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Post by lakers on Oct 31, 2018 10:42:06 GMT -5
When I heard Rothblatt say that, I thought the same thing. Rothblatt seems to like to simultaneously explore different solutions to a disease problem. Maybe both? I just re-listened to the question from Goldman (starts at roughly the 32:00 mark). Rothblatt said: "... during the past quarter, we acquired the exclusive rights to a very exciting product for idiopathic fibrosis which is not associated with PAH."
However, in that answer he also mentions the Samumed deal which would indicate that he was not talking about Samumed initially. So there is a possibility that he is initially talking about a MNKD approach towards IPF with a new version of tobramycin. Remember that tobramycin resides in Box 1 of Mike's pipeline matrix. The fact that Martine mentions this in response to what they are doing outside the scope of PAH correlates well with the description of the $10 million funding in the 10Q: "We also entered into a research agreement for the conduct of research by MannKind for products outside the scope of the licensing and collaboration agreement. MannKind received an initial payment of $10.0 million in consideration for its performance under the research agreement. The $10.0 million payment is included within research and development costs on our consolidated statements of operations for the three and nine months ended September 30, 2018."Q - Unidentified Analyst Is there any preferences with regard to collaboration vis-à-vis additional products as you get rather in license and partner with for specific areas you are focusing. Michael Castagna Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis, idiopathic pulmonary fibrosis are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs. www.google.com/amp/s/seekingalpha.com/amp/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conference
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Post by lakers on Oct 31, 2018 4:16:30 GMT -5
www.finsmes.com/2018/10/receptor-holdings-secures-29m-in-funding-round.htmlLed by Greg Wesner, Chief Executive Officer, Receptor Holdings owns or has exclusively licensed drug delivery technologies characterized by high bioavailability, rapid onset of action and lower variability and is applying these technologies to the field of cannabinoid therapy. Its wholly-owned subsidiary, Receptor Life Sciences, is focused on the development of cannabinoid drugs regulated by the U.S. Food and Drug Administration. It controls patented and disruptive oral and inhaled drug delivery technologies that are validated by their use in FDA-approved products. In initial studies, its oral dosage formulations facilitated rapid drug absorption from the GI tract with higher bioavailability than has been reported for existing oral cannabinoid products
[Bucket-1 means partnering with the original Pharmas. My guess is GWPH (not Greg Wesner Pharmaceutical Holdings) which also targets the same fields: epilepsy, MS, neurological disorders, cancer pain, PTSD].
Receptor’s inhalation technology combines a breath-powered inhaler with dry powder cannabinoid formulations that provides rapid, precise and discreet delivery of cannabinoid medicines to the deep lung.
Receptor Holdings also plans to introduce its technologies to the non-prescription cannabinoid markets that are developing in Canada, Europe and elsewhere.The last paragraph opens up a huge market, no prescription, no insurance, no PA, no ST, no PBM. RLS also develops its own inhaled Marinol (dronabinol) which is an FDA approved drug which has been marketed as a safe alternative to medicinal marijuana. Marinol is prescribed to help combat the side effects of cancer treatment, such as loss of appetite, nausea, vomiting, and pain. Marinol may imply partnering with original Pharmas too. Oral Dosage Forms CANNABINOID PRODUCT CANDIDATES These product candidates are powered by an FDA-approved absorption-enhancing excipient that facilitates rapid drug absorption from the GI tract and increases bioavailability. Cannabinoids can be formulated as tablets, capsules or liquid solutions. Inhaled Dry Powder CANNABINOID PRODUCT CANDIDATES Based on a best-in-class inhaled drug delivery platform, these product candidates combine a simple-to-use, breath-powered inhaler and cannabinoid dry powder formulations. Intended to provide ultra-rapid, precise and discreet delivery of cannabinoid medicines to the lung, without the need for heating or combustion.www.receptorlife.com/technologyAqueous solubility-enhancing excipient technologies: a review of recent developments www.europeanpharmaceuticalreview.com/article/70540/aqueous-solubility-enhancing-excipient-technologies-review-recent-developments/Application of novel excipients Although the conventional solubilising approaches illustrated thus far can improve aqueous