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Post by mnkdorbust on Oct 14, 2014 11:31:08 GMT -5
Couple of questions, which probably have no real answers. - To what level is the rather impressive pop today from this SA article? - Is there any chance we've put in a sustainable bottom or is this just a momentary head fake as a limited number of new retail investors excited by this article chase the price higher today, to be followed by more short pressure until facts on the ground change? Good question as i would like to know too. Seems like several initiated coverage today on MNKD although i have not validated the YMB posts. While the article is good for most of us here there shouldn't be any new information. I have a little dry powder for a couple more nibbles or a small bite.
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Post by dreamboatcruise on Oct 14, 2014 11:42:38 GMT -5
I have a little dry powder for a couple more nibbles or a small bite. I've been nibbling, but I got one of those nasty burns on the roof of my mouth like when the cheese is all bubbly on the top of a slice of pizza. Trying to decide if it's time yet to risk another bite of the MNKD pie.
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Post by cybergym66 on Oct 14, 2014 12:08:18 GMT -5
Couple of questions, which probably have no real answers. - To what level is the rather impressive pop today from this SA article? - Is there any chance we've put in a sustainable bottom or is this just a momentary head fake as a limited number of new retail investors excited by this article chase the price higher today, to be followed by more short pressure until facts on the ground change? Sometimes bottoms are real obvious, like when you get capitulation/very high volume traded. This "bottom" for MNKD looks like a technical bottom, as someone correctly (so far) pointed out that the gap around $4.60 (I think from just before AdCom) had been filled. We will know if that was the bottom if we can continue to move up and get through resistance that was once support. $5.10-15-ish range (guess). Interesting that we got stopped at about $4.92 which seems that hedges are maybe repositioning their put/call options before letting it continue up.
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Post by brentie on Oct 14, 2014 12:41:09 GMT -5
Couple of questions, which probably have no real answers. - To what level is the rather impressive pop today from this SA article? - Is there any chance we've put in a sustainable bottom or is this just a momentary head fake as a limited number of new retail investors excited by this article chase the price higher today, to be followed by more short pressure until facts on the ground change? Good question as i would like to know too. Seems like several initiated coverage today on MNKD although i have not validated the YMB posts. While the article is good for most of us here there shouldn't be any new information. I have a little dry powder for a couple more nibbles or a small bite. Pre-market Biotech Picks - Gilead Sciences, MannKind, IsoRay, Orexigen Therapeutics, and Sunesis Pharma "Investor-Edge has initiated coverage on the following equities: Gilead Sciences Inc. (NASDAQ: GILD), MannKind Corporation (NASDAQ: MNKD)" www.kcentv.com/story/26780433/pre-market-biotech-picks-gilead-sciences-mannkind-isoray-orexigen-therapeutics-and-sunesis-pharma
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Post by brentie on Oct 14, 2014 16:41:08 GMT -5
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Post by seanismorris on Oct 14, 2014 18:23:14 GMT -5
Afrezza mentioned. Not the only "ultra?"
Interview – Adocia hopes ultrafast insulin will be a sweet target for partners
Date October 08, 2014 Adocia’s shares have soared this year on the back of positive proof-of-concept data for its ultra-fast-acting Humalog. Now the French company is on the hunt for a partner to replace Eli Lilly, which backed out of an alliance on the insulin last year.
Discussions have been had with big pharmaceutical companies, but the universe of potential collaborators could also encompass device companies because of the characteristics of BioChaperone lispro U100, chief executive Gérard Soula tells EP Vantage. “This is more important now with the development of the artificial pancreas. It is important to have a spike in terms of delivery of the insulin, with a quick in and quick out.”
Not just pumps
Use in closed-loop insulin pumps is not the only market on which Adocia is focusing, but it is the most intriguing now that something approaching an artificial pancreas has been approved in Medtronic’s MiniMed 530G (Therapeutic focus – Artificial pancreas projects will deliver over time, October 4, 2013).
The more pressing need perhaps is for mealtime insulin that can control damaging blood-sugar spikes when the ingestion of food is unpredictable. Dosage of so-called prandial insulins like Humalog, Novolog or Apidra must be timed to coincide with the start of a meal – or sometimes up to 15 minutes before – which is a particular problem for parents with diabetic children.
