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JimsZ   Wednesday, 03/16/11 08:06:29 AM
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Latest updates

3/15/2011 March 14, 2011, Biodel Inc. Announces Accelerated Development Plan for Ultra-Rapid-Acting Insulins

Biodel Inc. announced that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins. Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes. This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog(R) each on separate occasions. This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog(R). In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year. If this Phase 1 study is successful, Biodel now anticipates initiating a Phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011. The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials-- one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes. Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials. Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog(R) as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing. In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles. If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.

2/4/2011 February 3, 2011, Biodel Inc. Reports Unaudited Earnings Results for the First Quarter Ended December 31, 2010

Biodel Inc. reported unaudited earnings results for the first quarter ended December 31, 2010. For the quarter, the company reported net loss of $5.3 million, or $0.20 per share, compared to a net loss of $11.1 million, or $0.47 per share, for the same period in the prior year.

2/1/2011 09064M10 9012155423~12/15/10~MMC~December 14, 2010, Biodel Announces Retirement of Solomon Steiner as Chief Scientific Officer~Biodel Inc. announced the retirement of Dr. Solomon Steiner as the company's Chief Scientific Officer. Steiner is a co-founder of Biodel and will remain a member of the company's board of directors. He served as Biodel's chairman, president and chief executive officer from its founding in December 2003 until March 2010 when Errol De Souza was named the company's president and chief executive officer and Charles Sanders was named board chairman.

12/15/2010 December 14, 2010, Biodel Announces Retirement of Solomon Steiner as Chief Scientific Officer Biodel Inc. announced the retirement of Dr. Solomon Steiner as the company's Chief Scientific Officer. Steiner is a co-founder of Biodel and will remain a member of the company's board of directors. He served as Biodel's chairman, president and chief executive officer from its founding in December 2003 until March 2010 when Errol De Souza was named the company's president and chief executive officer and Charles Sanders was named board chairman.

12/10/2010 December 9, 2010, Biodel Inc. Reports Earnings Results for the Fourth Quarter and Full Year Ended September 30, 2010

Biodel Inc. reported earnings results for the fourth quarter and full year ended September 30, 2010. For the quarter, the company reported a net loss of $8.1 million, or $0.31 per share, compared to a net loss of $10.5 million, or $0.44 per share, for the quarter ended September 30, 2009. For the full year ended September 30, 2010, operating loss before tax provision (benefit) was $38,394,000 against $42,933,000 a year ago. Net loss applicable to common stockholders was $38.3 million, or $1.58 per basic and diluted share, compared to $43.3 million, or $1.82 per basic and diluted share, for the fiscal year ended September 30, 2009.

12/7/2010 09064M10
9011025250~11/02/10~CON~November 1, 2010, FDA Issues Complete Response Letter to Biodel Inc. Regarding New Drug Application for Linjeta~Biodel Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company's new drug application (NDA) for Linjeta(TM) (human insulin \rDNA origin\) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control. The CRL stated that the FDA's review cycle is complete and that the application cannot be approved in its present form. Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company's next steps and requirements for approval of Linjeta(TM). The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls. With regard to efficacy, the FDA stated that, in the type 1 trial analysis, excluding data from India was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy. In the type 2 trial analysis, the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc modification of the statistical model as establishing conclusive evidence of efficacy. With regard to safety, the FDA commented that unequivocal non-inferiority needs to be achieved in order to compare the risk of hypoglycemia. The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration. The FDA also requested additional data related to stability and manufacturing. In addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron Inc. and Wockhardt Ltd. as a requisite for approval.

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