New High-Resolution Computer Tomography Data Demonstrates EVISTA(R)'s Effect on Bone Quality in Osteoporotic Patients

MUNICH, June 28, 2010 /PRNewswire/ --

- 3D Images Provide New Approach to Monitoring Bone Changes

Interim data from a prospective Investigator Initiated Trial (IIT) presented today at the ECTS, the 37th European Symposium on Calcified Tissues, in Glasgow, demonstrates that EVISTA(R) (raloxifene 60mg; once-daily, distributed in 34 countries by DAIICHI SANKYO), indicated for the treatment and prevention of osteoporosis in postmenopausal women, improves bone quality as measured by the high-resolution peripheral quantitative computed tomography (HRpQCT). Dr. Radspieler, Investigator of the IIT at the Osteoporosis Diagnostic- und Therapy centre Munich, evaluated prospectively micro-architectural changes of the bone of patients being treated with EVISTA(R) for 15.1 months. The trial showed that, all parameters analysed improved over the treatment period. Exemplary, raloxifene increased volumetric trabecular by 2.9% and 3.9% and cortical bone densities by 1.1% and 0.7% in the radius and the tibia respectively.

Dr. Helmut Radspieler comments: "With the help of 3D images we can now actually see into the micro-structure of bones. This makes it possible to determine the efficacy of different treatments, as shown here with raloxifene." He continues; "We now understand better and are also able to visualise that bone structure and not bone density alone is crucial to retain bone quality".

Bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) is the current gold standard for the diagnosis of osteoporosis, however, it is not as effective in the measurement of the therapeutic effect of an osteoporosis treatment(1). By using a new three-dimensional imaging technique called HRpQCT researchers were able to look inside the bone at the specific bone structure and quality. This provides a new approach to monitoring bone changes, especially while being treated medically for osteoporosis.

It was shown in clinical studies that raloxifene significantly increased BMD by 2% in both osteopenic and osteoporotic postmenopausal women compared to placebo(1). Compared with other osteoporotic drugs the numeric BMD increase with raloxifene is relatively low, although the vertebral fracture risk reduction is similar. The MORE (Multiple Outcome of Raloxifene Evaluation) study demonstrated that EVISTA(R) had a 55% relative risk reduction of vertebral fractures vs. placebo with a 2.4% absolute risk reduction in the risk of 1st vertebral fracture in patients with osteoporosis over 3 years(2). In addition, even the population of patients who lost BMD in the MORE study demonstrated a fracture risk reduction(3). Taking into account that bone strength is determined by both bone density and bone quality, it is assumed that less than 4% of fracture risk reduction is correlated to BMD after raloxifene treatment(3).

About Disease state for product information:

Osteoporosis, meaning 'porous bones' is a progressive disease which increases the risk of fracture, particularly in the spine, wrists and hips due to a reduction in bone strength. Osteoporosis can cause pain, loss of movement, inability to perform daily tasks, and in many cases, death. The declining level of oestrogen results in an increase in bone breakdown (resorption), which can lead to a loss of bone density and hence stability6.

About EVISTA(R):

EVISTA(R) (raloxifene 60mg) is a prescription medication called a Selective Estrogen Receptor Modulator (SERM). It is indicated for the treatment and prevention of osteoporosis in postmenopausal women. It has been shown that raloxifene made bones stronger and less likely to break(4). EVISTA(R) has been taken by up to 30,8 million women worldwide, up to 8 million of them were treated in Europe(5).

About DAIICHI SANKYO

DAIICHI SANKYO is a global pharmaceutical company that focuses on researching and marketing innovative medications. The company was created in 2005 through the merger of two traditional Japanese enterprises, Daiichi and Sankyo. With net sales of nearly 7.3 billion EUR in fiscal year 2009 (as of March 31st) , DAIICHI SANKYO is one of the world's 20 leading pharmaceutical companies. The company's world headquarters is in Tokyo, its European base is located in Munich. DAIICHI SANKYO has affiliates in 12 European countries and has been one of the strongest Japanese pharmaceutical companies located in Europe since it set up European production facilities and marketing offices in 1990. The company's research activities focus on the areas of cardiovascular diseases, hematology, anti-infectives and cancer. Its aim is to develop medications that are "best" in their class or to create new classes of pharmaceutical drugs. For more information, please visit: http://www.daiichi-sankyo.eu

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO EUROPE GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

1. Evista Summary of Product Characteristics. Latest Update: August 2008

2. Delmas PD, Ensrud KE, Adachi JD et al (2002) Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J Clin Endocrinol Metab. Aug;87(8)

3. Sarkar S, Mitlak BH, Wong M et al (2002) Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res. Jan;17(1):1-10.

4) Maricic M, Adachi JD, Sarkar S, Wu W, Wong M, Harper KD, (2002) Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis. Arch Intern Med.;162(10 ):1140-3

5. Periodic safety Update Report, PSUR 19 Global (10-June-2009 TO 09-December 2009)/ Data on File

6. Condren L. As oestrogen declines. World of Irish Nursing. 2002; 10(3); 31-32

http://www.inmo.ie/INMOPage_8_66.aspx last access 06.05.2010

SOURCE Daiichi-Sankyo