Biodel Inc. Completes Enrollment of Two Pivotal Phase III Clinical Trials of VIAject(TM) and Plans Manufacturing Facility for VIAject(TM)

Jan 03, 2008, 00:00 ET from Biodel Inc.

    DANBURY, Conn., Jan. 3 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq:  
 BIOD) today announced that the Company has completed enrollment of its two
 pivotal Phase III clinical trials of VIAject(TM), a rapid-acting injectable
 meal-time insulin for use by patients with Type 1 and Type 2 diabetes. The
 Company also announced its intention to build and operate a fill and finish
 manufacturing facility for VIAject(TM), on the campus of its current
 headquarters in Danbury, Connecticut.
     "We are pleased to have completed enrollment of the VIAject(TM)
 clinical trials on schedule," commented Solomon S. Steiner, Ph.D., Chairman
 and Chief Executive Officer of Biodel. "We believe that VIAject(TM)'s
 superior pharmacokinetic and pharmacodynamic profile should improve the
 treatment of millions of patients with diabetes."
     Biodel has now enrolled over 400 patients with Type 1 diabetes at
 approximately 60 clinical sites in the United States, Europe, and Asia, and
 over 400 patients with Type 2 diabetes at approximately 50 clinical sites
 in the United States, Europe, and Asia. Both studies are multi-center, open
 label and six months in duration, comparing the effects of VIAject(TM) to
 Humulin(R) R, the leading recombinant human insulin. Biodel expects to
 complete these trials and, if the trials are successful, the Company
 intends to submit a New Drug Application for VIAject(TM) to the Food and
 Drug Administration by the end of 2008.
     To prepare for commercialization of VIAject(TM), the Company plans to
 build a fill and finish manufacturing facility which will be dedicated to
 manufacturing a full line of VIAject(TM) liquid formulations and
 presentations. The dedicated manufacturing facility will improve margins,
 provide superior quality control, and better inventory control. Biodel
 anticipates that the facility will cost under $15 million and will be
 available for commercial production in 2009.
     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 lead product
 candidates are all insulin formulations developed by using the VIAdel(TM)
 technology, which reformulates existing FDA-approved peptide drugs. The
 Company's lead product candidate, VIAject(TM), is a rapid-acting injectable
 meal-time insulin in development for use by patients with Type 1 or Type 2
 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III
 clinical trials. Biodel's pipeline also includes VIAtab(TM), a sublingual
 tablet formulation of insulin in Phase I clinical development, and two
 osteoporosis product candidates, both of which are in pre-clinical studies.
 For further information regarding Biodel, please visit the Company's
 website at
     Safe Harbor
     This press release contains forward-looking statements within the
 meaning of the Private Securities Litigation Reform Act of 1995. All
 statements, other than statements of historical facts, including statements
 regarding our strategy, future operations, future financial position,
 future revenues, projected costs, prospects, plans and objectives of
 management are forward- looking statements. The words "anticipates,"
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 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 approval for our 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, 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 and our
 needs for additional financing; and other factors identified in our
 Quarterly Report on Form 10-K for the fiscal year ended September 30, 2007.
 The Company disclaims any obligation to update any forward-looking
 statements as a result of events occurring after the date of this press

SOURCE Biodel Inc.