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Post by madog365 on May 17, 2016 12:22:31 GMT -5
No offense taken.
The reason i said not to harp on the plant extracts piece is because it is only mentioned in the trademark and nowhere else. Just as Mannkind has many drug candidates to treat all types of diseases/conditions with patents and trademarks galore, receptor also has multiple therapeutic areas which they can choose to pursue simultaneously or not (3 of which they have disclosed). So when registering a trademark for their company they will make it very broad to cover off on all bases. Could they be using plant extracts in inhalers to treat pain? Sure - but they could also have no such intention in the short term. We have no idea until they tell us their drug pipeline.
My speculation does meet what we know about Receptor including what would fall into the trademark registration you posted. Plant extracts are not necessary, but covered.
Furthermore we know Mannkind has patents covering nasal inhalation and device registration for nasal inhalers in their past. Matt told us on the call the first big milestone payment is upcoming this year. IMO this is the milestone that has to do with development of the nasal delivery inhaler.
There is a massive national study (SNIFF) underway (treating dementia/alzheimers with inhaled insulin) in human trials with scheduled completion date of February, 2017. Big pharma companies watching this one like a hawk i'm sure.
Mannkind are the experts in delivering inhaled insulin and the only company with a product on the market right now. Who better to partner with to commercialize this treatment and be first to market?
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Post by agedhippie on May 17, 2016 12:30:39 GMT -5
Another interesting connection between Paul Allen and inhaled insulin to treat dementia/alzheimers. ... Could Receptor be the company set up to commercialize the research Paul Allen has been funding for many years? Human trials for this insulin use case are ongoing and some have even concluded. Was Mannkind brought in to provide a specific affordable technospehere inhaler for Nasal insulin due to their expertise in delivering inhaled insulin for diabetics? Was Mannkind brought in to provide a specific affordable technospehere inhaler for Nasal insulin due to their expertise in delivering inhaled insulin for diabetics? interesting.
Very unlikely. Intranasal insulin sprays are not unusual in research, the only tricky bit is preparing them and hospitals can do that (Mount Sinai did it for a trial in Canada). The insulin used is ordinary Regular insulin.
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Post by madog365 on May 17, 2016 12:39:39 GMT -5
There's a difference between the trials administered by professionals and commercializing a delivery device for millions of people to administer on their own. Mannkind can help with that.
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Post by agedhippie on May 17, 2016 13:38:31 GMT -5
There's a difference between the trials administered by professionals and commercializing a delivery device for millions of people to administer on their own. Mannkind can help with that. Nasal dispensers are a commodity item, why would they want to use Mannkind who have no experience in this area?
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Post by madog365 on May 17, 2016 14:08:05 GMT -5
Maybe for saline delivery. What other companies have fda approved inhaled insulin? What do you mean no experience in nasal delivery? Mannkind has multiple patents in this area as well as an registered nasal insulin inhaler device with the FDA.
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Post by madog365 on May 17, 2016 14:53:08 GMT -5
Interesting development on the mannkind nasal inhaler.. looks like the FDA registration page has been updated with the following: Afrezza; Commercial Inhaler, Gen2; AVP-825 Nose piece disposable inhaler Not really sure if it has any significance but googling AVP-825 shows it is related to Acute Treatment of Migraine in Adults for a different company Avenir. Perhaps MNKD is licencing the nose piece for our TS... but why? Screen capture i took in January: imgur.com/Ti7xJrjPage today: www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?lid=430594&lpcd=KCO
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Post by agedhippie on May 17, 2016 14:53:57 GMT -5
Maybe for saline delivery. What other companies have fda approved inhaled insulin? What do you mean no experience in nasal delivery? Mannkind has multiple patents in this area as well as an registered nasal insulin inhaler device with the FDA. I wasn't thinking of saline either. They might prefer one that exists off the shelf and is in use today rather than existing as a patent and maybe prototype. There are quite a few nasal drug delivery systems in use today!
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Post by cm5 on May 17, 2016 15:48:40 GMT -5
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Post by cm5 on May 17, 2016 15:51:33 GMT -5
Aware I'm beating a dead horse, so to speak, but perhaps the horse is not dead---
"Insulin resistance is a causal factor in prediabetes (PD) and type 2 diabetes (T2D) and increases the risk of developing Alzheimer disease (AD). Reductions in cerebral glucose metabolic rate (CMRglu) as measured by fludeoxyglucose F 18-positron emission tomography (FDG-PET) in parietotemporal, frontal, and cingulate cortices are associated with increased AD risk and can be observed years before dementia onset."
Arch Neurol. 2011 Jan;68(1):51-7. doi: 10.1001/archneurol.2010.225. Epub 2010 Sep 13.
Insulin resistance and Alzheimer-like reductions in regional cerebral glucose metabolism for cognitively normal adults with prediabetes or early type 2 diabetes.
Baker LD1, Cross DJ, Minoshima S, Belongia D, Watson GS, Craft S.
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Post by cm5 on May 17, 2016 16:15:48 GMT -5
Results of Pilot Study for SNIFF Arch Neurol. 2012 Jan;69(1):29-38. doi: 10.1001/archneurol.2011.233. Epub 2011 Sep 12.
Intranasal insulin therapy for Alzheimer disease and amnestic mild cognitive impairment: a pilot clinical trial.
Craft S1, Baker LD, Montine TJ, Minoshima S, Watson GS, Claxton A, Arbuckle M, Callaghan M, Tsai E, Plymate SR, Green PS, Leverenz J, Cross D, Gerton B.
