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Post by liane on Sept 24, 2016 11:39:21 GMT -5
Primatene is a mist - that is the drug is suspended in relatively large droplets. It is epinephrine, and used to dilate the smooth muscle in the bronchioles and open up the airway in an asthma attack. I am speculating - but I think more of the medication in this form is deposited higher up in the pulmonary tree - ie the bronchioles - vs Technosphere which has much smaller particles and has more deposited in the alveoli to be absorbed systemically in the bloodstream.
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Post by sportsrancho on Sept 24, 2016 11:51:27 GMT -5
Primatene is a mist - that is the drug is suspended in relatively large droplets. It is epinephrine, and used to dilate the smooth muscle in the bronchioles and open up the airway in an asthma attack. I am speculating - but I think more of the medication in this form is deposited higher up in the pulmonary tree - ie the bronchioles - vs Technosphere which has much smaller particles and has more deposited in the alveoli to be absorbed systemically in the bloodstream. Thank you:-) I didn't know how to answer this question on the other thread. But thought this was the case.
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Post by audiomr on Sept 24, 2016 12:16:46 GMT -5
Remember that in Europe EpiPens only cost about $120 a pair retail and not the $600 they cost in the US. Competing in the US will be easy, competing elsewhere will be far more difficult. Epi-TS would have significant benefits other than cost: smaller and thus easier to carry on your person, easier to use, painless. The market could be large even at price parity.
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Post by lakers on Sept 24, 2016 15:23:44 GMT -5
Disclosed Pipeline: Primatene® Mist Overview ■ Primatene® Mist, a proprietary and patent protected over-the-counter epinephrine inhalation product candidate, is intended for the temporary relief of mild symptoms of intermittent asthma ■ Acquired the trade name, Primatene® Mist, in 2008 ■ Company reformulated Primatene® Mist using HFA as a propellant and submitted an NDA in 2013 ■ In February 2014, the FDA’s advisory committee voted that data supported efficacy, but that safety had not been established for OTC use ■ Received complete response letter from the FDA in May 2014, which asked for additional data, label revisions and follow-up studies to support consumers’ ability to correctly use the product in the OTC setting ■ The Company conducted label comprehension studies and behavioral studies ■ The Company met with the FDA in October 2014; received comments on human factor study in January 2016 ■ The Company resubmitted its application in June 2016 and received a target action date of December 28, 2016 11 files.shareholder.com/downloads/AMDA-2XT20G/2898961531x0x906920/6FFA6C2B-78E3-446F-8E10-81EBF5406AAF/2016_Investor_Presentation.pdfEpiHale w/ different dosages could target 2 mkts: asthma and EpiPen.
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Post by lakers on Sept 24, 2016 15:33:23 GMT -5
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Post by BlueCat on Sept 24, 2016 17:37:15 GMT -5
Primatene is a mist - that is the drug is suspended in relatively large droplets. It is epinephrine, and used to dilate the smooth muscle in the bronchioles and open up the airway in an asthma attack. I am speculating - but I think more of the medication in this form is deposited higher up in the pulmonary tree - ie the bronchioles - vs Technosphere which has much smaller particles and has more deposited in the alveoli to be absorbed systemically in the bloodstream. Thank you:-) I didn't know how to answer this question on the other thread. But thought this was the case. I will tell you Primatene Classic can burn like hell, I'm assuming for the reason Liane speculates. And you gotta take more in to get it to where it needs to go. And the side effects at that point aren't fun. Lots of asthmatics I knew ran to it when years ago, Ventolin changed and seemed to become ineffective. Rescue is rescue and no one wants to inject their thigh with that railroad tie. But then they pulled Primatene too and it got scary. I would imagine there would be a dramatic difference from a TS version versus OTC Primatene, and like Afrezza, this would also be a life saver.
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Post by sla55 on Sept 26, 2016 16:09:35 GMT -5
www.investopedia.com/news/can-mannkind-compete-against-mylans-epipen-mnkd/?partner=YahooSABy Shobhit Seth | September 26, 2016 — 4:23 PM EDT MannKind Corp. (MNKD) has been successful in marketing its inhalable insulin product, called Afrezza. Though sales have been limited, the treatment has been popular with diabetic patients who find inhaling more convenient than injecting their insulin. Taking on Mylan The company is now reportedly working on a similar inhalable product for severe allergy patients that would directly compete with Mylan Pharmaceuticals Inc.’s (MYL) pricey EpiPen. The epinephrine drug is used to fight serious allergic reactions to food, insect bites and other allergens. EpiPen is a device that facilitates easy injection of epinephrine into the thighs without any special training to patients or their caregivers. However, EpiPen comes at a high cost of $600 for two pens, which has been a subject of wide criticism. (For more, see Two Senators Investigate Pricing of Mylan's EpiPen.) In the case of inhalable Afrezza, MannKind is developing its inhalable allergy drug-administering product. Reported to be in early stage of development, it could be an instant hit owing to its convenient use, painless administration, and a possible lower price. Challenges Though the proposition looks promising, MannKind has a few hurdles to cross. It took more than a decade to commercialize the Afrezza inhaler, and sales have not met expectations. The Afrezza product was rejected twice by the FDA prior to its approval in 2014. French pharmaceutical major Sanofi junked the marketing and distribution deal with MannKind limiting Afrezza's sales prospects. The death of Alfred Mann, the founder who invested $1 billion, in February earlier this year was another setback. The limited amount of cash, $63.7 million at the end of second quarter, may not be enough to fund the operations for long, putting a question mark on the sustainability of the new development programs. While Afrezza has entered the third month of marketing, sales revenues have been limited. Unless the company finds a strategic partner or financial backer, it may be a path full of struggle for the ambitious EpiPen competing product. There are a few positives for MannKind. There is a high interest in EpiPen’s alternative, so finding funding may not be that difficult. Additionally, clinical trials may not take long time, as it may be based on earlier approved Afrezza concept. (For more, see Analysts Battle Over MannKind -- but Who's Right?)
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Post by lakers on Sept 26, 2016 23:52:30 GMT -5
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Post by LosingMyBullishness on Sept 27, 2016 7:12:07 GMT -5
Wow, they even try to bullshit the Congress with virtual numbers. True AH company and CEO.
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