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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. -- Biodel Inc. (Nasdaq: BIOD BIOD Built-In Overflow Detection
BIOD Block Input Output Daemon
) 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 human insulin
n.
A protein that has the normal structure of insulin produced by the human pancreas but that is prepared by recombinant DNA techniques and by semisynthetic processes.
 in healthy volunteers and compared to regular human insulin in patients with type 1 diabetes type 1 diabetes
n.
See diabetes mellitus.
. 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 Insulin lispro (marked by Lilly as "Humalog®") is a fast acting insulin analogue; it was the first insulin analogue.

It was engineered through recombinant DNA technology so that the penultimate lysine and proline residues on the C-terminal end of the B-chain were reversed.
 (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 onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring.  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 type 2 diabetes
n.
See diabetes mellitus.
," stated Dr. Solomon Steiner, chief executive officer and chairman of Biodel. "The last patients recently completed these pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  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 Noun 1. recombinant human insulin - a form of insulin (trade name Humulin) made from recombinant DNA that is identical to human insulin; used to treat diabetics who are allergic to preparations made from beef or pork insulin
Humulin
.

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 sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue.

sub·lin·gual
adj. Abbr. SL
Below or beneath the tongue; hypoglossal.
 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. ; 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 Capital requirements

Financing required for the operation of a business, composed of long-term and working capital plus fixed assets.
 and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q Form 10-Q

See 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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:Jul 23, 2008
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