solubility,11 many compounds remain challenging. Considerable effort has recently been devoted to identifying improved excipients and manufacturing processes for poorly water-soluble compounds. The two most commonly used categories will be discussed here as they are most commonly employed: lipid-based and amorphous-form stabilisers. The use of lipids to deliver hydrophobic compounds through the intestinal lumen takes advantage of the ability of lipids to solubilise these compounds and that there are natural pathways to facilitate absorption of lipidic substances.17 Due to the myriad of lipid excipient choices, developing these formulations requires specialised knowledge and the necessity to screen a large number of excipient options before selecting the one combination that has the greatest chemical and physical stability. The product manufacturing process also requires unique equipment, as the liquid formulation is usually filled into soft gelatin capsules. Recently, considerable effort has been devoted to the stabilisation of amorphous pharmaceuticals using excipients to trap compounds in physical configurations that have limited tendency to crystallise. Table 1 contains a list of some of these novel excipients. Foremost in this category are the polymers based on hydroxypropyl methylcellulose (HPMC)18 and its acetate succinate variation (HPMC AS).19 Pioneering work at Bend Research has shown how to create spray-dried dispersions with these and other polymers that stabilise many pharmaceuticals with poor aqueous solubility. As an alternative to spray-drying, melt extrusion has become quite popular and was the impetus for the polymeric excipient Soluplus20 and the polyvinyl alcohol product Parteck MXP.21 There has been recent progress in the quest to understand at the molecular level how these polymers work, and how to engineer even more effective polymeric solubilisers.22-24 Mesoporous silica25,26 and other structured materials27,28 can solubilise APIs via an adsorption mechanism. However, to be effective as an oral product, the excipient must not only solubilise APIs but must also extend the time that the API stays in solution in vivo.29,30 Thus, researchers have employed the artificial stomach-duodenum model31 during formulation development to study prototype formulations and successfully explored combinations of polymeric and mesoporous silica excipients32,33 to enhance oral bioavailability of compounds with poor aqueous solubility. Table 1: Novel excipients used to solubilise pharmaceuticals list companies, excipient type, trade names.Companies: Sigma Millipore, Keystone Nano, Dow Chemical, Ligand, Nanologica, Phytoption, BASF, CTD, Shin-Etsu, Fuji Chemical Industries.
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Post by lakers on Oct 30, 2018 18:28:11 GMT -5
Interestingly, GW could potentially collaborate with GWPH. They are destined to work together!
GW Pharmaceuticals, the manufacturer of the first U.S.-approved drug derived from marijuana, announced Friday it had raised a $345 million in a public offering [over-subscribed].
The British company won approval this year from the U.S. Food and Drug Administration for Epidiolex, a medicine based on cannabidiol (CBD). Clinical trials conducted partly at Children's Hospital of Philadelphia showed the drug helped to control some rare forms of pediatric epilepsy.
In a first for a cannabis-derived medicine, the U.S. Drug Enforcement Administration last week rescheduled the drug to become a Schedule 5 substance. All marijuana products had previously been considered Schedule 1, a designation given to substances considered to be highly addictive with no recognized medical use. The DEA did not reschedule any other cannabidiol products.
Epidiolex is expected to be available at U.S. pharmacies before the end of the year. GW's other cannabis-derived drug, the peppermint flavored THC and CBD mouth spray branded Sativex, is awaiting approval by the FDA for pain associated with cancer.
“The closing of the Series A round will allow us to initiate IND-enabling studies in the United States and to formalize collaborations in Canada and Europe,” said Greg Wesner, Chief Executive Officer of Receptor Holdings. “The growing consensus is that cannabinoids have the potential to meet numerous and significant unmet medical needs for indications including epilepsy, chronic pain and post-traumatic stress disorder. By leveraging validated drug delivery technologies, we believe our products have the potential to set the standard of care for cannabinoid medicines in terms of onset of action, bioavailability and consistency.
“formalize collaborations in Canada and Europe” could mean GW already partnered in U.S. He wants to extend that in EU, Canada? The fact that he needs money to formalize means RLS will pay a partner for R&D, which is Mnkd. Will there be an announcement soon?
