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Post by nylefty on Aug 24, 2016 9:36:31 GMT -5
It is even for a long-term and patient investor difficult to comprehend why MNKD is not using media actively to their advantage in the area of Epi. Negotations in the back room are fine but that does not confine many other companies to get publicity to push up the interest and price. This is especially true if there is someone for the media to attack, like Mylan. In the past I had the impression that ol' Mannkind was playing too much by the book of old-school honest company in a sea of sharks. Still, even with the water being red from their own blood and the sharks circling, they are understating and underperforming when it comes to gaining media interest. I understand that getting Afrezza Sales up is first priority..but why not give one interview to see if the media picks it up? So what is the story you want media to pick up? I spent many years at NBC News, CBS News, ABC News, and the Fox News Channel and can assure you that at the present time no assignment editor or producer would buy the argument that Technosphere might be the answer to EpiPen's high prices. Assignment Editor: Let's see, the symptoms of anaphylaxis include shortness of breath, coughing, and wheezing....and you want to counter them by having people inhale a powder? Have you done any trials? No? Do you have any success stories? No? Sorry, not for us.
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Post by madog365 on Aug 24, 2016 10:04:52 GMT -5
That seems to be a popular dig on an inhaled epinephrine solution. Here's what CMO Urbanski said to counter:
"For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option."
The story for the media here is not about episphere. The story is about alternatives to the price gouging that Mylan is doing with the epipen. One of the alternatives is being developed by a company with a CMO who comes from Mylan and wants to see patients have more choices. I have seen this same type of story multiple times with different companies.
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Post by LosingMyBullishness on Aug 24, 2016 11:00:03 GMT -5
Thanks nylefty, good arguments. A lot of folks would think that a powder rather makes you cough and sneeze and media guys always address these basic concepts.
Picking up what madog said: What about a story around Ray seeking a better alternative with a lower price and better accessibility. Or what about a story about people who hadnt had a pen and would still be alive if they had a simple, inexpensive and unobtrusive inhaler with them. Would that be attractive to an assignment editor?
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Post by nylefty on Aug 24, 2016 11:47:07 GMT -5
Thanks nylefty, good arguments. A lot of folks would think that a powder rather makes you cough and sneeze and media guys always address these basic concepts. Picking up what madog said: What about a story around Ray seeking a better alternative with a lower price and better accessibility. Or what about a story about people who hadnt had a pen and would still be alive if they had a simple, inexpensive and unobtrusive inhaler with them. Would that be attractive to an assignment editor? The fact that Ray worked for Mylan and is now seeking an EpiPen alternative might merit a mention, but how much benefit would MannKind get from that? Any mention would almost certainly be followed by the fact that he's trying to use the same technology that's used in delivering Afrezza, which has been a flop so far, partly because of lung issues. And yes, Sanofi sandbagged us, but too many docs (and patients) still worry about lung problems. I've invested far too much of my retirement money in MNKD and desperately want it to succeed, but at this point I'm pinning my hopes on Afrezza sales, period.
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Post by anderson on Aug 24, 2016 11:52:13 GMT -5
It is even for a long-term and patient investor difficult to comprehend why MNKD is not using media actively to their advantage in the area of Epi. Negotations in the back room are fine but that does not confine many other companies to get publicity to push up the interest and price. This is especially true if there is someone for the media to attack, like Mylan. In the past I had the impression that ol' Mannkind was playing too much by the book of old-school honest company in a sea of sharks. Still, even with the water being red from their own blood and the sharks circling, they are understating and underperforming when it comes to gaining media interest. I understand that getting Afrezza Sales up is first priority..but why not give one interview to see if the media picks it up? So what is the story you want media to pick up? I spent many years at NBC News, CBS News, ABC News, and the Fox News Channel and can assure you that at the present time no assignment editor or producer would buy the argument that Technosphere might be the answer to EpiPen's high prices. Assignment Editor: Let's see, the symptoms of anaphylaxis include shortness of breath, coughing, and wheezing....and you want to counter them by having people inhale a powder? Have you done any trials? No? Do you have any success stories? No? Sorry, not for us. <sarcasm on> Guess that is why they took Primatene Mist (Epinephrine for Inhalation) off the market for asthma attack. An asthma attack is a sudden worsening of asthma symptoms caused by the tightening of muscles around your airways (bronchospasm). During the asthma attack, the lining of the airways also becomes swollen or inflamed and thicker mucus -- more than normal -- is produced. Who would want to inhale while this is happening. Guess that doesnt have anything in common with anaphylaxis symptoms. <sarcasm off> So basically you are saying Assignment Editors are idiots.
