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Post by mnkd10target on Dec 23, 2015 8:23:03 GMT -5
What does this mean for us? Why?
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Post by liane on Dec 23, 2015 8:26:46 GMT -5
Can you be more specific...?
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Post by mnkd10target on Dec 23, 2015 8:32:14 GMT -5
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Post by mindovermatter on Dec 23, 2015 8:33:33 GMT -5
What does this mean for us? Why? I think it means we only have to take our disappointment pill once a day??? |
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Post by mindovermatter on Dec 23, 2015 8:36:27 GMT -5
PARIS (Reuters) - French drugmaker Sanofi said on Wednesday it had submitted an application to the U.S. Food and Drug Administration (FDA) for a single daily insulin injection to treat adults with type 2 diabetes.
Sanofi said it had requested a six-month review of its new drug application by the FDA, rather than the standard 10 months.
"A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin," Sanofi's diabetes head, Pierre Chancel, said in a statement.
The latest application involves a combination of insulin glargine with its lixisenatide drug, Sanofi said.
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Post by mnholdem on Dec 23, 2015 8:49:53 GMT -5
That sounds like Lixilan. I think this will be the eventual replacement for Lantus and that Toujeo is merely a stopgap. Incidentally, Afrezza would be a great prandial combo with Lixilan.
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Zealand Pharma A/S (OTCPK:ZLDPF)(OTCPK:ZLDPY) earns a $20M milestone payment from licensee Sanofi (NYSE:SNY) triggered by the latter's submission of a New Drug Application (NDA) to the FDA seeking clearance of LixiLan, a single injection, fixed-ratio combination of lixisenatide and insulin glargine, for the treatment of type 2 diabetics.
Lixisenatide, a once-daily prandial GLP-1 receptor agonist invented by Zealand, is marketed ex-U.S. by Sanofi as Lyxumia for type 2 diabetes (Sanofi's NDA is currently under review by the FDA). Sanofi markets insulin glargine globally as Lantus.
Sanofi's LixiLan submission included a Priority Review Voucher that will shorten the review clock to six months, if accepted. The company intends to submit its Marketing Authorization Application (MAA) for LixiLan in Europe in Q1.
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I was wondering when Sanofi was going to use that voucher they bought last year...
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Post by mnkd10target on Dec 23, 2015 8:51:42 GMT -5
That sounds like Lixilan. I think this will be the eventual replacement for Lantus and that Toujeo is merely a stopgap. Incidentally, Afrezza would be a great prandial combo with Lixilan. Zealand Pharma A/S (OTCPK:ZLDPF)(OTCPK:ZLDPY) earns a $20M milestone payment from licensee Sanofi (NYSE:SNY) triggered by the latter's submission of a New Drug Application (NDA) to the FDA seeking clearance of LixiLan, a single injection, fixed-ratio combination of lixisenatide and insulin glargine, for the treatment of type 2 diabetics. Lixisenatide, a once-daily prandial GLP-1 receptor agonist invented by Zealand, is marketed ex-U.S. by Sanofi as Lyxumia for type 2 diabetes (Sanofi's NDA is currently under review by the FDA). Sanofi markets insulin glargine globally as Lantus. Sanofi's LixiLan submission included a Priority Review Voucher that will shorten the review clock to six months, if accepted. The company intends to submit its Marketing Authorization Application (MAA) for LixiLan in Europe in Q1. Looks like they've been working on it before Afrezza was even FDA approved. |
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Post by kbrion77 on Dec 23, 2015 10:26:13 GMT -5
That sounds like Lixilan. I think this will be the eventual replacement for Lantus and that Toujeo is merely a stopgap. Incidentally, Afrezza would be a great prandial combo with Lixilan. Zealand Pharma A/S (OTCPK:ZLDPF)(OTCPK:ZLDPY) earns a $20M milestone payment from licensee Sanofi (NYSE:SNY) triggered by the latter's submission of a New Drug Application (NDA) to the FDA seeking clearance of LixiLan, a single injection, fixed-ratio combination of lixisenatide and insulin glargine, for the treatment of type 2 diabetics. Lixisenatide, a once-daily prandial GLP-1 receptor agonist invented by Zealand, is marketed ex-U.S. by Sanofi as Lyxumia for type 2 diabetes (Sanofi's NDA is currently under review by the FDA). Sanofi markets insulin glargine globally as Lantus. Sanofi's LixiLan submission included a Priority Review Voucher that will shorten the review clock to six months, if accepted. The company intends to submit its Marketing Authorization Application (MAA) for LixiLan in Europe in Q1. Looks like they've been working on it before Afrezza was even FDA approved. Sanofi and Zealand have been partners since at least 2008. People need to understand Sanofi isn't going to drop every other development to focus on Afrezza. |
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Post by Deleted on Dec 23, 2015 10:36:24 GMT -5
kbrion77 with regards to your comment about understanding SNY isn't going to drop every other development to focus on afrezza, isn't that exactly the problem as an investor in MNKD right now? Anyone who is long MNKD could care less about SNY's other projects, products, or focus outside of afrezza. Why would we?!