The fact that the recently approved Afrezza can be taken right as a meal begins is perhaps one of its selling points, but it is only indicated for adults, leaving other projects to deal with the issue of children who may not eat exactly 15 minutes after an insulin injection. Indeed, Mr Soula notes that the data indicate that BioChaperone lispro U100 may keep blood sugar under control even if taken after a meal.
The phase IIa data reported a month ago found the Adocia insulin reached peak concentration more quickly and cleared the bloodstream more quickly than Humalog in type 1 diabetics, an effect that more closely duplicates the behaviour of endogenous insulin, according to Adocia. Type 1 diabetes destroys the insulin producing capacity of the pancreas through an autoimmune reaction, necessitating insulin therapy early in the disease progression.
Following the results, shares more than doubled over the course of September and the Lyon-based group ended the month at €37.55, making it one of the small-cap winners for the third quarter (Acquisitions help define performance of mid and small cap stocks, October 6, 2014). Shares have fallen back some since then, although they still stand well above their €16.04 float price in February 2012. The company is valued at €178m ($226m).
Type 1 diabetics constitute a minority among diabetics, just 5% in the US. Adocia has a second ultrafast product for the bigger type 2 market: Lispro U300, which is tilted toward overweight patients and those with severe insulin resistance. This product has 300 IU/mL to the 100 IU/mL of the type 1 product and is slated to enter its first phase I/II programme next year.
Partnership lost
Both insulins, along with a human insulin product called HinsBet and a product that is both ultrafast and long-acting, built around Lantus, are based on a technology called BioChaperone that protects the active proteins against enzymatic degradation.
The BioChaperone technology was the foundation of the now-terminated Lilly collaboration, which Mr Soula says was terminated because of a disagreement over how quickly to progress studies after satisfactory results in healthy patients. “They were not prepared to move the product into diabetic patients and to speed up the project,” he says.
That leaves only two major insulin players as potential partners: Sanofi, maker of Lantus and Apidra, and Novo Nordisk, maker of Tresiba and NovoLog. HinsBet has greater potential for snaring an alliance outside of the insulin oligopoly as it is a developing nation play: “We can make human insulin as fast as lispro but at the price of human insulin,” Mr Soula says.
Adocia closed out the first six months of 2014 with €16m ($20m) and today has sufficient cash for a full year of operation, which will include preparing the necessary documents and clinical plan for advancing into phase III. Mr Soula believes that in that time the big insulin players will come calling because of their need to stay ahead of biosimilar competition - indeed, the big insulin players themselves are preparing to launch biosimilars.
“All their franchises are in danger,” he says. “If they want to maintain their position they need innovation.”
The sign that Adocia’s technology represents the innovation the insulin giants need will be a signed licensing agreement.
To contact the writer of this story email Jonathan Gardner in London at jonathang@epvantage.com or follow @jonepvantage on Twitter
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Post by seanismorris on Oct 14, 2014 18:41:44 GMT -5
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Post by dreamboatcruise on Oct 14, 2014 19:35:23 GMT -5
Afrezza has much more rapid drop. It seems this would not have nearly the advantage in reducing hypos.
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Post by seanismorris on Oct 14, 2014 19:50:22 GMT -5
Lizard,
I agree on the hypos. I can see a niche market in insulin pumps...but I'd rather have a long lasting basal and Afrezza for meals.
They are calling it a mealtime insulin and in certain instances that may work, but it looks more like a hybrid insulin that does nothing really well. It reminds me of Afrezzas inhaled competitors that were scrapped.
We will have to see if a partner shows up.
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Post by suebeeee1 on Oct 15, 2014 10:55:20 GMT -5
Adrocia is administered through injection, correct? Can you imagine being a parent of a 6 year old with diabetes? "Honey, I'm about to stick you...again" or "Honey, take a puff on your inhaler".
Which choice would you want to offer your child?
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Post by mannmade on Oct 18, 2014 11:20:39 GMT -5
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Post by jpg on Oct 18, 2014 13:37:23 GMT -5
I certainly hope MNKD doesn't follow his advice. Anti TNF inhaled. Yeah... Brilliant... After his first medication choice I couldn't read anymore. Never follow the advice of someone who names himself Kumquat I guess... Watermelon, peach, prune or banana maybe. Kumquat definitely no. JPG
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Post by mannmade on Oct 21, 2014 12:17:58 GMT -5
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Post by otherottawaguy on Oct 21, 2014 15:26:39 GMT -5
Can we paste the article, and negate this bozo's penny a click?
