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Biodel Reports New Findings from Key Programs at Diabetes Technology Meeting

November 12, 2010

DANBURY, Conn., Nov. 12, 2010 /PRNewswire/ — Scientists from Biodel Inc. (Nasdaq: BIOD) reported new findings from the company’s Linjeta(TM), insulin glargine, “smart” basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

Dr. Frank Flacke presented results of a Phase 1 single-center, double-blind, randomized crossover trial in 13 subjects with type 1 diabetes who received a once-daily injection of Linjeta(TM) or one of two modified formulations of Linjeta(TM), each on a separate day (“Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta(TM)”). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta(TM) to the two modified formulations. The study found that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta. Modified formulation BIOD-102 was associated with a similar rate of absorption as Linjeta.

Dr. Roderike Pohl reported results of in vitro and preclinical testing of a modified form of insulin glargine in diabetic miniature swine to assess its duration of activity and pharmacokinetic profile compared to insulin glargine (“A New Formulation of Insulin Glargine with an Extended Release Profile”). The study found that certain excipients, when combined with insulin glargine, reduced the drug’s solubility and could prolong its duration of action to greater than 24 hours compared to an average 18.5 hours for insulin glargine.

Nandini Kashyap described results of in vitro and in vivo studies in diabetic swine which showed that a “smart” basal insulin formulation can release insulin in response to changing glucose concentrations (“Smart Basal Insulin Formulation That Releases Insulin in Response to Changing Blood Glucose Concentrations”). This suggests that a modified form of basal insulin can be regulated based on insulin need, which would be expected to result in fewer hyper- and hypoglycemic excursions.

Dr. Solomon Steiner announced progress in the development of a stable form of glucagon for potential use in automated bihormonal pumps that deliver insulin and glucagon (“A Stabilized Glucagon Formulation For Bihormonal Pump Use”). Although generally unstable, glucagon can be used to prevent the hypoglycemia which occurs as a result of low or falling glucose concentration when too much insulin is administered. Biodel’s glucagon was found to be chemically and physically stable beyond seven days and physiologically active after three days of exposure in diabetic miniature swine, suggesting its utility for use in a bihormonal pump.

These poster presentations are available on the company’s website, www.biodel.com.

Dr. Steiner, Biodel’s chief scientific officer, commented: “These presentations highlight the many applications of our drug delivery technology as well as the potential of our product candidates to improve the treatment and quality of life of people with diabetes. The new formulations of Linjeta(TM), insulin glargine, ‘smart’ basal insulin and stabilized glucagon described in these abstracts appear to improve the tolerability, pharmacokinetic activity, and in some instances stability, of the unmodified forms of these compounds. We look forward to validating our findings by advancing our product candidates through clinical testing.”

The Diabetes Technology Meeting focuses on the latest technological advances for people with diabetes. Its purpose is to bring together technology developers and users to facilitate the creation of new and cost-effective tools – including an artificial pancreas – to help people with diabetes. This year’s meeting includes sessions on technologies for metabolic monitoring, biomarkers for early diagnosis of diabetes, the performance of closed-loop artificial pancreas systems and alternative delivery routes for insulin.

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. Biodel’s product candidates are developed using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. Linjeta(TM) is Biodel’s most advanced product candidate and has been reviewed by the FDA which issued a complete response letter. Earlier-stage product candidates include VIAtab(TM), a sublingual tablet formulation of insulin, a line of basal insulins, and a stabilized formulation of glucagon. 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. Such forward-looking statements include statements about future activities related to the complete response letter regarding the company’s new drug application for Linjeta(TM); the company’s response to the complete response letter; the importance of the complete response letter; and the company’s focus, goals, strategy, research and development programs, and 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, our ability to respond to the complete response letter regarding our new drug application for Linjeta(TM) in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta(TM) 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(TM) technology; 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 3 clinical trial of Linjeta(TM) for patients with Type 1 diabetes; the possibility that patients taking Linjeta(TM) may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; 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 most recent quarterly report on Form 10-Q for the quarter ended June 30, 2010. 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 Lewis, +1-646-378-2952

SOURCE Biodel Inc.


Source: newswire



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