Biodel Announces Development Plans to Commercialize Glucagon Rescue Product Candidate for the Treatment of Severe Hypoglycemia

Biodel Announces Development Plans to Commercialize Glucagon Rescue Product
Candidate for the Treatment of Severe Hypoglycemia

- New Drug Application submission anticipated in 2015

- Acquired worldwide exclusivity to proprietary dual-chamber device

DANBURY, Conn., June 6, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced plans to submit a New Drug Application (NDA) to the FDA in
2015 for a novel glucagon rescue device to treat severe hypoglycemia.

Having previously signed a long-term commercial supply agreement for bulk
glucagon, Biodel expects to select a final formulation of its novel glucagon
therapy and appoint a contract manufacturing partner during the current
calendar quarter. The submission of an Investigational New Drug application to
the FDA is expected during the next 12 months. Initiation of a pivotal
clinical study is expected to occur during the second half of 2014, putting
the Company in a position to file an NDA to the FDA under the 505(b)(2)
regulatory pathway in 2015.

In preparation for the anticipated regulatory filing and commercial launch of
its glucagon rescue product, Biodel has signed a 15-year supply agreement with
Unilife Corporation for a customized proprietary device from its EZMix™
platform of dual-chamber devices with worldwide exclusivity for use with
glucagon. The device has been customized for convenient portability and ease
of use to enable rapid treatment during emergency situations with little to no
training. The device automatically reconstitutes lyophilized glucagon when
prepared for injection and features automatic, user-controlled retraction of
the needle upon full dose delivery, virtually eliminating dosing errors and
the risk of needle stick injuries. [A rendering of the device is available on
Biodel's website at www.biodel.com/glucagondevice]

Dr. Errol De Souza, Biodel's president and chief executive officer, stated:
"We are pleased with the rapid progress that we have made in identifying a
competitive, easy to use and innovative glucagon rescue presentation, which
leverages the strengths of room temperature stability and addresses the
limitations of currently marketed products. We look forward to providing more
detailed timelines as we progress through various stages of product
development."

About Severe Hypoglycemia & Glucagon Rescue Therapy

Diabetes patients using insulin commonly experience varying degrees of low
blood glucose concentration known as hypoglycemia. Mild to moderate
hypoglycemia symptoms such as headache, weakness, or dizziness are generally
treated with orally administered carbohydrates, such as orange juice or
glucose tablets. Severe hypoglycemia, however, often results in a loss of
consciousness or seizures, which typically renders the oral administration of
carbohydrates unsafe and requires another person's assistance. In such
emergency cases, an injection of glucagon can help rapidly raise the patient's
blood glucose concentration. The longer a patient is unconscious due to severe
hypoglycemia, the greater the chance of brain damage or death. It is estimated
that there are over 200,000 hospitalizations per year due to severe
hypoglycemia.

Glucagon is a hormone secreted by the pancreas which opposes the action of
insulin by promoting the breakdown of glycogen into glucose in the liver,
thereby raising the levels of blood glucose. Glucagon is inherently unstable
in a liquid solution and therefore is currently only available as a rescue kit
consisting of a vial containing a dry powder of glucagon and a syringe
containing a liquid solution. To administer glucagon with this kit, the liquid
solution must first be injected into the vial with the dry powder and mixed.
After the glucagon powder has dissolved, it is then drawn back into the
syringe and injected into the patient. In order to properly administer the
glucagon, a caregiver must be trained to follow this multi-step process in a
situation typically made challenging by the patient's condition.

It is widely understood by patients, physicians and Diabetes Educators that
the complexity of the currently available rescue kits and the training
required for proper administration of glucagon using those kits has resulted
in the underuse of glucagon as a rescue treatment for diabetes patients
experiencing severe hypoglycemia. It is estimated that only 10% to 20% of
high-risk patients currently have an unexpired glucagon kit. Given this low
level of market penetration, the current $125 million U.S. market could expand
significantly upon the introduction of an easy-to-use presentation. The device
supplied by Unilife requires three simple, intuitive steps as compared to
seven or more steps for the currently available rescue kits.

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. For more
information, please visit www.biodel.com.

About Unilife Corporation

Unilife Corporation (Nasdaq:UNIS) is a U.S. based developer and commercial
supplier of proprietary injectable drug delivery systems including EZMix™,
which is an innovative and highly differentiated platform of dual-chamber
syringes that meet the needs of lyophilized, powder filled or liquid-liquid
drug combinations. Proprietary features include orientation-free, ventless
mixing to minimize drug loss and maintain sterility until time of injection,
and the automatic, user-controlled retraction of the needle upon full dose
delivery to virtually eliminate the risk of needlestick injuries. EZMix™
dual-chamber syringes are designed for intuitive use by healthcare workers or
patients, with minimal steps required for reconstitution and injection of the
therapy. For more information, please visit www.unilife.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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