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Post by mnholdem on Dec 30, 2015 18:52:33 GMT -5
www.communitycatalyst.org/blog/glaxosmithkline-sets-out-to-dupe-migraine-sufferers-with-treximet-smoke-and-mirrors-pal#.VoRrCHpOKK1Read this older article, which was published about a year before Glaxo-Smith-Kline's blockbuster migraine medicine lost its patent protection. Then consider that MannKind already received a patent for a Technosphere version of the exact API and that GSK has been hit hard with generics of its migraine med sumatriptan. It it seems to me that developing GSK's Imitrex into an inhalable that works in a fraction of the time makes sense. GSK are very controlling, but I think they'd be interested in this to fend off the generics. Imitrex was selling for $25 a pill and it was expected that the generic migraine med would be around $7.50 a pill. I wonder what they could charge for an Imitrex (TS) that works in 5 minutes rather than 50-60 minutes? |
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Post by bioexec25 on Dec 30, 2015 19:07:38 GMT -5
I like it Mnholdem. If memory serves, Imitrex has a 60-70% type market penetration and upwards of 10% or so of our country suffers from Migraines. Seems like a win-win profit and patent cliff protection.
Question overall fully loaded financials as I just haven't seen or estimated those (sorry the CxO) but supportive overall.
Love the gap driver in efficacy, my goodness that is huge.
Is this your number one? Sorry if redundant Q, just didn't see.
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Post by liane on Dec 30, 2015 19:15:05 GMT -5
Sumatriptan already available as a nasal spray. www.medscape.com/viewarticle/429671_4In 1996 and 1997 sumatriptan was approved for use by intranasal administration in North America and Europe. Sumatriptan nasal spray is rapidly effective with an onset of efficacy beginning as early as 15 min post-dose compared with placebo. The 5 mg, 10 mg and 20 mg doses of sumatriptan nasal spray have been assessed thoroughly in five randomized, double-blind clinical studies[31]. Across the studies, all three doses of sumatriptan nasal spray were significantly more effective than placebo, but a higher incidence of headache relief 2 h post-dose was reported with the 20 mg dose compared with either the 5mg or the 10 mg dose. For sumatriptan nasal spray 20 mg, 55- 64% of patients reported headache relief 2 h post-dose compared with 25-36% of placebo patients. Headache recurrence is reported in 30-40% of patients treated with sumatriptan nasal spray[31]. In a study in which patients used the same dose of sumatriptan nasal spray for up to three attacks, 67% of patients responded for two of three attacks, and 35% of patients responded for all three attacks[15,32]. Like sumatriptan injection and tablets, sumatriptan nasal spray is effective and well-tolerated with long-term use for up to a year[31]. |
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Post by lakers on Dec 31, 2015 15:32:55 GMT -5
Sumatriptan already available as a nasal spray. www.medscape.com/viewarticle/429671_4In 1996 and 1997 sumatriptan was approved for use by intranasal administration in North America and Europe. Sumatriptan nasal spray is rapidly effective with an onset of efficacy beginning as early as 15 min post-dose compared with placebo. The 5 mg, 10 mg and 20 mg doses of sumatriptan nasal spray have been assessed thoroughly in five randomized, double-blind clinical studies[31]. Across the studies, all three doses of sumatriptan nasal spray were significantly more effective than placebo, but a higher incidence of headache relief 2 h post-dose was reported with the 20 mg dose compared with either the 5mg or the 10 mg dose. For sumatriptan nasal spray 20 mg, 55- 64% of patients reported headache relief 2 h post-dose compared with 25-36% of placebo patients. Headache recurrence is reported in 30-40% of patients treated with sumatriptan nasal spray[31]. In a study in which patients used the same dose of sumatriptan nasal spray for up to three attacks, 67% of patients responded for two of three attacks, and 35% of patients responded for all three attacks[15,32]. Like sumatriptan injection and tablets, sumatriptan nasal spray is effective and well-tolerated with long-term use for up to a year[31]. Potentially, there are three partnerships, sumatriptan (a known API for rapid FDA approval), CBD (longer FDA process), and 3-way w/ Torrey Pines (medium FDA process) which is far more superior than anything on the market. The later is effective after 2 mins, non-opioid, very hard to