2014

Biodel Reports Positive Top-Line Results from Study of Experimental Ultra-Rapid-Acting Insulin Formulations Conference Call Scheduled for Monday, April 16, at 8:30 AM EDT

DANBURY, Conn., April 15, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today announced positive top-line results from a Phase 1 clinical trial of its product candidates, BIOD-123 and BIOD-125 -- two proprietary ultra-rapid-acting formulations of recombinant human insulin (RHI).

  • BIOD-123 and BIOD-125 achieved the Company's target pharmacokinetic, pharmacodynamic and toleration profiles in a Phase 1 clinical trial; BIOD-123 favored as lead product candidate to advance to Phase 2
  • Projecting initiation of a Phase 2 clinical trial of BIOD-123 in the third calendar quarter of 2012
  • Continuing development of ultra-rapid-acting insulin analog-based formulations with selection of candidates and initiation of a Phase 1 clinical trial projected in the second half of calendar year 2012
  • Liquid glucagon formulation for use as a rescue treatment for patients experiencing severe hypoglycemia projected for NDA submission in the fourth calendar quarter of 2013 or first calendar quarter of 2014

The Phase 1 clinical trial evaluated the pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-123 and BIOD-125 relative to Humalog®, a rapid-acting insulin analog. The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the Company's previous Linjeta™ formulation used in Phase 3 clinical trials, but with improved injection site toleration characteristics.  The Phase 1 clinical trial was a single-center, randomized, double-blind, three-period crossover trial in 12 patients with Type 1 diabetes.  Each study drug was administered subcutaneously on separate days with a washout period between injections. 

Pharmacokinetic measurements were made using separate assays to quantify the active ingredients in the study drugs – RHI in the case of BIOD-123 and BIOD-125 and insulin lispro in the case of Humalog®.  The clinical trial was powered to measure differences in time to half maximal insulin concentrations.  Pharmacodynamic measurements were assessed using the euglycemic clamp method.  Local injection site discomfort was measured with a 100 mm visual analog scale (VAS) and patient questionnaires. 

In the Phase 1 clinical trial, absorption rates of BIOD-123 and BIOD-125 were significantly faster than that of Humalog® as indicated by 64% and 54% reductions, respectively, in mean times to half maximal insulin concentrations (p<0.001 for both BIOD-123 and BIOD-125 compared to Humalog®).  In a previous clinical trial, the Linjeta™ formulation demonstrated a 61% reduction compared to Humalog®.  Peak metabolic effects were not significantly different between the three study drugs. 

All three were well tolerated, with injection site tolerability generally perceived by patients to be similar to that of their usual mealtime injections used at home.  As measured on a 100 mm visual analog scale in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog® (BIOD-123 mean VAS 3.6 +/- 2.1 mm, Humalog® 1.8 +/- 1.1 mm, p=NS).  The VAS score for BIOD-125 was slightly higher as compared to Humalog® (mean VAS 6.8 +/- 2.9 mm, p<0.05).  However, this score was markedly improved relative to the Linjeta™ formulation, which had a mean VAS of 22.0 +/- 2.8 mm in a previous study. 

Dr. Alan Krasner, Biodel's chief medical officer, stated: "Biodel's previous Linjeta™ formulation demonstrated a desirable ultra-rapid absorption profile, but had challenges with respect to local injection site toleration.  The goal of our subsequent formulation development has been to maintain the ultra-rapid absorption profile of Linjeta™, while improving injection site toleration.  These recent data suggest that our latest formulations have achieved this goal, and we feel that further clinical development is warranted." 

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "The findings from these studies are very encouraging and will enable us to advance an ultra-rapid-acting RHI-based formulation into a Phase 2 clinical trial as early as next quarter.  In parallel, we will continue our development of ultra-rapid-acting insulin analog-based formulations, with the goal of advancing product candidates into a Phase 1 clinical trial later in 2012.  We expect our ultra-rapid-acting insulin program, along with our liquid glucagon rescue program that is targeted for NDA filing by the end of 2013 or early 2014, to generate multiple meaningful milestones in the short-term." 

Phase 1 Study in Patients with Type 1 Diabetes (n=12)

Pharmacokinetic Profiles of BIOD-123, BIOD-125 and Humalog®

Treatment

Metrics

Early 1/2 Tmax

(minutes)

Tmax

(minutes)

Late 1/2 Tmax

(minutes)

Humalog®

27.0 +/- 2.7

(25.9)

65.0 +/- 7.0

(67.5)

151 +/- 11

(150)

BIOD-123

9.8 +/- 1.1*

(9.6)

46.4 +/- 14.9

(25.0)

206 +/- 35

(170)

BIOD-125

12.4 +/- 2.0*

(9.4)

60.8 +/- 15.2

(30.0)

179 +/- 41

(140)

-- Data represent the Mean +/- SEM; Median Values are presented in parentheses. 

* p<0.001 vs. Humalog®


Injection Site Toleration Profiles of BIOD-123, BIOD-125 and Humalog®

Treatment

Metrics

Tolerability

(VAS 0 – 100mm)

Absolute Severity

Score

Relative Severity Score

Humalog®

1.8  +/- 1.1

0.17 +/-  0.11

2.92 +/-  0.08

BIOD-123

3.6  +/- 2.1

0.36 +/-  0.15

2.91 +/-  0.25

BIOD-125

6.8  +/- 2.9*

0.50 +/-  0.19

3.08 +/-  0.26

-- 100 mm Visual Analog Scale: 0=no discomfort, 100=worst possible discomfort

-- Absolute Severity Scale: 0=None, 1=Mild, 2=Moderate, 3=Severe

-- Relative Severity (compared to usual meal-time injections): 1=Much less, 2=Less, 3=Equal, 4=Increased, 5=Greatly increased

* p<0.05 vs. Humalog®

Biodel's senior management will host a conference call to discuss the results and provide an update on the Company's progress.

April 16, 2012 schedule:



8:15 am EDT:

Conference call participants should dial:


+1 ( 877 ) 303 – 8028  (United States) or


+1 ( 760 ) 536 – 5167  (International)



8:30 am EDT:

Conference call begins

Interested parties may access a live audio webcast of the conference call in the investor section of Biodel's website at www.biodel.com.  The audio webcast will be archived and available for replay through the website.

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.  We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.  For further information regarding Biodel, please visit the company's website at www.biodel.com.   

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates.  Forward-looking statements represent our management's judgment regarding future events.  All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements.  The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes; our ability advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the quarter ended December 31, 2011.  The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

BIOD-G
Contact: Seth D. Lewis, +1-646-378-2952

SOURCE Biodel Inc.



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