News Release

Yamanouchi Pharmaceutical Co., Ltd.

Nippon Boehringer Ingelheim and Yamanouchi Launched "MICARDIS Capsule 20mg and 40mg," a New Long Acting Angiotensin II Receptor Blocker
-24 Hours Action of it Ensures Blood Pressure Controlling in the Early Morning-

December 9,2002

Nippon Boehringer Ingelheim Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. announced today a sales commencement of "MICARDIS Capsule 20mg and 40mg" from 10 December. MICARDIS was approved on 8 October 2002, followed by its drug price listed on 6 December with the price of 193.80 yen for Capsule 40mg and 101.10 yen for Capsule 20mg. MICARDIS , manufactured by Nippon Boehringer Ingelheim, is distributed through Yamanouchi channel, while medical information activities are collaboratively conducted by both companies in the form of co-promotion in Japan.

MICARDIS is a new once daily oral administration anti-hypertension drug of ARB (Angiotensin II Receptor Blocker) class. 24 hours action of MICARDIS , unique amongst the ARB class, ensures blood pressure controlling in the early morning when patients have an elevated risk for cardiovascular events. It is also favourably administrated to patients with renal dysfunction, which in many cases complicates with hypertension, because of its unique hepatic/bilary metabolism without involvement of the kidneys.

It is estimated that less than half amongst some 30 millions of hypertension patients are under medical treatment in Japan. Treatment goal of hypertension is to prevent damages in important organs such as brain, heart and kidney. Therefore long acting treatment, which well controls blood pressure in the early morning when patients have an elevated risk for cardiovascular events, is highly expected. MICARDIS , as a long acting ARB, is expected to meet such medical needs. Also, it has recently been prevailed that the hormonogenesis mechanism called renin-angiotensin system has to do with a mechanism to cause an organ dysfunction besides controlling blood pressure. Accordingly, hypertension treatments that inhibit renin-angiotensin system, including ARBs, have been confirmed to have high organ protective features.

Akio Ohsawa, President of Nippon Boehringer Ingelheim commented on sales commencement of MICARDIS , "MICARDIS , with its distinguishing features from other anti-hypertension agents, will provide patients and physicians with a new and favourable treatment option for hypertension. We believe success of a product can be attained through pharmaceutical companies' commitment to provide favourable treatment to patients. Both companies will collaboratively devote themselves to the market with such commitment shared."

Toichi Takenaka, President of Yamanouchi expressed his expectations on MICARDIS saying, "we will provide this innovative treatment that meets medical needs through medical information activities conducted by more than 2,000 medical representatives of both companies together. MICARDIS will be quickly and effectively promoted with a banner, "Good Morning MICARDIS ", clearly defining the benefit of the product."

MICARDIS is on the market in over 65 countries, including the U.S.A. and European countries. The global sales of MICARDIS has been rapidly growing since its initial launch in the U.S. in 1998. Large-scale long-term clinical trials, ONTARGET, TRANSCEND and PROTECTION, are conducted globally to see effects of MICARDIS in protecting patients from cardiovascular disease and death, progression of renal dysfunction amongst other endpoints. Dr. Thomas Kuerner, Director and General Manager of Medical Development at Nippon Boehringer Ingelheim commented, "with those clinical trials, MICARDIS is expected to become the most extensively investigated ARB in the years to come. In Japan we are planning to conduct clinical trials so as to bridge future foreign data."


<Product Profile of MICARDIS Capsule 20mg and 40mg>

Generic name: telmisartan

Indication: hypertension

Dosage and Administration: Usually for adults, 40mg of telmisartan is orally administered once a day. The starting dose should be 20mg daily and the dose should be increased gradually. The dosage should be adjusted according to the patient's age and symptom but the maximum daily dose should be 80mg.

Product profiles:
1:

24 hours action of it ensures blood pressure controlling in the early morning when patients have an elevated risk for cardiovascular events

2:

20-24 hours elimination half-life of it is specifically long amongst ARBs.

3:

It works through inhibiting the vasoconstriction effect of angiotensin II type 1 (AT1) subtype receptor. It showed high affinity for AT1 receptor and did not easily disassociate.

4:

Its hepatic/bilary metabolism without involvement of the kidneys ensures favourable administration of it to patients with renal dysfunction.

5:

The cytochrome P450 isoenzymes is not involved in its metabolism.

6:

In studies conducted until the approval, adverse reactions to this product, including abnormal laboratory tests were observed in 134 (22.6%) of 593 cases. Major adverse reactions are dizziness, ALT (GPT) and sleepiness. Clinically significant adverse reactions reported are angioedema, hyperkalemia, renal dysfunction, syncope/unconsciousness, and hepatic dysfunction/jaundice.

7:

It is on the market in over 65 countries. Large-scale long-term clinical trials, ONTARGET, is conducted globally to see effects of it in protecting patients from cardiovascular disease and death, progression of renal dysfunction amongst other endpoints


Packaging (for both Capsule 20mg and Capsule 40mg):
140 capsules (14 capsules x 10) PTP
500 capsules (10 capsules x 50) PTP
700 capsules (14 capsules x 50) PTP
Bottle of 250 capsules

Drug price:
193.80 yen for Capsule 40mg
101.10 yen for Capsule 20mg


Date of initial marketing in Japan:10 December 2002

Distributed by: Yamanouchi Pharmaceutical Co., Ltd.

Manufactured by:Nippon Boehringer Ingelheim Co., Ltd.


<Company Prcofiles>

Nippon Boehringer Ingelheim Co., Ltd. (www.boehringer-ingelheim.co.jp)
Establishment: June 1961
Head Office: 3-10-1, Kawanishi-shi, Hyogo, Japan
President: Akio Ohsawa
Annual Net Sales: 79.3 billion yen (January-December 2001)
Number of Employees: 1,602 (as of December 2001)
Major Business: o Research & development, import, manufacturing, and marketing of pharmaceuticals
  o Import/export and marketing of pharmaceutical active ingredients and intermediates

Boehringer Ingelheim GmbH (www.boehringer-ingelheim.com)
Establishment: 1885
Head Office: Ingelheim, Germany
Representative: Prof. Rolf Krebs (Chairman of the Board)
Consolidated Net Sales: EUR 6,694 million (January-December 2001) / about 728 billion yen
Consolidated Number of
Employees:
About 28,000
Major Business: Research & Development, manufacturing, and marketing of prescription medicine, consumer healthcare products, animal health product, bio-pharmaceuticals, and chemicals
Operation Sites: 143 affiliated companies around the world

Yamanouchi Pharmaceutical Co., Ltd. (www.yamanouchi.com)
Establishment: April 1923
Head Office: 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan
President: Toichi Takenaka
Consolidated Net Sales: About 480 billion yen (April 2001-March 2002)
Consolidated Number of
Employees:

About 8,900 (as of end September 2002, consolidated)
Major Business: Developing, manufacturing, and import, export, and marketing pharmaceuticals, consumer health care, foods, medical equipment