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Post by Deleted on Aug 16, 2017 14:29:33 GMT -5
Michael Castagna
Thank you, Ray, Pat and Steve.
Let me quickly just touch on the pulmonary hypertension market, it’s not something we previously discussed on an earnings call. But based on the FDA meeting we made the decision to accelerate investment behind this program and pull forward to make sure that we don't lose time on time critical path in terms of developing our next pipeline candidate.
For those of you who don’t know PAH is a type of high blood pressure affecting the arteries or the lungs, and right eventual the heart. It’s estimated to impact of 250,000 individuals worldwide and is considered an orphan condition.
Market size exceeded $6 billion in 2016, but his considerable commercial potential due to the premium price paid for PAH therapies. Currently just to put some context around this, the current prostacyclin costs anywhere between $170,000 to $300,000 in a patient per year. The lifestyle and the quality of life for these patients is dramatically impacted by the current treatment out there.
For those of you who don't know, you currently need to take roughly 12 to 20 inhalation a day through an nebulizer and machined to get your effective dose and because of the complexity in the delivery as well as the absorption of the product, it’s very hard to get to the top end of therapeutic doses.
We believe we have an opportunity here to deliver appropriate dosing in the current ranges of all upper dose ranges that will really help these patient receive tremendous benefit and get their disease under control.
Today, the prostacyclin have about 45% market share and we currently labeled our Treprostinil Type 2 which will compete in this space. That is not the brand name, that is just our internal abbreviation as we refer to it.
We are excited about this milestone in the company's history. We are excited for development team to get the work to start focusing on bringing this molecule forward. Many of you are able to afford to bring this forward. And I want to articulate that the early phase development of these programs do not cost a lot of money, they take more time.
And the capital putting toward this is worth it because I don't want to lose another 3 to 6 to 9 month in time and in a critical development and way, which this to me, we haven’t shared timelines, but as we get through the single ascending dose study and build our confidence around to potential this molecule we will share updated timelines for potential launch. But obviously we are moving faster, because we believe there is an opportunity.
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Post by oldfishtowner on Aug 16, 2017 15:57:41 GMT -5
Michael Castagna Thank you, Ray, Pat and Steve. Let me quickly just touch on the pulmonary hypertension market, it’s not something we previously discussed on an earnings call. But based on the FDA meeting we made the decision to accelerate investment behind this program and pull forward to make sure that we don't lose time on time critical path in terms of developing our next pipeline candidate. For those of you who don’t know PAH is a type of high blood pressure affecting the arteries or the lungs, and right eventual the heart. It’s estimated to impact of 250,000 individuals worldwide and is considered an orphan condition. Market size exceeded $6 billion in 2016, but his considerable commercial potential due to the premium price paid for PAH therapies. Currently just to put some context around this, the current prostacyclin costs anywhere between $170,000 to $300,000 in a patient per year. The lifestyle and the quality of life for these patients is dramatically impacted by the current treatment out there. For those of you who don't know, you currently need to take roughly 12 to 20 inhalation a day through an nebulizer and machined to get your effective dose and because of the complexity in the delivery as well as the absorption of the product, it’s very hard to get to the top end of therapeutic doses. We believe we have an opportunity here to deliver appropriate dosing in the current ranges of all upper dose ranges that will really help these patient receive tremendous benefit and get their disease under control. Today, the prostacyclin have about 45% market share and we currently labeled our Treprostinil Type 2 which will compete in this space. That is not the brand name, that is just our internal abbreviation as we refer to it. We are excited about this milestone in the company's history. We are excited for development team to get the work to start focusing on bringing this molecule forward. Many of you are able to afford to bring this forward. And I want to articulate that the early phase development of these programs do not cost a lot of money, they take more time. And the capital putting toward this is worth it because I don't want to lose another 3 to 6 to 9 month in time and in a critical development and way, which this to me, we haven’t shared timelines, but as we get through the single ascending dose study and build our confidence around to potential this molecule we will share updated timelines for potential launch. But obviously we are moving faster, because we believe there is an opportunity. Mike was playing fast and loose with the numbers. The US population of PAH patients is estimated to be between 10,000 and 20,000 according to the American Thoracic Society (see: www.thoracic.org/patients/patient-resources/breathing-in-america/, chapter 17), not 250,000. Using the higher end estimate for US PAH patients and the higher end of annual prostacyclin costs you can get the $6 billion estimated annual market. 20,000 x x $300,000 = $6 billion. However, if MNKD is going after the prostacyclin market, it would be 0.45 of this or 0.45 x $6 billion = $2.7. Actually it would be much less than this because we used the high end of the estimates for both number of people in the US with PAH and the cost of the drug. A more realistic estimate would be, assuming MNKD gets 75% of the prostacyclin market, 0.75 x 0.45 x 15,000 x $170,000 = $860.6 million Not a quite a blockbuster drug in this patient population (certainly not as impressive as $6 billion), but close. Even if MNKD is expected to lower the cost of treatment as well as improve outcomes, it is still not a bad market potential for a pipeline that could quickly produce several such products. |