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Post by lakers on Oct 30, 2018 15:56:18 GMT -5
Haven't posted here in a while but wanted to chime in, To me one of the most interesting points on the new receptor website is the other piece of their product pipeline, namely the oral version. We already know that the inhaled dry powder form is powered by Mannkind's technosphere BUT who is behind the oral technology below: From their website: These product candidates are powered by an FDA approved absorption enhancing excipient that facilitates rapid drug absorption from the GI tract and increases bio-availability. Cannabinoids can be formulated as tablets, capsules, or liquid solutions. Does that mean they have another partner in the space? Possibly GWPH’s Epidiolex, and Sativex, or Eisai’s Banzel. GW Pharma is also studying Epidiolex in other conditions — including an ongoing phase 3 trial in tuberous sclerosis, for which results are expected next year — and is working on a capsule version, two strategies commonly employed to increase patent protections on a product. GW Pharma also has patents on another product, Sativex, a more complex compound that includes both CBD and THC and has already been approved in many other countries. Read more: mnkd.proboards.com/thread/10596/receptor-raises-29-website-live?page=5#ixzz5VRyYuOocBoth companies would want to make Inhaled versions to provide precision-dosing, high bioavailability and predictable, rapid absorption with every treatment. As MC mentioned, RLS has at least 2 yrs 9 mos head start before anyone else in Inhaled CBD versions. If you take into account TS, it’s almost insurmountable for anyone else to catch up, a huge and deep moat. It’s just a matter of time before WS realizes this. GWPH or Eisai would have no choice but partner up. If GWPH gets smart, they could acquire RLS, then becomes dominant in this space for decades to come. In this space inhaling is not necessarily a bad word when one can smoke marijuana medically or recreationally. Mnkd could stand alone as an arms dealer to the Pharma. The question is whether UTHR or GWPH will make a move for Mnkd first and whether Mnkd can resist it. Everything has a price if it’s high enough.
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Post by lakers on Oct 30, 2018 4:51:56 GMT -5
Coordinated fund raising. RLS and GWPH target the same field and drugs. I can foresee a collaboration between them. Medical-marijuana company GW Pharma to sell $300 million in stock offering By Max A. Cherney Published: Oct 1, 2018 4:29 pm ET GW Pharmaceuticals PLC gwph-1.63% said late Monday that it plans to sell $300 million worth of American depositary shares. Shares in the company fell 1.6% after hours. GW is a U.K.-based pharmaceutical company that seeks to make products with cannabis. The underwriters have an option to buy $45 million more shares within 30 days. Goldman Sachs, Morgan Stanley, J.P. Morgan and Cowen and Company are acting as joint book-running managers for the offering. GW Pharmaceuticals PLC- (NASDAQ:GWPH) received a $227.00 target price from equities research analysts at Morgan Stanley in a research note issued to investors on Thursday, October 11th. The brokerage currently has a “buy” rating on the biopharmaceutical company’s stock. Morgan Stanley’s price objective would indicate a potential upside of 64.24% from the stock’s previous close. Any discussion about the merits of GW Pharmaceuticals stock has to start with Epidiolex. In June, Epidiolex made history as it became the first plant-based cannabinoid drug to be approved by the U.S. Food and Drug Administration (FDA). GW Pharmaceuticals won FDA approval for Epidiolex in treating two rare forms of epilepsy -- Dravet syndrome and Lennox-Gastaut syndrome (LGS). The biotech also received very good news for Epidiolex in September. The U.S. Drug Enforcement Administration (DEA) gave the drug the least-restrictive classification available for a controlled substance -- Schedule V. This scheduling makes it much easier for physicians to prescribe Epidiolex. GW Pharmaceuticals could have a blockbuster on its hands. Market research firm EvaluatePharma thinks Epidiolex could generate annual sales of around $1 billion by 2022. Goldman Sachs analyst Salveen Richter is even more optimistic, pegging peak annual sales for the drug at $2.2 billion. While GW Pharmaceuticals launches Epidiolex in the U.S., it's also pursuing regulatory approval in Europe. The company hopes to win European approval in early 2019. In addition, the biotech is evaluating Epidiolex in clinical studies for treating rare diseases tuberous sclerosis and Rett syndrome. But Epidiolex isn't GW's only product. The company currently markets cannabinoid drug Sativex in several countries as a treatment for multiple sclerosis spasticity. GW is conducting a late-stage study of Sativex in hopes of securing U.S. approval. It also has earlier-stage studies underway for other cannabinoids targeting treatment of epilepsy, autism spectrum disorders, glioblastoma, neonatal hypoxic-ischemic encephalopathy, and schizophrenia. www.google.com/amp/s/www.fool.com/amp/investing/2018/10/21/better-buy-gw-pharmaceuticals-plc-vs-22nd-century.aspx
