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Post by mnholdem on Aug 16, 2015 18:59:43 GMT -5
EMA may consider Afrezza as a biosimilar since human insulin has been approved for human use since the 1980's. Afrezza does not have a new API. It has a new way of delivering its API - human insulin.
There is another thread here somewhere that Harry posted, as Chris-C notes above. This may be the same EMA case. You need to remember that, with the EMA, the trial data is reviewed first. EMA has a 210 maximum review deadline, after which the drug is submitted by the reviewing committee (I.e. PRAC) to the final approval committe for its decision on centralized authorization to market this human insulin throughout Europe. I was unsuccessful in pinning the case number to a sponsor and EMA did not return my two email inquiries.
This EMA application could be for anyone. It seems peculiar that the review process for this mystery applicant started a only a few weeks after Sanofi signed the License and Collaboration Agreement with MannKind Corporation. It also seems strange that MannKind stated back then that Sanofi would be taking Afrezza to the EMA shortly after partnering, then.....nothing. No news. No update. Damn strange, all of this.
I would think that if this is Afrezza, then EMA review would be considered a material event and must be made public in a SEC filing. Am I wrong? Is the review not material, but only the approval?
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Post by xoxoxoxo on Aug 16, 2015 19:08:34 GMT -5
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Post by peppy on Aug 16, 2015 19:28:04 GMT -5
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Post by xoxoxoxo on Aug 16, 2015 19:37:28 GMT -5
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Post by tschulze88 on Aug 16, 2015 19:47:01 GMT -5
Luckyjoe that's the first thing I saw... It's generic and not BOLD, which rules it out as Afrezza. The day will come soon enough though.
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Post by luckyjoe on Aug 16, 2015 20:47:31 GMT -5
From the regulatory perspective Afrezza is specifically characterized as a drug-device combination. The pharmacological properties of Afrezza are inherent to the combination of the inhalation device and technosphere insulin. This would absolutely preclude classification of Afrezza as an insulin biosimilar in the regulatory review process.
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Post by mnholdem on Aug 17, 2015 8:00:12 GMT -5
I once posted that Afrezza would likely not qualify for EMA's shorter "expedited" review process typically reserved for bio-similar submissions. This is because of the Technosphere particle used to transport the API (insulin human). Sounds now like I'm waffling (chuckle) but you're probably right that Afrezza being a drug-device would likely mean that it is not the "bio-similar" case we've been discussing.
Sure would be nice if the EMA could just tell us who the sponsor is for that case number.
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Post by charlespk on Aug 17, 2015 11:41:24 GMT -5
I also wish this was for Afrezza, however , it is very clear on the first page , that only those on bold letters are new applications , and it is not in bold.
2) At least to me it is clear that on page 3 and 4 , it is under non - orphan generic and biosimilar medicinal products and Afrezza is not a generic and it is not a biosimilar.
so in my opinion this is most likely for a biosimilar human insulin , given that some patents will expire soon
3 ) Most of the posters on this board know that human insulin has been made since the 80's by recombinant technology , as opposed to the old days when insulin was derived from animals like porcine insulin as an example, so the fact that it states human insulin does not mean its Afrezza , it can be any human insulin , very few have posted that it must be Afrezza if it says its human insulin ,but that is not a true statement . just wanted to clarify that .
SNY is going to submit to EMA , but we don't know if it has happened , and I think like many others here that they would announce submission as that is a material event under SEC .
Lets hope submission and approval comes soon , but again i feel that the one we are referring to here is for a biosimilar .