overdose, no drug resistant, finished animal trial, ready for human trial. CBD Misconceptions Updated: August 2, 2015 It doesn’t get you high, but it’s causing quite a buzz among medical scientists and patients. The past year has seen a surge of interest in cannabidiol (CBD), a non-intoxicating cannabis compound with significant therapeutic properties. Numerous commercial start-ups and internet retailers have jumped on the CBD bandwagon, touting CBD derived from industrial hemp as the next big thing, a miracle oil that can shrink tumors, quell seizures, and ease chronic pain—without making people feel “stoned.” But along with a growing awareness of cannabidiol as a potential health aid there has been a proliferation of misconceptions about CBD. “CBD is medical. THC is recreational.” Project CBD receives many inquiries from around the world and oftentimes people say they are seeking “CBD, the medical part” of the plant, “not THC, the recreational part” that gets you high. Actually, THC, “The High Causer,” has awesome therapeutic properties. Scientists at the Scripps Research Center in San Diego reported that THC inhibits an enzyme implicated in the formation of beta-amyloid plaque, the hallmark of Alzheimer’s-related dementia. The federal government recognizes single-molecule THC (Marinol) as an anti-nausea compound and appetite booster, deeming it a Schedule III drug, a category reserved for medicinal substances with little abuse potential. But whole plant marijuana, the only natural source of THC, continues to be classified as a dangerous Schedule I drug with no medical value. “THC is the bad cannabinoid. CBD is the good cannabinoid.” The drug warrior’s strategic retreat: Give ground on CBD while continuing to demonize THC. Diehard marijuana prohibitionists are exploiting the good news about CBD to further stigmatize high-THC cannabis, casting tetrahydrocannabinol as the bad cannabinoid, whereas CBD is framed as the good cannabinoid. Why? Because CBD doesn’t make you high like THC does. Project CBD categorically rejects this moralistic, reefer madness dichotomy in favor of whole plant cannabis therapeutics. “CBD is most effective without THC.” THC and CBD are the power couple of cannabis compounds—they work best together. Scientific studies have established that CBD and THC interact synergistically to enhance each other’s therapeutic effects. British researchers have shown that CBD potentiates THC’s anti-inflammatory properties in an animal model of colitis. Scientists at the California Pacific Medical Center in San Francisco determined that a combination of CBD and THC has a more potent anti-tumoral effect than either compound alone when tested on brain cancer and breast cancer cell lines. And extensive clinical research has demonstrated that CBD combined with THC is more beneficial for neuropathic pain than either compound as a single molecule. “Single-molecule pharmaceuticals are superior to ‘crude’ whole plant medicinals.” According to the federal government, specific components of the marijuana plant (THC, CBD) have medical value, but the plant itself does not have medical value. Uncle Sam’s single-molecule blinders reflect a cultural and political bias that privileges Big Pharma products. Single-molecule medicine is the predominant corporate way, the FDA-approved way, but it’s not the only way, and it’s not necessarily the optimal way to benefit from cannabis therapeutics. Cannabis contains several hundred compounds, including various flavonoids, aromatic terpenes, and many minor cannabinoids in addition to THC and CBD. Each of these compounds has specific healing attributes, but when combined they create what scientists refer to as a holistic “entourage effect,” so that the therapeutic impact of the whole plant is greater than the sum of its single-molecule parts. The Food and Drug Administration, however, isn’t in the business of approving plants as medicine. (See the scientific evidence.) “Psychoactivity is inherently an adverse side effect.” According to politically correct drug war catechism, the marijuana high is an unwanted side effect. Big Pharma is keen on synthesizing medically active marijuana-like molecules that don’t make people high—although it’s not obvious why mild euphoric feelings are intrinsically negative for a sick person or a healthy person, for that matter. In ancient Greece, the word euphoria meant “having health,” a state of well-being. The euphoric qualities of cannabis, far from being an unwholesome side effect, are deeply implicated in the therapeutic value of the plant. “We should be thinking of cannabis