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  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    I will quote some sections from their recent quarterly conference calls.

    "As I said on our last call in November, we anticipate our cash burn could increase significantly over the next two to three quarters and would then decline." -- Richard Ansderson, CFO of Mannkind

    That quote is from their 4th quarter (of 2007) conference call, held on March 4, 2008. A transcript can be found at seekingalpha.com/artic...

    "We anticipate our cash burn may increase further over the next one to two quarters and should then decline." -- Matthew Pfeffer, CFO of Mannkind

    That quote is from their 1st quarter conference call, held on May 5, 2008. A transcript can be found at seekingalpha.com/artic...
    Jun 17 19:33 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part IV) [View article]
    "I hope they ALL succeed and give diabetics the choice they deserve." -- R. J. Steffens

    Amen!
    Jun 17 19:14 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Retired pahrma:
    You bring up many good points about the need to flesh out a serious marketing assault, and I fully agree with you. Obviously, Mannkind will not and cannot have finalized their marketing plans until they sign up a partner. I realize that signing up a partner is a hurdle here, but I think that that can be overcome with well-crafted milestone agreements. i plan to discuus their partnership possibilities in more detail in Part 4.

    As for the debt, I thought that I responded adequately to your issue there. Is something still bothering you about that? If so, please tell me and I will try to clarify it.

    The burn rate is somewhat high, but Mannkind has stated that they have enough cash to last until the end of 2009. By that time, I believe that they hope to have a partner and will not have to go to the market and dilute present shareholder ownership.

    Please don't think that I believe MNKD to be a sure bet. Far from it! I will quote myself from a previous comment which I wrote above in response to Bfsc:
    "I am not claiming that Technosphere Insulin is a slam dunk and that there are no risks involved. Far from it. I am claiming, however, that their stock has fallen so far that the risk-reward ratio is quite attractive. Obviously, this is a risky stock and you wouldn't want to put too much of your portfoli in it. Certainly not more than you could handle losing, both financially and emotionally. However, I don't think that there is much risk of not receiving FDA approval. There is definitely more risk of it not doing well in the marketplace, certainly something that is far harder to predict. However, between you and me, I think that it has a decent chance of doing well in the market. I also think that on FDA approval the stock would jump and you would be able to make a nice profit then and there even if you didn't wait to see how the market actually takes it." Please cut me some slack. I'm still in middle of the six-part series, and I fully intend to discuss valuation and risk in my concluding part. I can't cover everything at once.

    I enjoy your comments. Keep them coming!
    Jun 16 19:50 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Mr BSG:
    I will try to answer some of your complaints on what I said one by one.

    "From the latest 10Q;" We expect to make substantial and increasing expenditures and to incur additional operating losses for at least the next several years as we......; " AT LEAST THE NEXT SEVERAL YEARS vs a few quarters, is quite different from your interpretation vs the facts, now isn't it." -- Mr. BSG

    Actually, what I quoted from them was that the cash burn rate will drop from its present rate of $100 million per quarter after a few quarters. They will certainly still be losing money afterwards. That is obvious because they still won't be selling anything by that time. I never said or implied otherwise. My quote was from their quarterly conference calls. You can find a transcript of their two most recent quarterly conference calls in Seeking Alpha's transcript section.

    "MannKind Suspends Partnership Talks for Inhalable Insulin After Pfizer Reports Possible Risk" -- Mr BSG

    A person would almost suspect you of purposely trying to confuse the issues. I will give you the benefit of the doubt. If you finish that very press release that you referenced, you will find that Mannkind says that they are waiting until the end of their Phase III trials to pursue partnership opportunities. They are in no means planning to try to sell it alone. The press release can be read in full on Mannkind's website at www.mannkindcorp.com/p.... You will find more information about their partnership plans in their most recent quarterly conference call, which transript can still be found in Seeking Alpha's transcript section. That conference call occurred on May 5, 2008 and reaffirmed their plan to find a partner after Phase III data is in.

