May 9, 2011
Dainippon Sumitomo Pharma Co., Ltd.

Dainippon Sumitomo Pharma announces the launch of SUREPOST® , a rapid-acting insulin secretagogue

Dainippon Sumitomo Pharma Co., Ltd. (DSP, Headquarters: Osaka, Japan; President: Masayo Tada) launches “SUREPOST® tablet 0.25 mg” and “SUREPOST® tablet 0.5 mg” (generic name: repaglinide), a rapid-acting insulin secretagogue, in Japan as of May 16, 2011.

SUREPOST® is a rapid-acting insulin secretagogue that binds to the sulfonylurea receptors in the pancreatic beta cells to stimulate the postprandial insulin secretion rapidly, thereby ameliorating postprandial blood glucose and lowering HbA1c in type 2 diabetes patients.

SUREPOST® is approved and marketed in over 90 countries worldwide, under the brand name “Prandin®” in the United States and “NovoNorm®” in European countries. In Japan, DSP took over development of the drug from Novo Nordisk and began clinical studies in 2004.

In clinical studies in patients with type 2 diabetes in Japan, as monotherapy as well as in combination with alpha-glucosidase inhibitors, SUREPOST® was found to be an effective and safe drug for reducing excessive postprandial glucose levels and substantially lowering HbA1c.

DSP promotes several products which have different mechanisms of action for type 2 diabetes, including METGLUCO®, a biguanide oral hypoglycemic drug, SEIBULE®, an alpha-glucosidase inhibitor, and GLIMICRON®, a sulfonylurea oral hypoglycemic. As a result of the launch of SUREPOST®, DSP expects to increase its line-up of products for type 2 diabetes and further contribute to therapy for this disease expanding the therapeutic options for patients.

Contact:
Corporate Communications
Dainippon Sumitomo Pharma
TEL +81-6-6203-1407

Reference
Profile of “SUREPOST®”

[Brand Name]
SUREPOST® tablet 0.25 mg
SUREPOST® tablet 0.5 mg
[Generic Name]
repaglinide
[Content / Description]
SUREPOST® tablet 0.25 mg: Each tablet contains 0.25 mg of repaglinide
SUREPOST® tablet 0.5 mg: Each tablet contains 0.5 mg of repaglinide
[Indication]
The reduction of postprandial blood glucose in patients with type 2 diabetes
SUREPOST® is to be used only when adequate effectiveness of either of the following treatments is not obtained:
(1) Diet and exercise alone or
(2) An alpha glucosidase inhibitor with diet and exercise
[Characteristics]
1.SUREPOST® is a cholekinetic rapid-acting insulin secretagogue.
2.It lowers HbA1c by 1.１7% in monotherapy (16 weeks).
3.In monotherapy and combination with alpha-glucosidase inhibitors, it reduced excessive postprandial glucose levels and lowered HbA1c, and the effect was maintained.
4. It is approved in over 90 countries worldwide (as of June, 2010).
[Day of Approval]
January 21, 2011
[Day of NIH price listing]
March 11, 2011
[List price]
32.50 yen / one 0.25 mg tablet
57.80 yen / one 0.5 mg tablet
[Packages]
SUREPOST® tablet 0.25 mg : [PTP] 100 tablets (10 tablets x 10), 500 tablets (10 tablets x 50)
SUREPOST® tablet 0.5 mg : [PTP] 100 tablets (10 tablets x 10), 500 tablets (10 tablets x 50)