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Post by lakers on May 11, 2017 1:44:25 GMT -5
For Treprostinil for pulmonary arterial hypertension, we have a pre-IND meeting scheduled with the FDA on June 28th. We expect that to be relatively successful as well as this pathway a little bit clear and so such before anaphylaxis, but we are also progressing into pipeline. Triptans for migraines, PTH and Symlin and I’ll update everyone at our next call. About three out of five people who take a medication in this class have their pain relieved within two hours. The best results occur when triptans are taken as soon as the first hint of the attack surfaces – as early in the migraine attack as possible. Triptans help relieve migraine pain as well as alleviate other migraine symptoms such as nausea and vomiting. Triptans do not prevent migraines. Some studies show that 50 percent to 60 percent of patients who take triptans consistently respond and have relief of their migraine symptoms. Sometimes medicines taken by mouth aren’t effective for migraine sufferers because of the symptoms of nausea and vomiting, which can make it difficult to swallow and digest medications. Because of this many of the triptans come in several forms: Regular tablets Dissolving tablets Injections Needleless injections Rectal suppositories Nasal sprays Patch System There are eight triptans available by prescription. Click on the links below to get specific information on each specific drug. Imitrex (Sumatriptan) Zomig (Zolmitriptan) Maxalt (Rizatriptan) Relpax (Eletriptan) Treximet (Sumatriptan and Naproxen Sodium Tablets) Amerge (Naratriptan) Frova (Frovatriptan) Axert (Almotriptan) Sumavel DosePro (sumatriptan) Zecuity (sumatriptan iontophoretic transdermal system) Migraines affect millions of people, which has made Imitrex is one of the top-selling drugs in the world. In 2008, Imitrex global sales were $1.27 billion, down from $1.37 billion the year before. Because of Imitrex’s years on the market and high usage, more is known about Imitrex’s safety than the other drugs in the class. Also since it’s been on the market for several years, there are generic drugs available for the migraine drug Imitrex. No other drug in the triptan class has a generic form available. The generic is sold under the drug’s chemical name sumatriptan. GSK makes Imitrex. It has a strong incentive to collaborate with Mnkd to take back market share from generic. Moreover, inhaled sumatriptan is ultra rapid acting, which can alleviate pain faster. Symlin Generic Name: pramlintide (PRAM lin tide) Brand Name: SymlinPen 120, SymlinPen 60 by AstraZeneca who needs to partner with Mnkd before the generic becomes available. Symlin is protected by 2 patents. One will expire this year. Another will expire in 2019. www.drugpatentwatch.com/p/tradename/SYMLIN&esWhat is Symlin? Symlin (pramlintide) is a man-made form of a hormone that occurs naturally in the body. Pramlintide lowers blood sugar in three ways. It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. Symlin also lowers the amount of glucose (sugar) your liver produces. Lastly, pramlintide triggers the feeling of fullness after meals to help control your appetite and decrease how much food you eat. Symlin is used together with insulin to treat type 1 or type 2 diabetes. Symlin is usually given after other diabetes medicines have been tried without success. |
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Post by kuka on May 11, 2017 2:02:03 GMT -5
I am guessing with TS ..relief could be in minutes ...SWEET
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Post by mnholdem on May 11, 2017 7:55:50 GMT -5
For Treprostinil for pulmonary arterial hypertension, we have a pre-IND meeting scheduled with the FDA on June 28th. We expect that to be relatively successful as well as this pathway a little bit clear and so such before anaphylaxis, but we are also progressing into pipeline. Triptans for migraines, PTH and Symlin and I’ll update everyone at our next call. By then, it would be great if CMO Dr. Raymond Urbanski were to update the Pre-IND section of pipeline table on the corporate website.
MannKind already has a patent for Sumatriptan (Technosphere) for migraines. If I were Matt, I would approach Glaxo-Smith-Kline (who markets Imitrex for migraines) to propose that they partner with MannKind for the development of an Imitrex(TS). I'd tell them that we're going to develop this anyway, so it may be advantageous for both companies to develop sumatriptan(TS) under the GSK brand instead of GSK eventually losing market share and MannKind absorbing all the development costs.
