THERMALIN DIABETES, INC. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Pre-mixed formulations of soluble prandial insulin an
THERMALIN DIABETES, INC. — SBIR Phase I award from Department of Health and Human Services.
- Amount
- $300,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase I
- Solicitation
- PA13-234
- NAICS
- —
- Place of performance
- OH
- Period
- —
Description
DESCRIPTION (provided by applicant): Pre-mixed formulations of soluble prandial insulin analogs and NPH micro-crystalline suspensions provide a simplified and cost-effective basal-bolus regimen for patients with Type 2 diabetes mellitus (T2DM) not effectively controlled by basal insulin therapy alone. Such twice-daily products (in vials or pre-filled in pens) account for gt 2B in sales in the developed world, and their use is rapidly growing in the developing world. The market leaders are Novo-Nordisk (NovoMix(r) 30 in which insulin aspart is formulated 30% as a soluble zinc hexamer and 70% as an NPH micro-crystalline suspension) and Eli Lilly and Co (Humalog(r) Premixed Insulin in which insulin lispro is formulated 25% as a soluble zinc hexamer and 75% asan NPH micro-crystalline suspension; a 50/50 product is also available). Despite their popularity and clinical utility with appropriate patients, these products are complicated to manufacture, not mixable with other insulin products, fixed in their ba