GL
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Post by Chris-C on Aug 17, 2015 14:07:53 GMT -5
I also wish this was for Afrezza, however , it is very clear on the first page , that only those on bold letters are new applications , and it is not in bold. <...> SNY is going to submit to EMA , but we don't know if it has happened , and I think like many others here that they would announce submission as that is a material event under SEC . Lets hope submission and approval comes soon , but again i feel that the one we are referring to here is for a biosimilar . GL You may be correct. But I'm not convinced that SNY would feel obligated to announce a submission to the European Medicines Agency. I can't find any SNY press release that announces a submission to the EMA, including Toujeo; but they do, of course, announce FDA and European approvals. Consequently, I don't think it is conclusive that the listing on the EMA website for Insulin human is not Afrezza. It's difficult to imagine why a submission has not been made at this stage given the rather deliberate and efficient manner in which SNY works. Since it is a product licensed in a partnership, I'm not sure what their obligation would be to the SEC to announce an application. Time will tell... |
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Post by BlueCat on Aug 17, 2015 18:51:27 GMT -5
One of my top questions is - when this is approved by EMA, how will the US stock market respond?
Will the average or even institutional investor understand potential implications beyond expanded addressable market? And what it would mean to have this available in SNY's 'home court'?
1. Label? Might the EMA go directly to "ultra rapid"?
2. Pulmonary tests? Would they still even require it? If so, might SNY go directly to GPs in a region where there is a more comprehensive approach to medicine with GPs - even pharmacists, for that matter.
3. Insurance? Sure there is insurance, but generally socialized medicine. I don't know enough about how the 'formulary' process would work in each of the countries, but I would think that if its approved by the EMA and a doctor (possibly even pharmacist- can they dispense insulin directly there?) wants to prescribe it, its just gonna happen.
4. Distribution channel? I should think getting this into pharmacies (agreements) in SNY's home territory would be much easier.
I see these as all potential high positives. The two elements that I would think are more in question is the manufacturing component. And time. EU bureaucracy is nothing if not well measured. C'est pas'd possible!
Unless of course SNY handles it the other, EU diplomatic way and then well, its instantaneous. So c'mon guys. What's the hold up?
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Post by babaoriley on Aug 18, 2015 0:58:24 GMT -5
Interesting point/counterpoint arguments whether that EMA filing is for Afrezza or not. I'm convinced it's not, not really as the result of the arguments here, even though they all have merit. It's because nothing at all would lead me to believe this could possibly be so close to a decision on such a major issue without a "public leak" or at least a private one, causing the stock to be trading in a fashion other than how it has been trading.
MNKD has had to earn everything that's it has gotten, it hasn't been easy, and all of a sudden finding that a submission was made to the EMA last summer and we're somewhat close to an answer - no way. Period. End of story.
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Post by cyn on Aug 19, 2015 16:55:27 GMT -5
All good stuff on this thread ... thanks to all! I've been scouring the EMA website for weeks looking for any hint of an Afrezza application submission with absolutely no success. Researching Christ's descendants on Ancestry.com would yield greater results! Horrible, absolutely horrible website for extracting public information! My time would be better spent going down to the local library and searching the century-old micro fiche files for information on Afrezza! If this is any indication of what we can expect with regards to the EMA's approval process, then I'm all for Sanofi-Mannkind focusing on and penetrating the diabetic market in every other corner of the plant before heading into Europe. IMO, let the EMA come to them to get Afrezza! God help the EMA!
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Post by liane on Aug 19, 2015 17:08:17 GMT -5
My understanding is that the EMA process is quite transparent - once the application has been made. The fact that no one can find any info tells me simply that the application has not been filed yet.
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Post by cyn on Aug 19, 2015 17:18:47 GMT -5
Agree that Afrezza application still pends. However, not so sure about EMA's transparency, even after a submission ... website is extremely cumbersome to navigate, search and cross-reference documents/applications.
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Post by kc on Aug 19, 2015 18:24:47 GMT -5
Have you seen this new update today on the UK NHS site?
Aug 15: Results of PIII trial, published in Diabetes care, found that in patient with TIIDM and HbA1c levels over or equal to 7.5% but less than 10% despite metformin alone or two or more oral antidiabetics, add-on prandial Afrezza reduced HbA1c by -0.4% (95% CI -0.575 to -0.23%) compared to placebo (p<0.0001) [32].
19/08/2015 13:56:56
www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4631 |
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