FDA Approves TWYNSTA® (telmisartan plus amlodipine) a New Single Pill Combination That Delivers Powerful and Consistent Blood Pressure Reductions Throughout 24 Hours

* TWYNSTA® delivers very powerful blood pressure (BP) reductions of up to 40/29
mmHg1 and a 24-hour BP response rate of up to 98%2 for hypertensive patients at
risk of cardiovascular (CV) events
* TWYNSTA® combines the proven evidence base in CV outcomes of telmisartan and
amlodipine3-9 in a convenient single pill
* TWYNSTA® achieves superior BP reductions compared to amlodipine 10mg and is
significantly better tolerated with 71% less peripheral oedema.10

INGELHEIM, Germany--(Business Wire)--
Boehringer Ingelheim announced today that the US Food and Drug Administration
(FDA) has approved TWYNSTA®, a new highly effective single pill combination
therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a
calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of
hypertension, alone or with other antihypertensive agents, and as initial
therapy in patients who are likely to need multiple drugs to achieve their blood
pressure goals.

This new combination benefits from the complementary modes of action of
long-lasting angiotensin receptor- and calcium channel-blockade. This provides
powerful efficacy in 24-hour BP reduction and control10-17 and combines it with
the proven evidence base in cardiovascular (CV) outcomes3-9 of both telmisartan
and amlodipine. Telmisartan is the only ARB with proven evidence to reduce CV
death, myocardial infarction (heart attack) and stroke beyond the effect of BP
reduction in a wide range of patients at risk of CV events.3-4 In the US, it is
the only ARB indicated for CV risk reduction in patients who are unable to take
ACE-inhibitors.18

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department
of Clinical Medicine of the University of Milan, Bicocca, Italy said, "In
hypertensive patients, treatment tolerance and compliance are significant
issues. The data for this combination of telmisartan and amlodipine show that it
is effective and well tolerated in a range of more complex, difficult-to-treat
patients as well as in those whose BP was previously not controlled on
monotherapy. This combination provides a valuable and important new option for
patients and physicians, particularly as it includes two components, telmisartan
and amlodipine, each with clinically proven CV protection in patients at
CV-risk."

The FDA approval of TWYNSTA® is based on the results of one placebo-controlled
and two active-controlled trials involving a total of 3,505 patients with stage
1 or stage 2 hypertension.*20-21 These trials demonstrated that TWYNSTA®
provided powerful BP lowering that was sustained for at least 24-hours, and was
also effective and well-tolerated in hypertensive patients at risk of CV events,
including patients with Type 2 diabetes, elderly and obese patients.

Professor Klaus Dugi, Corporate Vice President Medical Affairs, Boehringer
Ingelheim, commented, "We are delighted with the approval of TWYNSTA® and
believe that, with its excellent safety profile and demonstrated efficacy,
TWYNSTA® will help physicians and patients to overcome common barriers to
effective blood pressure control, such as treatment adherence."

TWYNSTA® will be available in the US from November 2009 in a flexible range of
dosing regimens (40/5mg, 40/10mg, 80/5mg, 80/10mg) enabling physicians to tailor
treatment to individual patient needs.

TWYNSTA® has recently also been submitted for approval in Europe and Japan, and
is on schedule to be submitted in other countries around the world. Boehringer
Ingelheim is committed to make this valuable new therapeutic option available to
patients and health care providers as soon as possible after Marketing
Authorisation approval is obtained.

To view `Notes to Editors` and references, click on the link below:

http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=6996

* Stage 1 hypertension, SBP mmHG 140-59 or DBP mmHG 90-99; Stage 2 hypertension
SBP mmHG >160 or DBP >10019

Boehringer Ingelheim GmbH
Corporate Division Communications
Phone: + 49 - 6132 - 77 90815
Fax: + 49 - 6132 - 72 6601
E-mail: reinhard.malin@boehringer-ingelheim.com

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