AMSTERDAM, September 19 /PRNewswire/ --

- For Non-US Media Only

New research, including two studies presented this week at the 43rd
Annual Meeting of the European Association for the Study of Diabetes (EASD),
further support the cardiovascular safety of ACTOS(R) (pioglitazone HCI) and
its benefits regarding improved blood glucose and blood lipid levels for
patients with type 2 diabetes. The unique outcomes, including some clinical
practice results, reinforce the consistency of pioglitazone data and
underscore that ACTOS(R) has different effects from the other
thiazolidinedione rosiglitazone due to differences in molecular structure.

New research(1) presented at EASD has shown that therapies which include
pioglitazone are associated with significant reductions in the risk of stroke
or myocardial infarction (MI) compared to non-thiazolidinedione therapies.
This retrospective analysis of case records from a large managed care
database of diabetes patients have shown that the adjusted relative risk of
stroke for the pioglitazone group was 20 percent lower than the group not
receiving pioglitazone. Likewise, the risk of heart attack over the study
period was 38 percent lower in patients receiving pioglitazone than in those
taking an anti-diabetes drug regimen that did not include pioglitazone. John
Betteridge, Professor of Endocrinology and Metabolism at University College,
London said: "The results of this analysis are very welcome and support the
findings from the PROactive study of pioglitazone for secondary prevention of
vascular events which showed a reduction in stroke and heart attack in this
high risk population."

In addition, the GLAI study(2), also presented at EASD, further reflects
the cardioprotective strength of pioglitazone. A new analysis of data from
the first three months of this six-month head-to-head study of pioglitazone
and rosiglitazone, in which the endpoint was the change in serum lipids,
demonstrated that initial treatment with a starting dose of pioglitazone (30
mg) was more effective than a starting dose of rosiglitazone (4 mg) in
improving blood glucose (HbA1c) levels and lipid levels. Also, researchers
found that in addition to lowering HbA1c significantly more than
rosiglitazone, pioglitazone also significantly decreased triglyceride levels
and non-HDL cholesterol (a predictor of cardiovascular death), and markedly
improved HDL-C levels ("good" cholesterol) versus rosiglitazone. "A likely
explanation for the different effects on heart attack and strokes between the
two drugs could be the favourable effect of pioglitazone in increasing HDL
cholesterol without adverse effects on LDL as demonstrated in the GLAI
study," said Professor Betteridge.

The data presented at EASD add weight to a growing body of evidence
including newly published findings from a large retrospective cohort trial
published recently in the journal of Pharmacoepidemiology and Drug Safety(3),
which showed that pioglitazone is associated with a 22 percent relative risk
reduction of hospitalization for acute myocardial infarction in patients with
type 2 diabetes compared to rosiglitazone. In addition, they correlate with
findings from a meta analysis published in the Journal of the American
Medical Association(4) which demonstrated that pioglitazone reduces the risk
of heart attack, stroke or death by 18 percent in patients with type 2
diabetes.

Notes to Editors

About pioglitazone

Pioglitazone was approved by the European Medicines Agency for the 
treatment  of type-2 diabetes in October 2000. The original label was most 
recently  extended in January 2007. In Europe, pioglitazone is indicated in 
the  treatment of type 2 diabetes mellitus as:

monotherapy

- in patients (particularly overweight patients) inadequately controlled
by diet and exercise for whom metformin is inappropriate because of
contraindications or intolerance

dual oral therapy in combination with

- metformin, in patients (particularly overweight patients) with
insufficient glycaemic control despite maximal tolerated dose of monotherapy
with metformin

- a sulphonylurea, only in patients who show intolerance to metformin or
for whom metformin is contraindicated, with insufficient glycaemic control
despite maximal tolerated dose of monotherapy with a sulphonylurea.

triple oral therapy in combination with

- metformin and a sulphonylurea, in patients (particularly overweight
patients) with insufficient glycaemic control despite dual oral therapy.