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Post by nylefty on Aug 24, 2016 12:16:13 GMT -5
Assignment Editor: Let's see, the symptoms of anaphylaxis include shortness of breath, coughing, and wheezing....and you want to counter them by having people inhale a powder? Have you done any trials? No? Do you have any success stories? No? Sorry, not for us. <sarcasm on> Guess that is why they took Primatene Mist (Epinephrine for Inhalation) off the market for asthma attack. An asthma attack is a sudden worsening of asthma symptoms caused by the tightening of muscles around your airways (bronchospasm). During the asthma attack, the lining of the airways also becomes swollen or inflamed and thicker mucus -- more than normal -- is produced. Who would want to inhale while this is happening. Guess that doesnt have anything in common with anaphylaxis symptoms. <sarcasm off> So basically you are saying Assignment Editors are idiots. No, but they're not medical experts either and would find your post confusing at best.
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Post by anderson on Aug 24, 2016 12:40:15 GMT -5
So Assignment Editors wouldnt research anything either so yes they are not worth talking to. Btw what do they do then?
Also Primatene Mist (Epinephrine for Inhalation) how is that confusing? Inhalation is Inhalation. Epinephrine, oh Epi in Epi pen stands for Epinephrine, yeah guess that would confuse some people.
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Post by nylefty on Aug 24, 2016 12:58:54 GMT -5
So Assignment Editors wouldnt research anything either so yes they are not worth talking to. Btw what do they do then? Also Primatene Mist (Epinephrine for Inhalation) how is that confusing? Inhalation is Inhalation. Epinephrine, oh Epi in Epi pen stands for Epinephrine, yeah guess that would confuse some people. You're sarcasm would be confusing to someone who didn't follow this drama. In my experience TV assignment editors are busy people, managing reporters and crews and dealing with an overwhelming number of PR attempts, leaving little or no time for "research." Research, if done at all, is done by producers and (sometimes) reporters. Not an ideal situation, but almost all news organizations are terribly understaffed these days.
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Post by flatrock on Aug 24, 2016 13:03:27 GMT -5
So what is the story you want media to pick up? I spent many years at NBC News, CBS News, ABC News, and the Fox News Channel and can assure you that at the present time no assignment editor or producer would buy the argument that Technosphere might be the answer to EpiPen's high prices. Assignment Editor: Let's see, the symptoms of anaphylaxis include shortness of breath, coughing, and wheezing....and you want to counter them by having people inhale a powder? Have you done any trials? No? Do you have any success stories? No? Sorry, not for us. <sarcasm on> Guess that is why they took Primatene Mist (Epinephrine for Inhalation) off the market for asthma attack. An asthma attack is a sudden worsening of asthma symptoms caused by the tightening of muscles around your airways (bronchospasm). During the asthma attack, the lining of the airways also becomes swollen or inflamed and thicker mucus -- more than normal -- is produced. Who would want to inhale while this is happening. Guess that doesnt have anything in common with anaphylaxis symptoms. <sarcasm off> So basically you are saying Assignment Editors are idiots. The pertinent point in treating anaphylaxis is getting epinephrine into the circulation. Intramuscular epinephrine actually causes vasodilation of the blood vessels and provides for rapid absorption and transport throughout the body. Insuring an adequate dose when the bronchial tubes are constricted could be a problem. From a review article: "Studies have shown that the plasma concentrations needed for hemodynamic stabilization cannot be reached with epinephrine inhalers. Since most cases of hypotension in anaphylaxis cannot be effectively treated with epinephrine inhalers, the prescriber should be aware of this before including them in an emergency pack." MNKD would probably be required to demonstrate that their formulation would consistently produce adequate systemic levels of the drug.