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Post by lakers on Oct 30, 2018 3:44:53 GMT -5
“In the field of cannabinoid research, Dr. Devinsky served as a principal investigator for the development of GW Pharmaceuticals' Epidiolex (cannabidiol, or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.” www.receptorlife.com/leadershipWith the new funding, RLS could collaborate with GWPH in EU and Canada. “Drugmakers commonly make their medicines synthetically — think a lab, not a greenhouse. But because its medications employ cannabinoids, GW Pharma is also involved in agriculture, growing cannabis plants both in partnership with another company, British Sugar, and on its own. Epidiolex, for example, is made from cannabis plants that have a very high percentage of cannabidiol (CBD), a component of cannabis that is distinct from the psychoactive component, THC. Read more: The first cannabis-derived drug was just approved in the U.S. GW Pharma then extracts a purified substance with a high concentration of CBD and mixes it with sesame oil to make a syrup. Patients with the two diseases it was approved for, Lennox-Gastaut syndrome and Dravet syndrome, can consume Epidiolex on its own or mix with food. So does Epidiolex’s U.S. approval merely mean that CBD helps those with these diseases — and potentially more down the road? In other words, patients could buy CBD from other sources, especially since GW Pharma plans to charge about $32,500 a year for Epidiolex. (Notably, though, Epidiolex “comes at a slight discount” relative to a common anticonvulsant taken by Lennox-Gastaut patients, Eisai’s Banzel ESALY-1.48% according to Stifel analyst Paul Matteis.) Stephen Schultz, vice president of investor relations, says: “not exactly.” “Our position on the matter is we do what we do because we believe physicians and patients desire a FDA-approved medicine. And they do that because they prefer that and believe there are specific things that come with a FDA-approved medicine,” he said, including consistency in the product, health insurance coverage, dosing instructions, and information for physicians about side effects and potential interactions with other drugs. Epidiolex, “even though it has what, relatively speaking, seems like a fairly high price, actually the cost to the patient is much lower than any reasonably high-quality, artisanal CBD product at clinically-meaningful doses,” because Epidiolex would be covered by insurance, Schultz said. Drug pipeline and intellectual property GW Pharma is developing Epidiolex for two other medical conditions, and has other products in clinical trials for autism spectrum disorders, the aggressive cancer glioblastoma, schizophrenia and more. CBD is also thought to have potential in more broad-based conditions like anxiety and depression. Asked about these, spokesperson Schultz said that the company’s list of drugs in development represents “only a fraction of the work we’ve done.” “We have a treasure trove of evidence of how cannabinoids can be utilized in the therapeutic market, beyond what we described in our current pipeline,” he told MarketWatch. Because Epidiolex is considered an “orphan drug” in the U.S., it has a market exclusivity period of seven-and-a-half years, as well as 12 patents either granted or allowed by the U.S. Patent and Trademark Office. GW Pharma is also studying Epidiolex in other conditions — including an ongoing phase 3 trial in tuberous sclerosis, for which results are expected next year — and is working on a capsule version, two strategies commonly employed to increase patent protections on a product. GW Pharma also has patents on another product, Sativex, a more complex compound that includes both CBD and THC and has already been approved in many other countries. Supply agreements GW Pharma breeds cannabis plants “to have a specific fingerprint, to meet a specific need,” Schultz said, then clones them so each generation is exactly the same. The company works with British Sugar to grow cannabis plants, leasing glasshouses at a location that Vice called “Britain’s biggest weed greenhouse,” as well as growing its own cannabis plants, including for its Sativex product. How much