Intarcia Therapeutics, Inc. Commences Enrollment of ITCA 650 Phase 2 Study in Type...

Intarcia Therapeutics, Inc. Commences Enrollment of ITCA 650 Phase 2 Study in
Type 2 Diabetes
Head-to-head comparison of DUROS(R) continuous delivery of exenatide vs.
twice-daily Byetta(R) (exenatide) injections over 3-month treatment duration

HAYWARD, Calif., Sept. 17 /PRNewswire/ -- Intarcia Therapeutics, Inc. today
announced the start of enrollment for a phase 2 study comparing its
proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide)
with Byetta, an FDA-approved twice-daily injection form of exenatide.
Building upon the successful completion of a 28-day phase 1b study of ITCA 650
in May of this year, the phase 2 study is intended to evaluate the doses
achieving the best results in the phase 1b in a larger study population and
for a longer duration of treatment. In addition, an extension phase of the
phase 2 study will evaluate dose response of ITCA 650. Patients receiving
Byetta for the first 12 weeks will be switched from Byetta to one of two doses
of ITCA 650 to evaluate the potential for improving treatment effect.

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"We are very pleased with the rapid progress and positive results achieved
thus far in the ITCA 650 program" said Ken Luskey, MD, VP, Clinical Research
for Intarcia. "In 2009, we expect to move the ITCA 650 program from
IND-filing through completion of phase 2 enrollment."

The ITCA 650 phase 2 study will involve 150 patients with sub-optimally
controlled type 2 diabetes treated with metformin. Patients will be recruited
at 50 clinical trial sites in the US and will be randomized equally to receive
one of two doses of ITCA 650 or twice-daily injections of Byetta. Upon
completion of the 12-week course of treatment, patients on all three arms will
be further randomized to receive higher doses of ITCA 650 for an additional 12
weeks. The extension phase will evaluate efficacy and tolerability of higher
doses of ITCA 650, as well as the effects of switching patients from
twice-daily injections of Byetta to ITCA 650. The study will provide important
information to support dose selection for ITCA 650 phase 3 evaluation,
anticipated to begin in the second half of 2010. Additionally, this phase 2
study will provide important insights into future clinical use of ITCA 650
with respect to switching patients from injectable Byetta therapy to ITCA 650.

"We have received strong interest in the ITCA 650 program since the
late-breaker presentation of preliminary phase 1b study results at the
American Diabetes Association Conference in June" said K. Alice Leung,
President and CEO of Intarcia. "We intend to select a commercial partner for
ITCA 650 prior to the start of phase 3 in the second half of 2010."

About ITCA 650
ITCA 650 therapy for type 2 diabetes consists of DUROS continuous delivery of
exenatide. The DUROS delivery technology comprises the proprietary DUROS
device, a matchstick-size miniature osmotic pump that is inserted
subcutaneously to provide continuous and consistent drug therapy, and
proprietary formulation technology that maintains stability of therapeutic
proteins and peptides at human body temperature for extended periods of time.
The DUROS technology can deliver up to a full year of therapy from a single
ITCA 650 insertion. Unlike other extended delivery technologies, such as
polymers or albumin fusions, DUROS delivery allows for steady state drug
delivery upon insertion and near immediate withdrawal of therapy to manage
side effects, if required. Exenatide, the active agent in ITCA 650, has been
approved in the US, Europe and many other markets and is currently marketed as
a twice-daily self-injection therapy for type 2 diabetes.

About Intarcia
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing
therapies to ensure enhanced treatment outcome by optimizing patient adherence
and improving the convenience and tolerability of drug therapies. Intarcia's
drug development expertise and competitive edge are demonstrated by its
abilities to stabilize proteins and peptides at human body temperature and to
deliver them in a constant and consistent manner via the proprietary DUROS
drug delivery platform. Intarcia is pursuing clinical stage development
programs for type 2 diabetes and hepatitis C.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
DUROS is a registered trademark of ALZA Corporation licensed to Intarcia
Therapeutics, Inc. in certain fields. Byetta is a registered trademark of
Amylin Pharmaceuticals, Inc.

SOURCE Intarcia Therapeutics, Inc.

James Ahlers of Intarcia Therapeutics, Inc., +1-510-782-7800