprisan in women with symptomatic uterine fibroids. Vilaprisan is a novel orally dosed, selective progesterone receptor modulator developed by Bayer for enabling long-term treatment of uterine fibroids.
Lastly, a study program is currently investigating the efficacy and safety of rivaroxaban for the treatment and secondary prevention of venous thromboembolism in children. Should this program see successful completion, Bayer would gain extended patent protection for Xarelto in Europe and the U.S. by a further six months.
Early Research Alliances
Several early research alliances aim to uncover new pathways in kidney diseases and oncology. A five-year strategic research alliance with Vanderbilt University Medical Center in Nashville aims to develop new compounds for treating kidney diseases. The goal is to rapidly transfer innovative approaches from the lab to preclinical development.
Additionally, Bayer and PeptiDream Inc., a Japanese biopharmaceutical company, entered a drug discovery agreement covering various therapeutic areas such as oncology and cardiology, as well as classes of drug targets. Using PeptiDream’s Peptide Discovery Platform System technology, the partners will work to identify novel drug discovery candidates for target structures that are difficult to address.
Also, an exclusive alliance with Loxo Oncology aims to develop and commercialize larotrectinib (LOXO-101) and LOXO-195 for the treatment of cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.
In recent news, Bayer and the University of Texas MD Anderson Cancer Center signed a five-year collaboration aimed at accelerating the development of new targeted treatments based on patient or tumor characteristics for which current therapies have not shown clinical efficacy. Bayer will contribute early stage as well as clinical assets from its development pipeline for further clinical development at MD Anderson Cancer Center. MD Anderson will apply its translational and clinical expertise to help accelerate ongoing and future clinical trials.