2 Things to Watch at MannKind

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.

Competition
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.


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Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On January 24, 2013, at 3:02 PM, pommerac wrote:

    Don't know why yoother to write this crap

  • Report this Comment On January 24, 2013, at 3:14 PM, pommerac wrote:

    Bother

  • Report this Comment On January 24, 2013, at 4:24 PM, yazzbro wrote:

    Don't you think if Afrezza gets FDA approval that Big Pharm might be lining up to partner up or buyout MannKind?? Afrezza is a potential game changer for sure.

  • Report this Comment On January 25, 2013, at 10:56 AM, TelsaRowe wrote:

    Dance Pharmaceuticals inhaled insulin? If everything goes absolutely flawlessly for their insulin product approval would come in 2017 at the earliest. Mnkd has absolutely nothing to worry about and contrary to the title mnkd investors should not keep an eye on this development. This has got to be the laziest most futile attempt at pumping I have read. Used to be Motley Fool had cognizant authors that put effort into their so called "articles". Not anymore. You sir, are part of the problem.

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