Biodel Inc.'s Insulin Drug Found Effective In Phase 2 Trial

Biodel's Concentrated Insulin BIOD-531 Demonstrates Superior Glucose Control Following Standardized Meals Compared To Marketed Insulins In A Phase 2 Clinical Trial In Patients With Type 2 Diabetes

Phase 2a Clinical Trial Data Demonstrate That a Single Dose of BIOD-531 Provides Superior Glucose Control After Two Consecutive Standardized Meals Compared to Humalog (R) Mix 75/25 and Humulin(R) R U-500; Conference Call and Webcast Will Be Held in Conjunction With Third Quarter Fiscal Year 2014 Financial Results Update on Monday, August 11, 2014 at 5:00 pm EDT

DANBURY, CT -- (Marketwired) -- 08/11/14 --Biodel Inc. (NASDAQ: BIOD) announced positive preliminary results from Study 3-152, a Phase 2a clinical trial comparing Biodel's proprietary, concentrated insulin formulation BIOD-531 to Humalog® Mix 75/25 and Humulin® R U-500 in patients with type 2 diabetes with moderate insulin resistance who use between 50 and 200 units of insulin per day.

Data Highlights

* BIOD-531 was associated with superior glucose control compared to Humalog® Mix 75/25 throughout the day of observation.
* BIOD-531 was also associated with superior glucose control compared to Humulin® R U-500.
* BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in superior glucose control compared to either Humalog® Mix 75/25 or Humulin® R U-500 dosed prior to the meal.
* Mean visual analog scores and absolute severity scores were low for all participants, suggesting excellent injection site tolerability.

Many type 2 diabetes patients in clinical practice are treated with pre-mixed insulins, such as Humalog® Mix 75/25, in order to receive both basal and prandial insulin in a single injection. Pre-mixed insulin is commonly dosed before breakfast and before dinner and is usually used in patients who are not candidates for an intensive basal-bolus insulin regimen that would require four or more injections per day. Humulin® R U-500 is the only concentrated insulin available in the U.S. and is usually used to treat type 2 diabetes patients with severe insulin resistance who require very high doses of insulin -- typically greater than 200 units per day.

BIOD-531 is an ultra-rapid-acting formulation of recombinant human insulin (RHI) at a concentration of 400 units/ml (U-400) combined with EDTA, citrate and magnesium sulfate. In the Phase 1 Study 3-150, the results of which were released in February 2014, BIOD-531 administered to non-diabetic, obese volunteers demonstrated ultra-rapid absorption and onset of action in comparison with Humalog® Mix 75/25 and Humulin® R U-500, and had an extended duration of action that is expected to be suitable for basal insulin needs.

The recently completed Study 3-152 was designed to test the hypothesis that a single dose of BIOD-531 would confer better postprandial glucose control for two consecutive meals compared to Humalog® Mix 75/25 when administered to type 2 diabetes patients with moderate insulin resistance.

In Study 3-152, glucose profiles were assessed after single subcutaneous injection of 0.6 U/kg doses of the study drugs administered with a standardized breakfast on separate days in a randomized four arm cross-over sequence in which subjects received pre-meal BIOD-531, pre-meal Humalog® Mix 75/25, pre-meal Humulin® R U-500 and post meal BIOD-531. In order to assess the duration of glucose lowering, subjects received a standardized lunch at 330 minutes (5.5 hours) after breakfast dosing with no insulin administered at that time. Glucose levels were measured every five minutes during the 720 minutes (12 hours) after test insulin dosing at breakfast.

The results of the current study demonstrate that the ultra-rapid-acting profile with an extended duration of action of BIOD-531 seen in Study 3-150 may translate into clinically meaningful benefits of superior mealtime and basal coverage for type 2 diabetes patients with moderate insulin resistance.

