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Post by wgreystone on Oct 3, 2018 13:52:57 GMT -5
Why RLS is still so quiet? Don't even have a web site.
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Post by jlaw277 on Oct 3, 2018 14:05:26 GMT -5
Question: Per item #4 above, does this mean that TreT could replace Remodulin (subcutaneous & IV), Tyvaso and Orenitram?
That represents collectively $1.23 Billion in sales in 2017. A low teens royalty (12%) on net sales would equal almost $150 million per year. And that is just on UTHR's existing revenues and does not include incremental market share a Best-in-Class drug would win. I had thought that IV and subcutaneous applications of Remodulin had more to do with the functional needs (i.e. long duration) and wouldn't be applicable to the TreT inhalable option. Very exciting. Yes, that is my impression from listening to what Mike said in his presentation. Mike actually specifically mentioned how much annual sales each of these products generates. I think that makes sense as all of these different products are actually based on the same active ingredient (Treprostinil, which also forms the basis of Tre-T), with the main differences among them being how they are administered. This article ( A Comprehensive Review of Treprostinil Pharmacokinetics via Four Routes of Administration) provides a brief summary and comparison of these products. Interestingly, $150 million per year (for Mannkind) is also the number I have in my mind. I think that is a realistic number if Tre-T indeed turns out to be "best-in-class". In this video, Martine Rothblatt noted that the annual revenue of the PAH drugs of UT is about $1.5 billion and that UT is paying $150 million royalty annually to GSK (because UT originally got the prototype of the PAH drugs from GSK for $25,000 + a 10% royalty). Talking about investment returns of GSK on this! Thank you for the reply. That is what I was hoping you would say. If you look at Slide 83 of the presentation they did after the ADA meeting, it quantifies the PAH market as $6+ billion with roughly $2.6 billion associated with prostacyclin related drugs. I think that a Best in Class would capture a good chunk of that. I think that the $1.5 billion number MR mentions has come down due to decreased revenues in Tyvaso ($100mm less per year than 2015). There is also a good review of the RLS opportunity on page 84. |
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Post by nylefty on Oct 3, 2018 18:08:49 GMT -5
Why RLS is still so quiet? Don't even have a web site. It's not a public company. Why do you think you deserve to be told by a private company what it's doing? |
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Post by tomtabb on Oct 3, 2018 18:26:36 GMT -5
Why RLS is still so quiet? Don't even have a web site. It's not a public company. Why do you think you deserve to be told by a private company what it's doing? I'm not sure how to interpret this from yesterday -- trademarks.justia.com/868/98/receptor-life-86898208.html"Status 603 - Abandoned - After Ex Parte Appeal" Does that mean they are no longer "Receptor Life Sciences"? |
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Post by sayhey24 on Oct 3, 2018 18:49:36 GMT -5
Mike said - "We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences"
I doubt he would call them that if that was not their name but does it matter? As long has they delivery on THC/CBD products which rock this cannabinoid "hot space" is all I care about.
We should hear soon on this.
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Post by nylefty on Oct 3, 2018 20:05:35 GMT -5
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Post by nylefty on Oct 3, 2018 22:37:30 GMT -5
AFAIK Receptor Life Sciences can continue to do business under that name and apply for trademarks for whatever products they come up with. Seems to me that it makes little difference that they can't trademark their company name since under the reasoning of the Trademark Office no other company could trademark that name either.
