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Post by crpminc on Apr 7, 2015 5:51:37 GMT -5
based on the contract between mnkd and sny, does mnkd have any legal recourse if sny fails to market Afrezza in a reasonable manor ? cant believe al mann would not have required some agreed upon standard. if there is some langue in agreement what is it ? is it being meet ?
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Post by esstan2001 on Apr 7, 2015 7:29:56 GMT -5
based on the contract between mnkd and sny, does mnkd have any legal recourse if sny fails to market Afrezza in a reasonable manor ? cant believe al mann would not have required some agreed upon standard. if there is some langue in agreement what is it ? is it being meet ? If Mannkind is not happy they can initiate dissolution of the partnership. So can Sanofi. IMO, we are not going there, not even close. Strongly agree with jpg that at this stage it is all about mind share and positive social media. What is excellent is the fact that there is hardly any negative feedback from the diabetic community once they get past the learning curve... matter of fact that is the primary criticism of Afrezza so far- getting the dose and timing right for each person. I am sure Saanofi is monitoring this and factoring it into trials design and the next stages of this roll out. IMO, this is executing to a plan. Someone else had highlighted how Afresa is going to have to contribute to the revenue hole left behind Lantus going off patent, once generics arrive on the scene. And I also do not buy that the reps dropping Afrezza in favor of Toujeo efforts- they do not compete at all. They complement. Ergo, whatever Veilbacher, the new CEO, and the Chairman had been saying all along about co-promotion efforts. Of course if you were a rep, you would push both- more commission. We are all just being impatient nervous nellys looking at 8-9 weeks of data. 6 months from now, different story. And I will bet it will be at that point. :-) |
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Post by mnholdem on Apr 7, 2015 9:38:54 GMT -5
I have absolutely NOTHING to substantiate this, but...
I happen to think Sanofi may be pressuring the FDA to get the label amended ASAP to state that Afrezza has been proven to reduce hypoglycemic events. It was publicly stated by the trial doctor recently that the FDA officials seemed to have spent more time refuting the data with the ADCOM than discussing what that data really showed. Perhaps Sanofi is "enlightening" the FDA.
I know, I know... Holdem is indulging in a little dreaming but can you imagine what kind of pop in share price an announcement of an improved Afrezza label with "reduced hypos" would generate? Do you realize how much easier it would be to get doctors on board? That label is certainly a HIGH priority and Sanofi has data from the current European Afrezza trials that can be submitted to the FDA. Finally, discussions of this sort between Sanofi and the FDA do not require disclosure so, of course, I have no way to validate my suspicions.
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Post by savzak on Apr 7, 2015 10:58:25 GMT -5
can you imagine what kind of pop in share price an announcement of an improved Afrezza label with "reduced hypos" would generate? Of course, you're absolutely right. But at this point, at or near $5, I just like to imagine the pop in the share price that would result from the market realizing that SNY has enough of a commitment to Afrezza that it even tried to get a better label without running additional trials. I'm not complaining, but I really do believe that SNY could do wonders for MNKD's pps by making a few enthusiastic disclosures about what their plans are. Of course, they have what they believe to be good business reasons for not doing that. As a result, here we sit in obscurity, at least so far as the market is concerned. |
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Post by esstan2001 on Apr 7, 2015 11:52:36 GMT -5
...and Sanofi has data from the current European Afrezza trials that can be submitted to the FDA. Finally, discussions of this sort between Sanofi and the FDA do not require disclosure so, of course, I have no way to validate my suspicions. Is this a known fact that you slipped into your wishful speculation? (don't get me wrong, I'm on board- my hopes and dreams too) Is anyone aware of any study activity that has commenced that is looking at these other factors beyond A1C that would benefit the label? I do not expect the FDA to react to anything other than a controlled trial; no anecdotal / social media data would be accepted AFAIK. |
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Post by mnholdem on Apr 7, 2015 13:20:17 GMT -5
EMA data is controlled data and Afrezza trials have been conducted in Europe for quite some time. The FDA certainly does make use of EMA data, especially when reviewing a drug that was approved overseas first. Regarding Afrezza, I recall reading a few months ago that all but two Afrezza trials have been completed.
The reason why Sanofi has "delayed" applying for centralized authorization to market Afrezza throughout Europe is totally incomprehensible and, frankly, the mystery fuels much of the speculation behind the rumor that Sanofi is planning to buy all rights to Afrezza.
Back to the point, however. It has been a few years since I reviewed the complete EMA/EMEA approval process, but my understanding is that in Europe the trials are conducted and then application is made for the EMA review committee to review the trial and supporting data. This review has to be completed in a maximum of 210 days (7 months) and then is submitted to the approving committee, which takes another 30-45 days to finalize marketing approval.