    "So your argument is that since its dropped from $14 to under $3 that it won't drop any further, yet you haven't presented a logical argument to support that rationale." -- Mr. BSG

    I fail to see where I said any such thing in the part that you quoted or any other part of my series or comments. I simply said that it doesn't concern me whether it was worth it for Mr. Mann to commit $1 billion of his money for so long. For that to be worth it for him, his stake in the company will have to rise to substantially more than $1 billion. His approximately 50% stake in the company is right now worth less than $150 million. However, for a purchaser who buys at the $3 level, he can make quite a nice profit if the shares go up only 2x - 5x, which would still keep Mr. Mann in the red. I certainly did not say that it's worth it to buy MNKD simply because it went down. That is an inane argument and nowhere contained in my words. I think that Technosphere Insulin will be approved by the FDA towards the end of next year, I think that Mannkind will find a partner, and I believe that the stock will rise in response. I also think that Technosphere Insulin will do better in the marketplace than people are giving it credit for. I've spoken at length in the first 3 articles in my series on why I think that this is so. You can certainly disagree with me but I don't see how that's called that having not "presented a logical argument to support that rationale".

    "T1 is a product of convenience, that eliminates needles at meal time." -- Mr. BSG

    That is true but that is not the whole truth. TI has significant medical advantages. Because of its faster entry and faster peak, it reduces post-meal glucose exursions more than conventional insulin, it has a much lower risk of hypoglycemia than conventional insulin, and it does not cause weight gain like conventional insulin, rather TI causes weight loss. I clearly spelled out these differences in Part 1 and Part 3 (the present article) of this series. Did you read them at all?

    Look, we can agree to disagree without being venemous at each other. I appreciate the give-and-take in the comments to my articles, and enjoy reading other people's views also, but I would appreciate if we can keep the discourse on a civil level. There is no need to stoop to calling anybody names or casting aspersions on their motives. Peace?
    Jun 16 19:35 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Retired pharma:
    Assets did not go down by $100 million between December 2007 and March 2008. Assets only went down around $78 million. CASH went down around $100 million ($99.2 million to be more exact). Most of that cash was spent on general expenses, their last Phase III trials for Technosphere Insulin which are currently coming to a close (ending September 1), and their regualtory activities as they put together their filing for Technosphere Insulin. Around $25 million was spent on the expansion of their factory which is also coming to a close (hence the greater decline in cash than assets). Mannkind has stated that they project similar cash flow for the next few quarters, after which they expect the cash burn rate to drop.

    They do not have debt of $1.2 billion. Their total debt as of March 31, 2008 is only about $167 million. The $1.2 billion figure is their accumulated deficit, which means how much money they have lost over the lifetime of the company. In other words, from all the various financings that they have done in the past 25 or so years of their existence, they have spent $1.2 billion of that money, with no profit to show from that (considering that they are still in development stage and have never sold any products yet).

    As for their ability to market it themselves, you are quite correct that that would be very difficult. Mannkind has stated that they plan to find a partner to co-market it with them, but they are not looking to sell the company. As I said at the end of this article, I am planning to discuss Mannkind's partnership opportunities and options in Part 4, the next part in this series.
    Jun 16 15:06 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    "Anyway, thanks for the articles and please keep it positive. The overall writings on TI have been an interesting read." -- Bfsc

    Thank you for the kind words. I appreciate the give-and-take that we have been able to share in the comments.
    Jun 15 23:26 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Bfsc (formerly Mr. 9787):
    You say that I have misstated a number of things in my dismissal of Generex as regards to a serious competitor for Mannkind. Let me take the issues one by one.

    "Nowhere in Generex's 10K's do they mention a 200 patient trial." -- Bfsc

    I was coming from the following quotes in their 2007 10-K -- "Between January 1999 and September 2000, we conducted clinical trials of our insulin formulation involving approximately 200 Type 1 and Type 2 diabetic patients and healthy volunteers." Rereading it, I admit that they may be combining all their trials together and between all of them there were 200 people. That just makes my point stronger. They did not test in nearly enough people to be ready for Phase III trials.

    "I said that the other countries approving Oral-lyn speak well of it's safety and efficacy results in over 1,500 patients to date." -- Bfsc

    Well, in their 2007 10-K, Generez states that "We conducted the first clinical trials of our buccal insulin formulation with human subjects in Ecuador in January 1998. We ultimately conducted a total of approximately 13 studies in Ecuador and an additional 26 trials in other countries over the period from 1998 to 2007. Each of these trials involved a selection of between 8 and 20 patients." With a total of 39 studies of a maximum of 20 people each, that gives the UPPER limit of how many people were tested in their trials as 780. I'm not sure where your 1,500 number is coming from. (Maybe you're counting the control groups also, while they're not? Or perhaps you are including people who used it not as part of trials?)

