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Post by fofos2000i on Dec 17, 2015 2:59:03 GMT -5
AN INHALABLE DRY POWDER FORMULATION COMPRISING GLP-1 FOR USE IN THE TREATMENT OF HYPERGLYCEMIA AND DIABETES
European Patent Application EP2954893
An inhalable dry powder formulation comprising a therapeutically effective amount of a glucagon-like peptide-1 (GLP-1) for prandial use in combination with insulin for the treatment of hyperglycemia and/or diabetes in a patient. The inhalable dry powder formulation preferably comprises a diketopiperazine having the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl, or a pharmaceutically acceptable salt thereof. The GLP-1 may be selected from the group consisting of native GLP-1, a GLP-1 metabolite, a GLP-1 analog, a GLP-1 derivative, a GLP-1 mimetic, an exendin, a GLP-1 peptide analog, a biosynthetic GLP-1 analog, or combinations thereof.
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Post by liane on Dec 17, 2015 5:09:52 GMT -5
Please provide a link.
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Post by fofos2000i on Dec 17, 2015 5:31:06 GMT -5
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Post by peppy on Dec 17, 2015 6:21:17 GMT -5
Remember the patent Sanofi put in for a different inhaler?
The link and thread are buried.
Thoughts?
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Post by greg on Dec 17, 2015 7:05:57 GMT -5
Critically, the Assignee: MannKind Corporation (25134 Rye Canyon Loop, Valencia CA 91355, US) |
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Post by Deleted on Dec 17, 2015 8:02:09 GMT -5
Upon approval, would this trigger a milestone from Sanofi?
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Post by Deleted on Dec 17, 2015 8:26:36 GMT -5
I go to the link, then click on the PDF. Around line 45, I see this: "In one embodiment, the inhalable GLP-1 and insulin combination therapy can comprise a rapid acting insulin or a long acting insulin such as insulin glulisine (APIDRA®), insulin lispro (HUMALOG®) or insulin aspart (NOVOLOG®), or a long acting insulin such as insulin detemir (LEVEMIR®) or insulin glargine (LANTUS®), which can be administered by an inhalation powder also comprising FDKP or by other routes of administration." Any patent law experts here - are they patenting using competitive products delivered via Technosphere and is it possible that Al & Co somehow have the right to license to Novo and Lilly too. I know, Sanofi would never do a deal like this but could there be a royalty deal down the road? Sanofi has a program (royalty) with Lilly with the later marketing a Lantus biosimilar starting fall of 2016 I believe. |
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Post by Deleted on Dec 17, 2015 8:27:45 GMT -5
Upon approval, would this trigger a milestone from Sanofi? Huh? All mile stones are Afrezza based. There's 25 mil pending on manufacturing/ development and 50 mil for Europe and Japan approval and the rest being sales milestones. I thought everyone here would say that even if asked in sleep |
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Post by Deleted on Dec 17, 2015 8:32:29 GMT -5
I recall Hakan being asked during the last conference call about a future milestone from Sanofi, Hakan stated it was an R and D milestone. I am not sure if it was related to Afrezza.
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Post by Deleted on Dec 17, 2015 8:34:02 GMT -5
I recall Hakan being asked during the last conference call about a future milestone from Sanofi, Hakan stated it was an R and D milestone. I am not sure if it was related to Afrezza. Sanofi gets 1st crack at a GLP-1 correct? |
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Post by Deleted on Dec 17, 2015 8:34:03 GMT -5
I recall Hakan being asked about a future milestone from Sanofi, Hakan stated it was an R and D milestone. I am not sure if it was related to Afrezza or not. As of now SNY and Mnkd only have business relationship and contract on Afrezza alone |
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Post by liane on Dec 17, 2015 8:38:57 GMT -5
I recall Hakan being asked during the last conference call about a future milestone from Sanofi, Hakan stated it was an R and D milestone. I am not sure if it was related to Afrezza. Sanofi gets 1st crack at a GLP-1 correct? Yes. |
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Post by docfrezza on Dec 17, 2015 13:44:51 GMT -5
I know that today everyone is getting caught up in the Martin mania. But I would like to know, what do you think about this new patent? Is this of any significance? And has such a patent been applied for in the USA?
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Post by mnholdem on Dec 17, 2015 14:27:08 GMT -5
Frankly, I think that the primary reason for the patent is to protect against other BPs creating an inhalable insulin with a delivery mechanism that even comes close to Technosphere.
"The inhalable dry powder formulation preferably comprises a diketopiperazine having the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine and wherein X is selected from the group consisting of succinyl, glutaryl, maleyl, and fumaryl, or a pharmaceutically acceptable salt thereof."
Technosphere uses the fumaryl diketopiperazine variety, FDPK, but other pharmaceutical companies might get the bright idea of substituting a different salt to develop their own dry formulations. IMO, this patent is a prudent measure that protects against that happening...or at least makes it much more difficult to avoid patent infringement.
PLUS it reinforces my belief that Sanofi is planning to acquire all the patent rights from MannKind Corporation and is now extending patent protection to fill in any cracks it thinks that MannKind might have missed.
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Post by peppy on Dec 17, 2015 14:41:29 GMT -5
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