The Company reported progress in advancing the clinical development of
its lead product candidates and success in executing its corporate goals:
* Filed an investigational new drug ("IND") application, amended an
existing IND, and initiated pharmacokinetics and pharmacodynamics trials
to develop a suite of six VIAject(TM) products for commercialization:
VIAject(TM) A: Single Vial 10ml (liquid; refrigerated or frozen)
-- 100 IU/ml
-- 25 IU/ml
VIAject(TM) B: Twin Vials 10ml (lyophilized cake and diluent; no
refrigeration required)
-- 100 IU/ml
-- 25 IU/ml
Pen Cartridge Systems 3ml
-- 100 IU/ml (1 IU increments)
-- 25 IU/ml (1/4 IU increments)
* Presented positive clinical data from the VIAject(TM) program:
* At the annual meeting of the American Diabetes Association, the
Company presented additional interim results from its Phase III
clinical trials for VIAject(TM) that demonstrated statistically
significant daily meal-time dose reductions in patients with Type
1 and Type 2 diabetes using VIAject(TM), significantly fewer mild
and moderate hypoglycemic events and reduction in weight gain.
* At the annual meeting of the European Association for the Study of
Diabetes, the Company presented VIAject(TM) Phase II meal study
data that demonstrated statistically significant and clinically
relevant improved glycemic control compared to regular human
insulin (Humulin(R) R) and lispro (Humalog(R)).
* At the annual Diabetes Technology Meeting, after the close of
fiscal year 2007, the Company presented the results of a meal
study comparing VIAject(TM) head-to-head with Humalog(R) in
patients wh
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