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With its fourth-quarter earnings report just around the corner, biotech company MannKind (NASDAQ: MNKD ) continues to inch its way toward an FDA decision regarding its ultra-rapid inhalable insulin product Afrezza. With each passing day, the debate among investors rages on as to whether this product can ultimately gain approval and be commercially viable. In a brand new premium report on MannKind, we outline every key topic investors have to know with this risky stock. The sample below focuses on two issues that all MannKind investors need to watch -- find out more in the full version.
The hunt for a partner
Let's fast-forward several months and assume that Afrezza finally gains FDA approval. Hip, hip, hooray -- right?
Not so fast. FDA approval might be MannKind's first hurdle, but it's definitely not the last. The company doesn't have any marketing capabilities in place currently, so it'll either have to build a sales team from scratch, outsource this service to a third party, or find a partner to commercialize Afrezza. The first two options seem difficult to accomplish given the company's limited resources, so a partnership is probably the best solution.
MannKind has made references to negotiations with interested parties in the past, but none of the established pharma companies have stepped up yet. The company stated in November that some "newcomers" expressed interest in potentially partnering with MannKind. However, we will likely have to wait until sometime into 2013 to find out how serious any of these parties really are.
It is possible that they are waiting for MannKind to complete its clinical trials in order to better assess Afrezza's chances of FDA approval. It's also possible that these companies remember Pfizer getting burned by Exubera and might be looking to other therapeutics that can boost their drug pipeline without exposing them to too much risk. Whatever the reason, the reality is that MannKind needs a partner to help bring Afrezza to market.
Big pharma companies may not be showing interest in inhalable insulin, but MannKind may not be the only game in town. Dance Pharmaceuticals announced plans in 2011 to develop a competing inhaled insulin product. Interestingly, Dance was started by John Patton, a key member of the Nektar Therapeutics team that developed Exubera. Given his knowledge of this industry -- and the many lessons learned from Exubera's failure -- Dance's product could be an improved, next-generation insulin that might better serve the needs of diabetes patients. Its product is still in early development, but this is a something investors should keep an eye on.