Post by lakers on Jan 8, 2016 19:59:47 GMT -5
Afrezza Adrift, Among Insulin Wars
www.healthline.com/diabetesmine/diabetes-tech-spectations-2016#2
Written by Mike Hoskins | Published on January 6, 2016
Afrezza: Sadly, this year kicked off with the breaking news on Tuesday that Sanofi had nixed its agreement with MannKind Corp. to manufacture and sell Afrezza inhaled insulin. Available since early 2015 following FDA approval the prior year, sales have been disappointing and rumors of Sanofi's pull-out have been circulating for months.
No, the news is not that MannKind is discontinuing Afrezza at this time. They've just lost their backing from pharma giant Sanofi, so all of the rights and responsibilities now default back to MannKind, which is left holding the bag. MannKind will be taking over the production of Afrezza from Sanofi in the next three to six months, according to reports. In a mid-day webinar Tuesday, MannKind's CFO Matt Pfeffer said the company is exploring strategic plays on what it will do next, hinting at finding a new partner. He assured users there will be "no interruption in therapy" and was quite bullish about MannKind's prospects, stating that the split with Sanofi is "not a setback but an opportunity for Afrezza."
We truly hope he is right, because many PWDs (including 'Mine editor AmyT and my own mother who lives with T1D) have been using and loving Afrezza this past year. Now, the Afrezza Era could very well be coming to an untimely end... we shall see.
Meanwhile, the uncertainty around inhaled insulin remains just one piece of the ongoing Insulin Wars that continue among the Big Three makers -- Eli Lilly, Novo Nordisk, and Sanofi -- that will only intensify in 2016 as they pursue both insulin and other new, competitive diabetes drugs.
Sanofi: Aside from the Afrezza news, Sanofi's new highly concentrated U-300 basal insulin Toujeo ("the Son of Lantus") hit the market this past year, to some excitement and also a bit of confusion on dosing conversion. Now Sanofi is setting its 2016 sights on GLP-1 agonists and GLP-1/basal insulin combo drugs here in the U.S. In September, they filed an FDA New Drug Appliaction for Lyxumia (lixisenatide). That paves the way for the combo drug Lixilan (Lyxumia + Lantus) once approved.
Novo: The New Jersey company's new long-lasting basal insulin Tresiba hit the market in 2015, and has been going head-to-head against Sanofi's Toujeo. Novo is also developing a faster-acting version of Novolog, which doesn't yet have a name other than its clinical trial moniker NN11218. Novo has finished Phase III clinical studies on this drug, and hopes to have it ready for market sometime in 2016.
Eli Lilly: In mid-December, the FDA approved their new basal insulin Basaglar, described as a less-expensive version of Sanofi's Lantus, that's been dominating the market for a decade now. Lilly has stated that Basaglar will be ready for market at the end of 2016. Of course, they'll have to compete with Toujeo and Tresiba as well, so expect marketing wars, Insulin Users!
www.healthline.com/diabetesmine/diabetes-tech-spectations-2016#2
Written by Mike Hoskins | Published on January 6, 2016
Afrezza: Sadly, this year kicked off with the breaking news on Tuesday that Sanofi had nixed its agreement with MannKind Corp. to manufacture and sell Afrezza inhaled insulin. Available since early 2015 following FDA approval the prior year, sales have been disappointing and rumors of Sanofi's pull-out have been circulating for months.
No, the news is not that MannKind is discontinuing Afrezza at this time. They've just lost their backing from pharma giant Sanofi, so all of the rights and responsibilities now default back to MannKind, which is left holding the bag. MannKind will be taking over the production of Afrezza from Sanofi in the next three to six months, according to reports. In a mid-day webinar Tuesday, MannKind's CFO Matt Pfeffer said the company is exploring strategic plays on what it will do next, hinting at finding a new partner. He assured users there will be "no interruption in therapy" and was quite bullish about MannKind's prospects, stating that the split with Sanofi is "not a setback but an opportunity for Afrezza."
We truly hope he is right, because many PWDs (including 'Mine editor AmyT and my own mother who lives with T1D) have been using and loving Afrezza this past year. Now, the Afrezza Era could very well be coming to an untimely end... we shall see.
Meanwhile, the uncertainty around inhaled insulin remains just one piece of the ongoing Insulin Wars that continue among the Big Three makers -- Eli Lilly, Novo Nordisk, and Sanofi -- that will only intensify in 2016 as they pursue both insulin and other new, competitive diabetes drugs.
Sanofi: Aside from the Afrezza news, Sanofi's new highly concentrated U-300 basal insulin Toujeo ("the Son of Lantus") hit the market this past year, to some excitement and also a bit of confusion on dosing conversion. Now Sanofi is setting its 2016 sights on GLP-1 agonists and GLP-1/basal insulin combo drugs here in the U.S. In September, they filed an FDA New Drug Appliaction for Lyxumia (lixisenatide). That paves the way for the combo drug Lixilan (Lyxumia + Lantus) once approved.
Novo: The New Jersey company's new long-lasting basal insulin Tresiba hit the market in 2015, and has been going head-to-head against Sanofi's Toujeo. Novo is also developing a faster-acting version of Novolog, which doesn't yet have a name other than its clinical trial moniker NN11218. Novo has finished Phase III clinical studies on this drug, and hopes to have it ready for market sometime in 2016.
Eli Lilly: In mid-December, the FDA approved their new basal insulin Basaglar, described as a less-expensive version of Sanofi's Lantus, that's been dominating the market for a decade now. Lilly has stated that Basaglar will be ready for market at the end of 2016. Of course, they'll have to compete with Toujeo and Tresiba as well, so expect marketing wars, Insulin Users!