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Post by compound26 on Aug 16, 2017 16:00:27 GMT -5
Michael Castagna Thank you, Ray, Pat and Steve. Let me quickly just touch on the pulmonary hypertension market, it’s not something we previously discussed on an earnings call. But based on the FDA meeting we made the decision to accelerate investment behind this program and pull forward to make sure that we don't lose time on time critical path in terms of developing our next pipeline candidate. For those of you who don’t know PAH is a type of high blood pressure affecting the arteries or the lungs, and right eventual the heart. It’s estimated to impact of 250,000 individuals worldwide and is considered an orphan condition. Market size exceeded $6 billion in 2016, but his considerable commercial potential due to the premium price paid for PAH therapies. Currently just to put some context around this, the current prostacyclin costs anywhere between $170,000 to $300,000 in a patient per year. The lifestyle and the quality of life for these patients is dramatically impacted by the current treatment out there. For those of you who don't know, you currently need to take roughly 12 to 20 inhalation a day through an nebulizer and machined to get your effective dose and because of the complexity in the delivery as well as the absorption of the product, it’s very hard to get to the top end of therapeutic doses. We believe we have an opportunity here to deliver appropriate dosing in the current ranges of all upper dose ranges that will really help these patient receive tremendous benefit and get their disease under control. Today, the prostacyclin have about 45% market share and we currently labeled our Treprostinil Type 2 which will compete in this space. That is not the brand name, that is just our internal abbreviation as we refer to it. We are excited about this milestone in the company's history. We are excited for development team to get the work to start focusing on bringing this molecule forward. Many of you are able to afford to bring this forward. And I want to articulate that the early phase development of these programs do not cost a lot of money, they take more time. And the capital putting toward this is worth it because I don't want to lose another 3 to 6 to 9 month in time and in a critical development and way, which this to me, we haven’t shared timelines, but as we get through the single ascending dose study and build our confidence around to potential this molecule we will share updated timelines for potential launch. But obviously we are moving faster, because we believe there is an opportunity. Mike was playing fast and loose with the numbers. The US population of PAH patients is estimated to be between 10,000 and 20,000 according to the American Thoracic Society (see: www.thoracic.org/patients/patient-resources/breathing-in-america/, chapter 17), not 250,000. Using the higher end estimate for US PAH patients and the higher end of annual prostacyclin costs you can get the $6 billion estimated annual market. 20,000 x x $300,000 = $6 billion. However, if MNKD is going after the prostacyclin market, it would be 0.45 of this or 0.45 x $6 billion = $2.7. Actually it would be much less than this because we used the high end of the estimates for both number of people in the US with PAH and the cost of the drug. A more realistic estimate would be, assuming MNKD gets 75% of the prostacyclin market, 0.75 x 0.45 x 15,000 x $170,000 = $860.6 million Not a quite a blockbuster drug in this patient population (certainly not as impressive as $6 billion), but close. Even if MNKD is expected to lower the cost of treatment as well as improve outcomes, it is still not a bad market potential for a pipeline that could quickly produce several such products. Mike was talking about a global target population, while you are talking about the US target population. "It’s estimated to impact of 250,000 individuals worldwide". If your number is close to accurate, then Mike's number is very conservative. And I do not think $860.6 million sales is anywhere underwhelming. And even if Mannkind does 1/10 of it, say $80 million a year, if Mannkind can get $20 million a year of profit out of it, and you give it a 20 time PE, that alone will give you a market cap of $400 million. Remember that our market cap has been hovering around $100 million for a while. So if we can indeed generate a sale of $800 million a year and if we can get $200 million a year of profit out of it, and you give it a 20 time PE, that alone will give you a market cap of $4 billion, which will translates into a PPS of $40. You are not happy about that? How about Mike finding some partner who is willing to provide a $50 million upfront fee for a PAH partnership? Mike, let's do it. |
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Post by peppy on Aug 16, 2017 16:03:31 GMT -5
Mike was playing fast and loose with the numbers. The US population of PAH patients is estimated to be between 10,000 and 20,000 according to the American Thoracic Society (see: www.thoracic.org/patients/patient-resources/breathing-in-america/, chapter 17), not 250,000. Using the higher end estimate for US PAH patients and the higher end of annual prostacyclin costs you can get the $6 billion estimated annual market. 20,000 x x $300,000 = $6 billion. However, if MNKD is going after the prostacyclin market, it would be 0.45 of this or 0.45 x $6 billion = $2.7. Actually it would be much less than this because we used the high end of the estimates for both number of people in the US with PAH and the cost of the drug. A more realistic estimate would be, assuming MNKD gets 75% of the prostacyclin market, 0.75 x 0.45 x 15,000 x $170,000 = $860.6 million Not a quite a blockbuster drug in this patient population (certainly not as impressive as $6 billion), but close. Even if MNKD is expected to lower the cost of treatment as well as improve outcomes, it is still not a bad market potential for a pipeline that could quickly produce several such products. Mike was talking about a global target population, while you are talking about the US target population. "It’s estimated to impact of 250,000 individuals worldwide". I still see the humor of this whole/hole thing. a orphan Viagra. oh haha. Man I am a bitch.
