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Post by thekindaguyiyam on Jan 6, 2018 18:59:04 GMT -5
Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been. Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's. clinicaltrials.gov/ct2/show/NCT03324776
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Post by dreamboatcruise on Jan 6, 2018 21:20:06 GMT -5
Founded in 1991, Mannkind is almost 27 years in the making. 2 years ago, our U.S. sales and marketing partnership with one of the Big 3 almost bankrupted us, causing us to drop from $11 to 50 cents. I think we can take a couple extra quarters or even years doing it ourselves to avoid that kind of criminal usury again. Also, the stat study results will help us sell the insurance companies on us. Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? The presentation at Cantor conference had a slide covering patents. It said that the FDA Orange Book patents covering Afrezza extend to 2032. Even after that point it may be more difficult than a typical generic drug to replicate Afrezza since it is a complicated device drug combo. What would a company need to do to prove that their copycat cartridges, inhaler and powder (particle size, uniformity, etc.) perform exactly the same as Afrezza? Is there possibility a copycat would need to go through its own expensive set of clinical trials to prove equivalence? (don't know the answers to these questions) Concern for others copying Afrezza is very far down on my list of what I'm concerned about.
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Post by slugworth008 on Jan 6, 2018 21:38:11 GMT -5
Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been. Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's. The fight in front of us - is the same fight we've always had - Formulary coverage. That is the key to all of the locks - IMO. Once we open that door, and the insurance companies realize how much serious money getting people on Afrezza sooner rather than later will save them - the sky is truly the limit for Afrezza.
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Post by sayhey24 on Jan 7, 2018 9:46:45 GMT -5
At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been. Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's. clinicaltrials.gov/ct2/show/NCT03324776"Afrezza first" - when this happens and becomes the norm it will be a huge day for diabetics. While both the STAT and the Levin studies are good steps the long term goal which has been greatly advanced by the 2017 CGM advances, is treating newly diagnosed PWDs asap, especially the "Prediabetics". Both the STAT and Levin are like "open book" tests and we already know the answer. Yes, human insulin works and has worked for thousands of years. The problem we have had is not if it works but rather having it work at the right time and having the right amount for the BG rise. Until CGMs we could guess but now there is no longer a need to guess. Both these studies should show that. However neither is dealing with the "Prediabetics" and early diagnosed T2s. An early intervention study using afrezza has not been done as far as I know. Thats the one IMO which would be huge. Until then we have the work VDex type groups are doing.
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Post by agedhippie on Jan 7, 2018 11:06:24 GMT -5
Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been. Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's. Just to say, it's not Afrezza only - it's Afrezza additionally: Brief Summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
I am not sure what the point of this is since Mannkind already did this study.
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Post by radgray68 on Jan 7, 2018 13:31:44 GMT -5
At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been. Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's. Just to say, it's not Afrezza only - it's Afrezza additionally: Brief Summary:
To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use.
I am not sure what the point of this is since Mannkind already did this study. Gaul diggity darnitt!!! You're right. There is no arm in the study for Afrezza as a solo treatment. I misread the intent of the word initiation in the title and incorrectly figured they wanted to actually test Afrezza. These guys are just repeating the large, b.s. FDA trials where they added Afrezza to patients who are already poisoned by other treatments. Now, after two years in the marketplace, we (Mannkind) know a lot more about titration and the need to be aggressive. And, I hope these researchers and doctors can do it right. But, I take back my enthusiasm for any real big news from the Levin study. I worry we'll never get away from effing step therapy, which, I'm sorry, only came about because of people's aversion to needles and the worry about hypoglycemic lows IN THE FIRST PLACE! Afrezza addresses both those, but ya gotta start with a clean slate to see how safe it can be IMO. Arghh! just have to grow through word of mouth and patient by patient. Trials alone can't do it anyway.
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Post by peppy on Jan 7, 2018 14:30:10 GMT -5
IS IT THAT THE BIG BOYS ARE WATING FOR INSURANCE COVERAGE?OR STAT STUDY? MAYBE THEY DONT BELIEVE THAT PRODUCT IS A BLOCK BUSTER? PLEASE SOME HELP ON THIS QUESTION SHAREHOLDER FOR 7 YEARS, THANK YOU your question: why haven't we found a partner in the u.s.a. yet? my reply: which one?
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Post by dreamboatcruise on Jan 7, 2018 14:51:50 GMT -5
IS IT THAT THE BIG BOYS ARE WATING FOR INSURANCE COVERAGE?OR STAT STUDY? MAYBE THEY DONT BELIEVE THAT PRODUCT IS A BLOCK BUSTER? PLEASE SOME HELP ON THIS QUESTION SHAREHOLDER FOR 7 YEARS, THANK YOU your question: why haven't we found a partner in the u.s.a. yet? my reply: which one? Which of these both have experience in diabetes space and yet do not have a directly competing product to protect? Though by the time Afrezza is on solid ground that would likely interest one of these in a serious way, I think MNKD itself will be best positioned to market and sell Afrezza. At that point why look for a partner, just raise money and go it alone.
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Post by agedhippie on Jan 7, 2018 16:43:37 GMT -5
your question: why haven't we found a partner in the u.s.a. yet? my reply: which one? Which of these both have experience in diabetes space and yet do not have a directly competing product to protect? Though by the time Afrezza is on solid ground that would likely interest one of these in a serious way, I think MNKD itself will be best positioned to market and sell Afrezza. At that point why look for a partner, just raise money and go it alone. I heartily agree. The US is easily the most profitable market and if we can retain it we should. The question for any buyer will be why Sanofi, with experience in the space, failed and the buyer believes they, without experience can do better. I cannot see anyone of any consequence being interested until Afrezza is a proven success at which point you may get a partner who picks it up to buy the revenue stream.
