|
|
Post by lakon on Apr 20, 2016 11:38:28 GMT -5
|
|
|
|
Post by lakon on Apr 20, 2016 11:43:38 GMT -5
|
|
|
|
Post by peppy on Apr 20, 2016 11:53:41 GMT -5
|
|
|
|
Post by jerrys on Apr 20, 2016 11:54:23 GMT -5
|
|
|
|
Post by peppy on Apr 20, 2016 11:57:29 GMT -5
check your history jerry. used for years, until it went off patent. Physicians, (liane) order it down ET tubes in codes. get a grip.
(added; I was paying attention to the empirical formula, an old theory, nitrogen reduces pulmonary resistance.)
|
|
|
|
Post by sccrbrg on Apr 20, 2016 12:12:55 GMT -5
check your history jerry. used for years, until it went off patent. Physicians, (liane) order it down ET tubes in codes. get a grip.
(added; I was paying attention to the empirical formula, an old theory, nitrogen reduces pulmonary resistance.)
I'm with Jerry on this one... I think this is a waste of money to pursue. Injectable Epi works fast enough. And I very highly doubt that most doctors and patients with severe allergies would want to rely on an inhalant. Best case for MNKD they would be able to convince a few to buy the inhalant with the injectable as a back up. Again, what parent/spouse/individual patient would want to gamble that the allergic reaction onset will be slow enough and/or caught in time to rely solely on an inhalant. An injectable epi works on everyone in nearly every situation, even unresponsive patients - inhalants do not. This is a worthless chase down the rabbit hole to me. |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Apr 20, 2016 12:23:49 GMT -5
check your history jerry. used for years, until it went off patent. Physicians, (liane) order it down ET tubes in codes. get a grip.
(added; I was paying attention to the empirical formula, an old theory, nitrogen reduces pulmonary resistance.)
I'm with Jerry on this one... I think this is a waste of money to pursue. Injectable Epi works fast enough. And I very highly doubt that most doctors and patients with severe allergies would want to rely on an inhalant. Best case for MNKD they would be able to convince a few to buy the inhalant with the injectable as a back up. Again, what parent/spouse/individual patient would want to gamble that the allergic reaction onset will be slow enough and/or caught in time to rely solely on an inhalant. An injectable epi works on everyone in nearly every situation, even unresponsive patients - inhalants do not. This is a worthless chase down the rabbit hole to me. Dr. Raymond W. Urbanski - Chief Medical Officer thinks otherwise seekingalpha.com/article/3862956-mannkinds-mnkd-investor-conference-call-transcript?part=singleThe last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around.
They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
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.
Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need.
And I would like to - Compare the price and convenience |
|
|
|
Post by peppy on Apr 20, 2016 12:24:55 GMT -5
check your history jerry. used for years, until it went off patent. Physicians, (liane) order it down ET tubes in codes. get a grip.
(added; I was paying attention to the empirical formula, an old theory, nitrogen reduces pulmonary resistance.)
I'm with Jerry on this one... I think this is a waste of money to pursue. Injectable Epi works fast enough. And I very highly doubt that most doctors and patients with severe allergies would want to rely on an inhalant. Best case for MNKD they would be able to convince a few to buy the inhalant with the injectable as a back up. Again, what parent/spouse/individual patient would want to gamble that the allergic reaction onset will be slow enough and/or caught in time to rely solely on an inhalant. An injectable epi works on everyone in nearly every situation, even unresponsive patients - inhalants do not. This is a worthless chase down the rabbit hole to me. crash cart check list. www.acls.net/acls-crash-cart.htm
every wing of every hospital floor, every doctors office and urgent care center. one more thing, you are having an asthma attack.... lungs, bronchi, bronchioles everything in spasm, you need to relax the spasm. epi.
|
|
|
|
Post by sccrbrg on Apr 20, 2016 12:27:32 GMT -5
I'm with Jerry on this one... I think this is a waste of money to pursue. Injectable Epi works fast enough. And I very highly doubt that most doctors and patients with severe allergies would want to rely on an inhalant. Best case for MNKD they would be able to convince a few to buy the inhalant with the injectable as a back up. Again, what parent/spouse/individual patient would want to gamble that the allergic reaction onset will be slow enough and/or caught in time to rely solely on an inhalant. An injectable epi works on everyone in nearly every situation, even unresponsive patients - inhalants do not. This is a worthless chase down the rabbit hole to me. Dr. Raymond W. Urbanski - Chief Medical Officer thinks otherwise seekingalpha.com/article/3862956-mannkinds-mnkd-investor-conference-call-transcript?part=singleThe last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around.
They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
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.
Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need.
