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Post by kpm1028 on Jan 15, 2016 17:15:43 GMT -5
Doing a little friday digging, I came across primatene mist, this product has been discontinued since the fda banned it for containing cfc. This inhalable epinephrine has not been available since. Primatene mist is owned by Armstrong Pharmaceuticals a subsidiary of Amphastar. Could this possibly be the first licensing agreement that was mentioned in the last slide of the jp. morgan powerpoint. en.wikipedia.org/wiki/Primatene_MistAmph 8/12/15 "With respect to Primatene, we are currently awaiting review comments from the FDA. We believe that once we receive the FDA’s comments, we should be able to.re-file the NDA approximately two months thereafter with an expectation of approval in 2016. The last full year sales of Primatene were $65 million in 2010. We believe that with some marketing efforts to inform consumers of its re-launch, we can see annual sales of Primatene eventually surpassing this number. We are still in the process of drafting a Phase 1/2 report for our Albuterol dry powder product candidate. We plan to file this report with the FDA in approximately two months and are currently working on proposed protocol for the Phase 3 study." |
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Post by mnholdem on Jan 15, 2016 17:22:27 GMT -5
Very nice detective work.
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Post by stevil on Jan 15, 2016 17:27:41 GMT -5
Doing a little friday digging, I came across primatene mist, this product has been discontinued since the fda banned it for containing cfc. This inhalable epinephrine has not been available since. Primatene mist is owned by Armstrong Pharmaceuticals a subsidiary of Amphastar. Could this possibly be the first licensing agreement that was mentioned in the last slide of the jp. morgan powerpoint. en.wikipedia.org/wiki/Primatene_MistAmph 8/12/15 "With respect to Primatene, we are currently awaiting review comments from the FDA. We believe that once we receive the FDA’s comments, we should be able to.re-file the NDA approximately two months thereafter with an expectation of approval in 2016. The last full year sales of Primatene were $65 million in 2010. We believe that with some marketing efforts to inform consumers of its re-launch, we can see annual sales of Primatene eventually surpassing this number. We are still in the process of drafting a Phase 1/2 report for our Albuterol dry powder product candidate. We plan to file this report with the FDA in approximately two months and are currently working on proposed protocol for the Phase 3 study." Wish I could ask someone here to try to figure out how much it costs to produce TS particles  Primatene used to be OTC and there was a number of people who were bummed about it in the pharmacy I worked in when it got discontinued. There were always a few packs in every tote that we unloaded. Pretty high demand. Hope the margins would be high enough to float us some extra cash... This would be a good start... |
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Post by kpm1028 on Jan 15, 2016 17:33:37 GMT -5
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Post by taylor810dn on Jan 15, 2016 18:42:47 GMT -5
FYI, here are a couple related posts from the Yahoo message board, and there is another one that basically says the poster's life was changed for the better when the Primatene mist came along, and then reversed when it was pulled off the market, and they would love for TS to put them back on the right track.
Yahoo
Armstrong Pharmaceuticals, a manufacturer of inhaled products for asthma, such as Primatene and other inhaled steroids, etc., is owned by Amphastar. MNKD has a deal for insulin with Amphastar. Bingo!
Oh, and Armstrong has filed for HFAs for Primatene to replace CFCs as the propellant. If they can use TS instead of a propellant altogether, well, bye bye carbon footprint! What could be better than a product that works AND is ecologically friendly?
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Post by mindovermatter on Jan 15, 2016 18:43:25 GMT -5
Amph's stats. Has ~70 million of cash on hand. Matt stated something about a deal that wouldn't have a lot of up front cash but would be beneficial. I can see that there would be a synergy between these two based on current relationship and business models. finance.yahoo.com/q/ks?s=AMPH+Key+Statistics |
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Post by matt on Jan 15, 2016 19:07:01 GMT -5
Epinephrine inhalers are still available, just not OTC due to the fluorocarbon propellants (the EPA has limited ability to mess with prescription drugs). BTW, it was the EPA that got Primatene banned, not FDA. Primatene is good stuff, I used it a lot due to the air pollution in central Tokyo when I lived in Japan in the mid-90's. They are supposedly working on a non-CFC formulation and have been for a few years.
