CHMP issues positive opinion for Micardis® (telmisartan) as the first treatment in its class to reduce the risk of cardiovascular (CV) morbidity in high CV risk patients

Ingelheim/Germany, 23 October 2009 - Boehringer Ingelheim announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion for the approval of Micardis® (telmisartan) for the reduction of cardiovascular morbidity in patients with:
I. manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
II. type 2 diabetes mellitus with documented target organ damage.

The CHMP opinion follows a review of clinical trial results including 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.¹ 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 to receive this positive opinion from the CHMP. This is an important development that will help physicians ensure that patients receive appropriate treatment tailored to their individual needs. If approved, Micardis® will offer a much needed alternative to ACE inhibitors in the treatment of patients with high CV risk.

Earlier this week, the US Food and Drug Administration (FDA) approved Micardis® 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.

• Cardiovascular disease is responsible for nearly one in three deaths worldwide and is the number one cause of death ³

• CVD causes nearly half of all deaths in Europe (48%) and in the EU (42%). ⁴ About half of all deaths from CVD are from coronary heart disease and nearly one-third are from stroke ⁵

• 15 million people each year suffer strokes and 5 million are left permanently disabled ⁶

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.

Notes to editors
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.

About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and was investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET™, PROTECTION™ and PRoFESS®, over 58,000 patients were enrolled to investigate the efficacy and cardiovascular protective effects of telmisartan.

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and MicardisPLUS® (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer Schering Pharma in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis®, Bayer Schering Pharma promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor® and PritorPlus® are also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET™ Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer Schering Pharma and GlaxoSmithKline.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 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.