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biodel inc (BIOD) Key Developments

Biodel Inc. Appoints Gary G. Gemignani as Chief Financial Officer, Effective September 15, 2014

Biodel Inc. announced that Gary G. Gemignani has been appointed as the company's Chief Financial Officer, effective September 15, 2014. Mr. Gemignani has over 25 years of experience in accounting, strategic planning and financing in the life sciences industry and has held senior leadership and management roles at Novartis, Prudential Financial, Wyeth and Arthur Andersen. Mr. Gemignani was most recently with Champions Oncology where he served as Chief Financial Officer and Executive Vice President with responsibility for raising capital, investor relations and all financial operations.

Biodel Inc. Reports Unaudited Consolidated Financial Results for the Third Quarter and Nine Months Ended June 30, 2014

Biodel Inc. reported unaudited consolidated financial results for the third quarter and nine months ended June 30, 2014. For the quarter, the company reported loss before tax benefit of $3.190 million against $9.637 million a year ago. Net loss was $3.204 million or $0.15 per basic and diluted share against $9.631 million or $0.66 per basic and diluted share a year ago. For the nine months, the company reported loss before tax benefit of $11.82 million against $18.52 million a year ago. Net loss was $11.84 million or $0.56 per basic and diluted share against $18.52 million or $1.29 per basic and diluted share a year ago.

Biodel Inc. Announces Positive Preliminary Results from Study 3-152

Biodel Inc. announced positive preliminary results from Study 3-152, a Phase 2a clinical trial comparing Biodel's proprietary, concentrated insulin formulation BIOD-531 to Humalog(R) Mix 75/25 and Humulin(R) 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(R) Mix 75/25 throughout the day of observation. BIOD-531 was also associated with superior glucose control compared to Humulin(R) 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(R) Mix 75/25 or Humulin(R) 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(R) 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) 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(R) Mix 75/25 and Humulin(R) 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(R) 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(R) Mix 75/25, pre-meal Humulin(R) 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(R) Mix 75/25. BIOD-531 was associated with superior glucose control compared to Humalog(R) 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(R) 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(R) 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(R) 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(R) 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(R) Mix 75/25 treatment. Pre-Meal Administration of BIOD-531 vs. Pre-Meal Administration of Humulin(R) R U-500: BIOD-531 was also associated with superior glucose control compared to Humulin(R) 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) 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) 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) R U-500 treatment (p=0.032). Post-Meal Administration of BIOD-531 vs. Pre-Meal Administration of Humalog(R) Mix 75/25 and Pre-Meal Administration of Humulin(R) 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(R) Mix 75/25 or Humulin(R) 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(R) 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(R) Mix 75/25 treatment (p=0.003) and 29.1 +/- 6.1% for pre-meal Humulin(R) 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.

Biodel Inc. to Report Q3, 2014 Results on Aug 11, 2014

Biodel Inc. announced that they will report Q3, 2014 results at 4:00 PM, US Eastern Standard Time on Aug 11, 2014

Biodel Inc., Q3 2014 Earnings Call, Aug 11, 2014

Biodel Inc., Q3 2014 Earnings Call, Aug 11, 2014

 

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