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Post by ashiwi on Jul 22, 2014 16:17:14 GMT -5
patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8,785,396.PN.&OS=PN/8,785,396&RS=PN/8,785,396 United States Patent 8,785,396 Leone-Bay , et al. July 22, 2014 Method and composition for treating migraines Abstract A method for treating migraines is disclosed. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent, including small molecules and peptides being administered to a patient in need of treatment. In particular, the drug delivery system is designed for inhalation for delivery of drugs to the pulmonary circulation in a rapid and therapeutically effective manner. Inventors: Leone-Bay; Andrea (Ridgefield, CT), Stowell; Grayson W. (Gaylordsville, CT), Guarneri; Joseph J. (Stamford, CT), Carlson; Dawn M. (New Milford, CT), Grant; Marshall (Newtown, CT), Smutney; Chad C. (Watertown, CT) Leona-Bay, a MNKD scientist was granted the patent to Migraine treatment today. Spiro and I met and spoke with Dr Leona -Bay after her Technosphere presentation at the Drug Delivery conference this past Jan. Along with Al Mann and Jonathon Goldman (partnership guy) she was very excited about it's potential and believe it could be bigger than Afrezza. With the patent protection granted it now allows MNKD to start partnering Technosphere/Crickett device for Migraines. I would not be surprised if we saw a Crickett partnership before the Afrezza deal is completed. In my opinion, for what it's worth, THIS IS HUGE.
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Post by BD on Jul 22, 2014 16:28:00 GMT -5
Rapid-acting would be awesome. Right now, when I get a migraine I pop a Maxalt, which takes exactly an hour and 20 minutes to work (on me, anyway). I'm sure whatever they use with Technosphere is going to work a lot faster!
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Post by ashiwi on Jul 22, 2014 16:36:26 GMT -5
Al told us it would work within a few minutes.
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Post by rak5555 on Jul 22, 2014 16:56:28 GMT -5
"I would not be surprised if we saw a Crickett partnership before the Afrezza deal is completed."
Are you expecting a delay in Afrezza? Just kidding. My serious question is whether Al or anyone else spoke about the revenue potential when you were at the conference?
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Post by ashiwi on Jul 22, 2014 17:29:11 GMT -5
Of course Al didn't talk specific numbers other than the statement that he thought The Crickett for migraine pain will be bigger than Afrezza. Which considering Al has already stated that Afrezza will be the biggest selling medical product of all time, is a very bold statement.
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Post by spiro on Jul 22, 2014 17:37:49 GMT -5
When we were talking to Leona-Bay and Goldman they said they believed that MNKD's pain treatment could be as big or bigger than Afrezza. It's obvious now that MNKD has been trying to secure patent protection for some of it's more valuable technosphere potential products.
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Post by brentie on Jul 22, 2014 20:11:41 GMT -5
When we were talking to Leona-Bay and Goldman they said they believed that MNKD's pain treatment could be as big or bigger than Afrezza. It's obvious now that MNKD has been trying to secure patent protection for some of it's more valuable technosphere potential products. Were they talking about the Migraine treatment or this one... www.tcpalm.com/business/torrey-pines-could-begin-human-testing-of-new-in
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Post by seanismorris on Jul 22, 2014 20:27:09 GMT -5
BD,
Wow, an hour and twenty before relief....that's terrible.
To answer the question about migraine medication via Technosphere, we are looking at 5min.
One complication here is we are probably looking at a different migraine medications, but I think less than 1/10 the normal time would be a reasonable expectation.
The sumatriptan injected version is 10min in 16% percent of patients. But, a large percentage is looking at up to 2 hours (some not at all)
Mannkind should have an easy time showing superiority.
----- The pharmacokinetic profiles of sumatriptan administered as sumatriptan-Na.sub.2FDKP powder, nasal spray, or intravenous injection (FIG. 24) were consistent with the previous PK study in rats. FIG. 24 depicts the pharmacokinetic profile of sumatriptan FDKP salt powder (38% sumatriptan) administered by pulmonary insufflation, sumatriptan administered by nasal instillation, and intravenous injection in female dogs wherein the data are plotted as .+-.SD. The data show that the time to maximum mean peak circulating sumatriptan concentrations (T.sub.max) was 5 minutes for the sumatriptan-FDKP salt powder and 60 minutes for nasal instillation. Even though C.sub.max and bioavailability were much lower for the sumatriptan-Na.sub.2FDKP powder, animals insufflated with sumatriptan-Na.sub.2FDKP exhibited a similar but faster pharmacodynamic response than those receiving the nasal spray.