    "I will also inform you that Generex has never licensed a patent (?) and has never earned revenue in that way." -- Bfsc

    I conced that I did not write my point well originally. Being only a comment I did not edit it for clarity so much, which perhaps I should have. I was referring to the following line from their most recent 10-Q discussing the source of their revenue -- "The Company is a development stage company, which has a limited history of operations and whose revenues is primarily comprised of $1 million received in conjunction with the execution of a development agreement, grant revenue from government agencies related to Antigen’s operations and $50,000 in conjunction with the execution of a licensing agreement. The Company has realized minimal revenues to date from the sale of its commercial products". My point was that they are not getting much money from their commercially available products, and that they can't be expected to fund the continuing development needs of the company, which I am sure you agree with.

    As a side point, counting just the things which Generex is working on mentioned in this thread, I counted a total of 8 things that they are in middle of developing. It beggars the imagination that they can really simultaneously pursue 8 very different drugs with only $9 million spent per quarter and 25 employees. From their most recent 10-K -- "At September 30, 2007, we had twenty-five full-time employees, including our executive officers and other individuals who work for us full-time but are employed by management companies that provide their services, and ten employees of our subsidiary Antigen. Eleven of our employees are executive and administrative, eleven are scientific and technical personnel who engage primarily in development activities and in preparing formulations for testing and clinical trials, and three are engaged in corporate and product promotion and product sales." So that's 11 employees involved in development activities pursuing 8 drugs (a breast cancer vaccine, HIV vaccine, a combo peptide vaccine, MAI vaccine, aviav flu vaccine, MetControl Gum, a prostste cancer drug, and Oral-lyn). I don't know. It just seems hard to swallow.

    "their recent financing arrangement contains warrants that when exercised brings the company an additional $50+ mm plus. Generex also has a $150,000 million shelf approved by shareholders in May 2006 that is fully intact." -- Bfsc

    Those warrants have a strike price that is presently 20% above the stock price, so I don't see it as anywhere near a sure thing that they will ever be exercised. As for the $150 million shelf registration, I'm sure you know that that just means that they already have permission from their shareholders to go raise that $150 million as equity, but they would still need to find investors willing to put up that money. I don't mean to imply that they are surely going bankrupt. I simply mean that their financial condition is more precarious. It doesn't bother me that Al Mann dedicated $1 billion of his own money to Mannkind and it doesn't concern me whether he makes back his money or not. I am simply looking at Mannkind's prospects here and now and judging whether they deserve to be selling for less than $3 a share like they are now, which I have decided they don't.

    "I am very familar with the guidance and you should read it closer. The part talking about the larger sized studies deals with Type "2" diabetes and Generex does not have ANY need to redesign their Phase III study protocol which is specifically for Type "1". --Bfsc

    I was simply refuting your statement that the guidance was only for "diabetes drugs that have certain issues -- such as some oral pills and inhaled insulin". I presume that you agree with me that it discusses all diabetes drugs. I agree with you that the section necessitating 2,500 patients, etc., in trials is referring to Type 2 Diabetes. But then again, Type 2 Diabetes is by far the more prevalent type, accounting for 90% to 95% of all diabetes. Limiting themselves to only Type 1 Diabetes further neutralizes any competition from them to Technosphere Insulin, which remains the main point of my thrust. I don't actually believe that the size of their studies as it stands now will suffice for FDA approval for Type 1 Diabetes either, but that is mostly immaterial and even if I conceded that point, Technosphere Insulin is mostly safe from competition from them.

    Look, maybe I spoke too harshly about Generex in general. My point was not about Generex, but rather about Generex in relation to Mannkind and Technosphere Insulin. I believe that even you will agree that Generex is certainly far away from FDA approval, significantly further than Technosphere Insulin. They have at best just started (as of June 2008) their Phase III trial and have so far only designed a Phase III trial for Type 1 Diabetes. Even if, for argument's sake, the FDA will ultimately approve them for Type 1 Diabetes with this trial, that's a long way off and doesn't even harm Technosphere Insulin's position so much being that it's confined to Type 1 Diabetes.