The worst they can say is "no". Regardless, I would encourage Matt Pfeffer to hire a seasoned dealmaker. Technosphere literally has endless possibilities and a proactive approach to partnerships is much better than waiting for the phone to ring or than making public appeals to BPs like former CEO Hakan Edstrom did.
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Post by boytroy88 on May 11, 2017 9:16:30 GMT -5
For Treprostinil for pulmonary arterial hypertension, we have a pre-IND meeting scheduled with the FDA on June 28th. We expect that to be relatively successful as well as this pathway a little bit clear and so such before anaphylaxis, but we are also progressing into pipeline. Triptans for migraines, PTH and Symlin and I’ll update everyone at our next call. By then, it would be great if CMO Dr. Raymond Urbanski were to update the Pre-IND section of pipeline table on the corporate website.
MannKind already has a patent for Sumatriptan (Technosphere) for migraines. If I were Matt, I would approach Glaxo-Smith-Kline (who markets Imitrex for migraines) to propose that they partner with MannKind for the development of an Imitrex(TS). I'd tell them that we're going to develop this anyway, so it may be advantageous for both companies to develop sumatriptan(TS) under the GSK brand instead of GSK eventually losing market share and MannKind absorbing all the development costs.
The worst they can say is "no". Regardless, I would encourage Matt Pfeffer to hire a seasoned dealmaker. Technosphere literally has endless possibilities and a proactive approach to partnerships is much better than waiting for the phone to ring or than making public appeals to BPs like former CEO Hakan Edstrom did.
I guess I'm an optimist of sorts in thinking that Matt has probably approach quite a bit of BPs and pitching TS to them but was probably turned down seeing how well we are selling Afrezza. I'm on the camp that, because of the SNY debacle, until we can show we are able to sell this technology to the public, little or no BP will even think about teaming with us on anything. |
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Post by lakon on May 11, 2017 9:30:42 GMT -5
By then, it would be great if CMO Dr. Raymond Urbanski were to update the Pre-IND section of pipeline table on the corporate website.
MannKind already has a patent for Sumatriptan (Technosphere) for migraines. If I were Matt, I would approach Glaxo-Smith-Kline (who markets Imitrex for migraines) to propose that they partner with MannKind for the development of an Imitrex(TS). I'd tell them that we're going to develop this anyway, so it may be advantageous for both companies to develop sumatriptan(TS) under the GSK brand instead of GSK eventually losing market share and MannKind absorbing all the development costs.
The worst they can say is "no". Regardless, I would encourage Matt Pfeffer to hire a seasoned dealmaker. Technosphere literally has endless possibilities and a proactive approach to partnerships is much better than waiting for the phone to ring or than making public appeals to BPs like former CEO Hakan Edstrom did.
I guess I'm an optimist of sorts in thinking that Matt has probably approach quite a bit of BPs and pitching TS to them but was probably turned down seeing how well we are selling Afrezza. I'm on the camp that, because of the SNY debacle, until we can show we are able to sell this technology to the public, little or no BP will even think about teaming with us on anything. I'm an optimist of sorts, too. My thinking is that you are correct, AND MannKind won't want or need to team ever again IF Afrezza TAKES OFF! There's no I in TEAM, but there is in MannKInd... I'm still of the opinion that MNKD should expand their preexisting relationships, such as Epi with AMPH. Another good strategy would be to take new patent expirations and either extend the patent runway for the original patent holder OR take market share away... |
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Post by ptass on May 11, 2017 11:47:21 GMT -5
Based on the call, i dont think developing TS products is even on their agenda at this point. No money to allocate and they seem to want to focus on making afrezza a commercial sucess. Also they probable want enough data to rest peoples concerns about lung safety first.