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Post by mannmade on Jul 22, 2014 20:38:33 GMT -5
Have same question as brentie. As I understood it, the Torrey Pines collaboration on pain med is a non-opiut substitute that you can take as much as you like for as long as you like without overdosing or getting addicted. To me this would be, if true, the largest selling drug in the history of pharma... Goodbye to vicodin etc...
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Post by spiro on Jul 22, 2014 20:41:33 GMT -5
Brentie, they told us that they had just visited Torrey Pines. Truthfully, I do not remember if the word migraine was mentioned. Maybe Ashiwi can recall what exactly was said.
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Post by seanismorris on Jul 22, 2014 21:05:06 GMT -5
One important point when looking at migraines is that we are talking about many different drugs (triptans). Each drug (I assume) has it's own market and place in migraine treatment. I imagine many successful brands are going to be looking into reformulating their existing drug to make it faster acting (using Technosphere) and to extend patents (to fight off generics).
Here are the drugs mentioned in the patent: sumatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan
Plenty of research material...
Also, some of side effects for the oral migraine medications are nasty. Many of them could potentially be avoided using an inhaled product (needs confirmation). So, there is a real medical need besides just 'faster acting'. I wouldn't be surprised if a Technosphere-migraine treatment wasn't 'fast tracked' for FDA approval. Such a product should have a minimal risk profile because it's use is less frequent (than Afrezza). Also, Mannkind's Cricket inhaler was designed for this product, so clinical trial complications should be minimal and approval swift. Comparably, the price tag from trials to full production should be low. So, this product could be the icing on the Afrezza partnership (seal the deal), or Mannkind could go it alone.
------ In an exemplary embodiment, a method is provided for treating a migraine headache, which method comprises administering to a patient in need of treatment a dry powder composition by oral inhalation; wherein the dry powder composition comprises an active agent for treating migraines, including, a triptan such as sumatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan and pharmaceutically acceptable salts thereof, and a substituted diketopiperazine such as fumaryl diketopiperazine, or a salt of the diketopiperazine such as disodium fumaryl diketopiperazine. The dry powder composition can be administered to the patient at the time of onset of the migraine headache as needed by the patient or as determined and instructed by the physician. In one embodiment, the dose of the triptan can reduce or avoid unwanted side effects associated with injectable or tablet drug therapy, including, flushing, sweating, vertigo, fatigue, tingling, drowsiness, dizziness, dry mouth, heartburn, abdominal pain, abdominal cramps, weakness, feeling of warmth or coldness, bitter taste from tablets and nasal sprays, and local burning from injection site by proving a reduced amount of triptan required with other modes of administration.
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Post by seanismorris on Jul 22, 2014 21:16:39 GMT -5
I think when we are talking about Torrey Pines and migraines we are talking about two entirely different markets.
The migraine patent mentions triptans.
Triptans (Serotonin Receptor Agonists) for Migraine Headaches Triptans narrow (constrict) blood vessels in the brain and relieve swelling.
With the Torrey Pines study, it was more about finding a powerful pain killer (opiate alternative) that's non additive, powerful, and fast acting. While, it could be used for migraines...I'm thinking it's more of chronic acute back pain, back spasms, etc.
So many potential markets, so little time...
From the other patent [0003] Acute pain is characterized by a sudden onset and relatively short duration, and is generally treated with opioid analgesics like morphine. Morphine and similar opioid analgesics suppress the perception of pain by reducing the number of pain sensations sent by the nervous system and the brain's reaction to those pain signals. Current opioid therapy using morphine and like compounds are effective to treat pain but the side effects they produce such as addiction, somnolence, tolerance, respiratory depression, and constipation limit their clinical use.
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Post by 4allthemarbles on Jul 22, 2014 21:33:11 GMT -5
Team, This might be an overly asked question, but:
What type of trial/ testing period would MNKD have to go through, if any, to bring this to market?
From a serious perspective, after years of phase studies with Afrezza/ Technosphere, what would we be up against for pain meds?
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Post by seanismorris on Jul 22, 2014 21:34:35 GMT -5
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Post by ashiwi on Jul 22, 2014 21:39:53 GMT -5
If I recall correctly, it was the Crickett device for migraine pain. I remember Al saying it was non addictive. The Crickett is a one time device. Pre- filled . It was being used on rats at Torrey pines. I just never understood how they got the rats to inhale? Al, Leone-Bay and Jonathan Goldman had visited the Torrey Pines facility in Port St Lucie the day before coming to the Drug Delivery Conference in Boca Raton which is about an hour away.
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