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Post by factspls88 on Aug 24, 2016 14:14:39 GMT -5
It is even for a long-term and patient investor difficult to comprehend why MNKD is not using media actively to their advantage in the area of Epi. Negotations in the back room are fine but that does not confine many other companies to get publicity to push up the interest and price. This is especially true if there is someone for the media to attack, like Mylan. In the past I had the impression that ol' Mannkind was playing too much by the book of old-school honest company in a sea of sharks. Still, even with the water being red from their own blood and the sharks circling, they are understating and underperforming when it comes to gaining media interest. I understand that getting Afrezza Sales up is first priority..but why not give one interview to see if the media picks it up? So what is the story you want media to pick up? I spent many years at NBC News, CBS News, ABC News, and the Fox News Channel and can assure you that at the present time no assignment editor or producer would buy the argument that Technosphere might be the answer to EpiPen's high prices. Assignment Editor: Let's see, the symptoms of anaphylaxis include shortness of breath, coughing, and wheezing....and you want to counter them by having people inhale a powder? Have you done any trials? No? Do you have any success stories? No? Sorry, not for us. Sorry lefty, but do you know what are the symptoms of asthma? They include shortness of breath, coughing and wheezing. Do you know what is used during an asthma attack? Answer: An inhaler. I know that because my son has had asthma for many, many years. Not that I'm saying this would change an assignment editor's negative opinion, but treating anaphylaxis with an inhaler is likely not one of the reasons.
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Post by lakers on Aug 24, 2016 15:43:09 GMT -5
Ray said,
seekingalpha.com/article/3809206-mannkinds-mnkd-ceo-matt-pfeffer-presents-at-34th-annual-jpmorgan-healthcare-conference-transcript?part=single
Some of the other products are going to be orally inhalation, but for systemic delivery. You can see a few there and I'll mention just a few parathyroid hormone for example. The PK profile of PTH delivery using our innovative device gives a pulsatile or burst-like activity.
This is very similar to what happens physiologically. We believe that this would lead to an increased efficacy and decreased safety issues compared to the current product that’s on the market.
The physiometric profile of drugs that we give via this route shouldn’t be surprising to you. It’s identical to what we see with Afrezza as we laid it to insulin.
Another product that's on air that's related or very closely related to our PK profile of being very high Cmax short Tmax partially you see being high, very conducive to efficacy in acute care types of conditions. So we are looking at Epinephrine in the anaphylaxis situation.
These are the three drug candidates that we have in our development pipeline as of today, sorry. One being [true] [ph] for PAH I believe that our previous administration has mentioned this several times.
We have three formulations tested and two of three are advancing. Palonosetron for Chemo and to nausea, we think this is an incredibly good asset from moderately mutagenic chemotherapeutic regimens. We have two formulations that are being tested next week and epinephrine for Anaphylaxis, we actually are testing formulations within the next week or two.
Of note for those of you who may think that a development program such as [True] [ph] may be costly, which I would agree, but when you look at the IND-enabling phase or the tech assessment phase, this is a relatively inexpensive from a capital standpoint. Most of the expense would come from already existing FCEs, which would be fairly immaterial. As we move into the clinical phases, Phase I and II well as you know the cost would go up tremendously. It is at that time that we would start looking for potential partners. So we either absorb most of that cost or through cost sharing. That’s the business opportunity that’s showing up on the bottom of the slide.
