|
Post by myocat on Jun 3, 2017 10:12:14 GMT -5
Thanks for letting me know. Can't keep up with zillion posts on this board LOL.
|
|
|
Post by mango on Jun 3, 2017 11:04:41 GMT -5
• The EU is currently negotiating a trade agreement with the four founding members of Mercosur (Argentina, Brazil, Paraguay, and Uruguay) as part of the overall negotiation for a bi-regional Association Agreement. The Mercosur Free Trade AgreementThe EU-Mercosur negotiations re-launched in May 2010. Ten negotiation rounds took place mostly focused on rules (as opposed to market access commitments) before negotiations were paused in 2012. On 11 May 2016, the EU and Mercosur exchanged offers for the first time since the re-launch, followed by a negotiation round in October 2016. The next round will be held in March 2017. The current negotiations cover a broad range of issues including: • tariffs • rules of origin • technical barriers to trade • sanitary and phytosanitary measures • services • government procurement • intellectual property • sustainable development • small- and medium-sized enterprises This free trade agreement will be part of the overall negotiation for a bi-regional Association Agreement which also comprises a political and a cooperation pillar. • All Mercosur countries, with the exception of Paraguay, no longer benefit from the Generalised Scheme of Preferences (GSP) scheme as of 1 January 2014, due to their classification as high middle-income countries. However, they remain GSP eligible countries. ec.europa.eu/trade/policy/countries-and-regions/regions/mercosur/
|
|
|
Post by mango on Jun 3, 2017 11:15:04 GMT -5
|
|
|
Post by mango on Jun 3, 2017 11:16:35 GMT -5
If the new trade agreements are favorable for the EU, could we potentially see Amphastar shipping directly to Biomm?
|
|
|
Post by mnholdem on Jun 3, 2017 13:49:55 GMT -5
As I understand it, Amphastar supplies the insulin, but they do not manufacture the Technosphere particles. I think the agreement states that BIOMM will have packaged Afrezza shipped to them from the Danbury plant.
|
|
|
Post by mango on Jun 3, 2017 13:56:51 GMT -5
mnholdem I think I got too carried away with Amphastar.
|
|
|
Post by sayhey24 on Jun 4, 2017 9:02:14 GMT -5
This list may be a bit dated but Biocon may not be as far along as you are saying. blog.diabeteslab.org/2016/01/the-future-of-insulin-new-insulin-formulations-under-development/For the RAAs why Sanofi wants to make generic Humalog I can't explain. Regardless, you are trying to make the argument NPH, the RAAs and afrezza are all the same and one can substitute for the other based on "price". I am not following this. If the goal is controlling meal time sugar spikes, NPH is not going to do it. Neither is Novalog, Humalog, Fiasp or any other current or in-works RAA. Only afrezza and a healthy pancreas do this. If Sanofi is now trying to make Lilly products and each is trying to eat each other's lunch yet the only product which will get the job done is afrezza, it just seems a matter of time before one has to back up the money truck and pay MNKD what they want for the buy-out. We are about 2 years away from people walking around with Tim Cook's CGM. Between what Verily is doing and what Cook is doing in 2 years its all about meal time control. T2's don't need a basal, don't need metformin, any SGLT or any other non-sense if they can address meal time spikes. The only way T2s can do this today is with ultra-low carb diets because no one wants the needles and hypo risk with current RAAs and insurance is not paying for it because no one is seeing the after meal sugar numbers today. The question is was Stefan Schwarz right? He knew early on the PCPs were going to continue to give the T2s ultra-poor care unless he could change the paradigm. Biocon is working on producing analogs because they are off patent, your argument was that BIOMM couldn't work on RAA because of patents. Sanofi has produced and got EMA approval to sell a Humalog biosimilar in Europe. So there is no question that BIOMM could produce an analog unobstructed by patent if they had the ability which they do not. Why has Sanofi produced a Humalog biosimilar? Because there is a huge established market for Humalog and it is easier to compete on price (as the Lantus biosimilars have proven) than it is to educate the market as Afrezza is trying to do. Take Brazil as an example - Humalog is costs the $18 for the equivalent of a box of Afrezza and Sanofi can undercut that. For most of the world that is what matters. "If the goal is controlling meal time sugar spikes..." is all very well but it's not the goal the medical profession care about. Rightly or wrongly (and I tend to your view here) their goal is HbA1c, and for that the trial data says they are all the same. Well not NPH because that's a basal insulin more like Levemir (in that it is twice daily) which is where the EU countries are looking at it. My argument is the days of A1c are limited with cloud CGMs. Maybe I am wrong but thats the