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Biodel Reports Positive Top-Line Results From Clinical Study of Ultra-Rapid-Acting Insulin Analog Candidates



Biodel Reports Positive Top-Line Results From Clinical Study of
Ultra-Rapid-Acting Insulin Analog Candidates

  * BIOD-238 and BIOD-250 demonstrate a pharmacokinetic profile superior to
    Humalog^® with ultra-rapid absorption and rapid declines from peak
    concentration
  * BIOD-250 demonstrates injection site toleration comparable to Humalog^®

DANBURY, Conn., Jan. 24, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced positive top-line results from a Phase 1 clinical trial of two
ultra-rapid-acting insulin analog-based formulations, BIOD-238 and BIOD-250,
conducted to evaluate the pharmacokinetic and injection site toleration
profiles relative to Humalog^®, a rapid-acting insulin analog. BIOD-238 and
BIOD-250 are combinations of Biodel's proprietary excipients with the marketed
formulation of Humalog^®.

The single-center, randomized, double-blind, three-period crossover trial in
12 patients with Type 1 diabetes was conducted in Australia. Each study drug
was administered subcutaneously on separate days. Pharmacokinetic measurements
were made using an assay to quantify the active ingredients in the study drugs
and Humalog^®. The clinical trial was powered to measure differences in time
to half-maximal insulin concentrations. The hypothesis tested in this study
was than Biodel's formulations of Humalog^® would have ultra-rapid absorption
profiles with comparable declines from peak concentration and comparable
injection site tolerability profiles relative to Humalog^®. Two approaches
were taken to mitigate injection site discomfort—reducing disodium EDTA
concentrations (BIOD-238) and addition of magnesium sulfate (BIOD-250), which
was observed to improve toleration in a previous study.

The pharmacokinetic profiles of BIOD-238 and BIOD-250 proved to be consistent
with our target product profile for analog-based ultra-rapid-acting insulin.
Absorption rates of BIOD-238 and BIOD-250 were significantly more rapid than
that of Humalog^®, as indicated by 35-45% reductions in mean times to half
maximal insulin concentrations (p<0.001 for BIOD-238 and p=0.001 for BIOD-250
vs. Humalog^®) and time to maximal insulin concentrations (p=0.013 for
BIOD-238 and p=0.025 for BIOD-250 vs. Humalog^®). Furthermore, the total
amount of insulin absorbed over the first 30 minutes following injection of
BIOD-238 and BIOD-250 was approximately double that seen for Humalog^®
(p<0.001 for BIOD-238 and p=0.002 for BIOD-250 vs. Humalog^®). The decline
from peak concentration, as indicated by time to half maximal concentration
after the peak, was significantly shorter for both BIOD-238 and BIOD-250
compared to Humalog^® (p=0.009 for BIOD-238 and p=0.016 for BIOD-250 vs.
Humalog^®).

Local injection site discomfort was measured with a 100 mm visual analog scale
(VAS) and patient questionnaires. 100 mm is defined as the worst possible
discomfort and 0 mm is defined a having no discomfort. In the trial, the VAS
score was numerically lower, but not significantly different for BIOD-250
compared to Humalog^® (mean VAS scores of 2.7 mm and 8.2 mm for BIOD-238 and
Humalog^®, respectively; p=NS). The VAS score for BIOD-238 was significantly
higher than that associated with Humalog^® (mean VAS score of 24.2 mm, p=0.029
vs. Humalog^®).

Dr. Alan Krasner, Biodel's chief medical officer, stated: "This study
corroborates pharmacokinetic observations made previously in the diabetic
swine model, namely that Biodel's excipients accelerate the absorption of an
insulin analog without prolonging the decline from peak concentration. This
profile is different than that of the recombinant human insulin-based
formulation BIOD-123, which is associated with a modestly longer decline from
peak concentration compared to Humalog^®. The optimal decline from peak
concentration for a prandial insulin is unknown and what is desirable may vary
by patient."

Errol De Souza, Biodel's president and chief executive officer, stated: "The
findings from these studies are very encouraging. Having established the proof
of principle in man, we are now focused on replicating the pharmacokinetic and
tolerability profiles of BIOD-250 in formulations utilizing lispro, the active
pharmaceutical ingredient in Humalog^®, and in achieving commercial stability.
We are pleased to have confirmed that we have a tolerability profile
equivalent to currently marketed products, as previously seen in our Phase 1
trial of the recombinant human insulin-based ultra-rapid-acting candidate
BIOD-123. BIOD-123 is now in a Phase 2 clinical trial scheduled to generate
top line data in the third calendar quarter of 2013."

 
Pharmacokinetic Profiles of BIOD-238, BIOD-250 and Humalog^®
                                                           P-value   P-value
               Variable     BIOD-238  BIOD-250  Humalog^®  BIOD-238  BIOD-250
                            N=10      N=11      N=10       vs.       vs.
                                                           Humalog^® Humalog^®
               Early ½      13.7 ±    14.6 ±    24.8 ± 2.9
               T[max        1.9       1.9       (22.6)     <0.001    0.001
                 ](minutes) (13.6)    (12.9)
               T[max        35.5 ±    40.9 ±    62.5 ± 8.4
Absorption     ](minutes)   2.5       6.1       (60.0)     0.013     0.025
                            (37.5)    (40.0)
               AUC[ins0-30  1278 ±    1186 ±    598 ± 126
               ](mU*min/L)  164       133       (654)      <0.001    0.002
                            (1105)    (1260)
               AUC[ins0-45  2421 ±    2160 ±    1486 ± 216
               ](mU*min/L)  245       195       (1458)     <0.001    0.01
                            (2132)    (2327)
               AUC[ins0-60  3476 ±    3081 ±    2505 ± 280
               ](mU*min/L)  326       245       (2358)     0.002     0.066
                            (3197)    (3125)
Decline from   Late ½ T[max 123.8 ±   132.3 ±   166.5 ±
peak           ](minutes)   10.5      18.7      10.6       0.009     0.016
concentration               (125.3)   (117.0)   (183.4)
Data represent the Mean ± SEM; Median Values are presented in parentheses.

 
 
Injection Site Toleration Profiles of BIOD-238, BIOD-250 and Humalog^®
Metrics                        BIOD-238          BIOD-250        Humalog^®
                               N=10              N=11            N=10
Tolerability                   24.2 ± 7.0*       2.7 ± 1.6       8.2 ± 4.5
(VAS 0 – 100 mm)               (15.0)            (0.0)           (2.0)
Absolute Severity Score        1.09 ± 0.2*       0.1 ± 0.1       0.5 ± 0.2
                               (1.0)             (0.0)           (0.0)
Relative Severity Score        3.6 ± 0.03        2.9 ± 0.02      3.2 ± 0.1
                               (4.0)             (3.0)           (3.0)
-- Data represent the Mean ± SEM; Median Values are presented in parentheses.
-- 100 mm Visual Analog Scale (VAS): 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 insulin injections): 1 =
Much less, 2 = Less,
3 = Equal, 4 = Increased, 5 = Greatly increased
-- * p<0.05 vs. Humalog^® 

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.  

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 liquid glucagon formulation that is intended to treat
patients experiencing severe hypoglycemia; our ability to successfully
complete a Phase 2 clinical trial of a proprietary insulin formulation in a
timely manner, and the outcome of that trial; 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 liquid formulation of glucagon; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a liquid formulation of
glucagon; 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-K for the year ended September 30, 2012. 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
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