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Post by lakon on May 14, 2017 9:24:07 GMT -5
Based on the call, i dont think developing TS products is even on their agenda at this point. No money to allocate and they seem to want to focus on making afrezza a commercial sucess. Also they probable want enough data to rest peoples concerns about lung safety first. What call did you listen to? The CMO has consistently reported their agenda and progress on new TS developments. The most recent calls have started talking about the next set of TS candidates beyond the three API (Epi, Trep, & Pal) on the agenda for a while now. WRT lung safety, you might want to listen to the old ADCOM if you can find it. The oncologist on the panel was not concerned about lung safety. The primary concern was not Technosphere, but rather that insulin is a growth factor. The oncologist bluntly said that if you have a tumor, lung or otherwise, that is responsive to insulin, you have a serious problem whether you inject or inhale the insulin. Frankly, you have a serious problem whether a PWD on insulin or NOT. The same tumor would be responsive to naturally secreted insulin from the pancreas. Technosphere and insulin are NOT carcinogenic according to ANY data. Until data show otherwise, we know the bad outcomes of poorly treated diabetes so let's treat what we know rather than worry about things we do not know AND have plenty of evidence to the contrary of the "concerns". |
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Post by ptass on May 14, 2017 9:48:04 GMT -5
Seems like the discussion was more of an aferthought than something front and center. They didn't even mention anything about TS until the question/answer portion of the call and what they said seem to be the same as the prior call. Urbanski didn't sound to enthusiast either but maybe thats just the way he talks. Don't get me wrong I believe TS will be huge one day, it just seems like they have enough on their plate with Arrezza.
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Post by #NoMoreNeedles on Dec 27, 2018 12:16:03 GMT -5
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Post by mango on Dec 27, 2018 22:01:30 GMT -5
Really interesting stuff chan. Thanks. Will have to read about what Translate Bio has there for CF. I'd love to MannKind go that route, it's a debilitating and life-limiting condition. I'm friends with a girl whose husband had CF and died at ~21 years of age. "About MRT5005 We believe MRT5005 will be the first clinical-stage mRNA product candidate designed to deliver mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to the lung. MRT5005 is being developed to treat all patients with CF, regardless of the underlying genetic mutation. In 2015, the FDA granted orphan drug designation to MRT5005 for the treatment of CF. We have initiated a double-blind, placebo-controlled Phase 1/2 clinical trial of MRT5005 in which we plan to enroll at least 32 patients with CF." Sounds interesting. "Inhaled Zolmitriptan for Acute Treatment of Migraine CVT-427 is an investigational agent under development for the acute treatment of migraines – painful headaches that may be accompanied by nausea, vomiting or sensitivity to light. An estimated 36 million people in the US, and over 40 million people in Europe, suffer from migraines. Using our proprietary ARCUS® technology, CVT-427 is a novel inhaled formulation of zolmitriptan. Zolmitriptan belongs to a class of drugs known as triptans. Triptans, which are most commonly taken orally, are a leading therapy for acute treatment of migraines. There are currently no approved inhaled migraine therapies. A majority of migraine sufferers say rapid pain relief is the most important factor influencing their medication preference. Oral triptans can be associated with slow onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Another consideration in treatment of acute migraine is nausea. It is estimated that almost 90% of people with migraines experience nausea, making swallowing an oral therapy unpleasant and potentially difficult to keep down. Inhaled treatments, such as those that utilize our ARCUS technology, enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system. Clinical trials will evaluate the effect of CVT-427 following administration, in addition to tolerability and safety measures. We presented data from Phase 1 clinical trial of CVT-427 at the 58th Annual Scientific Meeting of the American Headache Society in June, 2016." My ex-brother-in-law has migraines and he's used Cannabis with really good success. Dr. Ethan Russo has done a great deal of research and studies on migraine. He found it is an endocannabinoid deficiency. There is an imbalance in endocannabinoid tone, which is, according to the scientific evidence via lumbar puncture among other things, is the underlying defect responsible for migraine. Maybe RLS and MannKind should start tinkering in this realm. Wonder if Cannabinoids and Triptans work synergistically together. Maybe so Maybe not. |
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Post by mango on Dec 28, 2018 1:20:58 GMT -5
Forgot about this, Bucket #1 Inhaled DNase (deoxyribonuclease) for cystic fibrosis There's also a possibility of dry powder Mannitol too for CF, and MannKind already uses that in their formulations.  |
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Post by Clement on Dec 28, 2018 11:03:45 GMT -5
Sumatriptan.
Remember the recent Zacks article?
The author expects that next in the mnkd pipeline (outside UTHR) is sumatriptan.
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Post by #NoMoreNeedles on Dec 28, 2018 11:14:34 GMT -5
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