Is This a MannKind Killer?

Talk to MannKind (NASDAQ: MNKD  ) bulls, and you'll hear two reasons why its insulin Afrezza is the best thing since sliced bread.

  1. The drug more closely mimics how the body secretes insulin after a meal to lower blood sugar, doing its job and leaving the bloodstream quickly. Since it doesn't stick around as long as injected fast-acting insulins such as Eli Lilly's (NYSE: LLY  ) Humalog or Novo Nordisk's (NYSE: NVO  ) NovoLog, there's less of a risk of hypoglycemia, or low blood sugar levels.
  2. Afrezza is inhaled rather than injected, allowing patients to avoid needles.

The first point is completely valid. Severe hypoglycemia is very dangerous. Even removing mild hypoglycemia events can be beneficial because it alleviates the need for snacking between meals, which can lead to weight gain.

The second point is where I think the bulls miss the target. Injecting insulin isn't nearly as bad as MannKind bulls want it to be. Both Humalog and NovoLog are available as pen injectors, which makes the injecting insulin fairly simple and discreet.

And convenience is at the end of a long list of things doctors look at when deciding whether to prescribe a drug. Safety trumps convenience. Always.

While I haven't seen any red flags when it comes to Afrezza's safety, the drug hasn't been tested on nearly as many patients as have taken injected insulin. In general, doctors don't like exposing the lungs to drugs that don't treat lung diseases, so doctors are bound to be more comfortable with known side effects of injected insulin compared to the unknown side effects of Afrezza that might pop up once the drug is on the market.

The best of both worlds
Biodel
(NASDAQ: BIOD  ) is testing an ultra-rapid-acting insulin called BIOD-123 that has the potential to have the same positive characteristics as Afrezza -- quick on and quick off -- but it's injected rather than being inhaled, reducing the potential pushback from doctors.

The biotech already tried once before to gain Food and Drug Administration approval for an ultra-rapid-acting insulin, but the agency turned down the marketing application for Linjeta, citing problems with the way its clinical trials were run.

Biodel went back to the drawing board, reformulating the Linjeta into BIOD-123. The biotech has guided for data release from a phase 2 trial in the third quarter, so we don't have to wait too much longer to see if the new formulation can reduce blood sugar levels while avoiding hypoglycemia events.

With a sub-$100 million market cap, investors don't seem to be giving the company much credit. Given the company's history with Linjeta, I can't blame them. At this valuation, Biodel looks tempting, but it's a bit of a crapshoot whether the new formulation will produce positive results given the limited data to date.

A positive phase 2 proof-of-concept trial would be a blow to MannKind, Eli Lilly, and Novo Nordisk, but certainly not a knockout punch. BIOD-123 still has to go through phase 3 trials, putting it a couple of years away from getting on the market (assuming the data could be repeated). The Linjeta phase 2 data looked good, too.

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Read/Post Comments (19) | Recommend This Article (8)

Comments from our Foolish Readers

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  • Report this Comment On August 30, 2013, at 11:48 AM, legaleagle9 wrote:

    I disagree. As a diabetic that had to inject up to 8 shots a day through two pregnancies (and is still a diabetic), I would beg my doc for an inhaled product over the injection pens any day! Even with the convenience of the pens, you are still injecting a needle into your body which causes bruises and pain at varying levels depending on the day, where the shot goes in, etc. Hiking up my skirt or shirt to inject a pen into myself is not exactly discreet. I also have a friend whose daughter was diagnosed with diabetes as an infant. If this is approved, I will be first in line to ask for it and I know he will be second in line if it is approved for children.

  • Report this Comment On August 30, 2013, at 12:13 PM, stclark98 wrote:

    legaleagle9

    Its interesting to follow the controversy generated by a product that may well prove to be one of the most successful medical breakthroughs in some time.

    Thanks for sharing your "front line" view, as it shows the desire from a perspective that nondiabetics or investors rarely have the chance to hear.

    I disclose that I have and will remain LONG on Mannkind as although it may be controversial, if it can help a mere fraction of those who suffer with diabetes it will be worth all the efforts that Alfred Mann has spent a major part of his life trying to accomplish.

    Good luck with your treatment.

    Steve

  • Report this Comment On August 30, 2013, at 12:36 PM, JUDYREITZ wrote:

    I believe many diabetics would find inhaled insulin a welcome relief after sticking themselves with needles, having their bodies black and blue from the bruising of insulin injections. I would never want my child to go through that. I am sure many parents would consider inhaled insulin a Godsend. The gentleman writing this article must of never experienced it himself or had a child with type 1 diabetes. Until you live it and feel it, don't be so quick to judge how life changing Afrezza could be for many people. Technology and brilliant minds have touched all of our lives for the better, in some way. I believe Mr. Mann is one of those brilliant minds and he has made one giant leap for Mannkind.

