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Post by lakers on Oct 2, 2018 15:53:52 GMT -5
190. (WO2018175992) RAPID AND CONTROLLED DELIVERY OF COMPOSITIONS WITH RESTORED ENTOURAGE EFFECTS patentscope.wipo.int/search/es/detail.jsf?docId=WO2018175992&recNum=190&office=&queryString=&prevFilter=%26fq%3DICF_M:%22A61K%22&sortOption=Fecha+de+publicación,+orden+descendente&maxRec=1974954 Datos bibliográficos más recientes de la Oficina Internacional Formular observación Enlace permanente Enlace permanente Marcador de página Nº de publicación: WO/2018/175992 Nº de la solicitud internacional: PCT/US2018/024188 Fecha de publicación: 27.09.2018 Fecha de presentación de la solicitud internacional: 23.03.2018 CIP: A61K 47/10 (2017.01) Solicitantes: RECEPTOR LIFE SCIENCES[US/US]; 2578 Constance Dr. W Seattle, Washington 98199, US Personas inventoras: LEONE-BAY, Andrea; US WESNER, Gregory; US Mandataria/o: WINGER, Rachal, C.; US WITTKOPP, Cristina J.; US NGUYEN, Thu; US Datos de prioridad: 62/475,763 23.03.2017 US Título (EN) RAPID AND CONTROLLED DELIVERY OF COMPOSITIONS WITH RESTORED ENTOURAGE EFFECTS (FR) ADMINISTRATION RAPIDE ET CONTRÔLÉE DE COMPOSITIONS AYANT DES EFFETS ENTOURAGE RESTAURÉS Resumen: (EN) Fast-acting oral formulations with restored entourage effects are described. The formulations include beneficial combinations of plant-derived molecules to provide restored entourage effects, and one or more carriers. The carriers can include N-acylated fatty amino acids, absorption enhancers, and/or various other beneficial carriers. The fast-acting oral formulations can create administration benefits.
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Post by lakers on Oct 2, 2018 15:15:18 GMT -5
Mike spoke about RLS during the Oppenheimer presentation. RLS is manufacturing an inhaled version of cannabinoid for chemo patients dealing with nausea and vomiting. RLS’s treatment will compete with the slower acting oral synthetic, Marinol. Read more: mnkd.proboards.com/thread/9701/mannkind-receptor-life-sciences#ixzz5QXRc9rJXOnly a 5 minute onset compared to 1 to 2-1/2 hours for the other brands listed PLUS no effect on appetite, which the others cannot claim. I'm hoping that ,with Andrea helping with its development, an IND will soon be filed. That may trigger a 2nd milestone payment, too. Read more: mnkd.proboards.com/thread/9701/mannkind-receptor-life-sciences#ixzz5QXS7BiIII think Palonosetron could be a good next application for MNKD as the sister compound Ondansetron has had increasing off label use for many kinds of nausea and vomiting conditions. For example my primary care doc recently offered it to me during a GI viral illness. I have used Ondansetron during a bout of prolonged vertigo and for motion sickness and it is very effective. The oral medication has a 45 minute time to effect and so an inhaled formulation and shorter action would be really nice. Also, constipation is a major side effect after use and I wonder if this might be less with a technosphere product as my guess is this side effect is driven by the serotonin receptors in the gut which might have less impact with an inhaled treatment. Both meds are serotonin 5-HT3 antagonists. Hope I am posting something already on the board. Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=9#ixzz5So4ygOEaThe folowing shows Tobra-T potential in Bucket-1. Chiesi USA or Dr. Reddy could partner w/ Mnkd Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5So6jnY2rseekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-global Bucket 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.
