Conference call scheduled for 8:30am today
DANBURY, Conn., Nov. 1, 2010 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) 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 LinjetaTM (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 LinjetaTM.
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."
Biodel's senior management will host a conference call today to discuss the CRL.
8:15 am EDT:
Conference call participants should dial:
+1 (877) 303 - 8028 (United States) or
+1 (760) 536 - 5167 (International)
8:30 pm EDT:
Conference call begins
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 VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. LinjetaTM 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 VIAtabTM, 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.