  • Report this Comment On August 30, 2013, at 12:49 PM, JUDYREITZ wrote:

    ......Oh yes.... and I am "ALL IN" when it comes to Mannkind. I am pretty sure it was Motley Fool that said Mannkind is that kind of investment..........You have to believe in it and I have put my money where my mouth is.

  • Report this Comment On August 30, 2013, at 1:29 PM, Kimamarie wrote:

    I am a hospital pharmacist the author of this article doesn't understand pain and suffering plus tissue damage that diabetics suffer with injections.In addition insulin one of the most dangerous drugs on the market hundreds of dosing errors are made every year.Metered dose inhaler would help eliminate these errors. I am long Mnkd

  • Report this Comment On August 31, 2013, at 1:28 PM, matosjr wrote:

    BIOD-123 is definitely NOT a Mannkind killer not a blow. The author just has an opinion.

  • Report this Comment On August 31, 2013, at 1:43 PM, manipulatethis wrote:

    Let me try and understand what this so called doctor (it's a phd and not a MD) is typing. He believes that Biod-123, still in phase 2 and possibly 3 maybe 4 years away from being approved if apporved at all, is an Afrezza killer? Afrezza will most likely get approved (always a chance it won't) by mid 2014. BIOD-123 had to go through an entire revamp in its delivery system. We all know there are no guarantees in what the FDA will do but Orelli is clear in what he's doing. This is another MNKD hit piece. There is no reason to mention MNKD at all to espouse the possible investment opportunity with BIOD. One thing is for certain, we all know what that PHD stands for at the end of Orelli's name. Piled Higher and Deeper. Bobby, Afrezza will be on the market for many years before BIOD-123 escapes the FDA black hole.

  • Report this Comment On August 31, 2013, at 1:45 PM, manipulatethis wrote:

    sorry Brian, I called you Bobby. i guess we are all prone to getting entire things completely wrong once in a while. I get your name wrong and you get AFrezza all wrong.

  • Report this Comment On August 31, 2013, at 1:50 PM, noelnavarro wrote:

    This Brian character has absolutely no qualifications or credentials to write about diabetes. He is not an MD nor has he ever worked for a pharmaceutical company. He doesn't have any credentials either in finance to speak intelligently about investing.

  • Report this Comment On August 31, 2013, at 2:01 PM, skipolack wrote:

    Treatments from both companies have a lot of potential. Some patients/doc's will stick with injectables, which bodes well for BIOD, while some will want to try MNKD's Afrezza. Why not invest 50/50 in both companies?

  • Report this Comment On August 31, 2013, at 4:19 PM, SoCalBiotechguy wrote:

    1) You hit the point on how quickly Afrezza leaves the bloodstream but you completely miss the importance of onset of action.

    2) "Injecting insulin isn't nearly as bad as MannKind bulls want it to be." You support that statement with no data while there are many published reports citing that diabetics are tired of injections. Produce one report that says diabetics don't mind injections ... just ONE large market research report.

    3) " ...Afrezza's safety, the drug hasn't been tested on nearly as many patients as have taken injected insulin." I nominate this comment for the "duh." comment of the year. Of course, more patients have been on injected insulin, it's only been around for decades. Why don't you cite the 6,000+ patients that have tried Afrezza and compare that to the total number of patients that have tried other drugs. Also, consider the total patient market that defines orphan drug status and you'll find that your comment is actually quite meaningless.

  • Report this Comment On August 31, 2013, at 4:26 PM, XMFConnor wrote:

    As a type I diabetic and experienced investor, I'd say:

    1) First, there's nothing offensive about this article IMO. It gives a reasonable viewpoint and supports it with evidence

    2) I would include more discussion about insulin pumps and artificial pancreases (sp?). Europe already has versions of the latter and technology seems to be trending that way. And pumps are already well established and growing in the U.S. (look at PODD). While they still require an injection, it's basically only one every three days (depending on type of pump and use), and this is much easier for most people (again, its preference), than injections-- or inhaling would be.

    I'd be afraid of investing in this company. Even if it does get all of the FDA approvals, the technology is changing so quickly in this space, that many things--- such as artificial pancreas improvements-- could make it behind the tech curve.

  • Report this Comment On August 31, 2013, at 4:36 PM, SoCalBiotechguy wrote:

    XFMConnor .... "Injecting insulin isn't nearly as bad as MannKind bulls want it to be. Both Humalog and NovoLog are available as pen injectors, which makes the injecting insulin fairly simple and discreet."