This is the same sort of concept for Palonosetron and again we would be doing most of the tech assessment phase by ourselves and the preclinical work, looking for partners as we move along the value proposition line in the IND phase or the clinical phase.
The last slide, the last one of our clinical development candidates is Epinephrine for Anaphylaxis. I think the one point I want to raise here is this can be an incredibly short timeline. No real clinical studies would be required. Obviously you cannot do a clinical study in the Anaphylactic setting. So that would be e-study and some human factor studies would probably suffice. So we're looking at this opportunity as again one of our priority ones.
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Post by liane on Aug 24, 2016 16:02:12 GMT -5
FYI:
Primatene Mist was discontinued not because it was ineffective, but because its operation relied on chlorofluorocarbon (CFC) propellants, which the government says are harmful to the environment because they deplete the ozone layer in the earth's upper atmosphere.
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Post by peppy on Aug 24, 2016 16:09:28 GMT -5
FYI: Primatene Mist was discontinued not because it was ineffective, but because its operation relied on chlorofluorocarbon (CFC) propellants, which the government says are harmful to the environment because they deplete the ozone layer in the earth's upper atmosphere. Good thing it was bad for the Ozone. chloro (chroride/chlorine) Fluoro (Fluoride)
could not have been good for human beings either.
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Post by lakers on Aug 24, 2016 16:27:39 GMT -5
How Marketing Turned the EpiPen Into a Billion-Dollar Business In a 2007 purchase of medicines from Merck KGaA, drugmaker Mylan picked up a decades-old product, the EpiPen auto injector for food allergy and bee-sting emergencies. Management first thought to divest the aging device, which logged only $200 million in revenue. Then Heather Bresch, now Mylan’s chief executive officer, hit on the idea of using old-fashioned marketing in part to boost sales among concerned parents of children with allergies. That started EpiPen, which delivers about $1 worth of the hormone epinephrine, on a run that’s resulted in its becoming a $1 billion-a-year product that clobbers its rivals and provides about 40 percent of Mylan’s operating profits, says researcher ABR|Healthco. EpiPen margins were 55 percent in 2014, up from 9 percent in 2008, ABR|Healthco estimates. Photo illustration: 731 How Mylan pulled that off is a textbook case in savvy branding combined with a massive public awareness campaign on the dangers of child allergies. Along the way, EpiPen’s wholesale price rose roughly 400 percent from about $57 each when Mylan acquired the product. “They have done a tremendous job of taking an asset that nobody thought you could do much with and making it a blockbuster product,” says Jason Gerberry, a Leerink Partners analyst. But while EpiPen has given countless parents a sense of security that their children can go out in the world safely, the device’s soaring price—up 32 percent in the past year alone—has forced some families to make difficult choices in order to afford the life-saving medicine. The price increases are among the biggest of any top-selling brand drug, according to DRX, a unit of Connecture that tracks drug pricing. After insurance company discounts, a package of two EpiPens costs about $415, DRX says. By comparison, in France, where Meda sells the drug, two EpiPens cost about $85. “There is a danger with that,” says George Sillup, chairman of the pharmaceutical and health-care marketing department at Saint Joseph’s University. If the company raises the price too much, “that could create some backlash.” The company sees it differently. “Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness, and access to treatment,” Mylan spokeswoman Nina Devlin said in a statement. She said the company doesn’t control final retail prices for EpiPen and offers coupons that eliminate co-pays for most patients. Bresch declined to comment for this story. The CEO has made no secret of her strategy to increase demand for EpiPens by getting them stocked for emergency use in more schools and other public places. (So-called entity prescriptions allow for this.) “We are continuing to open up new markets, new access with public entity legislation that would allow restaurants and hotels and really anywhere you are congregating, there should be access to