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Post by lakers on Jan 15, 2016 19:43:01 GMT -5
Disclosed Pipeline: Primatene ® files.shareholder.com/downloads/AMDA-2XT20G/1352170617x0x863871/2BB3AAD0-2F69-4FDB-A0C8-ABC968822E83/Amphastar_IR_27th_Annual_Piper_Jaffray_Healthcare_Conference_2015-12-01.pdf [This drug doesn't use TS particle] Slide 16 ■ Primatene ®, 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 ® 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 is currently performing, behavioral studies ■ The Company met with the FDA in October 2014 ■ The Company anticipates re-filing the NDA 2016Slide 6 ■ Armstrong: Canton, MA, 251,750 square feet ■ Currently being qualified to manufacture inhalation products ■ Site for developing pipeline of MDI products ■ Future site of Primatene® HFA |
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Post by lorcan458 on Jan 15, 2016 21:54:19 GMT -5
Wish I could ask someone here to try to figure out how much it costs to produce TS particles I may be misinterpreting your question, but if you are asking if once everything is ready to go and the drug is for sale, how much per dose does TS add to the cost, I think that is very low. As for the R&D to get it for sale, that's an entirely different matter and I have no idea how much it will cost. |
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Post by mnholdem on Jan 16, 2016 8:03:27 GMT -5
FYI for new members: Amphastar Pharmaceuticals [AMPH], a company that specializes in generic versions of difficult to manufacture API, currently supplies the insulin (human) used in formulating Afrezza and has a 5-year supply contract with MannKind.
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Post by anderson on Jan 16, 2016 9:47:08 GMT -5
Wish I could ask someone here to try to figure out how much it costs to produce TS particles Primatene used to be OTC and there was a number of people who were bummed about it in the pharmacy I worked in when it got discontinued. There were always a few packs in every tote that we unloaded. Pretty high demand. Hope the margins would be high enough to float us some extra cash... This would be a good start... If you look in that article you see that MNKD can make FDKP in Danbury, but it looks like they are actually buying it from a large chemical supplier. Dont think FDKP(fumaryl diketopiperazine) is that expensive. Think the process of bonding it to other chemicals is where the magic comes in, so R&D then the build out of the processing equipment take up front cash. So the active ingredient in Primatene might be the driving factor of cost. If I remember correctly the largest cost in Afrezza is the insulin price. The factory, R&D ect should be low in if you are producing in bulk, part of our current problem. |
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gz
Newbie
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Post by gz on Jan 16, 2016 15:27:30 GMT -5
So when MNKD starts progressing (which it will) would it be logical for MNKD to purchase AMPH? AMPH has the insulin and epinephrine and a market cap of half a billion. I'm talking 2+ years down the road.
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Post by harryx1 on Jan 20, 2016 9:58:15 GMT -5
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Post by lakon on Jan 20, 2016 10:43:14 GMT -5
The content seems close enough to spread awareness, and the intent seems honest. It is interesting how Afrezza and Primatene Mist show up together rather coincidentally in the author's explanation. I wonder if the author knows about the relationship between MNKD and AMPH, considering how they make Afrezza and next-gen Primatene Mist, respectively.
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Post by lakon on Jan 20, 2016 10:59:17 GMT -5
As far as investments go, AMPH is probably a better short-term trade than MNKD, and it might be a leading indicator as a supplier if things turnaround for MNKD. I traded AMPH last year for profits that have been hard to come by with my MNKD holdings. MNKD might be better for day traders or buy-and-hold types as strange as it may seem to put those together. Anyway, digging deeper into the AMPH and MNKD relationships, and I mean people, should yield a treasure trove of insight. These people know each other and have history. AMPH is working on several drugs, about half are dry powder formulations. They have extensive knowledge and capabilities in this space, and they have a global footprint covering America [USA], Europe [France], and Asia [China]. To say they have synergies would be an understatement. You might consider looking at Albuterol [Salbutamol] as well as Epinephrine. Both can be used to treat contraindications for Afrezza. It is just something to think about...
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