Pre-Meal Administration of BIOD-531 vs. Pre-Meal Administration of Humalog ® Mix 75/25
BIOD-531 was associated with superior glucose control compared to Humalog® Mix 75/25 throughout the day of observation. A single dose of BIOD-531 administered immediately before breakfast (pre-meal) achieved significantly lower mean glucose concentrations than did Humalog® Mix 75/25 administered immediately before breakfast. The mean glucose concentration after breakfast was 167.8 ± 10.4 mg/dl with BIOD-531 treatment compared to 205.1 ± 8.3 mg/dl with Humalog® Mix 75/25 treatment (p < 0.001). Mean glucose concentrations were also significantly improved after lunch with pre-meal BIOD-531. Over the course of the entire day of observation, pre-meal BIOD-531 was associated with an average glucose concentration of 177.8 ± 11.9 mg/dl compared to 225.1± 10.7 mg/dl with Humalog® Mix 75/25 treatment (p < 0.001). The percentage of glucose readings within the target range of 70-180 mg/dl was increased more than two-fold following BIOD-531 treatment (46.3 ± 8.4%) compared to Humalog® Mix 75/25 treatment (20.6 ± 5.9 %; p=0.002). Likewise, the post-breakfast area under the curve for the glucose excursion and the mean maximal glucose concentrations after breakfast and after lunch were significantly improved with pre-meal BIOD-531 treatment compared to Humalog® Mix 75/25 treatment.

Pre-Meal Administration of BIOD-531 vs. Pre-Meal Administration of Humulin ® R U-500
BIOD-531 was also associated with superior glucose control compared to Humulin® R U-500. Mean glucose concentrations after the standardized breakfast were 167.8 ± 10.4 mg/dl with BIOD-531 treatment compared to 193.1 ± 8.3 mg/dl with Humulin® R U-500 treatment (p=0.006). Over the entire day of observation, mean glucose concentrations were 177.8 ± 11.9 mg/dl with BIOD-531 treatment compared to 197.2 ± 8.8 mg/dl with Humulin® R U-500 treatment (p=0.042). Over the course of the entire day of observation, glucose concentrations were in the target range of 70-180 mg/dl 46.3 ± 8.4% of the time with BIOD-531 treatment compared to 29.1 ± 6.1% of the time with Humulin® R U-500 treatment (p=0.032).

Post-Meal Administration of BIOD-531 vs. Pre-Meal Administration of Humalog ® Mix 75/25 and Pre-Meal Administration of Humulin ® R U-500
BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in a superior glucose control compared to either Humalog® Mix 75/25 or Humulin® R U-500 dosed prior to the meal. Mean glucose concentrations over the course of the day were 178.3 ± 11.2 mg/dl for post-meal BIOD-531 treatment compared to 225.1 ± 10.7 for pre-meal Humalog® Mix 75/25 treatment (p < 0.001). The percentage of readings within the 70-180 mg/dl target range was 46.2 ± 7.6% for post-meal BIOD-531 treatment compared to 20.6 ± 5.9% for pre-meal Humalog® Mix 75/25 treatment (p=0.003) and 29.1 ± 6.1% for pre-meal Humulin® R U-500 treatment (p=0.040).

Safety and Tolerability Mean visual analog scores and absolute severity scores were low for all participants, suggesting excellent injection site tolerability. There were no statistically significant differences in 100 mm visual analog scores among the treatment groups.

Dr. Alan Krasner, chief medical officer of Biodel, stated: "Many patients with type 2 diabetes who use pre-mixed insulins such as Humalog® Mix 75/25 may not achieve adequate prandial control due to the slow absorption of currently available, pre-mixed insulin formulations. These data released today validate the benefits of the ultra-rapid-acting onset of action of BIOD-531 seen in our previous Phase 1 study and clearly demonstrate the clinical superiority of this profile on post-prandial glucose control compared to Humalog® Mix 75/25 and Humulin® R U-500. The longer-term coverage provided by BIOD-531 was superior to the comparators as seen in lower glucose levels after the standardized lunch and the benefits are maintained even when dosed after the meal. This unique pharmacokinetic and pharmacodynamic profile, coupled with its high concentration and low injection volume has the potential to confer clinically significant benefits to a sub-optimally served population of patients with type 2 diabetes."

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "BIOD-531 is a valuable asset within Biodel's expanding portfolio. It appears from these data that BIOD-531 may have utility both in the niche but rapidly growing segment of insulin resistant patients largely treated by endocrinologists and currently served by Humulin® R U-500, as well as in the much larger segment of patients currently using pre-mixed insulins and often managed by primary care physicians. We are working with the FDA to define the clinical development program that will best characterize and assess this unique formulation so that we can rapidly advance BIOD-531 into later stage clinical trials. We look forward to updating you in the fourth quarter of 2014 on the data from the ongoing Phase 2 Study 3-151 in severely insulin resistant patients and the path forward for this exciting product opportunity."

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