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MannKind Needs More Leaps

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If you invest with your heart, then MannKind (Nasdaq: MNKD  ) is a great story.

Propelled by the will and the bankroll of billionaire chairman and CEO Alfred Mann, this tiny company is striving to make an inhaled form of insulin. MannKind seeks to succeed where Pfizer (NYSE: PFE  ) failed and where other giants, Eli Lilly (NYSE: LLY  ) and Novo Nordisk (NYSE: NVO  ) , gave up.

But if you invest with your head, then MannKind represents a risky proposition that the average investor should probably avoid.

Getting approval from the Food and Drug Administration, while always unpredictable, will be the least of MannKind's challenges. The biggest hurdles that MannKind must leap are getting enough doctors to prescribe the drug, enough patients to use it, and enough insurers to provide coverage equivalent to injectable insulin.

All of those "gets" require a belief that MannKind will do better with its Afresa than Pfizer's flop with Exubera. The FDA is scheduled to decide in January, but it's possible the agency will delay action. That's not necessarily a reflection on Afresa -- just the FDA.

Real and intangible obstacles
Both Afresa and Exubera are rapid-acting insulin taken by diabetics at the start of a meal, meant to mimic insulin release by nondiabetics and to control blood sugar levels.

Afresa is already ahead on one count: MannKind's palm-size inhaler that delivers powdered insulin is more convenient than the cumbersome device from Pfizer and Nektar Therapeutics (Nasdaq: NKTR  ) , which seemed better suited as a prop in a stoner movie or psychedelic music video.

Still, MannKind must avoid falling into Pfizer's trap of misreading market research that assumed patients would flock to inhaled insulin. When Pfizer withdrew Exubera in October 2007, year-to-date sales were an embarrassing $12 million. Investors take note: Insulin injection and infusion technology has improved over the years.

If the FDA approves Afresa as equivalent in efficacy to injectable insulin, MannKind must persuade many doctors to change their prescribing habits. Exubera might have encouraged such a change, but the FDA's approval included a warning that patients should beware of respiratory problems. Patients were strongly advised to receive periodic lung function tests. Smokers and people with lung diseases were told to avoid Exubera.

In April 2008, Nektar abandoned seeking a new partner for Exubera after an ongoing Pfizer clinical trial revealed "an increase in the number of new cases of lung cancer" in Exubera patients versus a control group. The new cases occurred among former smokers.

In contrast, MannKind says a two-year clinical trial shows no change in lung function between Afresa patients and users of other diabetic treatments.

Forecasting
The next signature event for MannKind could be a deal with a marketing partner, a protracted process that might be completed in the third quarter. I wouldn't count on Pfizer, Lilly, or Novo Nordisk.

Would insulin specialist sanofi-aventis (NYSE: SNY  ) be interested? It had a piece of Exubera before Pfizer bought out its stake. Would a maker of a noninsulin diabetes drug like Merck (NYSE: MRK  ) take a chance? Alas, it's busy trying to inhale Schering-Plough. Japan's Takeda Pharmaceutical also has a healthy noninsulin, blood-sugar control business.

A partner will see more data than will investors, so a marketing announcement would likely raise MannKind's shares. Still, a partner's faith won't alleviate doctors' and patients' concerns -- or insurers' attitudes -- about inhaled insulin given Exubera's history and advances in injection technology.

For investors, these concerns represent a step backward from MannKind.

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Fool contributor Robert Steyer doesn't own shares of any companies cited in this article. Pfizer is an Inside Value choice. Novo Nordisk is a Global Gains recommendation. The Motley Fool has a disclosure policy.


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 June 19, 2009, at 4:21 PM, aracer wrote:

    Under-researched Robert. MNKD is a strong buy precisely because of the herd mentality that "Exubera failed so all inhaled insulin will fail."

    Afresa is unique because the drug provides diabetics an ability to be healthy while eating like normal people, significantly better than current fast-acting options or Exubera. By replicating the body's natural insulin spike after eating, Afresa helps prevent the dangerous blood sugar swings that cause acute and long-term health problems for diabetics. The facts that Afresa does this without needles, weight gain or dosing calculations, and that it is easy to use like an asthma inhaler, are just gravy.

  • Report this Comment On June 19, 2009, at 4:58 PM, orlon6 wrote:

    The benefits of AFRESA is precisely why one should invest with the mind.Those who invest with the heart invested with the bong (foot long at that) treatment called Exubra. In fact some analysts inaccurately, due to poor research or other motives, associate MannKind with the development of Exubra. The benefits of AFRESA numerous such as lower glucose numbers, lower and more stable A1C, not to mention weight loss or at the minimum little or no weight gain. No my friend Robert, for those who do not relish the idea of 3-4X day injections, AFRESA inhaled 2X day, acting within 12-14 minutes, and no tail is the only way to go. The benefits here most certainly outweigh the costs.

  • Report this Comment On June 19, 2009, at 6:57 PM, goateyes wrote:

    Read this analysis and see what you think of Mannkind...it has six parts (this is part 6) with the first five parts given as links at the beginning of the article - be sure and read them in order to keep things straight...

    http://seekingalpha.com/article/82180-mannkind-overlooked-bi...

