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 (
gadobu-trol) 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 respon-
sible for any subsequent clinical development and commercial-
ization. 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 part-
nership 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 dis-
covery 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 pro-
grams 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 dura-
tion of the partnership.
Regeneron Pharmaceuticals and Bayer will jointly devel-
op a combination therapy of the angiopoietin2 (Ang2) anti-
body nesvacumab and the vascular endothelial growth factor
(VEGF) trap aflibercept, for the treatment of serious eye dis-
eases. Two separate Phase II studies are evaluating the combi-
nation therapy as a co-formulated single intravitreal injection
in patients with wet age-related macular degeneration or dia-
betic 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 to-
gether 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 de-
velopment 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 us-
ing 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. CP