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

Munich, June 28, 2010 (ots/PRNewswire) - 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

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: Contact: Dr. Iris Marr, International Brand Management,
Phone+49(0)89-78-08-807, iris.marr@daiichi-sankyo.eu. Dr.
MichaelaPaudler-Debus, Corporate Communications and Public Affairs,
Phone+49(0)89-78-08-685, michaela.paudler-debus@daiichi-sankyo.eu