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Post by porkini on Oct 4, 2018 0:22:30 GMT -5
Why RLS is still so quiet? Don't even have a web site. Not quite true and might not quite be your definition of a website, but here ya go: receptorlife.com/Thanks to some ID10T posting every freaking thing they found, they took away your right-click, so thanks in arrears. |
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Post by prcgorman2 on Oct 4, 2018 6:05:12 GMT -5
AFAIK Receptor Life Sciences can continue to do business under that name and apply for trademarks for whatever products they come up with. Seems to me that it makes little difference that they can't trademark their company name since under the reasoning of the Trademark Office no other company could trademark that name either. The denial does seem like the "mark" of a petty technocrat at the Trademark Office. |
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Post by lakers on Oct 4, 2018 17:27:47 GMT -5
Mike said - "We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences" I doubt he would call them that if that was not their name but does it matter? As long has they delivery on THC/CBD products which rock this cannabinoid "hot space" is all I care about. We should hear soon on this. Marinol for CINV IND filing will trigger a milestone payment from RLS. So will Other stealth compounds. Mike Castagna @castagna2011 Replying to @chuckbass1906 @kevinmik Kevin I don’t run RLS...We were years ahead of this market by partnering with RLS and they have been quietly working through the emerging market dynamics and I expect them to be more transparent in the future. 2:58 AM - Oct 4, 2018 |
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Post by winner on Oct 5, 2018 5:53:25 GMT -5
prcgorman2 posted: The mark of a petty technocrat
or could it be a vested interest by entities unknown to do whatever they can to make life difficult for MannKind. So looking forward to the coming months / years. I am of the opinion that we equity shareholders will be compensated exceptionally well for standing behind MannKind in their hour (years) of need.
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Post by lakers on Oct 11, 2018 2:20:45 GMT -5
Tobra-T, DNAse in Bucket-1 most likely move forward next. See the official slide on buckets.mnkd.proboards.com/thread/9037/mannkind-formulations-bucketsTop bucket is known compounds already delivered to the lung, not a lot of work and we have been at FDA to pass on this one, know exactly what’s required, very simple development program, very high predictability of success. med.stanford.edu/cfcenter/education/english/Meds-Nebs.htmlInhaled Medications and Nebulizers The Cystic Fibrosis Foundation and the Stanford CF Center staff recommend the following sequence for inhaled medications: Bronchodilators (Albuterol, Combivent, Xopenex) to open the airways Hypertonic Saline (7%) to mobilize mucus and improve airway clearance Pulmozyme (DNase) to thin mucus*Airway Clearance Technique: Vest, Flutter, Chest PT, IPV, etc. Antibiotics (TOBI, Colistin, Cayston). The previous therapies open and clear the airways of mucus, allowing these antibiotics to work on remaining bacteria. Steroids (Flovent, Pulmicort, QVAR) * When using the Vest for airway clearance, make sure there is aerosol delivery during the entire vest session. If you start coughing blood, temporarily stop Pulmozine, saline, airway clearance technique, and inhaled antibiotics. Call your CF doctor or nurse for further advice. With a respiratory illness or change in symptoms: Begin or increase airway clearance techniques. Use breathing treatments as ordered; you can use bronchodilators every three to four hours, and often additional Vest and/or hypertonic saline treatments are useful. Contact your CF doctor or nurse to see if antibiotics or additional intervention is needed. www.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix. Bucket two, known compounds non-lung delivery, acute use, those aren’t going to have as much work to be done because you’re acute in nature, not a lot of chronic administration and tox studies. Palonosetron for CINV, Rizatriptan (Merk), or Sumatriptan (GSK) for Migraine will likely round out the four compounds moving forward.As per the latest research citings of National Cancer Institute, in 2016 there were approximately 15.5 million cancer survivors due to early intervention of chemotherapy. Business analysts predict the rise in survivors to 20.3 million by 2030. The etiology of CINV is not very well understood, however the involvement of the chemo trigger zone and gastrointestinal mucosa have been reported in multiple studies. Chemotherapy induced nausea and vomiting are classified as acute, refractory and delayed. The intensity of CINV depends on the use of drugs in chemotherapy and patient factors. The challenges associated with the antiemetic prescribed for CINV are nonadherence and lack of effective guidelines for CINV treatment. Newer antiemetic drugs such as palonosetron and aprepitant have shown good pharmacokinetic properties in adult cancer patients, still more clinical trials are required for its safety in children. The major players steering the chemotherapy induced nausea and vomiting treatment market are Baxter Pharmaceuticals, Eisai, Inc., Helsinn Healthcare, GlaxoSmithkline, Plc, Merck & Co., Inc., ProStrakan, Inc., Pfizer, Inc., Sanofi-Aventis, Solvay Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. www.tampabayreview.com/news/business/chemotherapy-induced-nausea-vomiting-treatment-market-expected-reach-us-3626-1-mn-2026/38010/Potentially, Merk can partner with Mnkd for Inhaled Palonosetron and Rizatriptan. Alternatively, GSK could partner with Mnkd for Inhaled Palonosetron, Sumatriptan, and Tobra-T. It has preclinical GSK-2225745 for CF.
