Biodel Announces Plans to Advance BIOD-531 Based on Positive Clinical Trial Results

Biodel Announces Plans to Advance BIOD-531 Based on Positive Clinical Trial

  Phase 1 Clinical Trial Data Demonstrate that Biodel's Concentrated Insulin
BIOD-531 has a More Rapid Absorption and Onset of Action Versus Both Humulin^®
  R U-500 and Humalog^® Mix 75/25 and a Duration of Action Consistent with a
                                Basal Insulin

 Conference Call and Webcast Will be Held Today, February 12, 2014 at 5:00 pm

DANBURY, Conn., Feb. 12, 2014 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced preliminary results from Study 3-150, a Phase 1 clinical trial
comparing Biodel's proprietary insulin formulation, BIOD-531, to the marketed
products Humulin^® R U-500 (U-500R) and Humalog^® Mix 75/25. 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. Study 3-150 assessed the pharmacokinetic, pharmacodynamic
and injection site toleration profiles of single doses of the study drugs in
non-diabetic obese volunteers. The clinical trial included 1.0 U/kg and 0.5
U/kg doses of BIOD-531, as well as a 1.0 U/kg dose of Humulin^® R U-500 and a
0.5 U/kg dose of Humalog^® Mix 75/25.

The results of Study 3-150 confirm earlier findings in diabetic swine that
BIOD-531 is characterized by rapid absorption and onset of action, and an
extended duration of action that is expected to be suitable for basal insulin


  *BIOD-531 vs. Humulin^® R U-500 (1.0 U/kg dose) – Rate of Absorption and
    Onset of Action

BIOD-531 was associated with an increased rate of absorption as measured by
multiple pharmacokinetic parameters including a 92% shorter time to Early ½
T[max] (11.0 ± 1.9 min) versus U-500R (135.3 ± 34.9 min), a 43% shorter time
to T[max] (223.8 ± 62.3 min) versus U-500R (393.3 ± 58.3 min) and a 765%
increase in early insulin exposure as measured by AUC[ins0-30min ](2966 ± 383
mU*min/L) versus U-500R (343 ± 74 mU*min/L).BIOD-531 was associated with a
more rapid glucose lowering effect as measured by multiple pharmacodynamic
parameters including a 169% increase in AUC[GIR0-60min] (108.5 ± 22.0 mg/kg)
versus U-500R (40.4 ± 10.0 mg/kg).These differences were all statistically

  *BIOD-531 vs. Humalog^® Mix 75/25 (0.5 U/kg dose) – Rate of Absorption and
    Onset of Action

BIOD-531 was associated with an increased rate of absorption as measured by
multiple pharmacokinetic parameters including a 66% shorter time to Early ½
T[max] (16.4 ± 4.9 min) versus Humalog^® Mix 75/25 (47.9 ± 2.6 min), an 18%
shorter time to T[max] (131.3 ± 43.4 min) versus Humalog^® Mix 75/25 (160.0 ±
11.9 min) and a 917% increase in early insulin exposure as measured by
AUC[ins0-30min ](1200 ± 141 min) versus Humalog^® Mix 75/25 (118 ± 22
mU*min/L). BIOD-531 was associated with a more rapid glucose lowering effect
as measured by multiple pharmacodynamic parameters including a 375% increase
in AUC[GIR0-60min] (68.9 ± 13.4 mg/kg) versus Humalog^® Mix 75/25 (14.5 ± 4.7
mg/kg).With the exception of T[max], these differences were all statistically

  *BIOD-531 Duration of Action

Pharmacodynamic measurements for BIOD-531, including time to the end of the
glucose lowering effect (T[GIR Last]), at both 1 U/kg (1170.0 ± 59.3 min) and
0.5 U/kg doses (1076.2 ± 50.7 min), support the potential for BIOD-531 to
provide basal insulin needs.

  *Safety and Toleration

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

Dr. Alan Krasner, chief medical officer of Biodel, stated: "Patients with type
2 diabetes who use concentrated or pre-mixed insulins may not achieve adequate
prandial control due to the slow absorption of currently available
therapies.We believe that the preliminary BIOD-531 data released today
support our hypothesis that a concentrated formulation of recombinant human
insulin combined with our proprietary excipients can achieve an
ultra-rapid-acting onset of action and also provide basal insulin
coverage.This unique pharmacokinetic and pharmacodynamic profile, coupled
with its high concentration and therefore low volumes of injection, represents
a potential novel therapeutic that could be of use to many patients with
diabetes who use higher doses of insulin."

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
that it may have utility, and thus warrant development, 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 premixed insulins often
managed by primary care physicians.We plan to rapidly advance BIOD-531 into a
Phase 2 meal study in diabetic patients to further evaluate the benefits of
its ultra-rapid-acting profile on post prandial control of glucose.In
parallel, we will be contacting and working with the FDA to define the
clinical development program that will best characterize BIOD-531 so that we
can rapidly advance BIOD-531 into late stage clinical development as warranted
by the results of earlier stage clinical trials."

