Biodel's Concentrated Insulin BIOD-531 Demonstrates Superior Glucose Control Following Standardized Meals Compared to Marketed

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 
NEWS RELEASE TRANSMITTED BY Marketwired 
FOR: Biodel, Inc. 
NASDAQ SYMBOL: BIOD 
AUGUST 11, 2014 
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 - August 11, 2014) -  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 
/T/ 
--  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. 
/T/ 
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." 
/T/ 
----------------------------------------------------------------------------
 Blood Glucose Profiles of BIOD-531 Vs. HumalogMix 75/25 or HumulinR U-500 
Following Standardized Meal Challenges                  
---------------------------------------------------------------------------- 
Efficacy                                                     
Meal        Parameter              Treatment Group Comparison            
------------------------------------------------ 
HumalogMix  HumulinR               
BIOD-       75/25       U-500       BIOD-     
531Before  Before Meal Before Meal   531After   
Meal (A)      (B)         (C)       Meal (D)   
---------------------------------------------------------------------------- 
---------------------------------------------------------------------------- 
Change BGAUC0-                                                  
After        120min(mg.min/   7140 +/-   10302 +/-    8160 +/-    7319 +/-  
 Breakfast*  dl)                962         1051        533         889      
---------------------------------------------------------------- 
Change BGAUC0-                                                   
330min(mg.min/  23526 +/-   33751 +/-   30158 +/-   23833 +/-   
dl)                3054        2396        2342        3846     
---------------------------------------------------------------- 
Avg BG0-         167.8 +/-   205.1 +/-   193.1 +/-   173.4 +/-   
330min(mg/dl)      10.4        8.3         8.3         11.6     
---------------------------------------------------------------- 
BGMaximum0-      192.9 +/-   233.7 +/-   212.8 +/-   195.3 +/-   
120min(mg/dl)      12.3        12.5        7.0         10.7     
---------------------------------------------------------------- 
Percent                                                          
Values5-330min                                                  
Within 70- <                                                    
80 mg/dl Range   52.7 +/-    28.0 +/-    33.5 +/-    48.6 +/-   
(%)                10.3        9.1         9.5         10.3    
---------------------------------------------------------------------------- 
----------------------------------------------------------------------------
After       Avg BG5-         186.3 +/-   241.9 +/-   200.7 +/-   176.4 +/-  
 Lunch**     390min(mg/dl)      15.0        15.3        11.6        14.9     
---------------------------------------------------------------- 
BGMaximum0-      237.6 +/-   297.3 +/-   256.3 +/-   230.4 +/-   
120min(mg/dl)      15.5        16.1        13.4        14.4     
---------------------------------------------------------------- 
Percent                                                          
Values0-390min                                                  
Within 70- <                                                    
80 mg/dl Range   41.1 +/-    13.6 +/-    25.7 +/-    43.8 +/-   
(%)                9.1         6.4         6.9         9.8     
---------------------------------------------------------------------------- 
----------------------------------------------------------------------------
Overall     Avg Glucose0-                                                   
 Test        720min(mg/dl)   177.8 +/-   225.1 +/-   197.2 +/-   178.3 +/-  
 Period                         11.9        10.7        8.8         11.2     
---------------------------------------------------------------- 
Percent                                                          
Values5-720min                                                  
Within 70- <                                                    
80 mg/dl Range   46.3 +/-    20.6 +/-    29.1 +/-    46.2 +/-   
(%)                8.4         5.9         6.1         7.6     
---------------------------------------------------------------------------- 
---------------------------------------------------------------------------- 
--------------------------------------------------------------------------
 Blood Glucose Profiles of BIOD-531 Vs. HumalogMix 75/25 or HumulinR U-  
500 Following Standardized Meal Challenges               
-------------------------------------------------------------------------- 
Efficacy                                                   
Meal        Parameter             Treatment Group Comparison           
----------------------------------------------- 
P Value                     
----------------------------------------------- 
(A) vs. (B) (A) vs. (C) (B) vs. (D) (C) vs. (D)
-------------------------------------------------------------------------- 
-------------------------------------------------------------------------- 
Change BGAUC0-                                                
After        120min(mg.min/                                               
 Breakfast*  dl)              0.001       0.228       0.002       0.319    
-------------------------------------------------------------- 
Change BGAUC0-                                                 
330min(mg.min/                                                
dl)              0.003       0.036       0.004       0.051    
-------------------------------------------------------------- 
Avg BG0-                                                       
330min(mg/dl)   < 0.001      0.006       0.001       0.031    
-------------------------------------------------------------- 
BGMaximum0-                                                    
120min(mg/dl)   < 0.001      0.050      < 0.001      0.082    
-------------------------------------------------------------- 
Percent                                                        
Values5-330min                                                
Within 70- <                                                  
80 mg/dl Range                                                
(%)              0.026       0.074       0.067       0.172   
-------------------------------------------------------------------------- 
--------------------------------------------------------------------------
After       Avg BG5-                                                      
 Lunch**     390min(mg/dl)   < 0.001      0.205      < 0.001      0.060    
-------------------------------------------------------------- 
BGMaximum0-                                                    
120min(mg/dl)   < 0.001      0.212      < 0.001      0.101    
-------------------------------------------------------------- 
Percent                                                        
Values0-390min                                                
Within 70- <                                                  
80 mg/dl Range                                                
(%)              0.002       0.072       0.001       0.042   
-------------------------------------------------------------------------- 
--------------------------------------------------------------------------
Overall     Avg Glucose0-                                                 
 Test        720min(mg/dl)                                                
 Period                      < 0.001      0.042      < 0.001      0.058    
-------------------------------------------------------------- 
Percent                                                        
Values5-720min                                                
Within 70- <                                                  
80 mg/dl Range                                                
(%)              0.002       0.032       0.003       0.040   
-------------------------------------------------------------------------- 
-------------------------------------------------------------------------- 
/T/ 
/T/ 
Data presented are the Mean +/- SEM from twelve subjects randomized. One of 
these subjects discontinued after treatment with Humalog Mix 75/25 and     
Humulin R U-500 only. Blood glucose was measured every 5 minutes.          