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PAH
Aug 16, 2017 16:59:40 GMT -5
Post by peppy on Aug 16, 2017 16:59:40 GMT -5
Persistent Newborn Pulmonary Hypertension
Persistent pulmonary hypertension of the newborn (PPHN) is defined as the failure of the normal circulatory transition that occurs after birth. It is a syndrome characterized by marked pulmonary hypertension that causes hypoxemia secondary to right-to-left shunting of blood.
Signs and symptoms
PPHN is often associated with the following signs and symptoms of perinatal distress:
• Asphyxia
• Tachypnea, respiratory distress
• Loud, single second heart sound (S2) or a harsh systolic murmur (secondary to tricuspid regurgitation)
• Low Apgar scores
• Meconium staining
• Cyanosis; poor cardiac function and perfusion
• Systemic hypotension
• Symptoms of shock emedicine.medscape.com/article/898437-overview
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these babies are on ventilators.
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PAH
Aug 16, 2017 17:19:30 GMT -5
Post by lakers on Aug 16, 2017 17:19:30 GMT -5
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PAH
Aug 16, 2017 17:29:32 GMT -5
Post by dreamboatcruise on Aug 16, 2017 17:29:32 GMT -5
Does anyone know how the required dose might differ between treatment of PAH and ED? If PAH requires much larger doses it might be possible to have the high price for PAH and a much lower price to address ED market (emergency inhaler  ). |
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Post by falconquest on Aug 16, 2017 17:57:16 GMT -5
What would be nice is for Mannkind to get FDA approval for another Technosphere based product. This would lend some legitimacy to Technosphere and perhaps cause the market to rethink their position on this little company.
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PAH
Aug 16, 2017 18:13:58 GMT -5
peppy likes this
Post by liane on Aug 16, 2017 18:13:58 GMT -5
Does anyone know how the required dose might differ between treatment of PAH and ED? If PAH requires much larger doses it might be possible to have the high price for PAH and a much lower price to address ED market (emergency inhaler ). PAH requires a much lower dose; 5 or 20mg TID, max 20mg TID (3x/day) ED dose is 50mg with a maintenance dose of 25 - 100mg daily. |
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Post by lakers on Aug 16, 2017 18:15:16 GMT -5
Distribution Rights Agreement for Tyvaso®, a Treatment for Pulmonary Arterial Hypertension, in Japan www.mochida.co.jp/english/news/docs/2017/170328_Tyvaso.pdfseekingalpha.com/article/4095781-united-therapeutics-expectations-lowFour PAH-products—Remodulin, Tyvaso, Adcirca, and Orenitram—make up the bulk of Untited Therapeutcs’ sales. The 5th product is Unituxin, an oncology product. Thre are two possible treatments for PAH: prostacyclin analogues and PDE-5 inhibitors. Orenitram, Tyvaso and Remodulin are so-called prostacyclin analogues. Orenitram are Extended-Release Tablets, Tyvaso is an Inhalation Solution and Remodulin is approved for subcutaneous (under the skin) and intravenous (in the vein) administration. Adcirca is an oral PDE-5 inhibitor therapy. United Therapeutics acquired exclusive commercialization rights to Adcirca for the treatment of PAH in the United States from Eli Lilly. PDE-5 inhibitor are used in the treatment of erectile dysfunction and were the first effective oral treatment available for the condition. Because PDE5 is also present in the arterial wall smooth muscle within the lungs, PDE5 inhibitors have also been explored for the treatment of pulmonary hypertension. United Therapeutics is currently involved in six Phase 3 studies as well as multiple other drug device combination studies. In the first quarter of this year United Therapeutics released disappointing figures (flat sales). The competition from the generic players in the PAH-drug market was the primary reason for those disappointing revenues. In April 2017, United Therapeutics announced regulatory delays in the approval of RemoSynch, an implantable infusion pump for the administration of Remodulin. The commercialization of the device, which is developed in collaboration with Medtronic, would be postponed to 2018. Both