    I am not claiming that Technosphere Insulin is a slam dunk and that there are no risks involved. Far from it. I am claiming, however, that their stock has fallen so far that the risk-reward ratio is quite attractive. Obviously, this is a risky stock and you wouldn't want to put too much of your portfoli in it. Certainly not more than you could handle losing, both financially and emotionally. However, I don't think that there is much risk of not receiving FDA approval. There is definitely more risk of it not doing well in the marketplace, certainly something that is far harder to predict. However, between you and me, I think that it has a decent chance of doing well in the market. I also think that on FDA approval the stock would jump and you would be able to make a nice profit then and there even if you didn't wait to see how the market actually takes it.
    Jun 15 23:23 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part II) [View article]
    Benjamin_bear:
    You bring up many valid points. As I said in the article, I am working with the "statistics available to us" -- Pfizer did not open up their vaults to let me see all the raw data up closel. Your points are real, but it was Pfizer and the FDA who said that the results were not statistically significant, and they DID see all the raw data. The FDA still did not withdraw the drug from the market. I just think that we have to take the announcement in perspective and not to blow it up out of porportion (which I don't suggest you to be doing). The main point is that it was a weak signal in Exubera and no signal at all was found in the other inhaled insulins being developed, and particularly in Mannkind's own Technosphere Insulin. I do, however, believe that the FDA will want Mannkind to conduct long-term studies after going to market, which is not unusual and does not overly harm Mannkind's present position.

    Of course you are right that the most important thing is whether doctors and patients will be willing to try it. I'm sure some won't and I imagine some will. I think that education and marketing can do a lot in this area. And between you and me, I think that if the FDA approves it and they find a partner, the stock would rise substantially on that news alone, even before seeing whether the market accepts it.
    Jun 14 23:45 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part II) [View article]
    Benjamin_bear:
    You bring up many valid points. As I said in the article, I am working with the "statistics available to us" -- Pfizer did not open up their vaults to let me see all the raw data up closel. Your points are real, but it was Pfizer and the FDA who said that the results were not statistically significant, and they DID see all the raw data. The FDA still did not withdraw the drug from the market. I just think that we have to take the announcement in perspective and not to blow it up out of porportion (which I don't suggest you to be doing). The main point is that it was a weak signal in Exubera and no signal at all was found in the other inhaled insulins being developed, and particularly in Mannkind's own Technosphere Insulin. I do, however, believe that the FDA will want Mannkind to conduct long-term studies after going to market, which is not unusual and does not overly harm Mannkind's present position.

    Of course you are right that the most important thing is whether doctors and patients will be willing to try it. I'm sure some won't and I imagine some will. I think that education and marketing can do a lot in this area. And between you and me, I think that if the FDA approves it and they find a partner, the stock would rise substantially on that news alone, even before seeing whether the market accepts it.
    Jun 14 23:42 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Mr 9787:
    You bring up several issues. Let me address them one at a time. About reduced lung function in Type 2 diabetics. It has been well known for some time that diabetics have reduced lung function compared to the average person (in the area of 70% - 80% of an average person's lung capacity). That is definitely one of the reasons that inhaled insulins are being especially scrutinized over how thery further affect lung function. But my point was that Technosphere Insulin was tested for that in particular. It was found to cause no FURTHER reduction in lung function than that already found in diabetics and no difference was found between Technosphere Insulin and the conrol groups using regular insulin, unlike Exubera. If you mean to say that maybe 5 years down the road of using TI will cause lung damage, I obviously can't refute that. But the 2-year long lung safety trials that TI is presently undergoing will certainly be enough to satisfy the FDA. Don't forget that these trials were designed with the the approval of the FDA as to the design and sufficiency of the trials. I agree with you that it is likely that the FDA will want Mannkind to continue longer studies after it reaches the market, but that is a far cry from the FDA suggesting that ALL patients prescribed TI should undergo pulmonary tests.

    Of course, you are correct that TI will not be approved for children or smokers, simply because virtually no testing was done in either group. This, of course, lowers their initial addressable market, but there is still a large field left. I presume that it wouldn't take long for them to do trials in children and recieve approval for them also. As for smokers, I can't prophesize if trials in them would go well (because smokers' lungs absorb differently than regular lungs), but their preliminary trials in smokers (admittedly quite small) have not found any difference in absorption of TI between smokers and non-smokers, unlike Exubera.

