MannKind Corporation slightly lowered its financial losses for the first quarter of 2011 compared to the same period a year ago.
The Valencia-based biopharmaceutical company also said it has more specific details from the U.S. Food & Drug Administration for the review process of its insulin drug AFREZZA Inhalation Powder, which has not yet received approval.
For the first quarter that ended March 31, MannKind had net loss of $41.5 million, or $0.34 per diluted share, on revenues of $50,000. For the same period in 2010, the company had net loss of $44.7 million, or $0.40 per diluted share. The company did not disclose revenues for the first quarter of 2010.
The company also recently held an end-of-review meeting with the FDA regarding how to move forward with Mannkind’s AFREZZA drug. The federal agency previously delayed the drug’s review completion with a request for more clinical data and other information.
MannKind Corporation CEO Alfred Mann said the company was able to clarify many of the details about the FDA’s requirements for AFREZZA’s approval at the meeting. The agency said the meeting’s minutes would contain additional advice regarding aspects of MannKind’s planned studies, Mann added.
“Once the protocols are finalized, we are ready to initiate the required clinical studies at sites in the United States, Europe and Latin America,” Mann said. “As always, we remain committed to our goal of providing a novel treatment to the millions of patients with diabetes.”