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Biodel's concentrated insulin BIOD-531 contains 400 units per milliliter (U-400) of recombinant human insulin formulated with EDTA, citrate and magnesium sulfate. Based on its unique combination of ultra-rapid absorption with a basal duration profile, BIOD-531 may provide superior meal-time glucose control for patients using Humulin® R, U-500. For patients using premixed prandial/basal insulins, BIOD-531 could enable patients to minimize injection volume while benefitting from the ultra-rapid onset of action.

The current unmet medical need for a concentrated ultra-rapid-acting insulin formulation exists among a subset of type 2 diabetes patients who demonstrate severe insulin resistance and require greater than 200 units of insulin daily to meet their insulin needs. Currently Eli Lilly's Humulin® R U-500 is the only concentrated RHI product on the U.S. market. Humulin® R U-500 concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic profile with a more delayed onset than U-100 regular human insulin or rapid-acting insulin analog formulations.

Eli Lilly and Novo Nordisk market preparations of human insulin or rapid-acting analog prandial insulins premixed with intermediate-acting basal neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and 50/50. Premixes provide basal and bolus therapy with fewer injections per day. Premixes represent approximately thirty percent of the more than $8 billion global rapid-acting prandial insulin market.

Source: http://investor.biodel.com/releasedetail.cfm?ReleaseID=825395

BIOD-531’s ultra-rapid onset, basal duration profile, and high concentration offer improved prandial coverage while maintaining basal
coverage in insulin-resistant patients who require large doses of insulin and patients who use premixed formulations. It is hoped insulin-resistant patients will gain superior meal-time glucose control than with Humulin R, and premixed users will see improved prandial control with smaller injection volumes.

In diabetic swine, BIOD-531 demonstrated a faster rate of absorption and onset of action than Humulin R and Humalog, and a comparable duration of action to Humulin R. A U.S. phase I study has now begun and will compare pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-531 with Humulin R and Humalog (75/25 premixed), with data expected in first quarter of 2014.

Adapted from - Thomson Reuters Cortellis Competitive Intelligence

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