FDA Approves MICARDIS® (Telmisartan) As the First Treatment in its Class to Reduce the Risk of Heart Attack, Stroke, or Death from Cardiovascular Causes...

FDA Approves MICARDIS® (Telmisartan) As the First Treatment in its Class to
Reduce the Risk of Heart Attack, Stroke, or Death from Cardiovascular Causes in
Patients at High Cardiovascular Risk Who Are Unable to Take ACE Inhibitors

MICARDIS® is now indicated for cardiovascular (CV) risk reduction in patients
who are unable to take angiotensin-converting enzyme (ACE) inhibitors

* Boehringer Ingelheim`s MICARDIS® (telmisartan) is the ONLY treatment in its
class approved by the US Food and Drug Administration (FDA) in patients at high
CV risk who are unable to take ACE inhibitors
* MICARDIS® is the first indicated treatment option in its class to prevent
serious CV events in patients at high CV risk who are unable to take ACE
inhibitors
* This new indication is based on The ONTARGET Trial results which showed that
MICARDIS® may prevent one in five serious CV events or death from cardiac
causes.

INGELHEIM, Germany--(Business Wire)--
Boehringer Ingelheim announced today that the US Food and Drug Administration
(FDA) has approved a new indication for MICARDIS® (telmisartan) for the
reduction of the risk of myocardial infarction (heart attack), stroke, or death
from cardiovascular (CV) causes in patients 55 years of age or older at high
risk of developing major CV events who are unable to take ACE inhibitors.
MICARDIS® is the first treatment in its class to be approved for this
indication.

The FDA approval is based upon clinical trial results from The ONTARGET Trial
involving 25,620 patients and confirmed MICARDIS® as the only treatment option
in its class with proven cardiovascular protective effects in patients with high
CV risk. The results also demonstrated that MICARDIS® is better tolerated than
the previous gold standard ramipril and associated with higher treatment
adherence.1-2

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer
Ingelheim, commented, "We are delighted with this new indication for MICARDIS®,
which will provide both physicians and their patients who are at risk of
cardiovascular events with a much needed alternative to ACE inhibitors.
Approximately one in four patients are unable to tolerate an ACE inhibitor. Now,
these patients can be confident that with MICARDIS®, they have a proven,
effective and well tolerated option to reduce their risk of severe CV events."

The Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Evaluation Agency (EMEA) is currently reviewing a similar submission
for MICARDIS® in Europe. The recommendation from the CHMP is expected in
November.

* Cardiovascular disease (CVD) is responsible for nearly one in three deaths
worldwide and is the number one cause of death3
* Every year, nearly 900,000 Americans die from CVD. This is equivalent to
around 2,300 deaths every day or two every minute4
* 80 million Americans currently suffer from one or more forms of CVD4 - more
than the total population of France5
* CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%).6
About half of all deaths from CVD are from coronary heart disease and nearly
one-third are from stroke.7

MICARDIS® is one of the most studied antihypertensives in clinical trials and is
widely used with over five million patient years since its approval. Its safety
profile is similar to that of placebo.

~ENDS~

To view `Notes to Editors` and References, please click on the link below:
http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=6977

Photos/Multimedia Gallery
Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6076252&lang=en

Boehringer Ingelheim GmbH
Dr Reinhard Malin, +49-6132-77-35-82
Fax: +49-6132-77-66-01
E-mail: press@boehringer-ingelheim.com

Copyright Business Wire 2009