the Q1-figures and the RemoSynch-delay caused a sharp drop in the share price and lowered the expectations for United Therapeutics. According to United therapeutics “the decrease in Tyvaso sales resulted from the availability of oral prostacyclin-class therapies, and increased propensity to treat patients with multiple oral therapies earlier in their disease progression, which can delay the need to prescribe inhaled therapies. Given the progressive nature of PAH, we believe many patients will initiate Tyvaso in the future as their disease progresses.” Generic competition Adcirca faces generic competition due to the current commercial availability of generic sildenafil and potential commercial availability of generic versions of Adcirca following its patent expiry in November 2017. Generic sildenafil’s lower price relative to Adcirca could lead to pressure from payers to use generic products within the same class of therapy initially, which could erode Adcirca’s market share and limit its potential sales. Although we believe Adcirca’s once-daily dosing regimen provides a significant competitive advantage over generic sildenafil’s multiple dosing regimen, government payers and private insurance companies may favor the use of less expensive generic sildenafil over Adcirca. Generic versions of Remodulin are expected to be launched in the United States by Sandoz in June 2018 and by Teva, Par and Dr. Reddy’s in December 2018. Despite this generic competition, United Therapeutics’ management is convinced that overall revenues are set to continue to grow with Orenitram, Tyvaso and Remodulin. Take-over candidate? If we have to believe the rumors, both Gilead Sciences (GILD) and GlaxoSmithKline (GSK) are considering taking over United Therapeutics. Given the latter’s low valuation this would be a sensible option. seekingalpha.com/news/3285980-takeover-rumor-du-jour-gilead-glaxo-eyeing-united-therapeutics-shares-9-percentTakeover rumor du jour: Gilead and Glaxo eyeing United Therapeutics; shares up 9% Aug. 4, 2017 10:00 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor United Therapeutics (UTHR +8.5%) is up in early trading on rumors that Gilead Sciences (GILD -1.7%) and GlaxoSmithKline (GSK -0.2%) are eyeing the company. |
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PAH
Aug 16, 2017 18:19:08 GMT -5
Post by peppy on Aug 16, 2017 18:19:08 GMT -5
Does anyone know how the required dose might differ between treatment of PAH and ED? If PAH requires much larger doses it might be possible to have the high price for PAH and a much lower price to address ED market (emergency inhaler ). Treprostinil does not have the enzyme inhibitor. Treprostinil; 12.1 Mechanism of Action
The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation. www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf
Viagra; Mechanism of Action The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation. www.accessdata.fda.gov/drugsatfda_docs/label/2010/020895s033lbl.pdf
There is more than one way to skin a cat.
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PAH
Aug 16, 2017 18:28:52 GMT -5
Post by mytakeonit on Aug 16, 2017 18:28:52 GMT -5
You mean my penis releases nitric oxide? Like laughing gas? Well, that explains all the laughter ...
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PAH
Aug 16, 2017 18:32:32 GMT -5
Post by peppy on Aug 16, 2017 18:32:32 GMT -5
You mean my penis releases nitric oxide? Like laughing gas? Well, that explains all the laughter ... yes, watermelon stimulates Nitric Oxide also. especially the rhine.
There are recipes, boil it down, and put the juice in a bottle. It does not taste very good, surprisingly.
www.youtube.com/watch?v=Yrce3LqsGrw
www.youtube.com/watch?v=75UATjI_XIs
home made Viagra. (cat skinning 101)
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PAH
Aug 16, 2017 18:34:48 GMT -5
via mobile
Post by lakers on Aug 16, 2017 18:34:48 GMT -5
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PAH
Aug 16, 2017 18:37:41 GMT -5
via mobile
peppy likes this
Post by itellthefuture777 on Aug 16, 2017 18:37:41 GMT -5
Mannkind's factory $168 million exceeds the market cap $124 million)....lots of room for growth : )
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).
