INGELHEIM, Germany–(Business Wire)–
For NON-US Medical Media Only

Telmisartan, an angiotensin receptor blocker, is one of the best researched
drugs worldwide. It has been studied in clinical trials in more than 50,000
patients. Its positive safety profile has been confirmed also in a market
exposure of 34.5 million patient years. Convincing safety data for patients with
a high cardiovascular risk were collected in the three long-term outcome trials
ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to
five years. Following rigorous assessment of the data from these studies it was
concluded that there was no association with an increased risk of cancer in the
telmisartan arms.

Sipahi et al published a meta-analysis in the June issue of Lancet Oncology,
claiming that angiotensin receptor blockers (ARBs) used to lower hypertension
are associated with a modestly increased risk of new cancer diagnosis. The
finding is mainly based on the combination arm of telmisartan and ramipril, an
angiotensin converting enzyme (ACE)-inhibitor, and not on the trial arms of each
compound separately.

Patient health and safety is the primary concern of Boehringer Ingelheim. The
company continually monitors safety data for all medical products. Boehringer
Ingelheim`s comprehensive internal safety data analysis of primary data
contradicts the conclusions about an increased risk of potential malignancies
mentioned by Sipahi et al.

All studies1 with telmisartan included patients with cardiovascular risk factors
due to age and comorbidities. Specifically, in ONTARGET, with more than 25.000
patients, no statistically significant difference with respect to malignancies
was observed in patients treated with telmisartan vs ramipril. In TRANSCEND, a
6,000 patient trial, the difference did not reach significance either. In the
PRoFESS trial, another large-scale trial with more than 20,000 patients, the
telmisartan arm showed fewer cases of malignancies than the placebo arm.
Considering the analysis of all three trials an effect of telmisartan on
malignancies was not observed.

In ONTARGET, the one treatment arm with a combination of telmisartan and
ramipril was associated with a modestly increased risk of malignancies.
Consistent with our commitment to transparency, data from ONTARGET, TRANSCEND
and PROFESS have all been published and been widely shared with regulatory
authorities since 2008. It should be noted that product labelling for
telmisartan does not recommend the combination of telmisartan and ACE-inhibitors
such as ramipril.

“Our research efforts have centred on the need to protect patients, especially
older patients from cardiovascular risks such as myocardial infarction or
stroke. Telmisartan fulfills this need. It is the only ARB which has
cardiovascular protection in its label and has become a valuable treatment
option in the management of hypertension and cardiovascular risk. Doctors and
patients appreciate its excellent safety profile. In pre-clinical trials,
clinical trials and day-to-day patient exposure with telmisartan, we have not
seen any significant finding related to malignancies. Patients should consult
with their physicians before making any decision regarding their
antihypertensive therapy,” said Prof. Dr Klaus Dugi, Corporate Senior Vice
President Medicine at Boehringer Ingelheim.

Peer-reviewed meta-analyses of aggregate published data like Sipahi et al have
their appropriate place in scientific research. However, these analyses have
well-recognised limitations, such as combining study summaries rather than
analyzing individual patient data.

Telmisartan is one of the most studied anti-hypertensives in clinical trials,
which have all been made publically available. It is widely used as medication
to lower blood pressure and protect patients against severe cardiovascular
events such as myocardial infarction and stroke.

Notes to editors

Specifically, in ONTARGET, no statistically significant difference with respect
to malignancies was observed in patients treated with telmisartan vs ramipril
(HR 1.05, 95%CI 0.94, 1.16). In TRANSCEND, the difference did not reach
significance either (HR 1.17, 95%CI 0.97, 1.41). In the PRoFESS trial the
placebo arm showed more cases of malignancies than the telmisartan arm (HR 0.92,
95%CI 0.79, 1.06). *

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world`s 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 138
affiliates in 47 countries and 41,300 employees. Since it was founded in 1885,
the independent, family-owned company has been committed to researching,
developing, manufacturing and marketing novel products of high therapeutic value
for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

* Data on file

Boehringer Ingelheim GmbH
Corporate Communications
Media + PR
Ute E Schmidt, +49 6132 779 7296
press@boehringer-ingelheim.com

Copyright Business Wire 2010