Biodel to Submit New Drug Application for VIAject to FDA

Conference Call Tomorrow March 25 at 8:00 AM (ET)
DANBURY, Conn.--(Business Wire)--
Biodel Inc. (Nasdaq: BIOD) announced today its plan to submit a new drug
application (NDA) to the U.S. Food and Drug Administration (FDA) in the second
half of this year for approval to market VIAject for the treatment of diabetes.
VIAject is Biodel`s investigational ultra-rapid-acting injectable human insulin
intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA
will be based upon results from multiple pharmacokinetic and pharmacodynamic
studies as well as two completed Phase 3 studies of VIAject in patients with
Type 1 and Type 2 diabetes.

Preliminary results from the Phase 3 studies were reported last year at the 44th
Annual Meeting of the European Association for the Study of Diabetes (EASD).
Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject,
which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation
of VIAject that was used in the company's pivotal Phase 3 clinical trials.
Biodel believes that results from both Phase 3 studies showed that VIAject was
non-inferior to Humulin R, the leading recombinant human insulin, in terms of
blood glucose control, when measured by the mean change in patients' hemoglobin
A1c levels (HbA1c). The results also demonstrated lower incidence of
hypoglycemia and less weight gain in patients receiving VIAject as compared to
patients receiving Humulin R.

At the EASD conference, Biodel reported that preliminary efficacy results from
patients with Type 1 diabetes in India were not comparable to results from
patients in the United States and Germany. While non-inferiority of VIAject to
Humulin R was achieved without the data from India, it was not achieved when the
data from India was included. Biodel identified probable causes for the variance
in the data from India with the assistance of regulatory consultants and
presented the results to the FDA in its pre-NDA briefing package. Among the
causes noted in the briefing package, an identifiable subset of blood samples
from patients in India was found to be compromised due to excessive heat
exposure in transit to a central laboratory. When the compromised samples are
removed from the efficacy analysis, non-inferiority in both the Type 1 and Type
2 trials is achieved.

After reviewing all of the data from the two pivotal Phase 3 clinical trials
with regulatory consultants and meeting with FDA staff, the company has decided
to proceed with the submission of its NDA under section 505(b)(2) of the Federal
Food, Drug and Cosmetic Act. The FDA will review any submission the company
makes to determine whether it meets the requirements for filing. There can be no
assurance that the FDA will file the NDA, or that once filed, it will be
approved.

Biodel`s chairman and chief executive officer, Dr. Sol Steiner, stated: "After
investigating the cause of the anomalous data in India and discussing our
findings with the FDA, we are now comfortable proceeding with the preparation
and submission of the NDA for VIAject in the second half of this year. This is
based on a compelling package of pharmacodynamic studies demonstrating potential
advantages over currently available rapid-acting insulin analogs as well as the
results of both pivotal Phase 3 clinical trials, which we believe met the
endpoint of non-inferior change in HbA1c over six months. In the meantime, we
continue to collect safety data from the open-label extensions of the Phase 3
trials and are proceeding with plans to conduct additional development work this
year to further differentiate VIAject from the rapid-acting insulin analogs."

Conference Call and Webcast Information

Biodel's senior management team will host a conference call on Wednesday, March
25, 2009 at 8:00 AM Eastern Time. Live audio of the conference call will be
available to investors, members of the news media and the general public by
dialing 877-741-4248 (United States) or 719-325-4752 (international). To access
the call by live Webcast, please log on to the Investor section of Biodel's Web
site at www.biodel.com. An archived version of the Webcast will be available at
Biodel's Web site.

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 using
VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. For
further information regarding Biodel, please visit the company's website 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. 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, our ability to have our VIAject NDA
accepted for filing by the FDA; our ability to secure FDA approval for VIAject
and our other 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 technology,
particularly VIAject; the progress or success of our research, development and
clinical programs and the initiation and completion of our clinical trials; the
FDA`s findings regarding data anomalies observed in India in our Phase III
clinical trial of VIAject for patients with Type 1 diabetes; 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 December 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 D. Lewis, +1 617-583-1308

Copyright Business Wire 2009