FDA Grants Orphan Drug Designation to Biodel's Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Population

FDA Grants Orphan Drug Designation to Biodel's Glucagon for Prevention of
Hypoglycemia in Congenital Hyperinsulinism Population

DANBURY, Conn., Dec. 6, 2012 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced that the FDA has granted orphan drug designation for Biodel's
'glucagon' for the prevention of hypoglycemia in the congenital
hyperinsulinism (CHI) population.

The FDA grants orphan designation to promote development of therapies to treat
rare diseases. Once this designation is granted, the sponsor may be eligible
for a range of incentives including FDA grant funding for clinical trial
costs, tax credits related to development expenses, waiver of FDA user fees,
and a seven-year period of marketing exclusivity in the U.S. following FDA

Dr.Errol De Souza, President and Chief Executive Officer ofBiodel,
stated:"We welcome the FDA's recognition of the important contribution a
stable formulation of glucagon could bring to the lives of children suffering
from CHI.While our primary glucagon program is a rescue product for the
treatment of severe hypoglycemia in patients with diabetes, this designation
represents an important component of our strategy to maximize the value of our
product candidates to patients and shareholders in both our glucagon and
ultra-rapid-acting prandial insulin programs."

Biodel previously received a positive opinion for orphan drug designation from
the European Medicines Agency's Committee for Orphan Medicinal Products (EMA's
COMP) on January 17, 2012, and orphan designation by the European Commission
(EC) on March 5, 2012.

About Congenital Hyperinsulinism CHI

CHI is a genetically heterogeneous disorder characterized by excess,
dysregulated insulin secretion from pancreatic beta cells. It is the most
common cause of persistent hypoglycemia in neonates and infants and it occurs
at an incidence of 1:30,000 to 1:50,000 births. Children who present with this
disorder generally require aggressive artificial calorie support in order to
prevent hypoglycemia and resulting neurologic damage. Despite aggressive
treatment with available therapies, the estimated prevalence of permanent
neurologic damage from breakthrough hypoglycemia ranges from 20% to 50%. The
treatment paradigm for this condition typically begins with intravenous
glucose supplementation, often requiring highly concentrated glucose solutions
administered through central venous catheters in intensive care unit
settings.While some patients respond to treatment with diazoxide and/or
somatostatin analogs, the balance of the patients are eventually treated
surgically.Of these, many will need to undergo a near-total pancreatectomy
which in most cases leads to insulin-dependent diabetes mellitus by the time
the patient reaches adolescence.


Glucagon is a potential medical treatment for any form of CHI.Glucagon
increases blood glucose concentrations acutely by stimulating breakdown of
glycogen stores in the liver (glycogenolysis). In the setting of
hyperinsulinism, the liver contains excess glycogen due to insulin-dependent
inhibition of glycogenolysis.Pilot data describing clinical experience with
long-term subcutaneous infusion of glucagon to CHI patients have been
published.In a retrospective review of nine patients with CHI, glucagon
infusion over weeks to years allowed the reduction or discontinuation of
central glucose infusion in all children studied. The glucagon treatment was
generally well tolerated, with the most common side effect being a skin
rash.However, these glucagon infusions are complicated by frequent catheter
obstructions, sometimes occurring daily. This occurs because glucagon in its
currently marketed formulations is unstable in solution, particularly at
elevated temperatures. This instability in solution makes currently marketed
formulations of glucagon impractical for long-term use in these patients.

Biodel'sformulation of glucagon is designed to remain stable in solution for
a longer period than existing commercial formulations. Preliminary data have
been generated to show thatBiodel'sformulation has greater chemical
stability at elevated temperatures than existing commercial formulations. In
addition,in vitrotesting has shown chemical and physical stability when used
in a commercially available insulin pump.

AboutBiodel 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 formulation of glucagon 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 theU.S. Food and Drug
Administration, orFDA, 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 theFDAfor 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 theFDA; 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 endedJune 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.


CONTACT: Seth D. Lewis, +1-646-378-2952
Press spacebar to pause and continue. Press esc to stop.