    As for Generex: My information about them was taken straight out of their 10-Ks for 2005, 2006, and 2007. It speaks there clearly about the 200-patient trial and about their licensing revenue (although I believe that the licensing revenue was not recent). I admit that there have been some tests in regards to HbA1c also, but look at the details of the test that you link to. It has 25 people, split between the Oral-lyn group and the control group. That is simply nowhere near enough to show efficacy by the stricter standards of the developed countries. It is futile to try to claim that India's standards match that of the FDA and European regulators, when they certainly do not. That is certainly why they have not seeked approval in the U.S. and Europe yet, although they are wealthier countries and spend the lion's share of worldwide expenditures on medicines in general and diabetic medicines in particular. (The U.S. alone purchases about 1/2 of all diabetic medicines sold in the world.) The Special Access Authorization that Canada gave it aimply means that patients can buy it while it is still in middle of trials, a common thing, and nowhere close to an approval.

    The amount that Generex is losing per quarter has to be taken in context of how much cash they have, which is around $25 million, much less than Mannkind. They are going to have liquidity problems far sooner than Mannkind at their respective burn rates.

    Finally, the FDA guidance that I referenced is NOT just for "diabetes drugs that have certain issues -- such as some oral pills and inhaled insulin". It covers all diabetes drugs and has a number of pages about any new insulin (with a special subsection on inhaled insulin). But the parts that I quoted (about the necessary size and length of trials) were from the general part about ALL diabetes medications. I suggest that you reread it to ascertain that for yourself. It can be found at www.fda.gov/cder/guida.... The part that I quoted is at the end of the first paragraph on page 24 (beginning of Section E). I stand by my statement that Oral-lyn has ZERO chance of being approved in the U.S. or Europe until there is a major redoing of their Phase II and Phase III trials, which would take many years.
    Jun 14 23:32 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Ballhawker:
    I think that my last comment (the one right before yours) addressed those issues quite directly. I don't believe that it will EVER be available in the U.S. market, certainly not the way their clinical trials have been conducted up till now. If we would hypothesize someone buying Generex and starting the clinical trials from scratch, they would basically have to start from the beginning of Phase II, which would put them at at least 5 years away from market, assuming that all the trial results showed effectiveness and safety. I wish I could give you more data on the results from Oral-lyn's clinical trials, but I can't know more than Generex will release. It really is immaterial because as things stand now, Oral-lyn will never be approved, neither in the U.S. nor in Europe. If Generex raised more money or if someone would buy it from them and conduct fresh clinical trials of proper size and length, they would still be at least 5 years away from market, as I said before. Read my last comment for more details.
    Jun 13 13:30 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Re Oral-lyn as per Amitan's request:
    Oral-lyn is not inhaled insulin. It is actually sprayed into the mouth and absorbed by the cheek walls. None of it goes into the lungs. It is being developed by Generex (symbol: GNBT). At risk of being flamed (based on my observation of Oral-lyn comments elsewhere on the internet), let me tell you that Oral-lyn and Generex are a joke. Let me explain.

    Oral-lyn is commercially available right now! Where? Ecuador (approved in August 2004) and India (approved sometime in 2007). Why do you think that they seeked approval there first? Because their regulatory system is so weak as to be laughable and they don't insist on solid data before approving drugs. No need to guess on what data they have. Read their SEC filings and you will find that the Ecuador approval was based on a number of trials -- all containing between 8 and 10 people. That's barely enough people to be considered Phase I by FDA and European standards. These tests did not test for HbA1c lowering, the standard measure of effective treatment of diabetes. They only tested for post-meal lowering of blood sugar, which the FDA specifically singled out in their guidance (released in February) as not being sufficient to get approval.

    Since then they have done a trial with 200 people. Again they did not test for HbA1c lowering as the FDA requires. Now they want to start Phase III trials. They intend to enroll 750 patients and test them for 6 months, the first patient having started in June 2008. This time they intend to test for HbA1c lowering. That would keep them from filing for approval until at least the end of 2009, if not later. But this all doesn't matter. The small amount of people in their trials and the short length are an absolute joke. They have ZERO chance of getting approval, even if the trial data was positive (which we have no way of predicting). Just by way of comparison, the FDA draft guidance (released in February) calls for at least 2,500 patients in trials, with at least 1,300 to 1,500 patients exposed to the drug for a year and 300 to 500 patients exposed to the drug for 18 months. The shoddiness of their "clinical trials" is apparent. I imagine that their clinical trials are deficient in many other ways also, although obviously I can't prove that because I don't know of any peer-reviewed data available in the medical journals.

