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Post by prvs on Feb 15, 2016 12:04:38 GMT -5
Here's a time line of a generic drug company I follow; IGXT submitted the MAA for Rizaport, a generic form for a migraine drug in gel tab form to Germany on 10/1/14. On 12/1/14 IGXT announced that MAA review had started. On 11/9/15 IGXT announced that Rizaport had received marketing clearance. So it took about a year.
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Post by prvs on Feb 15, 2016 12:30:08 GMT -5
Some further information on Rizaport sales: It went into the National phase of marketing clearance in November 2015. This is the stage where price is determined. National clearance takes 3-6 months. So in all sales won't begin until 16-19 months after the original MAA submission.
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Post by sneaker on Feb 15, 2016 12:40:20 GMT -5
You also need to take into account though that healthcare in Europe doesn't operate like the US market.
Medicine that is 'approved' as being safe is not necessarily approved for prescription by the healthcare service if it's not cost-effective. Most Europeans will not have private medical insurance and will exclusively use their country's nationalised system. If the European healthcare services aren't convinced of the cost v. benefit of Afrezza, it won't sell in any volumes at all. Alternatively, price Afrezza at par or even slightly below the cost of the standard bolus insulins, along with an impartial rigorous study proving effectiveness, and the injectable bolus insulin market will collapse overnight in favour of Afrezza.
Realistically though, better to focus on the approvals process in the Middle East if you want to look at foreign sales.
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Post by matt on Feb 15, 2016 13:12:31 GMT -5
EU approvals are cut and dried. The file goes to the European Medicines Agency who then has 210 days to act on the file unless there is a "clock stop". A clock stop happens if there are technical questions that cannot be answered quickly, and in theory a clock stop can go on forever, but most are relatively brief. If EMA recommends approval, the recommendation goes to the EU Parliament for final action, a process that takes 60 days. So a normal EU approval process is 210+60 = 270 days which is the same as for FDA.
What you don't see is the back and forth between two rapporteurs, who are country representatives on the Committee for Human Medicinal Products and the sponsor. The rapporteurs go around and get informal advice and guidance from the EMA, solicit opinions from other committee members, and so on as a way to identify speed bumps. Many times the sponsor will work to address any open issues identified informally BEFORE the file is submitted (FDA is also good about giving helpful advice to those that want to listen).
What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got. Sanofi certainly had enough time to get a non-controversial product through the process so there may have been some unaddressed concerns.
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Post by babaoriley on Feb 16, 2016 1:49:33 GMT -5
"What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got."
Although we can't know it (for now), we sure as hell can make an educated guess.
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Post by peppy on Feb 16, 2016 4:04:11 GMT -5
EU approvals are cut and dried. The file goes to the European Medicines Agency who then has 210 days to act on the file unless there is a "clock stop". A clock stop happens if there are technical questions that cannot be answered quickly, and in theory a clock stop can go on forever, but most are relatively brief. If EMA recommends approval, the recommendation goes to the EU Parliament for final action, a process that takes 60 days. So a normal EU approval process is 210+60 = 270 days which is the same as for FDA. What you don't see is the back and forth between two rapporteurs, who are country representatives on the Committee for Human Medicinal Products and the sponsor. The rapporteurs go around and get informal advice and guidance from the EMA, solicit opinions from other committee members, and so on as a way to identify speed bumps. Many times the sponsor will work to address any open issues identified informally BEFORE the file is submitted (FDA is also good about giving helpful advice to those that want to listen). What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got. Sanofi certainly had enough time to get a non-controversial product through the process so there may have been some unaddressed concerns. What is the price tag? Any idea of the price ($$) paid along the way?
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Post by sneaker on Feb 16, 2016 6:13:22 GMT -5
That doesn't particularly mean anything though. The EMA approval just means a product can be legally sold within the European Union. What is of far more importance is who will be buying it.
For instance, in the UK, treatment options are determined by NICE, which draws up guidelines according to cost vs. benefit. EMA approval means NICE will consider Afrezza when drawing up guidelines but unless Afrezza proves to deliver on the cost vs. benefit, it will not be recommended for the NHS. Probably every single person with diabetes in the UK receives their treatment through the NHS alone and would never consider 'going private' - which means pretty much every single person with diabetes in the UK will never use Afrezza if it doesn't 'pass'.