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Post by peppy on Oct 11, 2018 6:07:22 GMT -5
in response to above, come on baby let the good times roll.  Note date: Apr 27, 2017 at 6:59pm Post by peppy on Apr 27, 2017 at 6:59pm 'Superbug' fungus new menace in US hospitals, mostly NY, NJ The fungus called Candida auris is a harmful form of yeast. Scientists say it can be hard to identify with standard lab tests. U.S. health officials sounded alarms last year because two of the three kinds of commonly used antifungal drugs have little effect. "It's acting like a superbug" bacteria, said Dr. Paige Armstrong of the Centers for Disease Control and Prevention. On Tuesday, state health officials provided new details about the 44 cases in New York. Seventeen New York patients died, but state officials said everyone infected had other illnesses and the fungus was not necessarily the cause of death. New Jersey has had 15 cases, Illinois, 4, and there's been one case in Indiana, Maryland and Massachusetts, according to the CDC. abcnews.go.com/Health/wireStory/superbug-fungus-menace-us-hospitals-ny-nj-47017203 www.washingtonpost.com/news/to-your-health/wp/2017/03/10/deadly-fungal-infection-that-doctors-have-been-fearing-now-reported-in-u-s/?utm_term=.1202f771606fwww.merckmanuals.com/professional/infectious-diseases/fungi/antifungal-drugsAmphotericin BAmphotericin B has been the mainstay of antifungal therapy for invasive and serious mycoses, but other antifungals (eg, fluconazole, voriconazole, posaconazole, the echinocandins) are now considered first-line drugs for many of these infections. Although amphotericin B does not have good CSF penetration, it is still effective for certain mycoses such as cryptococcal meningitis. For chronic mycoses, amphotericin B deoxycholate is usually started at ≥ 0.3 mg/kg IV once/day, increased as tolerated to the desired dose (0.4 to 1.0 mg/kg; generally not > 50 mg/day); many patients tolerate the target dose on the first day. For acute, life-threatening mycoses, amphotericin B deoxycholate may be started at 0.6 to 1.0 mg/kg IV once/day. Amphotericin b is a Lipid-based Polyene Antifungal and Polyene Antifungal. The chemical classification of amphotericin b is Polyenes. FDA Pharmacology Summary from FDA Pharm Classes Amphotercin B is a polyene antifungal antibiotic produced by Streptomyces nodosus, with antifungal activity. Amphotericin B binds to ergosterol, an essential component of the fungal cell membrane, thereby causing depolarization of the membrane and altering cell membrane permeability. This leads to leakage of important intracellular components, cell rupture, and eventually cell death. This agent may also induce oxidative damage in fungal cells and has been reported to stimulate host immune cells. Molecular Formula: C47H73NO17 pubchem.ncbi.nlm.nih.gov/compound/amphotericin_b#section=Top Read more: mnkd.proboards.com/thread/7692/superbug-fungus-candida-auris-deaths?page=1#ixzz5TcWlMcyE |
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Post by jlaw277 on Oct 17, 2018 8:56:07 GMT -5
Tobra-T, DNAse in Bucket-1 most likely move forward next. See the official slide on buckets.mnkd.proboards.com/thread/9037/mannkind-formulations-bucketsTop bucket is known compounds already delivered to the lung, not a lot of work and we have been at FDA to pass on this one, know exactly what’s required, very simple development program, very high predictability of success. med.stanford.edu/cfcenter/education/english/Meds-Nebs.htmlInhaled Medications and Nebulizers The Cystic Fibrosis Foundation and the Stanford CF Center staff recommend the following sequence for inhaled medications: