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