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Post by itellthefuture777 on Apr 14, 2020 11:10:37 GMT -5
Treprostinil Technosphere ® . We are developing a dry powder formulation of treprostinil called Treprostinil Technosphere for the treatment of PAH, under a license from MannKind Corporation ( MannKind ). Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat ® inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. We believe this product, which is a small, pocket-sized inhaler that does not need electricity, will have significant convenience advantages over current inhaled prostacyclin alternatives, which rely on the use of lengthy breathing sessions with nebulizers that need to be plugged in. We expect to file for FDA approval of this therapy in the near term, once we compete the necessary studies. sec.report/Document/0001082554-20-000004/ |
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Post by peppy on Apr 14, 2020 11:19:35 GMT -5
Treprostinil Technosphere ® . We are developing a dry powder formulation of treprostinil called Treprostinil Technosphere for the treatment of PAH, under a license from MannKind Corporation ( MannKind ). Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat ® inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. We believe this product, which is a small, pocket-sized inhaler that does not need electricity, will have significant convenience advantages over current inhaled prostacyclin alternatives, which rely on the use of lengthy breathing sessions with nebulizers that need to be plugged in. We expect to file for FDA approval of this therapy in the near term, once we compete the necessary studies.sec.report/Document/0001082554-20-000004/thank you itell. This is the reason for the price pop.  |
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Post by mango on Apr 14, 2020 11:42:07 GMT -5
Treprostinil Technosphere ® . We are developing a dry powder formulation of treprostinil called Treprostinil Technosphere for the treatment of PAH, under a license from MannKind Corporation ( MannKind ). Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat ® inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. We believe this product, which is a small, pocket-sized inhaler that does not need electricity, will have significant convenience advantages over current inhaled prostacyclin alternatives, which rely on the use of lengthy breathing sessions with nebulizers that need to be plugged in. We expect to file for FDA approval of this therapy in the near term, once we compete the necessary studies.sec.report/Document/0001082554-20-000004/thank you itell. This is the reason for the price pop. The TreT clinical trial will be wrapping up very soon. TreT coming to a town near you. Estimated Primary Completion Date : May 2020 Estimated Study Completion Date : August 2020 |
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Post by sellhighdrinklow on Apr 14, 2020 11:45:51 GMT -5
If all goes as hoped with the study, what kind of income can MNKD hope to receive if FDA approved, etc., etc?
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Post by peppy on Apr 14, 2020 11:48:33 GMT -5
If all goes as hoped with the study, what kind of income can MNKD hope to receive if FDA approved, etc., etc? I do not know. However, smarty pants over here is wondering if TrepT will disappear from pharmacy shelves like hydroxychloroquine. |
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Post by mango on Apr 14, 2020 12:51:16 GMT -5
If all goes as hoped with the study, what kind of income can MNKD hope to receive if FDA approved, etc., etc? I believe the current Tyvaso net product sales is ~500M and is expected to increase not only due to more general PAH patients, but also because of new indications (new PAH groups) for inhaled treprostinil that are currently in ongoing clinical trials. Martine Rothblatt has spoken on this several times and has stated it could add tens of thousands of additional patients to inhaled treprostinil therapy, which means tens of thousands of more Technosphere Treprostinil patients and significantly more $ in royalties. MannKind will receive low double digit royalties. If we use the lowest double digit royalty percentage possible, 10%, that equates to ~50M annually. The actual amount will likely grow and become much more over time and from the new indications/WHO Groups. |
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Post by itellthefuture777 on Apr 14, 2020 13:06:46 GMT -5
Treprostinil Technosphere ® . We are developing a dry powder formulation of treprostinil called Treprostinil Technosphere for the treatment of PAH, under a license from MannKind Corporation ( MannKind ). Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat ® inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. We believe this product, which is a small, pocket-sized inhaler that does not need electricity, will have significant convenience advantages over current inhaled prostacyclin alternatives, which rely on the use of lengthy breathing sessions with nebulizers that need to be plugged in. We expect to file for FDA approval of this therapy in the near term, once we compete the necessary studies.sec.report/Document/0001082554-20-000004/thank you itell. This is the reason for the price pop. Hey Mango does this mean we can add that $10 billion sales worth of Insulin to the books now that Mannkind bought from Pfizer for only $3 million? www.fda.gov/news-events/press-announcements/insulin-gains-new-pathway-increased-competition |
