Boehringer Ingelheim Launches Industry’s Largest Thromboembolic Disease Clinical Trial Program to Date

- Dabigatran Etexilate Being Evaluated As Oral Treatment -

Ridgefield, CT - January 24, 2006 – Boehringer Ingelheim announced the launch of the industry’s largest thromboembolic disease clinical trial program to date. This clinical trial program has been initiated to investigate the new oral direct thrombin inhibitor, dabigatran etexilate and is comprised of seven trials that will involve in total more than 27,000 patients worldwide. Dabigatran etexilate is an investigational drug that is under evaluation for the prevention and treatment of thromboembolic disease and was discovered through internal research programs at Boehringer Ingelheim. One of the primary indications being investigated includes stroke prevention in a trial fibrillation (SPAF). Atrial fibrillation is the most common form of cardiac arrhythmia and accounts for 15 percent of all strokes. Patients with atrial fibrillation and one or more additional common risk factors, such as hypertension, diabetes or heart failure, have a five-fold higher risk of stroke compared to the general population.¹

Dabigatran etexilate will also be investigated as a treatment for the prevention of deep vein thrombosis (DVT) after hip or knee replacement surgery, acute DVT treatment, and secondary prevention of DVT. Venous thromboembolism is a common and potentially life-threatening disease. It is estimated that one fifth of patients who develop deep vein thrombosis die of sudden death due to pulmonary embolism.²

“We are hopeful that dabigatran etexilate will provide a therapeutic benefit for a wide range of patients who experience atrial fibrillation and are at a high risk of stroke. The prevention of stroke has a high priority for patients and caregivers, especially in aging populations worldwide. Through the development of Aggrenox® (aspirin/ extended-release dipyridamole) and other stroke-related products, Boehringer Ingelheim has gained a significant amount of knowledge about the prevention and emergency treatment of stroke. The results from this family of trials will undoubtedly help us to build upon this body of medical knowledge,” said Dr. Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for worldwide Research, Development and Medicine.

Currently, the therapeutic options for preventing thromboembolic diseases are very limited. Most anticoagulants are only available in an injectable form, which limits their use in long-term treatment. The most commonly used oral product is warfarin, which has been on the market for more than 50 years. Warfarin requires time consuming and costly monitoring that can significantly impact the quality of life of patients, due to its potential for causing adverse effects when taken with food and other drugs.

An ideal therapy would provide predictable and reliable protection for patients at risk of thromboembolic events, be suitable for long-term use with a low risk of bleeding, and not require coagulation monitoring. It is hoped that through further clinical development, dabigatran etexilate will demonstrate its ability to meet these requirements. Dabigatran etexilate has been successfully investigated in thromboembolic diseases in several Phase II clinical trials involving more than 2,500 patients. It is the most advanced new oral anticoagulant in clinical development.

Further studies investigating dabigatran etexilate
This family of seven, multi-center, randomized global trials is designed to investigate the novel oral direct thrombin inhibitor dabigatran etexilate as a potential treatment for several thromboembolic medical conditions. The trials will involve more than 27,000 patients from Asia, Australia, Europe, the Americas, and South Africa. Patients will be divided into different treatment arms involving dabigatran etexilate compared with warfarin or enoxaparin.

The RE-LY^TM Phase 3 study is designed to investigate dabigatran etexilate as a potential treatment for SPAF. The first patients have been recruited for this study, for which total enrolment is targeted at 15,000 patients from almost 1000 study centers worldwide. The study will use warfarin as a comparative drug and is expected to run for a period of up to three years.

RE-MODEL^TM is a study designed to investigate thromboembolism prevention after knee surgery in 2,000 patients throughout the European Union, South Africa and Australia. RE-MOBILIZE^TM is a study designed to investigate dabigatran etexilate for the same indication in a similar patient population in North America.

RE-NOVATE^TM is a study being conducted in the European Union, South Africa, and Australia that is enrolling approximately 3,300 patients that have completed hip surgery. RE-SOLVE, RE-COVER and RE-MEDY are additional studies expected to start early in 2006 to investigate dabigatran etexilate for the treatment and secondary prevention of venous thromboembolism.

About dabigatran etexilate
Dabigatran etexilate is a promising new oral direct thrombin inhibitor that specifically and reversibly inhibits thrombin, the key enzyme for blood clot formation.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 45 countries and nearly 36,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

Antithrombotic Therapy in Atrial Fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy; published in CHEST 2004;126;429 - 456;
Prevention of Venous Thomboembolism: the Seventh ACCP Conference on Antithombotic and Thrombolytic Therapy; published in Chest 2004; 126; 338 - 400

Contact:

Mark Vincent
Communications & Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: +1 (203) 798-4412