as a medicine first,” said Dr. Tod Mikuriya, “that happens to have some psychoactive properties, as many medicines do, rather than as an intoxicant that happens to have a few therapeutic properties on the side.” “CBD is legal in all 50 states.” Purveyors of imported, CBD-infused hemp oil claim it’s legal to market their wares anywhere in the United States as long as the oil contains less than 0.3 percent THC. Actually, it’s not so simple. Federal law prohibits U.S. farmers from growing hemp as a commercial crop, but the sale of imported, low-THC, industrial hemp products is permitted in the United States as long as these products are derived from the seed or stalk of the plant, not from the leaves and flowers. Here’s the catch: Cannabidiol can’t be pressed or extracted from hempseed. CBD can be extracted from the flower, leaves, and, only to a very minor extent, from the stalk of the hemp plant. Hemp oil start-ups lack credibility when they say their CBD comes from hempseed and stalk. Congress may soon vote to exempt industrial hemp and CBD from the definition of marijuana under the Controlled Substances Act. Such legislation would not be necessary if CBD derived from foreign-grown hemp was already legal throughout the United States. “'CBD-only’ laws adequately serve the patient population.” Fifteen U.S. state legislatures have passed “CBD only” (or, more accurately, “low THC”) laws, and other states are poised to follow suit. Some states restrict the sources of CBD-rich products and specify the diseases for which CBD can be accessed; others do not. Ostensibly these laws allow the use of CBD-infused oil derived from hemp or cannabis that measures less than 0.3 percent THC. But a CBD-rich remedy with little THC doesn’t work for everyone. Parents of epileptic children have found that adding some THC (or THCA, the raw unheated version of THC) helps with seizure control in many instances. For some epileptics, THC-dominant strains are more effective than CBD-rich products. The vast majority of patients are not well served by CBD-only laws. They need access to a broad spectrum of whole plant cannabis remedies, not just the low THC medicine. One size doesn’t fit all with respect to cannabis therapeutics, and neither does one compound or one product or one strain. “CBD is CBD—It doesn’t matter where it comes from.” Yes it does matter. The flower-tops and leaves of some industrial hemp strains may be a viable source of CBD (legal issues notwithstanding), but hemp is by no means an optimal source of cannabidiol. Industrial hemp typically contains far less cannabidiol than CBD-rich cannabis. Huge amounts of industrial hemp are required to extract a small amount of CBD, thereby raising the risk of toxic contaminants because hemp is a “bio-accumulator” that draws heavy metals from the soil. Single-molecule CBD synthesized in a lab or extracted and refined from industrial hemp lacks critical medicinal terpenes and secondary cannabinoids found in cannabis strains. These compounds interact with CBD and THC to enhance their therapeutic benefits. www.projectcbd.org/article/cbd-misconceptions |
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Post by Deleted on Dec 31, 2015 15:56:10 GMT -5
Sumatriptan already available as a nasal spray. www.medscape.com/viewarticle/429671_4In 1996 and 1997 sumatriptan was approved for use by intranasal administration in North America and Europe. Sumatriptan nasal spray is rapidly effective with an onset of efficacy beginning as early as 15 min post-dose compared with placebo. The 5 mg, 10 mg and 20 mg doses of sumatriptan nasal spray have been assessed thoroughly in five randomized, double-blind clinical studies[31]. Across the studies, all three doses of sumatriptan nasal spray were significantly more effective than placebo, but a higher incidence of headache relief 2 h post-dose was reported with the 20 mg dose compared with either the 5mg or the 10 mg dose. For sumatriptan nasal spray 20 mg, 55- 64% of patients reported headache relief 2 h post-dose compared with 25-36% of placebo patients. Headache recurrence is reported in 30-40% of patients treated with sumatriptan nasal spray[31]. In a study in which patients used the same dose of sumatriptan nasal spray for up to three attacks, 67% of patients responded for two of three attacks, and 35% of patients responded for all three attacks[15,32]. Like sumatriptan injection and tablets, sumatriptan nasal spray is effective and well-tolerated with long-term use for up to a year[31]. Potentially, there are three partnerships, sumatriptan (a known API for rapid FDA approval), CBD (longer FDA process), and 3-way w/ Torrey Pines (medium FDA process) which is far more superior than anything on the market. The later is effective after 2 mins, non-opioid, very hard to overdose, no drug resistant. all that matters to me is the $$$$ upfront in those partnerships to let Afrezza gain ground |