More importantly, the challenge goes beyond simply proving Afrezza offers a superior cost/benefit analysis. NICE makes decisions on a national level whereby some drugs which are better are not actually recommended, because the costs associated with them will mean there isn't enough cash left over for cost-effective treatments for other patients with completely different conditions ie. NICE won't spend more on Afrezza if that means it won't be able to buy as many radiotherapy treatments.
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Post by agedhippie on Feb 16, 2016 7:15:42 GMT -5
That's not the end of it. Once NICE approves a drug it then passes to the regional commissioning committees who will issue guidance on whether or not a drug should be prescribed. Then there is the doctor since it comes out of his drug budget (it is not their money but they have a pot to spend each year).
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Post by prvs on Feb 16, 2016 8:02:46 GMT -5
EU approvals are cut and dried. The file goes to the European Medicines Agency who then has 210 days to act on the file unless there is a "clock stop". A clock stop happens if there are technical questions that cannot be answered quickly, and in theory a clock stop can go on forever, but most are relatively brief. If EMA recommends approval, the recommendation goes to the EU Parliament for final action, a process that takes 60 days. So a normal EU approval process is 210+60 = 270 days which is the same as for FDA. What you don't see is the back and forth between two rapporteurs, who are country representatives on the Committee for Human Medicinal Products and the sponsor. The rapporteurs go around and get informal advice and guidance from the EMA, solicit opinions from other committee members, and so on as a way to identify speed bumps. Many times the sponsor will work to address any open issues identified informally BEFORE the file is submitted (FDA is also good about giving helpful advice to those that want to listen). What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got. Sanofi certainly had enough time to get a non-controversial product through the process so there may have been some unaddressed concerns. Wouldn't there be an SEC filing if SNY had submitted an application for approval? Or at least an announcement? If there was no application, all of this is moot until MNKD submits one. But thanks for the education! It will be interesting to see how this plays out. My take is that MNKD should focus 99% of their efforts on US sales in order to get the needed revenue for the continuance of the company. |
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Post by bthomas55ep on Feb 16, 2016 8:11:36 GMT -5
I guess I am thinking that the length of time required to get Afrezza approved and selling in a foreign jurisdiction is irrelevant. The question I have is how long will it take to sell rights of Afrezza to an entity that will pay a large up front payment in exchange for exclusivity for a particular region (Asia, EU, Middle East). It would be nice to see at least $500 Million in exchange for these territories. Mannkind could then focus on rolling out Afrezza in the U.S. and expanding the T/S pipeline without the daily threat of bankruptcy. IMO.
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Post by LosingMyBullishness on Feb 16, 2016 8:15:50 GMT -5
I guess that MNKD management has already drawn up both the timeline of approval in UK and continental EU and their trials to show superiority. Without superiority they can forget about meaningful sales in Europe. Big Pharma is well positioned in EU and UK. Might be that they can get some sales in Middle east or China to improve cash situation, but even that should need several months to kick in. MNKD success will be decided this year and short-term EU and UK are irrelevant.
