MannKind addresses Afrezza concerns following FDA response

In an analyst call this morning, MannKind discussed yesterday's complete response letter from the FDA for Afrezza, the company's inhaled insulin drug. The part of the response that sent tongues wagging yesterday was the FDA's request that the company submit available clinical data that support the "clinical utility" of Afrezza. Analysts and investors wondered whether the agency's wording meant that didn't see a need for another insulin product.

For MannKind, it comes down to a question of interpretation. "We interpret this request as a desire to understand the positioning of Afrezza within the range of available therapies, and a desire to know how, and in whom, and when in the course of therapy it should be used," CEO Alfred Mann said in the conference call. He emphasized that the agency asked for no additional studies and expressed no safety concerns about the drug.

The company also said that it believes its next-generation inhaler, known as "Dreamboat," will settle labeling question raised by the FDA. MannKind had planned to launch Afrezza with its existing MedTone devices and switch patients to the Dreamboat after securing a separate FDA OK for the product. Now the developer says it may submit an application for its new device in its response to the FDA's letter.

Mann said that his company is closer to a partnership deal now that it's received FDA feedback on the drug. According to the company, MannKind and an interested party were close to a deal for Afrezza last July, but uncertainties about the drug impacted valuation, making it pointless to close the deal until more agency guidance was received. "We were reluctant to partner until we had regulatory feedback because we couldn't determine the real value of Afrezza," Mann claimed. He added that the company's chances for a partnership are higher now that the list of outstanding items with Afrezza has been reduced to a few items.

MannKind has enough cash to make it into 2011. However, during the conference call, Mann said the company will work to reduce its spending over the next few weeks to move it farther into 2011. He didn't elaborate on how the developer plans to cut costs.

Mann seemed riled when asked whether the FDA had indicated whether the company would face an expert panel prior to the approval of Afrezza. "They've said very explicitly for almost a year now that we're not going to have a panel. Period." The bottom line? "We have no reason to believe that our plan to launch in 2011 will be adversely affected by the issues raise in the letter."