Biodel Announces Completion of Dosing in Phase 2 Clinical Trial of BIOD-123 in Patients With Type 1 Diabetes

Biodel Announces Completion of Dosing in Phase 2 Clinical Trial of BIOD-123 in
Patients With Type 1 Diabetes

Top-Line Data Expected in Third Quarter of 2013

DANBURY, Conn., July 11, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced that all scheduled follow-up visits have been completed for
patients enrolled in the Phase 2 clinical trial of BIOD-123, an
investigational ultra-rapid-acting injectable mealtime insulin therapy.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"Completing the BIOD-123 Phase 2 clinical trial is another significant
milestone in the development of novel ultra-rapid-acting mealtime insulins to
aid patients and healthcare professionals in the treatment of diabetes. We
look forward to sharing the top-line results by the end of this quarter."

Study Design

The Phase 2 clinical trial of BIOD-123 is a randomized, open label, parallel
group study conducted at 33 investigative centers in the United States. In the
trial, 132 patients with type 1 diabetes were randomized to receive either
BIOD-123 or Humalog^® to use as their mealtime insulin during an 18 week
treatment period. Both arms of the study used insulin glargine, sold as
Lantus^®, as the basal insulin. The clinical trial is designed to evaluate
HbA1c control as the primary endpoint, and secondary endpoints include
postprandial glucose excursions, glycemic variability, hypoglycemic event
rates and weight changes.

About BIOD-123

BIOD-123 is a proprietary formulation of injectable recombinant human insulin
with EDTA, citrate and magnesium sulfate. It is designed to be more
rapid-acting than mealtime insulin analogs currently used to treat patients
with type 1 and type 2 diabetes. In earlier-stage clinical trials, BIOD-123
has been shown to be more rapidly absorbed following subcutaneous
administration and have comparable injection site tolerability relative to the
rapid-acting insulin analog marketed as Humalog^®. Administered at the start
of a meal, the time to peak insulin levels achieved by BIOD-123 more closely
mimics the first-phase mealtime insulin release observed in healthy
individuals. Since its inception in 2006, Biodel's ultra-rapid-acting insulin
program has involved 20 clinical studies and more than 1,000 patients with
diabetes.

About Diabetes

Diabetes is a group of diseases characterized by high blood glucose levels
that result from defects in the body's ability to produce and/or use insulin.
Humans need a minimum level of glucose in their blood at all times to function
and stay alive. Insulin is a peptide hormone naturally secreted by the
pancreas to regulate the body's management of glucose. When a healthy
individual begins a meal, the pancreas' rapid release of insulin, known as
first-phase insulin release, is critical to the body's overall control of
glucose. Many patients with diabetes lack first-phase insulin release and must
treat themselves with daily meal-time insulin injections to avoid the negative
effects of hyperglycemia.

About Biodel

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 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 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 March 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

CONTACT: Seth D. Lewis, +1-646-378-2952
 
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