The slower-than-anticipated Afrezza rollout in the U.S. (planned, I assume) seems to be the primary reason for the delay, and Sanofi may not consider it a "delay" at all. We all know that it's no longer Toujeo that's responsible for holding up application in Europe, as Toujeo has been approved in both Europe and the USA.
Besides the "usual suspects", such as gathering anecdotal data from new patients and/or the educating of physicians/endos, I strongly suspect that Sanofi is attempting to get the label fixed before the major marketing push.
...if there's any reason to be hush-hush, re-labeling would be a BIG one. Assuming that one or more of the competing pharmaceutical companies is behind all this negativism and so-called "market corruption", they'd go ballistic if Afrezza was re-labeled as a having a distinct advantage over their own drugs. So the competitors may also be pressuring the FDA and providing reasons why the label should NOT be expanded.
We're talking $billions in revenue at stake in this debate over a potentially disruptive new diabetes treatment option.
In speculating like this, I'm simply trying to think ahead by identifying what are the most important things that need to be taken care of. That label is top of the list - IMHO.
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Post by esstan2001 on Apr 7, 2015 13:39:50 GMT -5
EMA data is controlled data and Afrezza trials have been conducted in Europe for quite some time. The FDA certainly does make use of EMA data, especially when reviewing a drug that was approved overseas first. Regarding Afrezza, I recall reading a few months ago that all but two Afrezza trials have been completed. The reason why Sanofi has "delayed" applying for centralized authorization to market Afrezza throughout Europe is totally incomprehensible and, frankly, the mystery fuels much of the speculation behind the rumor that Sanofi is planning to buy all rights to Afrezza. Back to the point, however. It has been a few years since I reviewed the complete EMA/EMEA approval process, but my understanding is that in Europe the trials are conducted and then application is made for the EMA review committee to review the trial and supporting data. This review has to be completed in a maximum of 210 days (7 months) and then is submitted to the approving committee, which takes another 30-45 days to finalize marketing approval. The slower-than-anticipated Afrezza rollout in the U.S. (planned, I assume) seems to be the primary reason for the delay, and Sanofi may not consider it a "delay" at all. We all know that it's no longer Toujeo that's responsible for holding up application in Europe, as Toujeo has been approved in both Europe and the USA. Besides the "usual suspects", such as gathering anecdotal data from new patients and/or the educating of physicians/endos, I strongly suspect that Sanofi is attempting to get the label fixed before the major marketing push. ...if there's any reason to be hush-hush, re-labeling would be a BIG one. Assuming that one or more of the competing pharmaceutical companies is behind all this negativism and so-called "market corruption", they'd go ballistic if Afrezza was re-labeled as a having a distinct advantage over their own drugs. So the competitors may also be pressuring the FDA and providing reasons why the label should NOT be expanded. We're talking $billions in revenue at stake in this debate over a potentially disruptive new diabetes treatment option. In speculating like this, I'm simply trying to think ahead by identifying what are the most important things that need to be taken care of. That label is top of the list - IMHO. Essentially agree with everything you pose. Yes there were trials in the EU / even Russia at some point; that data was all part of the US FDA submission as best as I recall. The key thing that you bring out (that I was unaware) is that there may still be 2 trials underway, and what protocol design they were set to follow. Were / are the endpoints identical to the trials used for approval? What sway would SNY (and those that have something to lose) have on FDA / EMA, allowing them to be modified mid-stream to add more endpoints... I kept operating under the assumption that new trials would be set up and run to expand the label; anything that can be done to accelerate this would certainly be a game changer not factored into the current price. |
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Post by Deleted on Apr 7, 2015 14:24:50 GMT -5
If you are correct, perhaps part of the hush hush is to get manufacturing capacity increased while waiting for all the trial data to be finished, submitted and ultimately, approval for label changes. With claims of ultra-rapid acting and hypo reductions, Rx count would jump significantly so supply chain would be critical. The most recent annual report said a 2nd manufacturing facility would be built well before Danbury reached capacity and the new facility I believe could be owned by Sanofi. Other chatter indicated that in April, some key doctors or Key Opinion Leaders as they are known in the industry would be receiving Afrezza training (via webcast??). EMA data is controlled data and Afrezza trials have been conducted in Europe for quite some time. The FDA certainly does make use of EMA data, especially when reviewing a drug that was approved overseas first. Regarding Afrezza, I recall reading a few months ago that all but two Afrezza trials have been completed. The reason why Sanofi has "delayed" applying for centralized authorization to market Afrezza throughout Europe is totally incomprehensible and, frankly, the mystery fuels much of the speculation behind the rumor that Sanofi is planning to buy all rights to Afrezza. Back to the point, however. It has been a few years since I