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Post by lakers on Dec 31, 2015 16:09:19 GMT -5
Potentially, there are three partnerships, sumatriptan (a known API for rapid FDA approval), CBD (longer FDA process), and 3-way w/ Torrey Pines (medium FDA process) which is far more superior than anything on the market. The later is effective after 2 mins, non-opioid, very hard to overdose, no drug resistant. all that matters to me is the $$$$ upfront in those partnerships to let Afrezza gain ground There could be more than one partnership for pain, migraine mgmt. There should be upfront licensing Not tied to profitability for immediate recognition, learning from Sanofi deal. |
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Post by Deleted on Dec 31, 2015 16:13:21 GMT -5
all that matters to me is the $$$$ upfront in those partnerships to let Afrezza gain ground There could be more than one partnership for pain, migraine mgmt. There should be upfront licensing Not tied to profitability for immediate recognition, learning from Sanofi deal. S You mean more than 1 API in pain and 1 partner for each of those API , and the same with Migraine management? Same API across multiple partners would be headache |
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Post by Deleted on Dec 31, 2015 16:18:54 GMT -5
Hopefully during Q1 at least one partnership is announced.
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Post by mnholdem on Dec 31, 2015 16:58:21 GMT -5
MannKind distinguishes between the two ("pain" and "migraine") listing them separately on their website under Technosphere Capabilities, which indicates to me that these are two separate API. At previous conferences, management told us that pain and pulmonary hypertension were to be areas of medicine for their first two pipeline drugs.
However, these were to be drugs that MannKind was planning to develop themselves.
The point of my original post is that other branded drugs can also be developed into Technosphere versions if management were to take the initiative to go after those companies.
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Post by lakers on Dec 31, 2015 17:22:26 GMT -5
MannKind distinguishes between the two ("pain" and "migraine") listing them separately on their website under Technosphere Capabilities, which indicates to me that these are two separate API. At previous conferences, management told us that pain and pulmonary hypertension were to be areas of medicine for their first two pipeline drugs. However, these were to be drugs that MannKind was planning to develop themselves. The point of my original post is that other branded drugs can also be developed into Technosphere versions if management were to take the initiative to go after those companies. TEVA Aims to be #1 in Migraine, Pain, good partner Read more: mnkd.proboards.com/thread/4147/teva-aims-migraine-pain-partner#ixzz3vwJlMiOKGSK is equally likely as well. GSK could extend to cover RA (Rheumatoid Arthritis), Flolan (antiemetic). There is good synergy between Mnkd+GSK, Mnkd+TEVA. The new CEO brings more gravity and experience to hammer out deals. TEVA could extend to cover MS. Could Teva partner w/Mnkd for expiring Copaxone MS BLockBuster? Hakan has publicly alluded to MS by targeting central nervous disorder in an interview. You can dig it up. Read more: mnkd.proboards.com/thread/3827/teva-partner-expiring-copaxone-blockbust#ixzz3vwMBhbejI'd imagine both TEVA and GSK want Mnkd's TS. I refrain from saying the not obvious ... Hakan said Mnkd at its core is a drug dev co. As such, Afrezza may potentially be spun off. The remaining co will focus on drug dev alone, not mfgr. With upcoming partnerships, BoD may potentially consider spinning off to increase SH value. Disclaimer: Anything said here is just an opinion. Don't base your investment decision on this. Do your own due diligence at your own risk. |
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Post by suebeeee1 on Dec 31, 2015 17:35:57 GMT -5
Hopefully during Q1 at least one partnership is announced. We may be surprised before! |
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Post by bradleysbest on Dec 31, 2015 18:33:17 GMT -5
Before I lose my entire investment....
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