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Linjeta

Generic name: human insulin [rDNA origin]
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Complete Response Letter for Linjeta NDA

FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta

DANBURY, Conn., Nov. 1, 2010 /PRNewswire/ -- Biodel Inc. announced today 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 (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.

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.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward. We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes."

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 technology, which reformulates existing FDA-approved peptide drugs. Linjeta is Biodel's most advanced product candidate, which has been reviewed by the FDA and issued a complete response letter. Earlier-stage product candidates include VIAtab, 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; 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 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 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 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 for patients with Type 1 diabetes; the possibility that patients taking Linjeta 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.

Posted: November 2010

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