Biodel shares down after FDA issues complete response letter Print E-mail
By Staff and Wire Reports   
Monday, 01 November 2010 05:55

Shares of Biodel Inc. (Nasdaq:BIOD) were down over 50% in pre-market trading after the specialty biopharmaceutical company focused on the development and commercialization of treatments for diabetes 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 Linjetaâ„¢ (human insulin) injection aimed at the treatment of type 1 and type 2 diabetes.

The FDA said that it completed it's review of the drug which aims to improve glycemic control but that the application cannot be approved in its present form. The regulatory agency also included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.

The FDA has also requested additional data related to stability and manufacturing. Regulators also identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.

Biodel plans to contact the FDA within the coming weeks to request a meeting and 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."

Biodel's senior management will host a conference call today to discuss the matter with investors at  8:15 am EDT:

Conference call participants should dial: +1 (877) 303 - 8028 (United States) or +1 (760) 536 - 5167 (International)

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