can it eventually grow? GW Pharma has invested in expanding its manufacturing capacity in recent years, Schultz told MarketWatch, expecting high demand for its Epidiolex upon the U.S. launch. “As we need to expand growing and formulation capacity in other areas, we should be able to do that quite effectively,” Schultz said, describing the process of growing cannabis as “straightforward.” “We are quite experienced in sophisticated growing techniques. But in the end it’s an agricultural process — we can grow as much cannabis product as we need to.” www.marketwatch.com/amp/story/guid/8F025816-D081-11E8-B326-A961118322ECIMHO, the RLS’ Inhaled Marinol for CINV IND filing could trigger a Milestone payment. Potentially, GWPH could eventually acquire RLS for Inhaled Epidiolex, and Sativex. www.receptorlife.com/receptor-enters-into-collaboration-and-license-agreement-with-mannkindMannKind will be eligible to receive development and commercialization milestones of up to $102.25 million as well as mid-single to low double-digit royalties on net sales of product [Huge Market] www.curetoday.com/articles/fda-approves-liquid-formulation-of-thccontaining-drug-for-cinvFDA Approves Liquid Formulation of THC-Containing Drug for CINV Syndros is a liquid version of Marinol (dronabinol) soft gel capsules and contains tetrahydrocannabinol (THC), the primary active compound in cannabis (marijuana). Marinol is developed by AbbVie Inc. “Syndros is the first and only FDA-approved dronabinol solution for oral use. It is a liquid that is easy to swallow and allows for the dosage to be titrated to clinical effect,” John N. Kapoor, chairman, CEO and president of Insys,
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Post by lakers on Oct 20, 2018 12:00:20 GMT -5
Compounds with pre-clinical work done, ready for immediate partnership.
EpiHale: with Mylan, TEVA Palonosetron: CINV with GSK (Flolan)
Aerodynamic, and temperature stability are done:
Sumatriptan: Migraine with GSK (Imitrex)
Tobra-T: CF with Novartis (TOBI® Podhaler® (Tobramycin Inhalation Powder) ), Chiesi USA (BETHKIS® (Tobramycin Inhalation Solution) indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa), GSK
A second TS partnership is needed to sustain Pps above $3 to grease the skid for $2.38 note conversion in the next few months.
Three possible partnerships with GSK. James, BoD, was GSK CMO.
Humira-T seems the next great candidate for AbbVie. HUMIRA is a $22 B blockbuster in 2018. This could sustain Pps well over $3 * 10X.
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Post by lakers on Oct 18, 2018 15:12:51 GMT -5
MannKind has a patent on a Technosphere sumatriptan, an API commonly used for migraines. Pre-clinical studies showed that Sumatriptan-TS would go to work in ~5 minutes, while the widely-prescribed Imitrex (Sumatriptan - GSK) can take over an hour to relieve migraine pain. mnholdem said: www.google.com/patents/US8785396 - 13. A method of treating a migraine comprising: providing a patient with migraine symptoms an inhaler comprising the pharmaceutical composition of claim 1 in a dry powder form comprising bis-3,6[(N-fumaryl-4-aminobutyl)]-2,5-diketopiperazine, the aliphatic amino acid and 1-50 mg of sumatriptan or rizatriptan; wherein the aliphatic amino acid is L-leucine and wherein a therapeutically effective amount of said dry powder composition is administered to said patient by oral inhalation. The branded version of this drug is call Imitrex, and is manufactured and distributed by GlaxoSmithKline. The generic version is manufactured by Suntory Pharmaceuticals. Here is a link to their webpage for their sumatriptan: www.sumainject.com/aspx/HowToUse.aspxRead more: mnkd.proboards.com/thread/3590/technosphere-migraine-connection-raymond-urbanski#ixzz5UJcQwjJkExpress Scripts Covers Amgen and Lilly, but Snubs Teva's New Migraine Drug www.biospace.com/article/express-scripts-covers-amgen-and-lilly-but-snubs-teva-s-new-migraine-drug/Published: Oct 17, 2018 In its analysis, Reuters said Amgen’s Aimovig is a preferred migraine treatment. However, before a patient can be prescribed the drug, he or she must first try two older preventative treatments, according to the article
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Post by lakers on Oct 16, 2018 14:26:57 GMT -5
I would really, really, really like to see Technosphere Tobramycin (T-Tobra or T-Tobi) and would also like to see Technosphere Amphotercin B (T-AmphB) just as much!!!!!!!!!!!!! It’s called Tobra-T, pronounced as To-braT, the term of endearment. Think of it as the spoiling brat brother of TOBI Podhaler® and Mnkd as the merchant arms dealer which is the company it was destined to become with the valuation it deserves.