    The second statement is not evidence that supports the hypothesis in the first statement.The author provides no "evidence" to support his opinion which is incorrect. In fact, there is abundant evidence to the contrary. Injecting insulin is one of the BIGGEST COMPLAINTS from insulin dependent diabetics.

  • Report this Comment On August 31, 2013, at 4:54 PM, manipulatethis wrote:

    XMFconnor,

    Afrezza is being used with an advanced insulin pump to create the artificial pancreas. Al Mann is working on it as you type your garbage.

  • Report this Comment On August 31, 2013, at 8:21 PM, TMFTypeoh wrote:

    Nice article, but there is a HUGE barrier to inhaled insulin not discussed here......dosing.

    Anyone remember exubera? It was the first inhaled insulin to hit the market, and it failed miserably. Why? Well, there were several reasons, but the biggest was the dosing.

    With a pen you can dose in 0.5 unit increment, and with a pump its as small as 0.025 units.

    Exubera had dosages of 3 units, 6 or 10 (if memory serves.....though that may be wrong). And it was very, very confusing with how many tabs you needed to dose properly.

    Combine that with its size (some called it the "insulin bong"), and its was a massive failure.

    Mannkinds insulin sounds interesting. However, you still will have to take a long acting insulin via injection! This insulin would cover meals/corrections, but not your long acting needs. Yes, you could go from 4-8 shouts per day down to 1-2, but your not needle free.....keep that in mind.

    I'm a huge fan of Al Mann....i think he is terrific. However, he's wrong about inhaled insulin. Way to many unknowns, and changing doctors/nurses/aprns minds on a grand scale about inhaled insulin (especially in the wake of exubera) will be a massive uphill battle. Color me skeptical.

  • Report this Comment On August 31, 2013, at 8:31 PM, SoCalBiotechguy wrote:

    TMF aka Brian Orelli former co-worker? >>>

    Great reminder on the benefits of Afrezza. The convenience is not only in the inhaled delivery, fastest acting insulin and clearance but in the simplicity of titration.

    Check out any presentation where Al reviews the technospheres, the whistle-sized dreamboat device and kinetics. He explains the simplicity in titration. Remember, patients can now titrate to better control a1C without increased risk of hypo events. This will mean better control.

    The product has always been positioned as prandial insulin but also consider what the Affinity 2 trial could mean in terms of expanded label.

    In short, my belief is that Mannkind's criticism of some "analysts" (and I use that term loosely) applies to Brian and the TMF crew of followers. Being an analyst means a little more than being able to understand some basic science and reading a product label.

    My humble 2 cents.

  • Report this Comment On September 02, 2013, at 7:17 PM, sanityrules wrote:

    There seems to be an effort underway to hype up Biodel's insulin development. Seeking Alpha is another place one sees similar articles. But it is a long ways away from the FDA and in essence, possibly an improvement over what is.

    With regard to the FOOLs so called 'experts'. Been a member of the fools site for years, and one of the worst things they did for their credibility was to create this arena for so called 'analysts' to write like this. My take on articles like this is, there is a REASON he wrote this, he had an agenda when he did. Maybe the fool should start making their DISCLOSURE statement one of where the author has to STATE WHY he took the time to write an article, not whether or not he has a position in the stock. Again, folks don't do something without a reason. Maybe he should also have to say, while I don't own of the stocks, I also receive no compensation in any form for writing this article?? Just curious...

    My reason for this comment: obviously, I fully disagree with his 'thesis' and yes, own MNKD, have followed them for years. Hate to say it, but given the effort I have seen to hype up Biodel over the last several months, this appears to be another attempt to do so... now WHY is that? Hmmm..

  • Report this Comment On September 03, 2013, at 1:07 AM, plcfischer wrote:

    Simple answer is no, Biodel is not a MNKD killer. And here is why:

    1) MNKD has finished phase 3 studies, Biodel will not be finished phase 2 studies for a few more months. If approved Afrezza will be on the market for well over a year before BIOD-123.

    2) Afrezza reaches its peak in 12-14 minutes. I see no information about the speed of BIOD-123 in the story, but I found some information on the Biodel website for the older formulations. BIOD-238: 37.5 minutes, BIOD-250: 40.0 Minutes, Humalog: 60.0 minutes. So Afrezza is about 3 times faster.

    3) Needles do matter.

    Some patients will not be able to take Afrezza because of cough or lung problems. For them a drug like BIOD-123 could be a godsend. So BIOD-123 will not be much if any competition for Afrezza, but would still be nice to have.

  • Report this Comment On September 03, 2013, at 2:26 PM, horticultor wrote:

    The short answer to the headline question is "No."

    Next?

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