an EpiPen,” Bresch said at a conference on Sept. 17. Over the past seven years, Mylan has hired consultants who had worked with Medtronic to get defibrillators stocked in public places. Bresch, the daughter of Senator Joe Manchin (D-W.Va.), turned to Washington for help. Along with patient groups, Mylan pushed for federal legislation encouraging states to stock epinephrine devices in schools. CEO Bresch Photographer: Chris Goodney/Bloomberg In 2010 new federal guidelines said patients who had severe allergic reactions should be prescribed two epinephrine doses, and soon after Mylan stopped selling single pens in favor of twin-packs. At the time, 35 percent of prescriptions were for single EpiPens. The U.S. Food and Drug Administration had changed label rules to allow the devices to be marketed to anyone at risk, rather than only those who’d already had an anaphylaxis reaction. “Those were both big events that we’ve started to capitalize on,” Bresch said in October 2011. In 2013, the year following the widely publicized death of a 7-year-old girl at a school in Virginia after an allergic reaction to peanuts, Congress passed legislation encouraging states to have epinephrine devices on hand in schools. Now 47 states require or encourage schools to stock the devices. Since 2012, Mylan has helped popularize its brand by handing out free EpiPens to more than 59,000 schools. Last year it signed a deal with Walt Disney to stock EpiPens in Disney’s theme parks and on cruise ships. And Mylan spent $35.2 million on EpiPen TV ads in 2014, up from $4.8 million in 2011, according to researcher Nielsen. Mylan disputes the ad spending figures but declines to offer alternatives. In part because of Mylan’s efforts, the number of patients using EpiPen has grown 67 percent over the past seven years. Many kids with allergies own multiple sets, for school and home. And for doctors, who write prescriptions for the name they know best, the EpiPen brand “is like Kleenex,” says Robert Wood, a pediatric allergist at Johns Hopkins University School of Medicine. So far rivals haven’t been able to break Mylan’s market grip. Sanofi’s Auvi-Q, introduced in 2013, is in the shape of a credit card and—unlike EpiPen—gives step-by step audio instructions. But Sanofi priced Auvi-Q about the same as EpiPen, and the product struggled initially to gain insurance coverage. Sanofi says 9 out of 10 patients with commercial insurance can now receive coverage for Auvi-Q prescriptions. Yet in the first half of 2015, EpiPen had about an 85 percent share of epinephrine prescriptions vs. only 10 percent for Auvi-Q, according to Symphony Health Solutions data compiled by Bloomberg. Still, allergy sufferers without generous health benefits feel the pain. Denise Ure, a social worker in Seattle, has a peanut allergy so severe that the last time she ingested a nut crumb in 2011, she needed three EpiPens and was hospitalized. Ure says she cried last year when she found out a prescription for two EpiPens would cost her about $350. “I was terrified because there’s this life-saving medicine that I needed, and I couldn’t afford it,” she says. Ure now carries two EpiPens she got in Canada, where they cost about half as much. The biggest threat to EpiPen could come from Teva Pharmaceutical Industries. It settled a patent lawsuit in 2012 allowing it to market a generic version of EpiPen as early as this year, if it wins FDA approval. Mylan isn’t too worried. Predicted Bresch in August: “You would not see the traditional market loss because of just the brand equity with EpiPen.” The bottom line: When Mylan bought EpiPen in 2007, the devices had $200 million in annual sales. Today revenue exceeds $1 billion. www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business
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Post by LosingMyBullishness on Aug 24, 2016 16:35:45 GMT -5
FYI: Primatene Mist was discontinued not because it was ineffective, but because its operation relied on chlorofluorocarbon (CFC) propellants, which the government says are harmful to the environment because they deplete the ozone layer in the earth's upper atmosphere. Good thing it was bad for the Ozone. chloro (chroride/chlorine) Fluoro (Fluoride)
could not have been good for human beings either.
Peppy, where were you during chemistry lessons and during the years CFC were discussed in all media back and forth as Ozone killer ? CFC had been used for decades because they are very stable and no harm to humans.
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