DB160

	Lead Identification	Candidate Selection Proof of Principle	Pre-Clinical Development	Phase 1	Phase 2a
Development Phase

Product/Technology Name: DB160 (DPP-IV Inhibitor)

Condition/Disease Targeted: Type 2 Diabetes

Purpose: DB160 is a highly potent and selective small molecule Dipeptidyl Peptidase-IV (DPP-IV) inhibitor.  DPP-IV is an enzyme that inactivates GLP-1.

GLP-1 is a key hormone that counteracts the four causative factors of high blood sugar:

• increased glucose absorption from the gut,
• increased glucose production in the liver,
• decreased glucose uptake in fat and muscle, and
• decreased insulin secretion.
  

By blocking the activities of DPP-IV, the rapid breakdown of GLP-1 is diminished.  This allows GLP-1 to remain active, improving blood sugar levels while maintaining a low risk of resultant hypoglycemia.

Product Development: Our clinical candidate, DB160, is in pre-clinical development. We are currently evaluating the competitive environment for DB160 and potential positioning of the compound for other indications.  During this ongoing evaluation we have focused our resources on other drug development programs.  If our evaluation concludes that further development is warranted we would expect to file an IND application to the FDA during third quarter of 2009 assuming sufficient additional funding is secured.

DB160 has a competitive product profile with early toxicology studies pointing to potential safety and pharmacokinetic advantages over competitor molecules.  Once-a-day oral administration is expected.

Viability: Clinical studies have indicated that orally-delivered DPP IV inhibitors reduce blood glucose and increase insulin sensitivity in Type 2 diabetic patients.

In the U.S. alone DPP-IV inhibitor sales are projected to exceed $5.9B in 2020 [out of a $61B diabetes drug U.S. Market: WR Hambrecht & Co. estimates (2006)]