BIOD - Biodel, Inc. - Q3 2013 Earnings Call Transcript

    The results from this trial were specially encouraging. BIOD-238 and BIOD-250, like BIOD-123 demonstrated a significantly more a rapid rate of absorption when compared to Humalog . Furthermore, BIOD-250 like BIOD-123 also compared favorably to Humalog with regards to injection site tolerability. On the other hand, BIOD-238 and BIOD-250 in contrast to 123 had a significantly faster decline from peak concentration compared to Humalog .

    These differences were all highly statistically significant. The analog-based candidates have a different pharmacokinetic profile such as BIOD-123 and makes it a distinct clinical characteristics and different settings. Therefore both programs were in development and may eventually be positioned in different market segments.

    For example, the analog-based formulations distinct from a pharmacokinetic profiles maybe particularly suited continues. We are currently developing both Lispro and Asphalt based formulations so the focus on improving the overall stability profile for these analog-based ultra-rapid-acting formulations. As you may recall, Lispro is the active pharmaceutical ingredient for API in Humalog and Asphalt is the API in Novolog.

    We are in discussions with the number of manufactures to commercial supplies for both Lispro and Asphalt. Once an API supply is secured, we would expect additional formulation work to take place over variety to provide six months. As we advance this promising program, we continue to remain engaged in discussions wit major players in the insulin space.

    Let me now turn to our concentrated insulin program. The user concentrated insulin to treat type 2 diabetes patients with severe insulin resistance continues to increase at a greater rate than the overall market and currently represents approximately $300 million in annual revenues. Insulin resistant patients often require more then 200 units of insulin daily and are not well so by the standard insulin concentrations of 100 units per meal or U-100 formulations.

    Currently, Humalog and Humulin® R U-500 is the only concentrated insulin product available to these patients. Because the Humulin R. U-500 duration of action is long enough to provide basal coverage, Humulin R. U-500 concentrated insulin in often administered by patients twice a day. However, its offset of action in delayed growth is to equivalents doses of U-100 rapid-acting insulin analog is not does not well suited to provide optimal meal-time insulin coverage.

    During our last earnings call, we announced the selection of BIOD-531 as our lead concentrated insulin candidate. BIOD-531 is a concentrated U-400 formulation of RHI disodium EDTA, citrate and magnesium sulphate. At the American Diabetes Association 73rd Scientific Sessions in June, we presented pharmacokinetic and pharmacodynamic profile of the BIOD-531 in the diabetics swine model.

    This presentation which is also available on our website shows that the BIOD-531 has a more rapid onset of action relative to Humulin R. U-500 and similar to what's superior to that of standard U-100 Humalog . BIOD-531 also demonstrated a comparable duration of action relative to Humulin R. U-500 which indicates that like Humulin R. U-500 BIOD-531 could address basal insulin needs as well.

    The BIOD-531 pharmacokinetic and pharmacodynamic profile suggest that it could compete with insulin premixes and provide superior mealtime coverage. Premixes provide basal and bolus therapy with fewer injections per day. Currently, Eli Lilly and Novo Nordisk market presentations of Human insulin a rapid-acting insulin analog such as Novolog or Humalog premix but intermediate acting basal neutral protamine insulins in a variety of ratios such as 70:30, 75:25, and 50:50.

    In the U.S., the analog-based premix alone sell approximately $1.5 billion annually. While the premix is also prandial and basal coverage with one injection of the prandial component is suboptimal. BIOD-531 ultra-rapid-acting onset and basal duration profile couples with the high concentration could offer a truly novel therapeutic that provides basal coverage and improve prandial coverage to patients who are insulin resistant or use premix insulins.

    We are eager to continue the rapid advancement of these program. And engineering batch for BIOD-531 has been manufactured and the clinical supply has scheduled for manufacture this quarter. An amendment to the investigation of new drug application has been submitted to the FDA.

    Phase 1 clinical study initiation is anticipated next quarter. The trial will be a randomized blinded four way cross over phase 1 clinical trial in which the pharmacokinetic, pharmacodynamic and injection site toleration profile of the BIOD-531 will be defined and compared to Humulin R. U-500 and to Humalog Prandial Basal premix insulin.

    In this study, 12 volunteers will receive single injections of each insulin on separate days in a randomized treatment sequence. The identity of each study drug will be blinded at the time of injection. After each test transaction, volunteers will undergo uglycemia class studies.

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