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Post by kbrion77 on Dec 23, 2015 10:46:09 GMT -5
kbrion77 with regards to your comment about understanding SNY isn't going to drop every other development to focus on afrezza, isn't that exactly the problem as an investor in MNKD right now? Anyone who is long MNKD could care less about SNY's other projects, products, or focus outside of afrezza. Why would we?! Agreed to a certain extent but this is the life of partnering with big pharma. In my opinion there is some overreaction going on with this as everyone wants communication from MNKD. Do I, of course I do but I'm not going to start complaining every time Sanofi announces something that is not MNKD related. |
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Post by slugworth008 on Dec 23, 2015 11:08:10 GMT -5
kbrion77 with regards to your comment about understanding SNY isn't going to drop every other development to focus on afrezza, isn't that exactly the problem as an investor in MNKD right now? Anyone who is long MNKD could care less about SNY's other projects, products, or focus outside of afrezza. Why would we?! TRUTH! Personally I'd like to see a bit more focus on Afrezza for a change. |
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Post by nadathing on Dec 23, 2015 11:22:04 GMT -5
I don't think it means anything other than SNY intends to dominate and own the diabetes market. They cannot do it without Afrezza.
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Post by mssciguy on Dec 23, 2015 11:27:18 GMT -5
I don't think it means anything other than SNY intends to dominate and own the diabetes market. They cannot do it without Afrezza. I read elsewhere that SNY wants control of the whole global distribution chain prior to going global with Afrezza. Does anyone else agree with this? Don't they already have control? Have there really been issues with SNY's global distribution chain? Wouldn't Afrezza be more easily distributed globally than liquid prandials, which are susceptible to all kinds of stability issues? When will SNY go global with Afrezza? .................. Sorry just trying to fill the vacuum .................. |
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Post by Deleted on Dec 23, 2015 12:14:22 GMT -5
I don't think it means anything other than SNY intends to dominate and own the diabetes market. They cannot do it without Afrezza. I read elsewhere that SNY wants control of the whole global distribution chain prior to going global with Afrezza. Does anyone else agree with this? Don't they already have control? Have there really been issues with SNY's global distribution chain? Wouldn't Afrezza be more easily distributed globally than liquid prandials, which are susceptible to all kinds of stability issues? When will SNY go global with Afrezza? .................. Sorry just trying to fill the vacuum .................. Maybe Al can spin off Afrezza for $15B + a royalty and leave us with some current and future income along with Mannkind Tech Co. |
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Post by cjc04 on Dec 23, 2015 12:40:00 GMT -5
I read elsewhere that SNY wants control of the whole global distribution chain prior to going global with Afrezza. Does anyone else agree with this? Don't they already have control? Have there really been issues with SNY's global distribution chain? Wouldn't Afrezza be more easily distributed globally than liquid prandials, which are susceptible to all kinds of stability issues? When will SNY go global with Afrezza? .................. Sorry just trying to fill the vacuum .................. Maybe Al can spin off Afrezza for $15B + a royalty and leave us with some current and future income along with Mannkind Tech Co. .....Uhhh.......... Yea maybe...... Maybe like any day now would be great! |
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