The Burrill Report


The U.S. Food and Drug Administration informed Biodel that it would not approve in its present form its application for Linjeta (recombinant human insulin) injection for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control. Biodel said it 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 FDA wants the company to 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 and Wockhardt as a requisite for approval.

The Food and Drug Administration has notified Bristol-Myers Squibb that it will need more time to complete review of the company’s application to begin marketing ipilimumab in pre-treated advanced melanoma. The agency said it has moved its decision date to March 26, 2011 from December 25, 2010. In response to an FDA request, Bristol-Myers Squibb submitted further analysis of data pertaining to the current application for pre-treated advanced melanoma and the agency considers this to be a major amendment to the drug’s BLA.

Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab. The company looks forward to continuing its close collaboration with the FDA on this application and addressing an important unmet medical need for patients with advanced melanoma. Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities worldwide for pre-treated advanced melanoma.

Arena Pharmaceuticals said that Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals has decided not to advance its experimental diabetes drug the two were developing following the end of its phase 1 study and that it is terminating their collaboration effective December 28, 2010. The drug, APD597, is a GPR119 agonist intended for the treatment of type 2 diabetes that, along with other compounds and intellectual property, will revert to Arena upon termination of the collaboration.

Allegations Mannkind wrongfully terminated an executive who red-flagged foreign clinical trial data for its inhaled insulin-and-inhaler combination, Afrezza, are without merit says the company. A lawsuit filed by John Arditi, Mannkind’s former chief scientific officer and vice president of worldwide regulatory affairs, claims that the company terminated his employment in retaliation for his assertion that scientific misconduct marred clinical trials of Afrezza carried out in Russia and Bulgaria [see story]


November 05, 2010
http://www.burrillreport.com/article-fda_rejects_biodel%e2%80%99s_diabetes_drug.html