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Post by mindovermatter on Feb 16, 2016 8:44:54 GMT -5
I guess that MNKD management has already drawn up both the timeline of approval in UK and continental EU and their trials to show superiority. Without superiority they can forget about meaningful sales in Europe. Big Pharma is well positioned in EU and UK. Might be that they can get some sales in Middle east or China to improve cash situation, but even that should need several months to kick in. MNKD success will be decided this year and short-term EU and UK are irrelevant. On a side note, I hope Mannkind is using the fact that Sanofi did nothing to get EU approval for Afrezza as a evidence that Sanofi sat on Afrezza to extract a nice parting paycheck from SNY. |
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Post by jurystillout on Feb 16, 2016 15:26:22 GMT -5
EU approvals are cut and dried. The file goes to the European Medicines Agency who then has 210 days to act on the file unless there is a "clock stop". A clock stop happens if there are technical questions that cannot be answered quickly, and in theory a clock stop can go on forever, but most are relatively brief. If EMA recommends approval, the recommendation goes to the EU Parliament for final action, a process that takes 60 days. So a normal EU approval process is 210+60 = 270 days which is the same as for FDA. What you don't see is the back and forth between two rapporteurs, who are country representatives on the Committee for Human Medicinal Products and the sponsor. The rapporteurs go around and get informal advice and guidance from the EMA, solicit opinions from other committee members, and so on as a way to identify speed bumps. Many times the sponsor will work to address any open issues identified informally BEFORE the file is submitted (FDA is also good about giving helpful advice to those that want to listen). What we can't know is whether Sanofi began the informal consultation with the rapporteurs and, if they did, what feedback they got. Sanofi certainly had enough time to get a non-controversial product through the process so there may have been some unaddressed concerns. Wouldn't there be an SEC filing if SNY had submitted an application for approval? Or at least an announcement? If there was no application, all of this is moot until MNKD submits one. But thanks for the education! It will be interesting to see how this plays out. My take is that MNKD should focus 99% of their efforts on US sales in order to get the needed revenue for the continuance of the company. By the time Mnkd gets control of Affrezza (away from sny) they will not have enough time (money) to boost US sales or euro sales enough to generate needed revenue for continuance of the company. If mnkd is planning on surviving they have to have another plan for generating quick income. Take a couple of minutes and send a polite e-mail to MNKD and ask what that plan is. I've done this with no reply however the more people asking may help get the message acrossed that this needs to be addressed ito some degree. |
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Post by dreamboatcruise on Feb 17, 2016 1:08:15 GMT -5
I guess I am thinking that the length of time required to get Afrezza approved and selling in a foreign jurisdiction is irrelevant. The question I have is how long will it take to sell rights of Afrezza to an entity that will pay a large up front payment in exchange for exclusivity for a particular region (Asia, EU, Middle East). It would be nice to see at least $500 Million in exchange for these territories. Mannkind could then focus on rolling out Afrezza in the U.S. and expanding the T/S pipeline without the daily threat of bankruptcy. IMO. Obviously the time matters unless you are mistakenly thinking that hundreds of millions would be paid all upfront. SNY only paid $150M initially and that was for something that already had approval... in the largest drug market. Not sure how the entire rest of the world stacks up compared to dollar value of US market, but it seems even if we got some up front, it won't be a long term solution to cash problem... though perhaps it could enable a secondary offering that is only painfully dilutive rather than crushingly dilutive. |
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Post by bthomas55ep on Feb 17, 2016 7:17:26 GMT -5
I guess I am thinking that the length of time required to get Afrezza approved and selling in a foreign jurisdiction is irrelevant. The question I have is how long will it take to sell rights of Afrezza to an entity that will pay a large up front payment in exchange for exclusivity for a particular region (Asia, EU, Middle East). It would be nice to see at least $500 Million in exchange for these territories. Mannkind could then focus on rolling out Afrezza in the U.S. and expanding the T/S pipeline without the daily threat of bankruptcy. IMO. Obviously the time matters unless you are mistakenly thinking that hundreds of millions would be paid all upfront. SNY only paid $150M initially and that was for something that already had approval... in the largest drug market. Not sure how the entire rest of the world stacks up compared to dollar value of US market, but it seems even if we got some up front, it won't be a long term solution to cash problem... though perhaps it could enable a secondary offering that is only painfully dilutive rather than crushingly dilutive. Thanks DBC - Yes. Upfront. As I am suggesting that Mannkind fully license and give all Afrezza rights to that entity for the TBD ROW Region. More correctly Sanofi was going to pay $1 Billion in Milestone payments if all the markers were hit AND split revenue after cost 65/35. In this scenario, said company buys all the rights to the EU forever for say $200 Million -- at that point, they can even rebrand under another name if they wish. They would fully own the product, brand, and license for the Region. If Mannkind could find three such candidates - one for EU, one for Asia, and one for the Middle East, perhaps it would be worth $500 Million in total one time. It would be up to these companies to take their new product and roll them out in their markets as appropriate. Under this context, I would once again say - the time to get Afrezza approved and rolling out in these markets would be irrelevant to Mannkind. They could continue their focus on the U.S. Territory of Afrezza they still own and developing the T/S pipeline (but with a few years of cash on hand). IMO or rather my hope of what they are doing. |
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