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Post by lakers on Oct 16, 2018 14:02:53 GMT -5
Don’t forget that MC made a point to mention a possible molecule partnership with Novartis in his last cc as well. Would be huge if they did a second or third molecule partnership outside of UTHR with a big pharmaceutical like Novartis. Am not saying they will but no reason for MC to mention if not thinking of it or perhaps in very early discussions. It’s rather obvious what the second compound is (Tobra-T for Cystic Fibrosis) and who the potential parter is (Novartis). Trobramycin was first approved to treat these infection in 1997 under the brand name TOBI by Novartis, and in 2002 as Bethkis by Chiesi USA. Dr. Reddy acquired Tobramycin Inhalation Solution (generic equivalent to Tobi™) from Teva. in 2016. Aug. 31, 2018, Mylan closed an agreement with Novartis to purchase the worldwide rights to commercialize their global cystic fibrosis products consisting of TOBI Podhaler® and TOBI® solution, which will further enhance Mylan’s respiratory portfolio in the U.S., Europe and certain Rest of World markets. Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018. Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=5#ixzz5Sol4q1LbLike all aminoglycosides,tobramycin does not pass the gastro-intestinal tract, so for systemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin. The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis. Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections: meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague). Tobramycin is preferred over gentamicin for Pseudomonas aeruginosa pneumonia due to better lung penetration. www.google.com/amp/s/seekingalpha.com/amp/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conferenceBucket one turns out to be one of the easiest. It really is known compounds already delivered to the lung. We met with FDA. We saw very clear feedback in terms of the pathway to approval. Limited to no clinical work and really a program that looks at Phase 1 dose finding bioequivalency. So a very efficient program to develop and not a lot of concerns when the drugs are delivered to the lung. You don't have to worry about the dosing as much. And in that particular one, we were looking at the higher end dose saying, can we achieve higher therapeutic levels than we have seen with other Treprostinil relay programs and that was the unmet need we were trying to solve for in addition to the convenience factor. Q - Unidentified Analyst Is there any preferences with regard to collaboration vis-à-vis additional products as you get rather in license and partner with for specific areas you are focusing. Michael Castagna Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis, idiopathic pulmonary fibrosis are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs.
The other area I look at is respiratory, there is a lot of inhalers that really just haven't been reinvented. So I think as we forget about the old drugs work really well, but sometimes you don’t always get enough drugs. So when we think about a lot of the inhalers that are out there, we think there is opportunity in the respiratory space. Respiratory is the one that I wouldn't go alone, but you could see an exclusive partnership with someone that's in the respiratory space that want the device powder portfolio that we could do a lot of work for.
