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Glenmark's Novel Molecule for Diabetes, Melogliptin to Enter Phase III Trials
Date:6/24/2009

    Release Highlights

    - Melogliptin continues to demonstrate potential to be the
      best-in-class in achieving glycemic control with low incidence of
      hypoglycemia and neutral effect on body weight

    - Global Phase III trials likely to start by end 2009

    - IND approved by USFDA

    - Glenmark takes a step closer towards becoming the first
      Indian company to have a truly global innovative drug for the world

In the recently completed 12 week Phase IIb clinical trial in 494 patients with type 2 diabetes mellitus (T2DM), 'Melogliptin', Glenmark's investigational medicine from a new class of diabetes treatments called dipeptidyl peptidase 4 (DPP-4) inhibitors, improved glycemic control in patients with type 2 diabetes mellitus and exhibited excellent safety and tolerability profile. In addition, patients taking Melogliptin experienced low incidence of hypoglycemia and neutral effect on body weight.

In this 12-week, randomized, double-blind, placebo-controlled, parallel group study, Melogliptin significantly reduced HbA1c from baseline as compared to placebo with a mean average reduction of 0.75% in patients receiving 50mg twice daily dose (p<0001) and 0.60 % in patients receiving 100 mg once daily dose (p<.0001).

In a subgroup of patients with higher baseline HbA1c of 8.5%-10%, Melogliptin reduced HbA1c from baseline as compared to placebo with a mean average reduction of 0.88 % and 1.05 % in patients receiving 100mg once daily dose and 50mg twice daily dose respectively, which compares favorably to reported results of other DPP-4's.

The Phase IIb results for Melogliptin demonstrate potential for offering class leading improvements in glycemic control and metabolic function. Glenmark recently received IND approval from the USFDA to carry out a clinical study in the US. Glenmark continues to be in discussions with various licensing partners
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SOURCE Glenmark Pharmaceuticals Ltd.
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