And I would like to - Compare the price and convenience Of course he does, he's the one spearheading the development for a publicly held company. If you ask the doctors and patients if they'd rather risk their lives or the lives of their patients for price and convenience, I doubt you'll get the same answer. |
|
|
|
Post by end2war on Apr 20, 2016 12:35:29 GMT -5
It seems to me, and this is just off the cuff thinking, that a person with the allergy would carry both an inhalant and a needle. They would use the inhalant first and the needle second, if necessary. Only with an epi inhaled epi drug the needle will not be necessary. So, I do not agree with those that say this would not be a good product to develop. I think, off the cuff, it would sell great and be used in place of needles.
|
|
|
|
Post by mnholdem on Apr 20, 2016 13:01:16 GMT -5
From the article I posted in the other thread:
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.
Read more: mnkd.proboards.com/thread/5453/building-marketing-organization#ixzz46OEpjpHN
---
Cost is a big factor. Some of you may be correct in your assertion that a physician won't care about the cost and yet we've heard physicians use the cost argument for not prescribing Afrezza (source: Analyst interviews at the ADA 2015 meetings). The article above (whose link appears in the other thread) states that the EpiPen injects about $1 of epinephrine and yet, "After insurance company discounts, a package of two EpiPens costs about $415, DRX says."
That is a lot of money. The needle hurts - really hurts - because it's much larger than the needle used in a insulin pen, which are relatively painless (a few would argue that they hurt too after repeated stabbings).
Also, the argument that doctors will not want to prescribe an inhaler (for fear of putting the patient's life at risk?) rings a bit hollow to me when you consider that the #1 over-the-counter medicine sold for the relief of physician-diagnosed, bronchial asthma, is also an inhaled medicine (aka Primatene® Mist) as are many similar inhalants currently prescribed for emergency use for respiratory distress.
Asthmatics also known when it's time to take a puff...and that is WAY before they can no longer breathe, for crying out loud.
|
|
|
|
Post by therealisaching on Apr 20, 2016 13:16:10 GMT -5
Also, its common for people to carry the epipen for some time and it expires. Some people dont refill based on cost and cross fingers that it will still work. |
|
|
|
Post by lakon on Apr 20, 2016 13:24:35 GMT -5
I expected the naysayers to be on top of this one again. It is Epi after all.  Of course, thinking a little deeper is often helpful, and it would seem one of the naysayers stumbled upon a need and marketing angle that I wanted to discuss. sccrbrg said, "Best case for MNKD they would be able to convince a few to buy the inhalant with the injectable as a back up. Again, what parent/spouse/individual patient would want to gamble that the allergic reaction onset will be slow enough and/or caught in time to rely solely on an inhalant. An injectable epi works on everyone in nearly every situation, even unresponsive patients - inhalants do not." How about MNKD convinces ALL to buy the inhaled dry powder formulation with the injection as a back up? In other words, MNKD uses the same sales script that Mylan used to get every hospital, doctor's office, clinic, ambulance, school, public facility, patient, etc. to buy Epinephrine Technosphere as the first phase treatment before an invasive procedure is needed, thus avoiding negative outcomes of using an auto injector when unnecessary. Nobody ever said that auto injectors had to be replaced as an option, but rather, a new safer/easier option is available before auto injection. The vast majority of cases would not require the auto injector; however, there would always be a need for auto injection to resolve extremely adverse reactions. The idea is to catch an adverse reaction earlier when patients are already fumbling around with antihistamines and/or debating if the needle is needed. How about treating the majority of cases that could have been saved by inhaling, but the patient did not have the option. Treat the rule AND the exception. What if a patient has an adverse reaction that gets bad enough to force someone untrained to use the auto injector? Sometimes that inexperienced person fails to deliver the Epi properly, such as piercing an artery, and the patient dies. Sometimes it is as simple as the only other person is too afraid to stab her friend... How about MNKD makes a device like their old colleagues at BIOD did for glucagon? Maybe a combo inhaler, auto mixer, and injector... www.biodel.com/content/pipeline/glucagon.htm |
|
|
|
Post by seanismorris on Apr 20, 2016 13:36:37 GMT -5
I could see someone using both the inhaler and pen...
Is it worth developing? I don't know, the US FDA seems hostile to the idea of TS alternatives that could inflate the cost of approval.
We might want to pursue approval in other countries first (EU/Israel?).
|
|
|
|
Post by lakon on Apr 20, 2016 13:40:19 GMT -5
Also, its common for people to carry the epipen for some time and it expires. Some people dont refill based on cost and cross fingers that it will still work. I am so glad that you brought this fact up. While individuals may make this horrible decision, institutions, like hospitals, will refill for fear of liability. That's a huge cost to keep restocking expired EpiPens. The devices themselves are relatively complicated and far more costly than a dry powder inhaler. A dry powder will likely have a longer shelf-life AND be far cheaper to begin with. Thanks to the infinite wisdom at the FDA, a dry powder will "expire", just like Afrezza needs refrigeration and expires. The good news is for safety's sake, or FDA mandate, reoccurring sales will be somewhat predictable, maybe mail prescribers a subscription... |
|