bet I have made. If I am right the days of current RAAs are also limited so competing in a shrinking market on price seems like another brilliant move by Sanofi when they already have Aprida. Maybe BIOMM sees it the same way as me. If I am right and guys like Tim Cook bring broad awareness to meal time sugar spikes current approaches to treating diabetics will finally change. Maybe Cook will fail and Google's Onduo will also fail and the general public will continue to follow current medical "best practices". We won't know the answer to this for a few years. What we do know is A1c is only used because it is a cheap test prior to CGMs when nobody knew their numbers. As I have said before prior to real time sensor technology treating diabetes was a black art. Bernstein was the first to bring engineering to diabetes. My bet is Apple and Google can now take it to the next level and when they do for T2s its all about meal time spikes. Treat the spikes from day one and get them back back under 100 two hours after eating and many will see not only remission but reversal. I was ecstatic to see Dr Bruce Bode say afrezza should be prescribed to all T2s within a year or two and now I have just seen Dr. Bernstein talking positively about afrezza. It was nice to also see Dr. Gary Scheiner put out a rather positive review after being anti-afrezza since day one. integrateddiabetes.com/my-review-of-afrezza-fast-acting-inhaled-insulin/amp/We have 40+ years of studies saying if T2s are treated with insulin from day one they will see in many cases improvement in beta-cell function. However we don't have one study yet using CGMs and afrezza with newly diagnosed T2s using non-diabetic BG targets. My bet is as good as the 40+ years of studies using old school insulin results are, the results using afrezza getting the PWDs back under 100 within 2 hours will be phenomenal. Do this for 3 to 6 months and my bet is the "brilliant" medical community will be shocked by the results and BP and the ADA will be pissed. The technology is all there, IMO now its all about marketing and money and lets hope Mike is good at marketing and has a few friends with money because its going to take an Apple or Google to do this. In the mean time maybe Mike can get his sales guys to get every endo to prescribe afrezza to every T1 for corrections. There is no excuse why this should not be happening, now. Did you get your afrezza yet for corrections?
|
|
|
Post by agedhippie on Jun 4, 2017 9:18:11 GMT -5
In the mean time maybe Mike can get his sales guys to get every endo to prescribe afrezza to every T1 for corrections. There is no excuse why this should not be happening, now. Did you get your afrezza yet for corrections? I don't because my insurance only allows one mealtime insulin so it's all or nothing. Now if Afrezza was cheap enough and OTC I would buy it out of pocket for corrections.
|
|
|
Post by peppy on Jun 4, 2017 9:44:38 GMT -5
In the mean time maybe Mike can get his sales guys to get every endo to prescribe afrezza to every T1 for corrections. There is no excuse why this should not be happening, now. Did you get your afrezza yet for corrections? I don't because my insurance only allows one mealtime insulin so it's all or nothing. Now if Afrezza was cheap enough and OTC I would buy it out of pocket for corrections. sayhey, what makes you think insurance will cover both rapid acting subq and afrezza?
|
|
|
Post by compound26 on Jun 16, 2017 10:22:31 GMT -5
|
|
|
Post by matt on Jun 16, 2017 11:05:10 GMT -5
For the RAAs why Sanofi wants to make generic Humalog I can't explain. This is pretty easy to understand. Pricing in the insulin market is headed south, due mainly to competition for the PBM market. PBMs don't make their money on discounts; they make the money on rebates which are paid at the end of the year. The way pharma companies get the PBMs to enforce formulary restrictions is by promising big rebates tied to market share figures; miss the market share target percentage for the preferred brand and the rebate takes a major hit. When Lantus was the only game in town, Sanofi did not have to play nice with the PBMs. Now that there are biosimilars, Lilly and Novo can enforce their sole source formulary placement much more effectively, and this has killed Sanofi's diabetes business. By adding new insulin options to the Sanofi product line, they can play a bit of catch-up and try to recapture lost market share. It is also the reason Afrezza will never make much of a dent in the PBM sector unless it becomes a widely prescribed product. With the way the rebates work, each fill of Afrezza hurts the PBM because it makes it that much harder to hit the necessary market share percentage to get the maximum rebate. Even if Mannkind priced Afrezza at $0, it still might be in the economic interest of the PBM to fill with the preferred brand rather than Afrezza. The rebate formulas are designed to achieve this precise result and there is a LOT of money on the table for the PBM.
