Biodel Announces Publications Demonstrating Superior Metabolic Profile of VIAject(TM)...

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Wed Jul 23, 2008 4:30pm EDT

Biodel Announces Publications Demonstrating Superior Metabolic Profile of VIAject(TM) Compared to the Rapid-acting Analog Humalog(R) and Regular Human Insulin in Healthy Volunteers and Compared to Regular Human Insulin in Patients with Type 1 Diabetes

DANBURY, Conn.--(Business Wire)--
Biodel Inc. (Nasdaq: BIOD) announced today the publication of
positive findings from studies demonstrating the superior metabolic
profile of VIAject(TM) ultra rapid-acting insulin compared to the
rapid-acting analog, Humalog(R), and regular human insulin in healthy
volunteers and compared to regular human insulin in patients with type
1 diabetes. The articles appear in the current issues of the journals
Diabetologia and Journal of Diabetes Science and Technology.

   In the Phase I glucose clamp study (Steiner et al., Diabetologia,
2008), ten healthy volunteers received subcutaneous injections of
VIAject(TM) ultra rapid-acting insulin, insulin lispro (Humalog(R)) or
regular human insulin on separate days. The study showed that
VIAject(TM) was absorbed and produced its metabolic effect faster than
both regular human insulin and insulin lispro (Humalog(R)) at the same
dose.

   In a Phase II glucose clamp study (Hompesch et al., J. of Diabetes
Science and Technology, July 2008), fourteen patients with type 1
diabetes were randomly assigned to receive two sequences of three
subcutaneous injections of 0.1 IU/kg of VIAject(TM) or regular human
insulin on separate days. Patients receiving VIAject(TM) had an
earlier onset of action and shorter time to maximal plasma insulin
concentration when compared to regular human insulin, confirming
previous findings in healthy volunteers that VIAject(TM) is absorbed
more quickly and has a more rapid onset of action and clearance than
regular human insulin.

   "We welcome the publication of these earlier findings. These data
led to the pivotal Phase III clinical trials assessing efficacy and
safety in patients with Type1 and Type 2 diabetes," stated Dr. Solomon
Steiner, chief executive officer and chairman of Biodel. "The last
patients recently completed these pivotal Phase III trials and we look
forward to analyzing and reporting these data."

   About VIAject(TM)

   VIAject(TM) is an ultra rapid-acting injectable human insulin
intended for meal-time use by patients with Type 1 or Type 2 diabetes.
In Phase I and Phase II clinical trials, VIAject(TM) has been shown to
have a more rapid onset of activity than those reported for the
existing rapid-acting insulin analogs. As a result, VIAject(TM) may be
safer, require a lower dose and promote weight loss when compared to
currently marketed meal-time insulins. VIAject(TM) has been tested in
two pivotal Phase III clinical trials, which compared the effects of
VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.

   About Biodel Inc.

   Biodel Inc. is a specialty biopharmaceutical company focused on
the development and commercialization of innovative treatments for
endocrine disorders, such as diabetes and osteoporosis. Biodel's
product candidates are developed by using VIAdel(TM) technology, which
reformulates existing FDA-approved peptide drugs. The company's lead
product candidate, VIAject(TM), is an ultra rapid-acting injectable
meal-time insulin in development for use by patients with type 1 or
type 2 diabetes. VIAject(TM) has been tested in two pivotal Phase III
clinical trials. Biodel's pipeline also includes VIAtab(TM) a
sublingual tablet formulation of insulin in the Phase I stage of
clinical testing, and two pre-clinical osteoporosis product
candidates. For further information regarding Biodel, please visit the
company's website at www.biodel.com.

   Safe Harbor

   This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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, our ability to secure FDA
approval for our product candidates under Section 505(b)(2) of the
Federal Food, Drug, and Cosmetic Act; our ability to market,
commercialize and achieve market acceptance for product candidates
developed using our VIAdel(TM) technology; the progress or success of
our research, development and clinical programs, the initiation and
completion of our clinical trials, the timing of the interim analyses
and the timing or success of our product candidates, particularly
VIAject(TM) and VIAtab(TM); our ability to secure additional patents
for VIAject(TM) and our other product candidates; our ability to
protect our intellectual property and operate our business without
infringing upon the intellectual property rights of others; our
estimates of future performance; our ability to enter into
collaboration arrangements for the commercialization of our product
candidates and the success or failure of those collaborations after
consummation, if consummated; the rate and degree of market acceptance
and clinical utility of our products; our commercialization, marketing
and manufacturing capabilities and strategy; our estimates regarding
anticipated operating losses, future revenues, capital requirements
and our needs for additional financing; and other factors identified
in our Quarterly Report on Form 10-Q for the quarter ended March 31,
2008. The company disclaims any obligation to update any
forward-looking statements as a result of events occurring after the
date of this press release.

The Trout Group LLC
Seth Lewis, 617-583-1308

Copyright Business Wire 2008
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