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Post by lakers on Oct 2, 2018 13:19:40 GMT -5
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Post by lakers on Sept 28, 2018 15:22:36 GMT -5
Preventive Migraine market Competetive Landscape - A great opportunity for MC, former VP of Amgen, Novartis Drugmakers are using an unusual tactic to compete in a new class of medication to treat the 38 million Americans who have migraines amp.thisisinsider.com/prices-for-new-migraine-treatments-for-2018-2018-9Lydia Ramsey, Business Insider Sep 28, 2018, 12:09 PM ET Amgen and Novartis, Aimovig: $575 per month list price, two months of free samples, followed by a patient assistance program that provides up to a year of coverage if commercial insurance doesn't cover it. For those with commercial insurance, there's a $5 copay program that's capped at $2,700 a year. Teva, Ajovy: $575 per month list price, and a savings card that lets patients access Ajovy for free until December 2019. Lilly, Emgality: $575 per month list price, as well as starter kits in doctors' offices. Lilly also plans to have a patient access program that provides up to 12 months of Emgality for free. Wei-Li Shao, the vice president of Lilly's neuroscience business told Business Insider that the company is also in conversations with organizations responsible for paying for medications, such as pharmacy benefit managers, to strike up "value-based agreements" in which the drugmaker would get paid for a medication based on how well it reduces migraines in a particular patient. For the drugmakers, providing the drug for free serves as a way to get access to more patients at the upstart. Because the treatments are preventative and migraines are a chronic condition, the expectation is that patients will be on the medication for a long enough time to make up for it, even if the drugmakers aren't making money off of it for months after it comes on the market.
"We view this strategy as testament to the recognized long-term size/value of this largely prevalent pool of patients where we expect a significant degree of 'stickiness' once patients are on treatment with a specific agent as opposed to competing on price," RBC Capital Markets analyst Kennen MacKay said in a note Friday.
Analysts expect Aimovig alone to reach $1 billion in annual sales by 2022, while Wells Fargo projected Ajovy to have $818 million in sales by 2022.
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Post by lakers on Sept 28, 2018 2:12:43 GMT -5
MC said Mnkd will be moving several forward. I expect a major pipeline update. My Bucket 1 conjecture follows. Tacrolimus: Lung Transplant, PAH PDE5 Inhibitors: Adcirca (Tadalafil) TrepT+PDE5 Inhibitors Vancomycin: Bacteria Lung infection with MSRA Linezolid: Infection with VRE, MSRA Amphotericin B: Pulminary Aspergillosis Xellia also reported progress on the development of its pipeline of value-added anti-infectives. Its Premixed Vancomycin is a novel liquid dosage form of vancomycin in a ready-to-use infusion bag, and was recently granted QIDP designation from the US Food and Drug Administration (FDA). A new drug application (NDA) submission for this product to the FDA is anticipated during 2018. Xelia is also beginning to expand its US commercial organisation as it prepares for the launch of this and other original anti-infective drug products. QIDP designation is granted under the Generating Antibiotic Incentives Now (GAIN) Act in the US and provides certain incentives for the development of antibiotics that include priority review and eligibility for fast-track designation.
PRV can be sold for $110M-$350M
Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz5SNfczSVo
TobraT 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/user/1882/recent?page=2#ixzz5SNcuVheECINV: Palonosetron, 2 formulations have been eval'ed Both showed aceptable aero, will require additional work to improve Ambient temp stability Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5SNdVonbuThe patent expiry of leading drugs such as Emend, Aloxi, and others is expected to negatively impact the revenue of CINV. Since the 1950s, amphotericin B (AmB) has been used in the clinical practice to treat systemic fungal infections and leishmaniasis, a neglected parasitic disease that can be fatal if left untreated. Fungizone® (a micellar dispersion) was the “gold standard” for more than three decades but due to the safer profile of novel lipid-based medicines (AmBisome®, Abelcet® and Amphocil®), it is used as second-line in the developed world. These medicines exhibit similar efficacies but more favourable safety profiles (mainly lower nephrotoxicity and infusion-related side effects) allowing the administration of larger doses and therefore higher efficacy. However, all formulations required to be parenterally administered because of its low oral bioavailability (0.2–0.9%) due to the precipitation of drug in aqueous media. In the last decade, strong partnerships between academia and industry has led to the development of innovative drug delivery systems able to deliver and target orally AmB in effective concentration while reducing its nephrotoxicity and infusion-related side effects. Currently, three major platform technologies (cochleates, chitosan nanoparticles and SEDDS) that are undergoing clinical trials. Humira: adalimumab Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=11#ixzz5SPRQ5nrw
