On Friday, shares of inhalable insulin developer MannKind (Nasdaq: MNKD ) were down over 16% following the company's announcement of two delays.
First, MannKind said was that it was pushing back its second-quarter financial results to Thursday of this week, because of accounting issues with its clinical trial expenses for the second quarter. When it comes to drug development, some delays are much worse than others, and this one doesn't sound like a big deal.
The second delay announcement was that partnership discussions for MannKind's inhalable insulin product, Technosphere, were going slower than expected. On the Friday conference call management said this was partly a result of the potential partner's worries that Technosphere could have the same reimbursement issues that Nektar Therapeutics (Nasdaq: NKTR ) and Pfizer's (NYSE: PFE ) competing product Exubera has, where some government agencies are unwilling to pay for it.
MannKind's management has been doing all it can to distance Technosphere from Exubera, which is fast becoming one of the worst commercialization failures of all time. Exubera brought in a dismal $4 million in sales for the second quarter, even with Pfizer's marketing muscle behind it.
The reimbursement concerns are just one of several issues plaguing Exubera, along with the drug's possible long-term pulmonary safety concerns and the current bulkiness of the device. The Exubera marketing disaster has surely scared potential Technosphere partners, but MannKind said it was working on addressing these issues with additional clinical trials and hopefully demonstrating to European regulatory agencies, for example, that the cost of Technosphere will be worthy of reimbursement.
Whatever happens with a potential partner for Technosphere, 2008 will be a busy year for MannKind. All of its pivotal phase 3 studies have completed patient enrollment and results are expected to start arriving in the second quarter next year and on an ongoing basis thereafter.
If all goes according to plan, MannKind expects to file an FDA marketing application for Technosphere at the end of 2008. Before investors start debating the commercialization opportunity with the drug, though, perhaps a greater focus should be on examining its odds of getting approved.
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