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Post by mango on Apr 14, 2020 13:11:01 GMT -5
If all goes as hoped with the study, what kind of income can MNKD hope to receive if FDA approved, etc., etc? I believe the current Tyvaso net product sales is ~500M and is expected to increase not only due to more general PAH patients, but also because of new indications (new PAH groups) for inhaled treprostinil that are currently in ongoing clinical trials. Martine Rothblatt has spoken on this several times and has stated it could add tens of thousands of additional patients to inhaled treprostinil therapy, which means tens of thousands of more Technosphere Treprostinil patients and significantly more $ in royalties. MannKind will receive low double digit royalties. If we use the lowest double digit royalty percentage possible, 10%, that equates to ~50M annually. The actual amount will likely grow and become much more over time and from the new indications/WHO Groups. After a quick glance, I may be off by ~100M on the Tyvaso annual net product sales, which appear to be a little over 400M. I believe the $500M I was referring to is in addition to the tens of thousands of additional/new patients after the clinical trials wrap up and from general increase in PAH patient populations. So, starting out, our number may be closer to ~40M but is highly likely to grow to 50M in the short term, and beyond that in the long term. 😎 |
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Post by itellthefuture777 on Apr 14, 2020 13:13:27 GMT -5
www.fda.gov/news-events/press-announcements/insulin-gains-new-pathway-increased-competitionToday is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies. Biologic drugs, including insulin, treat some of the most serious diseases and conditions. The drugs transitioning today are used in the treatment, diagnosis and prevention of many of these conditions, including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more. But these life-saving drugs often also contribute significantly to drug costs. Historically, it was more difficult to develop generic versions of these drugs under the Federal Food, Drug and Cosmetic (FD&C) Act due to scientific challenges and limitations on the scope of data that can be relied upon in a generic drug application. This framework contributed to limited competition for these drugs, resulting in fewer choices and higher prices for patients. Today’s transition opens a new pathway for manufacturers to seek FDA approval of and bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition. When Congress created the biosimilars pathway in the Biologics Price Competition and Innovation Act of 2009, Congress also created a 10-year timeline for stakeholders to prepare for the regulatory transition of biological products that were historically regulated under the FD&C Act; now that the day has arrived, the FDA can begin receiving applications for proposed biosimilars to these licensed transition biological products, including insulin products that millions of Americans rely on every day to maintain stable blood glucose. Approved biosimilars will be able to come to market, where there is incredible potential to reduce health care costs, as has been seen with increased generic drug offerings. On the generic drugs side, we know from an FDA analysis that even with one generic on the market, prices are 31 to 39% lower than before the generic competition. Similarly, biosimilars marketed in the U.S. typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products. Over the last 10 years, the FDA has worked hard to establish a strong framework for the biosimilar and interchangeable regulatory pathway, as well as providing clarity to all involved on what the transition means to them and how it may affect our many stakeholders. Our Biosimilars Action Plan was established to improve the efficiency of the biosimilar and interchangeable product development and approval process and to maximize scientific and regulatory clarity for the biosimilar product development community. Through this action plan, we’ve worked to support robust competition from biosimilars, including supporting market competition and providing clear direction to industry on many relevant topics leading up to the transition. In just the last six months, we’ve taken several important actions on biosimilars, and in preparation for this transition, including partnering with the Federal Trade Commission regarding efforts to address false or misleading statements and promotional communications by biologic product manufacturers, deter anti-competitive business practices and support a competitive marketplace for biosimilars; issuing a final rule, draft guidance and final guidances to provide clarity to industry; providing information for patients and health care providers about what the transition means to them; and expanding and digitizing the FDA’s database of FDA-licensed biological products, otherwise known as the Purple Book. These actions, among the many others we’ve taken in this space, reflect the tireless work of our dedicated workforce to ensure a smooth regulatory transition and provide clarity for biosimilar developers. We stand ready to review incoming applications from industry. We will also continue to work closely with those interested in producing biosimilar and interchangeable products to support efficiency in development, review and approval of these medicines. Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ### So..we can add that $10 billion sales worth of Insulin Mannkind owns to the books now? |