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Post by lakers on Sept 25, 2018 17:58:55 GMT -5
Intracellular kinase inhibitors Grant US-8604031-B2 Abstract Intracellular kinase inhibitors and their therapeutic uses for patients with T cell malignancies, B cell malignancies, autoimmune disorders [such as Rheumatoid Arthritis] and transplanted organs [championed by UTHR].Inventor Gary A. Flynn Sandra Aeyoung Lee Mary Faris David William Brandt Subrata Chakravarty Original Assignee MannKind Corporation (United States)
Current Assignee Pharmacyclics (United States)
AbbVie (United States)
[maker of the Giga Blockbuster Humira $21B/yr for Rheumatoid Arthritis, Crohn's disease, ulcerative colitis and psoriasis. 13 indications:
Rheumatoid Arthritis. ... Juvenile Idiopathic Arthritis. ... Psoriatic Arthritis. ... Ankylosing Spondylitis. ... Adult Crohn's Disease. ... Pediatric Crohn's Disease. ... Ulcerative Colitis. ... Plaque Psoriasis. Hidradenitis Suppurativa Uveitis
Adalimumab is a TNF-inhibiting, anti-inflammatory, biologic medication. It binds to tumor necrosis factor-alpha (TNFα), which normally binds to TNFα receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNFα, adalimumab reduces this inflammatory response. Because TNFα is also part of the immune system, which protects the body from infection, treatment with adalimumab may increase the risk of infections.]Legal status Expired - Fee Related Expires 2031/08/21 Document history Publication date 2013/12/10 Filing date 2007/05/18 Priority date 2006/05/18 experts.umich.edu/details/patent/US-8604031-B2patentimages.storage.googleapis.com/83/5a/12/cb6ea21235c5b0/US8604031.pdfCompound description is on page 7. patents.google.com/patent/US8604031/en17Invention Background Intracelularkinasesplayimportantfunctionsincelsof theimmunesystem.Forexample,interleukin-2inducible15 tyrosinekinase(ITK)playsakeyroleinTceldevelopment anddiferentiation;itregulatesIL-2productionviaphospho lipaseCy1(PLCY1)andnuclearfactorofactivatedTcels (NFAT);itmediatesTh2celdiferentiation;anditregulates Tcelmigrationandrecruitmenttolymphaticorgans.Bru ton'styrosinekinase(BTK)isinvolvedinsignaltransduction pathwayswhichregulategrowthanddiferentiationofB lymphoidcels.BTKalsoisinvolvedinplateletphysiology byregulatingtheglycoproteinVI/FcreceptorYchain(GPVI25 FcRY)-coupled collagen receptor signaling pathway. For thesereasons,inhibitorsofintracellularkinasesareusefulfor treatingbloodcelmalignancies,SolidtumorsandforSup pressingtheimmunesystem,forexampleinpatientswith autoimmunedisordersororgantransplants.Intracelular30 kinaseinhibitorsalsoareusefulforpreventingorreducingthe riskofthromboembolism. UTHR CEO said: “Let’s now transition to our product pipeline, which currently consists of numerous investigational programs including therapies for PAH and other forms of pulmonary hypertension, innovative drug delivery devices, gene therapy and oncology. We will also continue to work on technologies to ultimately create an unlimited supply of tolerable, transplantable manufactured organs for those who suffer from end-stage organ disease. Lastly, our Sapphire gene therapy clinical trial for pulmonary arterial hypertension and our Distinct clinical trial with dinutuximab for small cell lung cancer continues to progress and enroll patients; in fact, the Distinct clinical trial in lung cancer is now over 50% enrolled. These seven ongoing Phase III clinical trials as well as our other R&D programs are expected to sustain our revenue growth in the near and medium term. Longer term, we are working very diligently to drive further revenue growth through R&D programs that are currently underway to develop technologies in the nascent field of organ manufacturing.Read more: mnkd.proboards.com/user/1882/recent?page=2#ixzz5S9rmIrne
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Post by lakers on Sept 24, 2018 15:01:51 GMT -5