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Post by pat on Jan 7, 2018 17:21:31 GMT -5
Aged...
Did Sanofi fail to sell the drug
or did the incoming chief abort the effort prematurely because of his prior experience with exubera?
Theres a big difference.
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Post by xanet on Jan 7, 2018 17:23:01 GMT -5
I would expect big players to be a little leery after Sanofi failed to sell it. Sure, we know things are different now, but that may not be as obvious to others not so invested. Maybe I just read your comment differently than you intended it, but technically, Sanofi didn't fail to sell it; they just stopped selling it. They were selling it fine until they stopped trying. Sanofi's new replacement CEO didn't want to sell it. All the "big players" as you call them know that. In fact, they know that and think about Afrezza even more than we do. And, you are correct that things are different now. We're in the age of CGM's now, and Afrezza is the only shining star in that arena. If any of the big players were wringing their hands in fear of Afrezza, they would have bought us out. Afrezza is a fantastic breakthrough product, but while sales are low, I doubt it's taken as a serious competitor. It is investors like us and people whose lives have been transformed by Afrezza that think about it. I hope I am wrong and a deal is announced tomorrow. :-)
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Post by dreamboatcruise on Jan 7, 2018 18:02:05 GMT -5
Aged... Did Sanofi fail to sell the drug or did the incoming chief abort the effort prematurely because of his prior experience with exubera? Theres a big difference. No one can really know the thinking that went into the decision. From things that we've heard from MNKD management, and even VDEX... it appears that there were some real obstacles regarding proper education/titration, retention, insurance coverage, etc. that Sanofi (and now MNKD) would have to overcome. Could Sanofi have eventually been successful... I think so as I think MNKD will eventually be successful on their own. To me it is clear that we got screwed by having Sanofi curtail their Afrezza efforts long before MNKD was then allowed to take over. That action by SNY was contrary to the agreement... though perhaps having a minimum time before Sanofi could back out was simply a flawed desire on MNKD's part when negotiating the deal. Sometimes those sorts of clauses are beneficial, but in this case I think it did nothing but harm to MNKD. Rarely does a deal like this really compel a partner to use their best efforts.
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Post by agedhippie on Jan 7, 2018 18:46:48 GMT -5
Aged... Did Sanofi fail to sell the drug or did the incoming chief abort the effort prematurely because of his prior experience with exubera? There's a big difference. Clearly Sanofi failed to sell the drug - the numbers tell the story. Was there a better way? Yes - it turns out that it takes a dedicated in-house sales force, but that is not Sanofi's operating model and they are not about to change their entire sales model for a drug they don't even own. Mannkind on the other hand didn't have a choice, they had to find a model, and they had to make it work. Ultimately they took three swings to get there (partnership, contract sales, in-house sales). Sanofi made the right choice for Sanofi at the time. Mannkind management failed by not having contingency a plan for what to do if Sanofi did terminate. I confess I never saw it coming (that's where my first LEAP holding went down in flames) however it's their job to do that planning, especially when the sales started to drop towards the end and the risk of Sanofi exiting started to rise.
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Post by timri on Jan 7, 2018 18:52:09 GMT -5
Aged... Did Sanofi fail to sell the drug or did the incoming chief abort the effort prematurely because of his prior experience with exubera? Theres a big difference. No one can really know the thinking that went into the decision. From things that we've heard from MNKD management, and even VDEX... it appears that there were some real obstacles regarding proper education/titration, retention, insurance coverage, etc. that Sanofi (and now MNKD) would have to overcome. Could Sanofi have eventually been successful... I think so as I think MNKD will eventually be successful on their own. To me it is clear that we got screwed by having Sanofi curtail their Afrezza efforts long before MNKD was then allowed to take over. That action by SNY was contrary to the agreement... though perhaps having a minimum time before Sanofi could back out was simply a flawed desire on MNKD's part when negotiating the deal. Sometimes those sorts of clauses are beneficial, but in this case I think it did nothing but harm to MNKD. Rarely does a deal like this really compel a partner to use their best efforts. Afrezza got sandbagged. They couldn’t push afrezza and their own drug at the same time and the incoming ceo saw that. Why split the revenue when you could sell your own drug and keep all the profits. If sanofi didn’t have another similar diabetes drug It would be different. I would like to see a partner, there are just to many Pcps we could be reaching to prescribe insulin. I was in Stat health yesterday and they even do scripts for insulin we are missing a huge market by not getting a partner that has a huge sales rep base. Plus trep trials will be very expensive. Diluting at the share price we are at currently will not cut it. Management knows it. It’s just a matter of time till a deal of some sort is announced.
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Post by golfeveryday on Jan 7, 2018 18:58:34 GMT -5
Which of these both have experience in diabetes space and yet do not have a directly competing product to protect? Though by the time Afrezza is on solid ground that would likely interest one of these in a serious way, I think MNKD itself will be best positioned to market and sell Afrezza. At that point why look for a partner, just raise money and go it alone. I heartily agree. The US is easily the most profitable market and if we can retain it we should. The question for any buyer will be why Sanofi, with experience in the space, failed and the buyer believes they, without experience can do better. I cannot see anyone of any consequence being interested until Afrezza is a proven success at which point you may get a partner who picks it up to buy the revenue stream. respectfully disagree in a large way. Sny was selling and backed off. Mnkd has proven afrezza is a very promotionally sensitive drug, which works in spectacular fashion by the way. A partner will come on board at some point, likely soon. Here’s why. Mnkd Sales team is 7x smaller than a national sales team. Extrapolate existing sales to a national team. It would mean Breakeven and beyond very quickly.
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