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Post by benyiju on Feb 22, 2016 19:22:09 GMT -5
They may have already done MannKind some damage if speculations are correct about Sanofi sandbagging Afrezza to buy time for LixiLan to come to market, but once they are on the market, are they a major threat to Afrezza's potential market share? Novo's Xultophy threat is still a ways off, but it looks like LixiLan is coming sooner rather than later: Sanofi cuts the FDA line with a diabetes combo www.fiercebiotech.com/story/sanofi-cuts-fda-line-diabetes-combo-hoping-lap-novo/2016-02-22 |
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Post by benyiju on Feb 22, 2016 19:36:05 GMT -5
And a related question, how much of a threat are GLP-1 drugs more generally? They seem to be racking up big script numbers. Of course they have their own problems, but have they massively chopped down the potential market for Afrezza before it even gets going?
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Post by peppy on Feb 22, 2016 19:46:41 GMT -5
Sanofi Redeems $245M Priority Review Voucher for Type 2 Diabetes Treatment - www.raps.org/Regulatory-Focus/News/2016/02/22/24378/Sanofi-Redeems-245M-Priority-Review-Voucher-for-Type-2-Diabetes-Treatment/#sthash.6LLx8hUO.dpuf
In redeeming the voucher, Sanofi had to pay a $2.7 million fee in addition to the standard new drug filing fee of $2.4 million. Retrophin sold the PRV to Sanofi last May for one of the highest amounts ever: $245 million (AbbVie bought one in August for $350 million). The sale to Sanofi came after Retrophin obtained the voucher following the 17 March 2015 approval of Asklepion Pharmaceuticals' drug Cholbam (cholic acid), which is the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders. Asklepion transferred the PRV to Retrophin, which had licensed the rights to the voucher under an earlier agreement.
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Post by peppy on Feb 22, 2016 19:51:12 GMT -5
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Post by dreamboatcruise on Feb 22, 2016 19:59:42 GMT -5
Unless this combo is so effective as to stop progression it would seem all T2 are likely to eventually need prandial insulin... but I'm not a medical doctor.
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Post by benyiju on Feb 22, 2016 20:02:03 GMT -5
fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Not many type two's are using Afrezza. Type one's are the big afrezza market IMO. That's what the Sanofi official line has been, but 'blockbuster' potential of Afrezza requires substantial T2 takeup, no? |
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Post by peppy on Feb 22, 2016 20:27:04 GMT -5
fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Not many type two's are using Afrezza. Type one's are the big afrezza market IMO. That's what the Sanofi official line has been, but 'blockbuster' potential of Afrezza requires substantial T2 takeup, no?I do not think afrezza requires type 2 use to be a blockbuster. Opinions vary on the board. I do think Afrezza needs insurance coverage and advertising.
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Post by peppy on Feb 22, 2016 20:42:24 GMT -5
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Post by sccrbrg on Feb 22, 2016 21:07:37 GMT -5
So basically, they intentionally screwed us to bide time so that they could get their own "Superior to RAA" insulin to market. One that will undoubtedly have an easier path to market given its standard method of delivery. ;lakhdg;lkahdvamsedflk;aewf |
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Post by agedhippie on Feb 22, 2016 21:15:45 GMT -5
So basically, they intentionally screwed us to bide time so that they could get their own "Superior to RAA" insulin to market. One that will undoubtedly have an easier path to market given its standard method of delivery. You do realize that Lyxumia is not insulin don't you? |
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Post by suebeeee1 on Feb 23, 2016 1:05:37 GMT -5
fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Not many type two's are using Afrezza. Type one's are the big afrezza market IMO. That's what the Sanofi official line has been, but 'blockbuster' potential of Afrezza requires substantial T2 takeup, no? I certainly am not the science geek that peppy and others on this board are, but as a spouse of a type 2 using Afrezza, I can't imagine why the acceptance from t2s had not been even greater than t1s. Afterall, diabetes is progressive and virtually all t2s who take any of the current oral diabetes drugs will eventually need insulin, if they live long enough. A1c becomes more and more difficult to control as insulin production is exhausted. A prescription to Afrezza, ESPECIALLY early enough (perhaps first line?) may keep a diabetic from ever needing a basal. Or at least that is the hope. Reports from t2s have been that A1c had been reduced significantly, with about as much effort as popping pills, less hypo than injectable insulin and less side effects than many of they newer orals. It is human insulin after all. So why wouldn't there be substantial take by tbs? |
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Post by mnholdem on Feb 23, 2016 5:57:13 GMT -5
suebeeee1 , now you're singing my song. I think the short answer to your question is because Sanofi priced Afrezza at a 50% premium to injected RAA insulin. The premium may have been justified if Sanofi had designed a trial (using those early adopter) to provide empirical evidence that early insulin treatment with Afrezza results in drug-free remission in a substantial number of early T2 diabetics, but they didn't run the trial. Therefore, the pricing premium became the major barrier to market acceptance. Once patients' pancreas become damaged enough, their treatment costs skyrocket in comparison to oral medication. Sanofi failed to demonstrate the real benefit of Afrezza because remission would significant impact their (and every BP's) diabetes franchise. MannKind should target Type 1's to generate cash, and use that cash (or form a partnership) to initiate superiority trials and a study to validate that intensive insulin treatment can result in repair of the pancreas leading to drug-free remission of diabetes mellitus if administered early enough. If MannKind can accomplish that, they will get preferred coverage, change the standard of care and capture a huge chunk of the diabetes treatment market, IMHO.
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Post by stevil on Feb 24, 2016 5:07:24 GMT -5
Unless this combo is so effective as to stop progression it would seem all T2 are likely to eventually need prandial insulin... but I'm not a medical doctor. We were taught in my biochem class that GLP-1 has shown the ability to increase beta cell mass. In theory, this is the closest we've gotten to a cure for diabetes if it indeed does regenerate beta cells that then also function properly. |
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Post by stevil on Feb 24, 2016 5:15:10 GMT -5
Might be too much scientific jargon, but did a quick search and found an article from 2002!!! (amazing how much was known back then about GLP-1) It's pretty descriptive and does a good job explaining how it works if anyone is interested. diabetes.diabetesjournals.org/content/51/suppl_3/S434.full |
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Post by derek2 on Feb 24, 2016 6:39:09 GMT -5
That's what the Sanofi official line has been, but 'blockbuster' potential of Afrezza requires substantial T2 takeup, no?I do not think afrezza requires type 2 use to be a blockbuster. Opinions vary on the board. I do think Afrezza needs insurance coverage and advertising.
Although the T1 market is small in population (10% of diabetics), it's actually over 40% of the insulin market (in dollars), given that all T1s use insulin and only a small minority of T2s do. IMO, if Afrezza could get traction in the T1 market, that would be more than sufficient to drive blockbuster status. As an added bonus, the T1 market is far less segmented. About a dozen treatment alternatives (including pump) vs. 70+ for T2. |
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