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Post by cm5 on May 17, 2016 16:26:53 GMT -5
Just think of the possibilities for Technosphere---whether inhaled or with a nasal adapter---
Chinese researchers see the light---
Prog Neurobiol. 2013 Sep;108:21-43. doi: 10.1016/j.pneurobio.2013.06.004. Epub 2013 Jul 11.
Decoding Alzheimer's disease from perturbed cerebral glucose metabolism: implications for diagnostic and therapeutic strategies.
Chen Z1, Zhong C.
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China.
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Post by cm5 on May 17, 2016 16:50:07 GMT -5
It's all so very obvious that it hurts!
Progression of brain atrophy and cognitive decline in diabetes mellitus; A 3-year follow-up
S.G.C. van Elderen, MD, A. de Roos, MD, A.J.M. de Craen, PhD, R.G.J. Westendorp, MD, G.J. Blauw, MD, J.W. Jukema, MD, E.L.E.M. Bollen, MD, H.A.M. Middelkoop, MD, M.A. van Buchem, MD and J. van der Grond, PhD Address correspondence and reprint requests to Dr. Saskia G.C. van Elderen, Department of Radiology, Leiden University Medical Center, Postbus 9600, 2300 RC, Leiden, the Netherlands doi: http://dx.doi.org/10.1212/WNL.0b013e3181f25f06 Neurology September 14, 2010 vol. 75 no. 11 997-1002
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Post by fofos2000i on May 18, 2016 2:42:11 GMT -5
Another interesting connection between Paul Allen and inhaled insulin to treat dementia/alzheimers. April 26, 2016 - alleninstitute.org/what-we-do/brain-science/news-press/press-releases/allen-institute-releases-powerful-new-data-aging-brain-and-traumatic-brain-injuryThe Allen Institute for Brain Science has announced major updates to its online resources available at brain-map.org, including a new resource on Aging, Dementia and Traumatic Brain Injury (TBI) in collaboration with UW Medicine researchers at the University of Washington, and Group Health. The resource is the first of its kind to collect and share a wide variety of data modalities on a large sample of aged brains, complete with mental health histories and clinical diagnoses...The study samples come from the Adult Changes in Thought (ACT) study, a longitudinal research effort led by Dr. Eric B. Larson and Dr. Paul K. Crane of the Group Health Research Institute and the University of Washington to collect data on thousands of aging adults, including detailed information on their health histories and cognitive abilities...."This study was made possible by the amazing generosity of the ACT participants and their families, incredible collaboration among our partners, and the generosity and vision of the Paul G. Allen Family Foundation,” Who are Dr Larson and Dr Crane? They are the researchers first responsible for studying the link between glucose levels, inhaled insulin, and the brain - Specifically in treating Alzheimers and Dementia. www.psychiatryadvisor.com/alzheimers-disease-and-dementia/inhaled-insulin-improves-memory-dementia-treatment/article/430731/www.ncbi.nlm.nih.gov/pmc/articles/PMC3955123/At the very least we can conclude the Paul Allen is aware of the ACT study since he is the one funding it. Additionally, it is well known that Paul Allen has a personal mission for curing the disease as it has affected him with the death of his mother. "Faye Allen was first diagnosed with Alzheimer’s in 2003, and her battle with the disease was one of the inspirations behind Paul Allen establishing the Allen Institute for Brain Science. Paul Allen earlier this year invested $300 million into the research organization to help investigate the mysteries of the human brain." Could Receptor be the company set up to commercialize the research Paul Allen has been funding for many years? Human trials for this insulin use case are ongoing and some have even concluded. Was Mannkind brought in to provide a specific affordable technospehere inhaler for Nasal insulin due to their expertise in delivering inhaled insulin for diabetics? Was Mannkind brought in to provide a specific affordable technospehere inhaler for Nasal insulin due to their expertise in delivering inhaled insulin for diabetics? interesting.
are we going nasal ? www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?lid=430594&lpcd=KCO
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Post by victoria on May 18, 2016 3:41:26 GMT -5
I'm confused: doesn't the fda link above and previously list the fda registered products made by Vision Technical Moulding (in the case of the gen2 inhaler, as a contractor for mannkind in plastics fabrication one assumes)? The database entry is an "establishment and device listing" which to me implies it lists the establishment and what fda registered devices they manufacture. Avp 825 itself seems to be an Optinose product for migraines, whose rights will be transferred to Avenir in due course. Not ruling out that the actual inhaler design for avp 825 might be licensed to optinose by mannkind but am not from memory aware of a news release about that... unless... Optinose or Avenir are RLS... cue dramatic music www.optinose.com/press-releases/optinose-announces-fda-acceptance-new-drug-application-avp-825-acute-treatment-migraine(I'm referring back here to madogs post re this above, I just noticed it).
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Post by madog365 on May 18, 2016 6:57:01 GMT -5
Mankind has had a registered nasal inhaler device with the FDA for a few years now with this listing. The point I was making was that in the past few months there has been a change made to the registration that added the AVP-825 nosepiece which is important because it was created by Optinose to deliver drugs to the brain via nasal inhalation it is supposedly more effective and allows for more accurate dosing Than regular sprays. To me it seems mankind is licencing their technology for a specific application.
Now avenir has a few drugs in their pipeline that use this tech. One of which is for migraines which leads me to believe they would not license the nosepiece to Mannkind or anyone else who will be selling a competing drug treating migraines. The other drug is for Alzheimers agitation.
I started a new thread to continue discussion about this development. Seems to me that this is a very important piece of new information about what Mannkind is working on behind the scenes.
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