Pharmacokinetic and Pharmacodynamic Profiles of BIOD-531 Vs. Humulin^® R U-500 or
Humalog^® Mix 75/25
                            Treatment Group Comparison
                                        Humulin^® P-Value            Humalog^® P-Value
           Pharmacokinetic    BIOD-531 R         of       BIOD-531 Mix 75/25 of
Parameter  (PK) or            (1 U/Kg)  U-500     BIOD-531 (0.5      (0.5      BIOD-531
           Pharmacodynamic    (n=12)    (1 U/Kg)  Vs.      U/Kg)     U/Kg)     Vs.
           (PD) Variable                (n=12)    U-500   (n=12)    (n=12)    75/25
              Early ½ T[max]  11.0 ±    135.3 ±            16.4 ±    47.9 ±
ABSORPTION   (minutes)       1.9       34.9      0.001    4.9       2.6       0.002
                              [8.2]     [99.6]             [10.4]    [46.3]
              T[max]          223.8 ±   393.3 ±            131.3 ±   160.0 ±
          PK (minutes)       62.3      58.3      0.006    43.4      11.9      0.846
                              [195.0]   [360.0]            [37.5]    [150.0]
              AUC[ins 0-30    2966 ±    343 ± 74           1200 ±    118 ± 22
            min]            383       [249]     0.001    141       [96]      <0.001
              (mU*min/L)      [3163]                       [1190]
              AUC[ins 0-60    6375 ±    1773 ±             2642 ±    996 ± 136
            min]            681       238       0.001    223       [868]     <0.001
              (mU*min/L)      [5911]    [1575]             [2793]
              AUC[GIR 0-60    108.5 ±   40.4 ±             68.9 ±    14.5 ±
          PD min]            22.0      10.0      0.001    13.4      4.7       <0.001
              (mg/Kg)         [101.1]   [44.5]             [52.8]    [6.4]
DURATION      Late ½ T[max]   633.6 ±   900.5 ±            530.6 ±   495.7 ±
OF ACTION  PK (minutes)       42.1      70.9      0.002    59.5      63.0      0.519
                              [674.6]   [858.9]            [583.9]   [429.7]
              T[GIR-50%-late] 838.2 ±   1007.7 ±           830.3 ±   925.2 ±
          PD (minutes)       52.8      75.5      0.008    70.1      90.5      0.380
                              [845]     [967]              [770]     [967]
              T[GIR Last]     1170.0 ±  1353.0 ±           1076.2 ±  1304 ±
            (minutes)       59.3      79.7      0.002    50.7      53.6      0.002
                              [1188.5]  [1500]             [1028.5]  [1321.5]
Data represent the Mean ± SEM; Median Values are presented in [parentheses].

Study Design

Study 3-150 is a four-way cross-over Phase 1 clinical trial in which the
pharmacokinetic, pharmacodynamic and injection site toleration profiles of
BIOD-531 were evaluated and compared to Humulin^® R U-500 and to Humalog^®Mix
75/25. Thirteen non-diabetic obese volunteers with a median body weight of
approximately 100 kg were randomized.Subjects received a single injection of
each insulin on separate days in a randomized treatment sequence. The identity
of each study drug was blinded at the time of the injection. After each test
injection, volunteers underwent euglycemic clamp studies to determine the
pharmacodynamic profile of the study drug. On two of the test days, BIOD-531
and Humulin^® R U-500 were administered at doses of 1.0 U/kg, which is the
range used by patients with type 2 diabetes and severe insulin resistance. On
the other two days of the four-period study, BIOD-531 and Humalog^®Mix 75/25
were administered at doses of 0.5 U/kg. This dose reflects that which might be
used by patients with moderate degrees of insulin resistance who use
premixes.Injection site toleration was assessed with a 100 mm visual analog

About BIOD-531

Biodel'sconcentrated 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. For patients using premixed
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 RHI product on the U.S. market. Humulin^®R U-500
concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic
profile 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 premixed with intermediate-acting basal
neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and
50/50. Premixes provide basal and bolus therapy with fewer injections per day.
Premixes represent approximately thirty percent of the more than$8
billionglobal rapid-acting prandial insulin market.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on Wednesday, February
12, 2014 beginning at 5:00 p.m. Eastern Standard Time to discuss these
results. A live audio and visual webcast of the conference call will be
available to investors, members of the news media and the general public by
going to To access audio only by
telephone, dial (877) 303-8028. (United States) or +1 (760) 536-5167
(international). An archived version of the webcast will be available on
Biodel's website. Interested parties may also access an audio replay by
dialing (855) 859-2056 (US) or (404) 537-3406 (International) and entering
conference ID number 30917555. 

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 

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.


CONTACT: John Graziano, +1-646-378-2942
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