Headquarters: Leverkusen, Germany
Year Established: 1971
Revenues: $49,274 (-3%)
Pharma Revenues: $17,300 (+15%)
Net Income: $4,330 (-4%)
R&D: $2,936 (+15%)
TOP SELLING DRUGS
Leverkusen, Germany-based Bayer rounds out this year’s top 15, jumping up four spots from number 19 on $17.3 billion in revenues, which grew from $15 billion in 2015. The Pharmaceuticals segment focuses on cardiology and women’s healthcare, and on specialty therapeutics in the areas of oncology, hematology and ophthalmology.
Pharmaceuticals performed well driven by key growth products, including the cardiovascular drug Xarelto, and Eylea, for macular degeneration. Xarelto sales jumped 25% to $3 billion, due to expanded volumes in Europe and Japan, while Eylea also made substantial gains, seeing its sales rise 28% to $1.7 billion.
Phase III and beyond
In May 2016, a Phase III study investigating regorafenib (Stivarga) in unresectable liver cancer reached its primary endpoint, a statistically significant improvement of overall survival. The study investigated regorafenib in patients with hepatocellular carcinoma whose disease had further progressed during prior treatment with sorafenib (Nexavar). Based on these data, it submitted regorafenib for marketing authorization for the treatment of unresectable liver cancer in Europe, Japan and the U.S. in 3Q16.
In June 2016, Bayer agreed with Orion Corp. to expand the global clinical development program for the androgen receptor (AR) antagonist BAY-1841788 (ODM-201). A new Phase III study is evaluating BAY-1841788 in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who are starting first-line hormone therapy.
Also in June, Bayer formed a new research partnership with the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) for a Phase III study that will investigate regorafenib as a single agent for adjuvant treatment following completion of standard adjuvant chemotherapy in patients with advanced but not yet metastatic colon cancer.
In September 2016, a Phase III trial was initiated to evaluate vericiguat, a soluble guanylate cyclase (sGC) stimulator, in patients suffering from chronic heart failure with reduced ejection fraction. The development and commercialization of vericiguat are part of the worldwide strategic collaboration between Bayer and Merck & Co. in the field of sGC modulation.
In terms of filings and approvals during the year, in February 2016, Bayer received approval from the European Commission for Kovaltry for the treatment of hemophilia A in patients of all age groups. Kovaltry is an unmodified recombinant factor VIII product that in clinical trials has demonstrated efficacy and tolerability as an on-demand therapy and for prophylactic use two or three times per week by hemophilia A patients. In March 2016, Kovaltry was approved by the FDA and the Japanese Ministry of Health, Labour and Welfare (MHLW).
Also in March 2016, the Japanese MHLW granted marketing authorization for Xofigo for the treatment of adult patients with castration-resistant prostate cancer and bone metastases.
In May 2016, the FDA approved Gadavist/Gadovist (gadobutrol) as the first contrast agent for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in patients of all ages.
Additionally, the FDA approved Bayer’s new low-dose levonorgestrel-releasing intrauterine system with the brand name Kyleena. The new system releases the lowest daily hormone dose in an intrauterine system for up to five years of protection against pregnancy. Bayer also completed the corresponding decentralized registration procedure for the EU. On this basis, it is expected that the health authorities of the EU member states will grant national marketing authorizations in the coming months.
In November 2016, an expansion of indications was filed for Stivarga (regorafenib) in the U.S., Japan and Europe. The filings pertain to the second-line treatment of patients with unresectable hepatocellular carcinoma. The FDA granted priority review status to regorafenib in the registration process for the expansion of indications. The Japanese Ministry of Health, Labour and Welfare (MHLW) granted priority review status for the registration filing in January 2017.
During the year, Bayer entered several partnerships to advance its drug development initiatives. Bayer and Evotec entered into a five-year, multi-target research partnership to develop multiple clinical candidates for the treatment of kidney diseases such as chronic kidney disease in diabetes patients. Both companies will contribute drug targets and a comprehensive set of high-quality technology platforms to jointly develop innovative treatment options for these severe conditions. The partners will share responsibilities during preclinical development of potential candidates.
Bayer receives exclusive access to selected candidates as well as to Evotec’s CureNephron target pipeline. Bayer will be responsible for any subsequent clinical development and commercialization. Evotec will receive a minimum of €14 million over the contract period including research payments and an undisclosed license fee. In addition, Evotec is eligible to receive preclinical, clinical and sales milestones of potentially over €300 million.
Back in 2012, Bayer and Evotec entered into a five-year partnership in the therapeutic area of endometriosis. Currently in its fourth year, this alliance has delivered four preclinical candidates and one first-in-class clinical program has been initiated.
Bayer and X-Chem entered an expanded global drug discovery collaboration across multiple therapeutic areas and target classes. Bayer has expanded access to X-Chem’s DEX technology, which is based on DNA-encoded libraries of small molecules with more than 120 billion molecules. The collaboration aims to discover lead structures for complex drug targets in areas of high unmet medical need. X-Chem received an upfront payment, research and development funding, as well as development milestones totaling as much as $528 million. Bayer has an exclusive option to license any programs under the collaboration. X-Chem will also receive royalties and sales milestones. The companies have been working together since 2012 and Bayer has licensed two programs of small molecules from X-Chem that address complex target structures such as protein:protein interactions. The new multi-year collaboration expands the scope and duration of the partnership.
Regeneron Pharmaceuticals and Bayer will jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody nesvacumab and the vascular endothelial growth factor (VEGF) trap aflibercept, for the treatment of serious eye diseases. Two separate Phase II studies are evaluating the combination therapy as a co-formulated single intravitreal injection in patients with wet age-related macular degeneration or diabetic macular edema.
Preclinical data demonstrates that angiopoietins act together with the VEGF family to promote the formation and maturation of blood and lymphatic vessels in the eye. Ang2 and VEGF together therefore have the potential to influence the pathological development of new blood vessels and the permeability of blood vessel walls in certain diseases of the eye.
Regeneron and Bayer currently collaborate on the global development and commercialization of Eylea (aflibercept) Injection and on the global development of REGN2176-3, the Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) antibody rinucumab co-formulated in a single intravitreal injection with aflibercept, which is currently in Phase II trials in patients with wet age-related macular degeneration.
With the Broad Institute it formed a strategic partnership in the field of genome and drug research in cardiology aimed at using findings from human genetics to develop new cardiovascular therapies, and in the field of oncology, to identify and develop active ingredients that target tumor-specific gene alterations.
Also, with the German Cancer Research Center it formed a partnership for the development of new therapeutic options in oncology, especially in immunotherapy. It teamed up with ImmunoGen in the field of antibody-drug conjugates (ADCs) for novel tumor therapies. With Janssen Research & Development, Bayer is furthering development of Xarelto (rivaroxaban), and with MorphoSys AG, partnered on antibody-drug conjugates using MorphoSys’s HuCAL technology.