Bronchodilators (Albuterol, Combivent, Xopenex) to open the airways Hypertonic Saline (7%) to mobilize mucus and improve airway clearance Pulmozyme (DNase) to thin mucus*Airway Clearance Technique: Vest, Flutter, Chest PT, IPV, etc. Antibiotics (TOBI, Colistin, Cayston). The previous therapies open and clear the airways of mucus, allowing these antibiotics to work on remaining bacteria. Steroids (Flovent, Pulmicort, QVAR) * When using the Vest for airway clearance, make sure there is aerosol delivery during the entire vest session. If you start coughing blood, temporarily stop Pulmozine, saline, airway clearance technique, and inhaled antibiotics. Call your CF doctor or nurse for further advice. With a respiratory illness or change in symptoms: Begin or increase airway clearance techniques. Use breathing treatments as ordered; you can use bronchodilators every three to four hours, and often additional Vest and/or hypertonic saline treatments are useful. Contact your CF doctor or nurse to see if antibiotics or additional intervention is needed. www.marketresearch.com/product/sample-8026537.pdfShows potential partners on page 15, Appendix. Bucket two, known compounds non-lung delivery, acute use, those aren’t going to have as much work to be done because you’re acute in nature, not a lot of chronic administration and tox studies. Palonosetron for CINV, Rizatriptan (Merk), or Sumatriptan (GSK) for Migraine will likely round out the four compounds moving forward.As per the latest research citings of National Cancer Institute, in 2016 there were approximately 15.5 million cancer survivors due to early intervention of chemotherapy. Business analysts predict the rise in survivors to 20.3 million by 2030. The etiology of CINV is not very well understood, however the involvement of the chemo trigger zone and gastrointestinal mucosa have been reported in multiple studies. Chemotherapy induced nausea and vomiting are classified as acute, refractory and delayed. The intensity of CINV depends on the use of drugs in chemotherapy and patient factors. The challenges associated with the antiemetic prescribed for CINV are nonadherence and lack of effective guidelines for CINV treatment. Newer antiemetic drugs such as palonosetron and aprepitant have shown good pharmacokinetic properties in adult cancer patients, still more clinical trials are required for its safety in children. The major players steering the chemotherapy induced nausea and vomiting treatment market are Baxter Pharmaceuticals, Eisai, Inc., Helsinn Healthcare, GlaxoSmithkline, Plc, Merck & Co., Inc., ProStrakan, Inc., Pfizer, Inc., Sanofi-Aventis, Solvay Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. www.tampabayreview.com/news/business/chemotherapy-induced-nausea-vomiting-treatment-market-expected-reach-us-3626-1-mn-2026/38010/Potentially, Merk can partner with Mnkd for Inhaled Palonosetron and Rizatriptan. Alternatively, GSK could partner with Mnkd for Inhaled Palonosetron, Sumatriptan, and Tobra-T. It has preclinical GSK-2225745 for CF. It looks like per a 2013 article that the TOBI annual US Sales are about $350 million. Per the same deal terms that would be roughly $42 million per year in royalties assuming similar sales with a superior product to what is out there now including generic. As of August, Mylan now has rights to the Novartis formulation. Perhaps that might lead the way to a joint partnership with Mylan on EPI. Maybe you get a kit with a needle and an inhaler. |
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Post by slugworth008 on Oct 17, 2018 9:09:29 GMT -5
RLS is dead to me - JMHO
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