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Team analysis: Tanja Wesarg and Marco Jaspers use a mass
spectrometer to analyze protein structures.
on average, the
development of
a pharmaceutical
product to market
maturity takes about
10 to 12 years
and costs roughly
half a billion euros.
Generally only one
out of every 5,000
to 10,000 examined
substances ultimately
receives marketing
authorization.
18
cancer patients with bone metastases in Europe and
the United States in 2012. Together with its partner
OncoMed Pharmaceuticals, Bayer HealthCare is
working in the innovative research area of cancer
stem cell research. Cancer stem cells are believed to
play a signifi cant role in the development, metastasis
and recurrence of cancer. The objective is to jointly
develop new therapeutic options to target cancer
stem cells.
Eylea (afl ibercept), a drug product that is being developed
in collaboration with Regeneron Pharmaceuticals
Inc., could make an important contribution in the treatment
of eye diseases. The product, which is injected
into the vitreous body of the eye, is registered in various
countries and regions for the treatment of wet agerelated
macular degeneration and in the United States
also for the treatment of macular edema due to central
retinal vein occlusion. Further clinical trials on the treatment
of additional diseases of the ocular fundus are
currently ongoing.
Development of a pharmaceutical product: The long road
research
up to 10,000
substances
In vitro efficacy
tests
250
substances
oscillating, disposable bioreactor: Dr. Uwe Langer from Biotechnology
Development at Bayer HealthCare, developer Jörg Kauling and Annette Waldhelm
from Bayer Technology Services (left to right) check the product quality.
4.7
substances
0 2 4 6 8 10
In the fi eld of women’s health care, Bayer HealthCare
conducts research to discover innovative approaches to
treat gynecological disorders such as endometriosis and
uterine fi broids. The company has launched Visanne
(dienogest), a new treatment option for endometriosis, in
Europe. Bayer HealthCare is also working on further developing
the broad spectrum of contraceptives, ranging
from the development of new, low-dose oral contraceptives
with a fl exible extended dosing regimen through to
a new, low-dose intrauterine system. This long-term
contraceptive with a duration of action of up to three
years was granted regulatory approval in the European
Union (trade name: Jaydess) in December 2012 and in
the United States (trade name: Skyla) in early 2013.
The Medical Care Division conducts R&D into nextgeneration
advances in diabetes monitoring, radiology/
interventional radiology and cardiology to improve the
current portfolio of marketed products. The division
conducts proprietary R&D and also forms strategic
alliances with other companies to share technology and
Preclinical Clinical studies Application
Phase i Phase ii Phase iii
submitted
Efficacy and safety tests,
animal testing with
the final 10 to 20
substances
Tolerability
testing in
healthy human
subjects
3.3
substances
Testing in a
small
number of
patients
1.5
substances
Testing
generally in
several thousand
patients
1.2
substances
Documentation
examined by
regulatory
authorities
Approved
1
substance
12 years