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Post by cjm18 on Apr 14, 2020 15:01:16 GMT -5
I believe the current Tyvaso net product sales is ~500M and is expected to increase not only due to more general PAH patients, but also because of new indications (new PAH groups) for inhaled treprostinil that are currently in ongoing clinical trials. Martine Rothblatt has spoken on this several times and has stated it could add tens of thousands of additional patients to inhaled treprostinil therapy, which means tens of thousands of more Technosphere Treprostinil patients and significantly more $ in royalties. MannKind will receive low double digit royalties. If we use the lowest double digit royalty percentage possible, 10%, that equates to ~50M annually. The actual amount will likely grow and become much more over time and from the new indications/WHO Groups. After a quick glance, I may be off by ~100M on the Tyvaso annual net product sales, which appear to be a little over 400M. I believe the $500M I was referring to is in addition to the tens of thousands of additional/new patients after the clinical trials wrap up and from general increase in PAH patient populations. So, starting out, our number may be closer to ~40M but is highly likely to grow to 50M in the short term, and beyond that in the long term. 😎 I recall Mc speaking To the 400m but he threw out a larger number that included the label change. Don’t remember the number. Ok it was his latest conference. Said 50m from 500m in sales of tyvaso but new indications could double or triple that. |
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Post by brotherm1 on Apr 14, 2020 15:57:40 GMT -5
I’d keep an eye on Liquidia. They recently said they plan to file an NDA around November for their inhalable trepostinil. They don’t appear to have a lot of money for marketing power now, but I suspect they will look for a partner
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Post by parrerob on Apr 14, 2020 16:37:06 GMT -5
Guys... don't dream too mutch or too soon.... it will take time to arrive at a 50M$ fee... time to be hopefully approved, then to be commercialized then the switch will be not 0/1.
Very good news but we still need to cover the following 2/3 years.
Just to underline that this investment is still long, but very long.
The very next future (months) is not so exiting as we will have scripts anyhow low, we will have a quarter conference based on flat quarter (who is following since time the company knows very well what happen normally after each earning call)...
Scripts will recover quite sure (don't think our patients will suffer so much the financial crisis after the virus and social restrictions).
If We are able to survive 2022 will be finally the year where the company will be really evaluated by the market. From then my investment in mnkd will start to make sense.
Till then we need ~150M$, some will come from milestones, a few from Afrezza, some from loan...: rollercoaster.
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Post by radgray68 on Apr 14, 2020 17:47:19 GMT -5
The first piece of information I'm looking for is the retention rate of patients on Tre-T; those who request to stay on it after they've completed the trial. My guess/hope is, we have close to 100% ask to remain on it but anything close to 70% or more might still excite researchers and, more importantly, new shareholders. Am I the only one who is still hopeful for go ahead on the 2nd undisclosed molecule later this year if Tre-T trials are stellar?
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Post by mango on Apr 14, 2020 17:58:00 GMT -5
The first piece of information I'm looking for is the retention rate of patients on Tre-T; those who request to stay on it after they've completed the trial. My guess/hope is, we have close to 100% ask to remain on it but anything close to 70% or more might still excite researchers and, more importantly, new shareholders. Am I the only one who is still hopeful for go ahead on the 2nd undisclosed molecule later this year if Tre-T trials are stellar? My thinking is they are waiting until after successful TreT trial and/or approval before triggering the green light on the second molecule. Makes logical sense. I personally believe TreT will meet all of the primary and secondary endpoints and become a life-changer for people suffering with PAH. |
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Post by radgray68 on Apr 14, 2020 18:08:42 GMT -5
The first piece of information I'm looking for is the retention rate of patients on Tre-T; those who request to stay on it after they've completed the trial. My guess/hope is, we have close to 100% ask to remain on it but anything close to 70% or more might still excite researchers and, more importantly, new shareholders. Am I the only one who is still hopeful for go ahead on the 2nd undisclosed molecule later this year if Tre-T trials are stellar? My thinking is they are waiting until after successful TreT trial and/or approval before triggering the green light on the second molecule. Makes logical sense. I personally believe TreT will meet all of the primary and secondary endpoints and become a life-changer for people suffering with PAH. FDA ever fast track a drug because of patient requests/humanitarian reasons? We are working with a pretty well understood drug. Just a passing thought. Approval well before end of 2021 would be sweet. |
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