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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 lakers on Oct 5, 2018 3:32:13 GMT -5
One stealth compound could be: Nabiximols (USAN,[1] trade name Sativex) is a specific extract of Cannabis that was approved as a botanical drug in the United Kingdom in 2010 as a mouth spray to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis; it was developed by the UK company GW Pharmaceuticals.[2][3] The drug is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). Each spray delivers a dose of 2.7 mg THC and 2.5 mg CBD. In May 2003 GW Pharmaceuticals and Bayer entered into an exclusive marketing agreement for GW's cannabis-based medicinal extract product, to be marketed under the brand name Sativex. "Bayer has obtained exclusive rights to market Sativex in the UK. In addition, Bayer has the option for a limited period to negotiate the marketing rights in other countries in European Union and selected other countries around the world." In April 2011, GW licensed to Novartis the rights to commercialise nabiximols in Asia (excluding China and Japan), Africa and the Middle East (excluding Israel).[4] In June 2010, the Medicines and Healthcare products Regulatory Agency of the United Kingdom licensed nabiximols as a prescription-only medicine for the treatment of spasticity due to multiple sclerosis. This regulatory authorization represents the world's first full regulatory approval for the medicine. The spray is being marketed in the UK by Bayer Schering Pharma. Many people with MS cannot receive nabiximols due to local National Health Service (NHS) resistance to its funding;[5][6] but, in August 2014, the NHS in Wales agreed to fund Sativex for people with multiple sclerosis.[7] Nabiximols was also approved in Spain for MS spasticity in the second half of 2010 and was launched in that country in March 2011. It was approved in the Czech Republic in April 2011, in Germany in May 2011, in Denmark in June 2011 and in Sweden in January 2012 to people with MS who have not responded adequately to other medication for spasticity.[8] It has also been recommended for approval in Italy and Austria with formal approvals expected in these countries during 2011. In Spain and other European markets (excluding the UK), nabiximols will be marketed by Almirall. In Canada, nabiximols has been approved by Health Canada for the treatment of MS spasticity. It has also received a licence with conditions (NOC/c) for two additional uses: as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis,[9] and also for pain due to cancer.[10][11] Nabiximols is available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to people who they consider may benefit. The product has been exported from the UK to a total of 28 countries to date. In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement for Otsuka to develop and market the drug in the United States. The first large scale US Phase IIb trial, Spray Trial, for people with cancer reported positive results in March 2010. GW and Otsuka have now commenced the Phase III development of nabiximols in cancer pain. In December 2012, Sativex was approved in Poland.[12] In 2013, France legalized the use of cannabinoids in medicine, Sativex is the first one to be sold under prescription.[13] Nevertheless, at least until June 2016, this drug was never actually sold in pharmacies there.[14] GW Pharmaceuticals were issued a unique license to cultivate cannabis for the manufacturing of Sativex in the UK, granting them the sole legal right to research in aerosolized cannabis derived therapeutics, which in April 2013 became commercially viable when the UK Government scheduled the Sativex formulation to part IV of the UK Drugs Act. en.m.wikipedia.org/wiki/Nabiximols61 Incredible Benefits of Marijuana (Backed by Science) www.herbonaut.com/benefits-of-marijuana/
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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 lakers on Oct 2, 2018 18:38:36 GMT -5
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Post by lakers on Oct 2, 2018 17:52:02 GMT -5
The cat was out regarding Tobra-T as I had mentioned a few times. Ex-Novartis VP, MC said: Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis, idiopathic pulmonary fibrosis are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs.The other area I look at is respiratory, there is a lot of inhalers that really just haven't been reinvented. So I think as we forget about the old drugs work really well, but sometimes you don’t always get enough drugs. So when we think about a lot of the inhalers that are out there, we think there is opportunity in the respiratory space. Respiratory is the one that I wouldn't go alone, but you could see an exclusive partnership with someone that's in the respiratory space that want the device powder portfolio that we could do a lot of work for. seekingalpha.com/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conferenceChiesi USA or Dr. Reddy could partner w/ Mnkd Trobramycin was first approved to treat these infection in 1997 under the brand name TOBI by Novartis, and in 2002 as Bethkis by Chiesi USA.
Dr. Reddy acquired Tobramycin Inhalation Solution (generic equivalent to Tobi™) from Teva. in 2016.
Aug. 31, 2018, Mylan closed an agreement with Novartis to purchase the worldwide rights to commercialize their global cystic fibrosis products consisting of TOBI Podhaler® and TOBI® solution, which will further enhance Mylan’s respiratory portfolio in the U.S., Europe and certain Rest of World markets.
Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018. Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=5#ixzz5Sol4q1LbLike all aminoglycosides, tobramycin does not pass the gastro-intestinal tract, so for systemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin.
The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis.Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections: meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague). Tobramycin is preferred over gentamicin for Pseudomonas aeruginosa pneumonia due to better lung penetration.Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=5#ixzz5SolhOy9g
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