    Although they have been "approved" in Ecuador and India, they have yet to show significant revenue -- only $67,000 in the last nine months (as of April 31, 2008), much of which is from licensing other patents of theirs. I guess the drug market in Ecuador is not as lucrative as they thought. I would add that they were partners on Oral-lyn with Eli Lilly until Eli Lilly dropped them in 2003. They are losing money hand over fist with no revenue in sight and they are quickly destroying their equity. They may well be headed into bankruptcy (not tomorrow, but within the next 2 years) if they can't raise more money, and I don't know that they can. Did I mention that their stock is holding at $0.95? A penny stock -- well deserved.

    In short: Stay away from Generex and ignore the people hyping Oral-lyn.
    Jun 13 12:54 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part III) [View article]
    Mr 9787:
    You are correct in stating that Mannkind has not reported detailed Phase III results yet, mostly because the major Phase III trials won't be over and the data in till the end of this year.

    However, your implication that my statement that "Mannkind found no evidence of any drop in lung function whatsoever in their clinical trials" is not well-founded is not correct. Exubera was found to cause reduced lung function within a few WEEKS. Although Mannkind did not yet release Phase III data, they did release lots of Phase II data, with studies 3 months and 6 months long. In none of those studies was there any evidence of reduced lung function, which was specifically tested for using all the standard tests. I think that is ample evidence to show that it doesn't have Exubera's problems in that regard.

    I see no reason why the FDA would arbitrarily recommend pulmonary tests for Technosphere Insulin if it shows no problems in that regard. However, they will probably (and sensibly) advise against asthma patients, etc., using it until tests are done in that subset of the population.
    Jun 13 11:34 am |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part II) [View article]
    Ertsfan:
    I posted the previous comment too quickly. I meant to say that most of what I will say about Exubera in the coming article will apply equally to Aerx and Air.

    Scutchen:
    You are absolutely correct. I see that you have done your research on Mannkind.

    Just to transalate what Scutchen said into plain English for the non-medical audience: Injected insulin normally forms into hexamers (six insulin molecules bonded together). The body has to break this down into dimers (two insulin molecules bonded together) and finally into monomers (individual insulin molecules). Only monomeric insulin has the effect on blood sugar that diabetics need. So regular injected insulin takes much longer to start working, with even the "rapid-acting" insulins peaking in aroung 45 minutes to an hour. Technosphere Insulin, on the other hand, can be delivered to the body in monomeric form (the way the pancreas does) due to the unique design of the Technosphere particle. Thus, Technosphere Insulin peaks extremely quickly -- in around 12 to 14 minutes, similar to the fast Phase 1 spike of the natural body.

    Because it mimics the natural process of the healthy body, Technosphere Insulin reduces many of the problems of using injected insulin. There is less occurrence of hypoglycemia (low blood sugar) which is caused by the insulin lasting in the bloodstream for too much time, after the meal is already digested. There is also weight loss, instead of weight gain. I discussed this a bit in Part 1 and intend to get back to it again in Part 3 (although I left out much of the exact science behind it). I want to stress that this isn't just "theoretical" benefits that "ought" to happen. The reduction in hypoglycemia and the weight effect has been found in ALL their clinical trials so far.

    As Scutchen pointed out, this also makes it possible to bring the diabetic's round-the-clock blood sugar levels down to a normal range without fearing that the mealtime insulin will cause hypoglycemia. As of now, this fear causes doctors to manage the blood sugar levels of their patients at abnormally high levels which raises the risks of diabetic complications considerably. In fact, Mannkind has a ongoing study (Study 117) to show this exact issue.
    Jun 12 15:34 pm |Rating: 0 0 |Link to Comment
  • Mannkind: Overlooked Biotech With Excellent Prospects (Part II) [View article]
    Ertsfan:
    Aerx (from Novo Nordisk) and Air (from Eli Lilly) were both dropped from development by Novo Nordisk and Eli Lilly earlier this year. As I said at the end of the article, I am planning to discuss some of the differences between Exubera and Technosphere Insulin in Part 3, the next installment of this series. Kos's inhaled insulin (now under the wings of Abbott Laboartories is very early in development (still in middle of Phase 2). Although I don't know much about it (they never released too much information about it), it doesn't have a chance of reaching the market for AT LEAST another 4 years.

    As for the cancer rate in these other inhaled insulins, there has not been any signal of cancer in them. Abbott Laboratories published a press release saying that there was no increas in lung cancer and Aradigm (who co-developed Aerx with Novo Nordisk) also let out a press release that there was no lung cancer with Aerx.
    Jun 12 15:12 pm |Rating: 0 0 |Link to Comment
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