After thirty years, I've gone from four injections per day down to only one (my Lantus dose). My thighs and abdomen are a mess and it's gotten harder to get a good dose in recent years. Afrezza is nothing short of life-changing. Everyone should use this insulin.
MannKind Corp. ( MNKD ) said it has terminated its license and collaboration agreement with sanofi-aventis U.S. LLC (SNYNF, SNY) for the development and commercialization of Afrezza (insulin human) Inhalation Powder. The two companies will promptly start transition discussions in order to effect a smooth and orderly transition in the development and commercialization of Afrezza from Sanofi to MannKind over the next 90 to 180 days.
I couldn't possibly care any less if Sanofi is involved with this drug or not. My original post was about the drug, not who's selling it. Afrezza has made my life better. Period.
I hope they continue to make Afrezza, it is a great product, but I don't believe they have given it enough time. I hope mankind partners with one of the contract companies to continue selling this product. It needs another 3-5 years to get moving.
I always believed that this product would never succeed. About 15 years ago Pfizer has a similar product called INHALE. There was always a question about people with colds and other respiratory issues administering doses. There were also lung issues of administering a powder into the lungs on a daily basis and the potential risks. Finally the newer injectors are very easy and not very dramatic to administer.
Sorry, you don't get 5 years to get a new drug moving in the best of circumstances. Statutory patent life is 20 years from the first application priority date, and much of that life is used up during the development phase. Even with Hatch-Waxman patent extensions (US only), a drug that spent as long in the FDA process as Afrezza has eaten through most of its useful life. The key patents on Afrezza start to expire on June 29, 2020. Check your calendar; it is 2016. Add five years to "get moving" as you put it and it will be just in time to lose the market to a generic. Either Afrezza turns out to the blockbuster everybody thinks it will be, in which case the generics will be queued up to replace it, or it never gets traction in the market in which case this entire discussion is moot.
I think your point at the end has already been answered. Afrezza is not and will not ever be a blockbuster.
That's what they said about Zithromax, then Pfizer did nothing except lower the price and it took off to the top of the antibiotic market.
TS formulation is as much about generics as it is extending brand - that aside, with respect to Afrezza, mnkd holds patents on nearly every insulin based mix imaginable for their ts formulation - which is how novo and gsk have operated with respect to their insulin mixes - that's why insulin up until VERY RECENTLY has never been a generic option.