|
|
|
Post by zuegirdor on Jun 16, 2017 12:29:19 GMT -5
For the RAAs why Sanofi wants to make generic Humalog I can't explain. This is pretty easy to understand. Pricing in the insulin market is headed south, due mainly to competition for the PBM market. PBMs don't make their money on discounts; they make the money on rebates which are paid at the end of the year. The way pharma companies get the PBMs to enforce formulary restrictions is by promising big rebates tied to market share figures; miss the market share target percentage for the preferred brand and the rebate takes a major hit. When Lantus was the only game in town, Sanofi did not have to play nice with the PBMs. Now that there are biosimilars, Lilly and Novo can enforce their sole source formulary placement much more effectively, and this has killed Sanofi's diabetes business. By adding new insulin options to the Sanofi product line, they can play a bit of catch-up and try to recapture lost market share. It is also the reason Afrezza will never make much of a dent in the PBM sector unless it becomes a widely prescribed product. With the way the rebates work, each fill of Afrezza hurts the PBM because it makes it that much harder to hit the necessary market share percentage to get the maximum rebate. Even if Mannkind priced Afrezza at $0, it still might be in the economic interest of the PBM to fill with the preferred brand rather than Afrezza. The rebate formulas are designed to achieve this precise result and there is a LOT of money on the table for the PBM. What they call perverse incentives? Does this mean we are over or under regulating?
|
|
|
Post by peppy on Jun 16, 2017 15:58:42 GMT -5
This is pretty easy to understand. Pricing in the insulin market is headed south, due mainly to competition for the PBM market. PBMs don't make their money on discounts; they make the money on rebates which are paid at the end of the year. The way pharma companies get the PBMs to enforce formulary restrictions is by promising big rebates tied to market share figures; miss the market share target percentage for the preferred brand and the rebate takes a major hit.When Lantus was the only game in town, Sanofi did not have to play nice with the PBMs. Now that there are biosimilars, Lilly and Novo can enforce their sole source formulary placement much more effectively, and this has killed Sanofi's diabetes business. By adding new insulin options to the Sanofi product line, they can play a bit of catch-up and try to recapture lost market share. It is also the reason Afrezza will never make much of a dent in the PBM sector unless it becomes a widely prescribed product. With the way the rebates work, each fill of Afrezza hurts the PBM because it makes it that much harder to hit the necessary market share percentage to get the maximum rebate. Even if Mannkind priced Afrezza at $0, it still might be in the economic interest of the PBM to fill with the preferred brand rather than Afrezza. The rebate formulas are designed to achieve this precise result and there is a LOT of money on the table for the PBM. What they call perverse incentives?Does this mean we are over or under regulating? quote: PBMs don't make their money on discounts; they make the money on rebates which are paid at the end of the year. The way pharma companies get the PBMs to enforce formulary restrictions is by promising big rebates tied to market share figures; miss the market share target percentage for the preferred brand and the rebate takes a major hit. reply: is there no such thing as right and wrong anymore? Were are told somewhere along the line, the physician makes the decision? So physicians do not make the decisions? /photo/1?ref_src=twsrc%5Etfw&ref_url=http%3A%2F%2Fmnkd.proboards.com%2Fthread%2F6532%2Fafrezza-on-twitter-ii%3Fpage%3D70
|
|
|
Post by sayhey24 on Jun 16, 2017 19:22:22 GMT -5
|
|
|
Post by agedhippie on Jun 17, 2017 10:23:50 GMT -5
Apidra was always an also ran in the RAA race which is why Sanofi could adopt Afrezza. If Afrezza to make large inroads into the RAA market then all they were losing was Apidra and they could more than make that up in the share they would carve out of the rest of the RAA market. Plan B was the Humalog biosimilar. Sanofi is relying on the PBMs wanting a Humalog biosimilar for less than the cost of Humalog. My bet is that just as you saw PBMs moving to the Lantus biosimilar you will see a move to Sanofi's Humalog biosimilar. The PBMs get to drive down the cost of insulin to them (the rest of us not so much) and get their percentage of the saving. Sanofi gets to steal a large chunk of the Humalog market.
|
|