Breaking News

Tweet TWEET

Biodel Completes Enrollment in Phase 2 Clinical Trial of Ultra-Rapid-Acting Insulin Candidate BIOD-123 for the Treatment of

Biodel Completes Enrollment in Phase 2 Clinical Trial of Ultra-Rapid-Acting
Insulin Candidate BIOD-123 for the Treatment of Diabetes

Top-Line Data Expected in Third Quarter 2013

DANBURY, Conn., March 28, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced the completion of patient enrollment in a Phase 2 clinical
study of ultra-rapid-acting prandial insulin candidate BIOD-123 for the
treatment of diabetes. The trial will evaluate the use of BIOD-123 versus
Humalog^® on measures of HbA1c, postprandial glucose excursions, glycemic
variability, hypoglycemic event rates and weight changes.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated:
"Completing enrollment of the BIOD-123 Phase 2 clinical trial is a significant
milestone for Biodel, having nearly doubled the number of subjects in our
original trial design without changing the timelines. This larger Phase 2
trial will allow us to more effectively test the benefits of a product
candidate that has a more rapid absorption profile than currently marketed
insulins. We remain on track to report top line data from this trial in the
third calendar quarter of 2013."

The Phase 2 trial of BIOD-123 is a randomized, open label, parallel group
study being conducted at approximately 30 investigative centers in the United
States. In the trial, approximately 130 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 use insulin
glargine, sold as Lantus^®, as the basal insulin. The clinical trial will
evaluate HbA1c control as the primary endpoint, and secondary endpoints
include postprandial glucose excursions, glycemic variability, hypoglycemic
event rates and weight changes.

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-Q for the quarter ended December 31, 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