Pioglitazone is also indicated for combination with insulin in type 2
diabetes mellitus patients with insufficient glycaemic control on insulin for
whom metformin is inappropriate because of contraindications or intolerance

Takeda also manufactures Competact(R) which combines two widely used
diabetes treatments (metformin and pioglitazone) in a convenient single
tablet, to be taken twice daily. COMPETACT(R) was first launched in Europe in
October 2006.

Competact(R) 15mg/850mg tablets contains 15mg pioglitazone as
hydrochloride and 850mg of metformin hydrochloride. Indication: Treatment of
type 2 diabetes mellitus patients, particularly overweight patients, who are
unable to achieve sufficient glycaemic control at their maximally tolerated
dose of oral metformin alone.

About PROactive

PROactive (5) was a prospective, randomized,
placebo-controlled outcomes trial. The PROactive study included 5,238
patients with type 2 diabetes and a history of macrovascular disease, who
were force titrated up to 45 mg daily of either ACTOS or placebo. (5) In this
study, there was no difference in the number of macrovascular events between
standard of care and ACTOS, and standard of care alone. Although the study
failed regarding its primary endpoint, which was a composite of all-cause
mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome,
major leg amputation, coronary revascularisation and leg revascularisation,
the results suggest that there are no long-term cardiovascular concerns
regarding use of pioglitazone.

The ACTOS Summary of Product Characteristics was recently revised by the
EMEA to include this reassuring cardiovascular safety data. ACTOS is the only
thiazolidinedione (TZD) with safety data from a cardiovascular outcomes trial
in its label.

About Takeda in Europe

Takeda Pharmaceuticals Europe Ltd, based in London, UK, supervises the
overall business activities of Takeda's subsidiaries in Europe through
promoting pan-European strategies.

Takeda Global Research & Development Center, Inc., based in Deerfield,
Ill., USA, and London, U.K., is a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited and is responsible for Takeda's clinical
research and development in the U.S. and Europe.

Takeda Pharmaceutical Company Limited, located in Osaka, Japan, is a
research-based global company with its main focus on pharmaceuticals. As the
largest pharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to striving toward better health for
individuals and progress in medicine by developing superior pharmaceutical
products. Additional information about Takeda is available through its
corporate website, http://www.takeda.com

ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda
Pharmaceutical Company Limited.

(1) Y. Xu et al Risk of Stroke and Myocardial Infarction Are Reduced in
Patients with Type 2 Diabetes Treated with Pioglitazone: Results of a
Retrospective, Claims-Based Study. PS130 / Abstract #1257. Presented at EASD
on 18 September, 2007.

(2) T McCall et al. Effects of 30 mg of Pioglitazone vs 4 mg of
Rosiglitazone on Hyperglycemia and Dyslipidemia: Results from a Head-to-Head
Trial. PS80 / Abstract #0865. Presented at EASD on 19 September, 2007.

(3) Gerrits et al. A comparison of pioglitazone and rosiglitazone for
hospitalization for acute myocardial infarction in type 2 diabetes.
Pharmacoepidemiology and drug safety. 2007. Available online at
http://www.interscience.wiley.com. [Last accessed 6 September 2007].

(4) Lincoff et al. Pioglitazone and the risk of cardiovascular events in
patients with type 2 diabetes mellitus. JAMA. 2007; 298 (10):1216-1218

(5) JA Dormandy et al. Secondary prevention of macrovascular events in
patients with type 2 diabetes in the PROactive study (PROspective
pioglitAzone clinical trial in macroVascular events) a randomised controlled
trial. Lancet. 2005. 366:1279-89.

Contacts:

    Alison Wright
    Ketchum London
    +44-20-7611-3662 (office)
    +44-78-3573-4143 (mobile)

    Charlotte James
    Ketchum London
    +44-20-7611-3866 (office)
    +44-7771-568-915 (mobile)