  • Report this Comment On June 19, 2009, at 8:47 PM, Blaster399 wrote:

    Let's see his invention of the insulin pump, 6 companies founded by Alfred Mann and sold successfully to major pharma, currently running six other companies, and he has chosen to invest 3/4 billion of his own moneyi in Mankind . Fourteenth richest person in California, God what a looser. Exhubra is history and Lilly gave all their patients to Mannkind, and oh yes did I mention the successful completion of three cat 1 tests for Melanoma cancer which extended terminal patients life span by %46. This info is available off of Mankind's link to government testing data. You shorts are in trouble and you don't know how much..... YET

  • Report this Comment On June 19, 2009, at 9:14 PM, heydoc wrote:

    The last three comments are right on target. There is little to add except to criticize the lost opportunity the analysis creates. I am a physician and Robert's analysis is excellent, but limited by being made predomanently from the financial perspective. The insulin's activity is unique, and the change which is least important in Afresia is the fact that it is inhaled. It will be a game changer in the treatment of patients worldwide because its impact on the biochemistry of the patient is significantly better than other insulins. The short term differences seen in the patient's chemistry are mirrored by better clinical responses to therapy. These are likely to correspond to improved long term benefits that will dramatically extend lifespans and reduce morbidity.

    All the obstacles that confront marketing Afresia are real and of concern. Yet, if physicians learn the facts the barriers will fall like a house of cards. The key will be if Mannkind partners with a company willing to commit the money needed to redefine the disease.

    Also, the other drugs in the pipeline are as exciting as Afresia in their potential. This is a company to watch because it knows how to develop drugs---an old fashioned concept that Robert seems to have forgotten.

  • Report this Comment On June 22, 2009, at 11:52 AM, eeerrriiiccc wrote:

    It is interesting to read all of the expert assessments of Exubera. Things like its cumbersome size, pulmonary function problems, or close resemblance to a bong. Let's bear in mind what we are comparing it to: subcutaneous injections with syringes! More than 6 times per day for an average type 1 diabetic. For meal planning this means you need to decide in advance everything that you will eat, inject an appropriate amount of insulin and then stick to that meal plan in a timely manner otherwise risk a hypoglycemic 'event.' To carry insulin around requires some kind of case which provides both temperature control and crash protection for the delicate glass vials (if your insulin vial breaks, not only do you have a horrible smell to deal with, you have lost the option to eat) in addition to a days supply of syringes. Trust me, this is much more cumbersome than an Exubera inhaler.

    As for pulmonary function - this was just a bit of bad press, the patients who experienced pulmonary problems were smokers and, in any case, there was not a statistically significant difference between those taking Exubera and the control group. With injections, on the other hand, patients experience bruising and massive buildups of scar tissue at the injection sites - this is just taken as part of the program.

    The criticism that it looks like a bong is simply absurd, again, we are comparing this to syringes! It is fun to laugh about, but I would say going from heroin paraphernalia to marijuana paraphernalia is a decent improvement!

    I have read a lot of criticisms of Exubera, but never from anybody whose opinion has any relevance to the subject. I have been a type 1 diabetic for 13 years and have been using Exubera ever since it was released. It is by far the most significant advancement in diabetes care that I have experienced. When Exubera was pulled from the market it was a real shock, but I stocked up and am hoping my supplies will last until something like Afresa is available.

    Not only is Exubera incredibly more portable than injectable insulin - I am almost always on the road, I know a thing or two about this - it is also much more durable. No longer do I have to fill my bags with insulation and padding and worry about my insulin vials breaking. The ability to inhale insulin rather than inject it fundamentally changes the way you are able to control diabetes. The game of planning large meals in advance in order to avoid multiple injections is over - I can graze as I please because taking a hit off the insulin bong is such a non issue. When in public places like out at restaurants I used to get stares and cause quite a scene when I pulled out a bag of needles and gave myself an injection. With the inhaler nobody takes notice because inhalers are so commonplace. I should also note that I am a fairly avid bicyclist, have regular pulmonary function tests, and have experienced no changes whatsoever.

    I don't expect anyone who isn't diabetic to really understand the implications of inhalable insulin, but as investors perhaps if you try giving yourself 7 or 8 injections tomorrow, or better yet 7 or 8 injections every day for a year, long enough that it becomes just like breathing, then find someone to tell you that you don't need to do it anymore, you will have a better understanding of what the product does! It's hard for me to really understand why Exubera didn't make it on the marketplace. I have to guess that it had more to do with a shoddy add campaign (even when I saw the adds, I didn't understand what they were for), or high costs for insurers (just a guess) or something more convoluted like Eli Lilly giving better perks to their docs. All I do know is that it had nothing to do with the quality of the product. For me, Exubera has been life changing and it seems criminal that it is no longer available.

    It is hard for me to imagine that a single minded company like MNKD will not be completely successful if only patients can be made aware of their product.

  • Report this Comment On September 24, 2009, at 3:12 PM, RoadShow wrote:

    The carrier agent for Exubera was not inert and therefore built up a residue in the lungs.

    The technospere carrier is inert and disappears almost entirely within 3 hours.

    This monomer mimics the pancreas when inhaled.

    The new dreamboat inhaler looks appealing.

    Lung function and usability will not be an issue this time around.

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Related Tickers

2/9/2012 4:00 PM
MNKD $2.41 Up +0.01 +0.42%
MannKind Corp CAPS Rating: **
NVO $135.02 Down -0.19 -0.14%
Novo Nordisk CAPS Rating: ****
PFE $21.14 Up +0.13 +0.62%
Pfizer, Inc. CAPS Rating: ****
SNY $37.41 Up +0.27 +0.73%
Sanofi (ADR) CAPS Rating: *****
LLY $39.52 Down -0.26 -0.65%
Eli Lilly & Co. CAPS Rating: ****
MRK $38.15 Down -0.27 -0.70%
Merck & Co., Inc. CAPS Rating: ****
NKTR $6.98 Down -0.23 -3.19%
Nektar Therapeutic… CAPS Rating: **

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