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MannKind's Pit Stop on the Road to Approval

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MannKind (NASDAQ: MNKD  ) will take a pit stop on the long road to approval of its inhaled insulin Afrezza when the drug is reviewed by a Food and Drug Administration advisory committee on April 1.

Unfortunately, it's hard to know whether this will be a short tune-up before an eventual approval or if the engine is about to blow up.

Normally, I'd say scheduling an advisory committee meeting is a negative for any company. MannKind's top-line data from the most recent phase 3 trials were positive, producing results comparable to Novo Nordisk's (NYSE: NVO  ) injected insulin Novolog. If the FDA was equally convinced by the larger data set, it wouldn't seem necessary to seek the advice of its outside advisors.

But let's not forget that the FDA didn't schedule advisory committee meetings during Afrezza's last two review cycles and we all know how those turned out. On some level, MannKind is better off with an advisory committee meeting because at least we know the FDA isn't going to enter a summary judgment, rejecting the drug device for a third time.

And, of course, the FDA routinely puts drugs in front of advisory committees that vote overwhelmingly for approval. Sometimes it seems like the FDA just wants someone to hold its hand through the process. In MannKind's case, with Afrezza's new mode of delivery, the FDA may simply be covering its butt. If post-marketing issues were to arise after an FDA approval, the agency could point to the advisory committee that endorsed Afrezza, saying it wasn't the only one that thought the drug should be approved.

What's under the hood?
For any drug approval, it's what investors don't know that's the biggest risk. The most likely issue to trip up Afrezza is safety data. Drugs that are delivered via the lungs -- but don't treat problems there -- will get extra scrutiny.

The FDA will need to make sure the device isn't lowering lung function, and it'll want to be convinced that the insulin isn't adversely affecting lung cells. You'll recall Pfizer (NYSE: PFE  ) and Nektar Therapeutics' (NASDAQ: NKTR  ) inhaled insulin Exubera was linked to lung cancer although the numbers were quite small. That wasn't the reason Pfizer had so much trouble selling Exubera, but it'll be a black mark on Afrezza none the less.

MannKind has released some safety and lung function data, but if there's a devil, he's usually hiding in the details.

Source: MannKind.

The checkered flag
Handicapping the advisory committee meeting is going to be difficult, but it could get a whole lot easier if MannKind signs a marketing deal with a major diabetes drugmaker. Any potential partner is likely to get access to all the data the FDA has, so it would be a great sign if a large pharma is willing to do a licensing deal risking its cash before the committee meeting.

On the other hand, if MannKind signs a deal with little to no up-front investment, it could be a sign to bring out the yellow flag, although that wouldn't necessarily mean Afrezza is done for. Races are occasionally won while under the caution flag.

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Read/Post Comments (7) | Recommend This Article (9)

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 12, 2014, at 10:00 PM, hopefull11 wrote:

    Ya, the joke is on you shorty!

  • Report this Comment On January 12, 2014, at 10:35 PM, MathewsJ wrote:

    Adverse Effects

    No significant differences in hypoglycemia, cough, pulmonary function, or body weight were found between TI plus IG and placebo groups in phase 2 RCTs.2,3 In a phase 3 trial comparing TI plus IG to BI,4 patients taking TI plus IG experienced significantly less weight gain (0.9 kg versus 2.5 kg; P = 0.0002) and hypoglycemia (48% versus 69%; P < 0.0001) than those taking BI. Both mild-to-moderate and total hypoglycemia were significantly lower with TI plus IG than with BI. The severe hypoglycemia event rate during the late night was also lower with TI plus IG.4 Patients taking TI plus IG experienced more cough (33% versus 6%) and upper respiratory tract infections (12% versus 7%) compared to those taking BI.4 An asymptomatic decline in pulmonary function as assessed by pulmonary function tests was observed in both groups over the 52 weeks of the study. The magnitude of the decline was numerically larger in the TI plus IG group but no statistically significant differences were found between groups. Changes in pulmonary function for both groups were considered to be small and not clinically relevant by the investigators.

  • Report this Comment On January 12, 2014, at 10:40 PM, MathewsJ wrote:

    To better determine the role of TI in diabetes management, long-term evidence is needed regarding the efficacy of TI compared with rapid-acting prandial insulins in patients with type 1 and type 2 diabetes.

    These studies followed patients for 112 weeks to 524 weeks and thus provide limited information about long-term efficacy and risk of weight gain and hypoglycemia.


  • Report this Comment On January 12, 2014, at 10:42 PM, MathewsJ wrote:

    Thus far, patients using TI report improved attitudes toward insulin therapy and high treatment satisfaction based on an insulin treatment questionnaire and health-related quality-of-life assessment.9,10 In addition to being less invasive, TI may provide advantages through its rapid action and short duration, and by improving glycemic control with minimal weight gain or hypoglycemia

  • Report this Comment On January 12, 2014, at 10:46 PM, MathewsJ wrote:

    I only see one problem (from that paper listed above) that may lead the FDA to reject Afrezza:The lack of long term evidence.

    This leads me to wonder how Exubera was approved.

  • Report this Comment On January 12, 2014, at 10:50 PM, MathewsJ wrote:

    Correction: 11 weeks to 52 weeks, not 112 to 524 weeks. 2 and 4 following 11 and 52, respectively, are for reference numbers (superscripts).

  • Report this Comment On January 12, 2014, at 10:59 PM, MathewsJ wrote:

    "In 2004, an FDA panel rejected Procter & Gamble's testosterone patch, Intrinsa, due to questions about its long-term safety — despite evidence of effectiveness."

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Brian Orelli

Dr. Orelli is a Senior Biotech Specialist. He has written about biotech, pharmaceutical, and medical device companies for The Motley Fool since 2007.

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