OOG
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Post by liane on Oct 21, 2014 15:32:45 GMT -5
Here you go OOG - although it makes me feel dirty to promote this slime. Note: there's a few miscellaneous graphics and charts that won't come through, but I doubt anyone will miss them.
MannKind Corporation's Investors Shouldn't Dance Around This Issue
By Brian Orelli | More Articles | Save For Later October 21, 2014 | Comments (7)
It's usually a good sign when a competitor of a company you're invested in struggles. Less competition for customers should result in higher sales.
But when the competitor is struggling for funding, investors should take notice: the lack of investor support could be a bad sign for the industry itself.
Source: Dance Biopharm
Such is the case for MannKind (NASDAQ: MNKD ) after Dance Biopharm told the Securities and Exchange Commission last week that it would not pursue an initial public offering. In April, Dance filed a registration statement that said it hoped to sell shares worth $75 million to help develop its Dance-501 inhaled insulin device.
Why the reversal? Per Dance's registration withdrawal letter filed with the SEC, "The Company is requesting withdrawal of the Registration Statement because it does not plan to file an updating amendment and pursue a public offering at this time."
Well, that isn't particularly helpful.
There are many possibilities as to why Dance might not want to "pursue a public offering at this time," but the most obvious is that it couldn't find investors willing to back the company at the valuation management thought reasonable. Dance Chairman and CEO John Patton owns 43% of the company, so it's in his best interest to secure the least costly capital possible; the higher the valuation of the company at the time funds are raised, the less his stake will be diluted.
At the end of March, Dance had $7.8 million in the bank, so it will likely need to raise cash before completing phase 3 trials for Dance-501. The first trial is scheduled to begin in the middle of next year, so the company has time to find additional cash.
Dance or industry specific? If investors aren't willing to pony up $75 million because they don't like Dance's technology, that's obviously good news for MannKind's investors. Reading through the IPO prospectus, though, I didn't see anything that looks like a big red flag.
Dance-501 uses liquid insulin instead of powder like MannKind's Afrezza, which should make it cheaper to operate and could reduce lung irritation. In the phase 2 trial, there were only three minor coughs among 535 separate inhalations.
Like Afrezza, Dance-501 reaches peak insulin levels before injected insulins such as Eli Lilly's (NYSE: LLY ) Humalog and Novo Nordisk's (NYSE: NVO ) Novolog, which helps rapidly bring down blood glucose levels at mealtime and more closely matches the insulin profile in nondiabetics.
Source: Dance Biopharm.
The one downside: the insulin seems to stick around longer than Humalog, which can lead to dangerously low blood sugar levels. While the potential side effect could be controlled by adjusting other medications that lower blood sugar levels, limited data -- the phase 2 trial only enrolled 23 patients -- could be why Dance can't get investors to buy in at acceptable terms. Long-term data on blood glucose levels won't be known until the company conducts a larger phase 3 trial.
More importantly, investors are probably worried about the lack of data on whether doctors will prescribe inhaled insulin. Pfizer's (NYSE: PFE ) Exubera was a commercial flop, although the device itself was unwieldy compared to Afrezza's and Dance-501's. Ironically, if Afrezza was already on the market and doing well, doctors' acceptance of inhaled insulin wouldn't be a problem and Dance might have been able to progress to its IPO.
Prove it You see the lack of investor confidence in Dance's inability to seek an IPO, but also in MannKind's share price, which has dropped dramatically from its post-approval high.
MNKD Chart
MNKD data by YCharts.
Fortunately, the lack of confidence isn't particularly worrisome for MannKind. As part of its recently signed deal with Sanofi (NYSE: SNY ) to market Afrezza, MannKind received $150 million up front, and Sanofi is loaning MannKind up to another $175 million to cover the losses from their partnership until Afrezza is profitable.
MannKind shouldn't need to raise capital in the near future, so the share price in the short term isn't a concern. (And even if it did need to raise capital, billionaire namesake and CEO Alfred Mann can continue to help foot the bill.) If Sanofi and MannKind can prove that doctors are willing to adopt inhaled insulin, investors will come back and MannKind's share price will go up substantially.
And that would make everyone dance.
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