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Intarcia Presents Positive ITCA 650 Phase 2 Study Results for Type 2 Diabetes at EASD
Date:9/22/2010

40 mcg/day

60 mcg/day

80 mcg/dayMean baseline HbA1c (%)

7.96

7.79

8.05

8.03Mean week 24 HbA1c (%)

7.07

6.93

6.67

6.67Mean HbA1c change at week 24

-0.89

-0.86

-1.38

-1.36HbA1c  < 7% at week 24

60%

71%

73%

79%Mean weight change at week 24 (lbs)

-1.8

-7.9

-6.8

-7.7"The reductions in HbA1c and weight are substantial, especially for a group of patients on metformin-only background therapy with baseline HbA1c levels at 8.0 percent.  We look forward to evaluating optimized dose regimens of ITCA 650 in broader patient populations in the phase 3 program," Graves said.

ITCA 650 therapy in the phase 2 trial was administered for the 90-day treatment period with a single insertion of ITCA 650 on day 1 and removal on or around day 90. The extension phase of the 2 trial evaluated higher doses of ITCA 650 using a single device to deliver 3 months of treatment. The phase 3 study planned for early 2011 will evaluate treatment regimens involving initial 12-week ITCA 650 dosing at 20 mcg/day transitioning to 60 mcg/day thereafter using even longer duration ITCA 650 devices.

A downloadable version of the ITCA 650 phase 2 presentation from EASD is available on the Intarcia corporate website at: http://www.intarcia.com/media_presentations.html

About ITCA 650ITCA 650 therapy for type 2 diabetes consists of DUROS continuous subcutaneous delivery of exenatide. The DUROS delivery technology comprises the DUROS device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy. Intarcia's proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature for extended periods of time.

The DUROS technology can
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SOURCE Intarcia Therapeutics, Inc.
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