BG: Blood glucose; Change BG: Change in blood glucose from baseline; AUC:   
Area under the glucose response curve                                       
*Test insulin was administered only for the breakfast meal                  
**No insulin treatment was administered at lunch (330 min after injection)  
---------------------------------------------------------------------------- 
/T/ 
Study Design
Study 3-152 was a single-blinded, four-arm cross-over study. Twelve subjects
were randomized and 11 patients completed the study. The patients evaluated in
this study were a typical population with type 2 diabetes who used between
50-200 units of insulin per day with mean age of 55 years old, mean baseline
HbA1c of 9%, mean weight of 99 kg, and mean BMI of 33.5 kg/m2. Subjects were
washed out of background diabetes medications (including insulins) and admitted
to the research unit the evening before study drug dosing. Overnight, blood
glucose concentration was stabilized at the target range of 100 +/- 20 mg/dl
using intravenous insulin. The intravenous insulin was discontinued no later
than 15 minutes before a standardized breakfast in the morning. Each subject
came in for the following four treatments administered subcutaneously on
separate days assigned in a random order: (a) BIOD-531 immediately before the
meal (pre-meal); (b) Humalog Mix 75/25 pre-meal; (c) Humulin R U-500
pre-meal; and (d) BIOD-531 twenty minutes after the start of the meal
(post-meal). The dose for each session was 0.6 U/kg. After the breakfast,
glucose concentrations were measured every 5 minutes throughout the day for a
total of 720 minutes (12 hours) after insulin dosing. In order to assess the
duration of glucose control of the test insulins, the subject received a
standardized lunch 330 minutes (5.5 hours) after breakfast dosing but did not
receive a lunch-time dose of insulin. Injection site toleration was assessed
with a 100 mm visual analog scale and severity scores.  
About BIOD-531
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 and pre-mixed insulins such as
Humalog Mix 75/25. Furthermore, for patients using pre-mixed 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 insulin product on the U.S. market. Humulin R U-500
concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic
profile for prandial coverage, 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 pre-mixed with intermediate-acting basal neutral
protamine insulins in a variety of ratios such as 70/30, 75/25 and 50/50.
Pre-mixes provide basal and bolus therapy with fewer injections per day.
Pre-mixed prandial/basal insulins have a suboptimal pharmacokinetic and
pharmacodynamic profile with a more delayed onset than prandial U-100 regular
human insulin or rapid-acting insulin analog formulations. Pre-mixes represent
approximately thirty percent of the more than $8 billion global rapid-acting
prandial insulin market.  
Conference Call and Webcast Information 
Biodel's senior management will host a conference call in conjunction with
Third Quarter Fiscal Year 2014 Financial Results Update on Monday, August 11,
2014 at 5:00 p.m. Eastern Daylight Time to discuss these results and provide a
company update. Live audio of the conference call will be available to
investors, members of the news media and the general public by dialing +1 (877)
407-7181 (Toll-Free US & Canada) or +1 (201) 689-8047 (International). To
access the call by live audio webcast, please log on to the investor section of
the company's website at www.biodel.com. An archived version of the audio
webcast will be available on Biodel's website or by dialing +1 (877)
660-6853 (Toll Free US & Canada) or +1 (201) 612-7415 (International) and
entering conference ID number 13588552.  
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. Biodel's product
candidates are developed by applying proprietary technologies to existing drugs
in order to improve their therapeutic profiles. More information about Biodel
is available 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 and our glucagon presentation that is intended to treat patients
experiencing severe hypoglycemia; 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 or a stable glucagon presentation; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a stable glucagon
presentation; 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, 2013. 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  
-30-
FOR FURTHER INFORMATION PLEASE CONTACT: 
CONTACT: 
John Graziano
+1-646-378-2942 
INDUSTRY:  Pharmaceuticals and Biotech - Biotech, Pharmaceuticals and Biotech -
Drugs, Pharmaceuticals and Biotech - Trials 
SUBJECT:  PDT 
-0-
-0- Aug/11/2014 11:00 GMT
 
 
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