reviewed the complete EMA/EMEA approval process, but my understanding is that in Europe the trials are conducted and then application is made for the EMA review committee to review the trial and supporting data. This review has to be completed in a maximum of 210 days (7 months) and then is submitted to the approving committee, which takes another 30-45 days to finalize marketing approval. The slower-than-anticipated Afrezza rollout in the U.S. (planned, I assume) seems to be the primary reason for the delay, and Sanofi may not consider it a "delay" at all. We all know that it's no longer Toujeo that's responsible for holding up application in Europe, as Toujeo has been approved in both Europe and the USA. Besides the "usual suspects", such as gathering anecdotal data from new patients and/or the educating of physicians/endos, I strongly suspect that Sanofi is attempting to get the label fixed before the major marketing push. ...if there's any reason to be hush-hush, re-labeling would be a BIG one. Assuming that one or more of the competing pharmaceutical companies is behind all this negativism and so-called "market corruption", they'd go ballistic if Afrezza was re-labeled as a having a distinct advantage over their own drugs. So the competitors may also be pressuring the FDA and providing reasons why the label should NOT be expanded. We're talking $billions in revenue at stake in this debate over a potentially disruptive new diabetes treatment option. In speculating like this, I'm simply trying to think ahead by identifying what are the most important things that need to be taken care of. That label is top of the list - IMHO. |
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Post by prosper on Apr 7, 2015 15:36:53 GMT -5
I have been long 20K+ shares for years and follow mnkd daily. I have not read anywhere that Sanofi or MNKD have submitted application to EU or any other countries. I would greatly appreciate any update with specifics that applications have been file anywhere else.
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Post by mnholdem on Apr 7, 2015 19:47:22 GMT -5
Prosper,
As I wrote earlier, in Europe the testing/trials data is gathered first, then the application is submitted. I think it's generally believed the application will be for a centralized authorization by the EMA that would enable Afrezza to be sold in all countries, as opposed to getting approved in one or two countries first, such as U.K. and France for example.
With the FDA a company must submit a New Drug Application (NDA) then the trial protocols are established. I suppose the EMA and FDA each thinks the other's procedure is all bass-ackwards, but I leave that debate to others. Incidentally, I think I wrote that I had recently read there are still ongoing trials, but I haven't had the time to confirm that. I did post a link I found in the U.K. a few months ago that listed Afrezza trial info, but I've forgotten where the information is located. I believe Matt has also mentioned EU trials, and recall mention of it in several reports back when Sanofi was announced as the marketing partner.
You are right. There has been no application submitted for approval of Afrezza in Europe. I cannot say that about Japan because I do not know if they publish notification of drug approval applications or not. They're fairly closed-mouthed over in Japan. It's also my understanding that EMA will not fast-track Afrezza. Even though human insulin has been established as safe for decades, the pulmonary delivery method and device is considered novel, which means that a full review will be conducted.
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Post by fpants on Apr 8, 2015 0:24:40 GMT -5
My understanding is the FDA denied the "superiority" claim due to the size of the trial just not lending enough statistical power to make the claim.
I imagine they would just have to do a supplemental trial to increase that statistical sampling. Any idea how big? Or how long it would take?
Your theory fits with Hakstrom's comments in the interview transcript from last fall someone shared today. He said they'd actively work on expanding the label.
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Post by seanismorris on Apr 8, 2015 1:07:45 GMT -5
I think Sanofi's could successfully argue that while the latest trials might not have enough data (patients) to conclude "superiority" if you took the sum of the trials "superiority" was conclusively (statistically) demonstrated.
I hope additional trials are unnecessary, and just some additional time is needed to slap some sense into the FDA.
It could take a while...I think the FDA conclusively demonstrated they didn't understand Afrezza, the data, nor treating diabetes patients at the Adcom.
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Post by mnholdem on Apr 9, 2015 18:26:58 GMT -5
This site of UK Medicines Information lists Afrezza regulatory status as "Phase III Clinical Trials" for UK and EU, while the status for US is "Launched". www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631Sign in is required for more details, I'm not a member, but this site does appear to confirm the earlier statements about Phase III clinical trials status in Europe. |
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Post by otherottawaguy on Apr 10, 2015 9:52:50 GMT -5
This item was noted over a year ago with no update to the status of the US trials completing. Thought we had a member here who knew a guy that new a guy... that has access. No peaks under the hood have been provided to date.
OOG
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Post by bradleysbest on Apr 10, 2015 10:39:08 GMT -5
Hopefully this is addressed or asked next month in Danbury.
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