As I understand Humira from a couple people who take it, it is taken weekly or every other week. Subq injection. Avoiding an in-home shot once a week is not a great reason to go inhaled. Whether the fast action of inhaled is better or worse for Humira, compared to slow absorption from subq, I don't really know Hellodolly said: “new inhaled version would protect and extend their patent on Humira?” also to ward off Multiple biosimilars and Lilly’s NCE. Eli Lilly’s Arthritis Drug Approved at Lower Dose with Boxed Warning Frank Vinluan 6/1/18 www.xconomy.com/indiana/2018/06/01/eli-lillys-arthritis-drug-approved-at-lower-dose-with-boxed-warning/Indianapolis-based Lilly said baricitinib will launch by the end of the month, priced at a more than 60 percent discount to blockbuster AbbVie (NYSE: ABBV) RA drug adalimumab (Humira). Adalimumab’s annual cost tops $40,000, according to calculations by the Institute for Clinical and Economic Review, a non-profit group and drug price watchdog. Because the FDA approval extends only to those patients who have not adequately responded to TNF blocking drugs such as adalimumab, it will be harder for Lilly to take market share from the AbbVie drug, which generated more than $18 billion in 2017 revenue. Baricitinib was originally developed by Wilmington, DE-based Incyte (NASDAQ: INCY). In 2009, Lilly licensed rights to develop the drug for inflammatory and autoimmune diseases. Following baricitinib’s approval, Incyte is now eligible for a $100 million milestone payment from its partner. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-announce-collaboration-development-andUnder the terms of the agreement, Lilly will receive worldwide rights to develop and commercialize INCB28050 as an oral treatment for all inflammatory conditions. In exchange for these rights, Incyte will receive an initial payment of $90 million and is eligible for up to $665 million in additional potential development, regulatory, and commercialization milestones, as well as tiered, double-digit royalty payments on future global sales with rates ranging up to twenty percent if a product is successfully commercialized.
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Post by lakers on Sept 24, 2018 14:34:52 GMT -5
Humira (Adalimumab) Humira is made by the pharmaceuticals giant AbbVie (NYSE:ABBV) and is approved for the treatment of, among other diseases, rheumatoid arthritis. The drug was made to inhibit production of TNF, or tumor necrosis factor, because TNF can cause severe inflammation and can impair the mobility of limbs and joints. Sales of Humira for full-year 2013 totaled a whopping $5.2 billion in the U.S. alone, a sales increase of nearly 18% year-over-year. The drug is taken by injection either by syringe or by injection pen usually weekly or biweekly in a new injection site every time. Pfizer (NYSE:PFE) has developed an oral form of the drug called Xeljanz, but a combination of sluggish sales and rejection by European regulatory authorities who questioned the drugs benefit-risk profile have taken a lot of the air out of the potential for the drug. Xeljanz causes side effects that Humira does not cause, so even the fact that it's taken orally does not convince many to use it. The opportunity is still open for a non-injected therapy to come in and steal market share from Humira, which is expected to see peak annual sales of $11.2 billion in 2016. Additionally, the rheumatoid arthritis market is expected to grow to $18.2 billion in 2023. Technosphere could be used to create an inhaled TNF inhibitor treatment that could compete with Humira for the sizable market that AbbVie's drug now dominates. The process would be simple: create a formulation with Technosphere particles and monoclonal antibodies that bind to and inhibit the TNF protein, and get FDA approval. Now I mean simple in theory, because actually making the formulation and getting passed regulatory hurdles is anything but simple. But the potential is there, and MNKD could benefit greatly from either creating this inhaled TNF inhibitor treatment itself or by licensing out Technosphere to another company that wants to try and develop the treatment. Read more: mnkd.proboards.com/thread/4986/agreement-mannkind-products#ixzz5S38W7uSH
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Post by lakers on Sept 24, 2018 14:04:58 GMT -5
not sure what kinds of apis could not be formulated via TS but if Abbvie had any other way of extending patent - they would. if ts huneria were somehow possible that would be amazing even vs a generic Blockade of XBP1 splicing by inhibition of IRE1α is a promising therapeutic option in multiple myeloma Naoya Mimura, Mariateresa Fulciniti, [...], and Kenneth C. Anderson www.ncbi.nlm.nih.gov/pmc/articles/PMC3382937/MKC-3946 has an expanded hydrophobic core and a solubilizing group, which produced a more potent and soluble IRE1α inhibitor (manuscript in preparation) than the original hit compounds,22 and was provided by MannKind Corp. Conflict-of-interest disclosure: V.T., U.M.M., Q.Z., and J.B.P. are employees at MannKind. P.G.R. serves on advisory boards to Millennium, Celgene, Novartis, Johnson & Johnson, and Bristol-Myers Squibb. N.C.M. serves on advisory boards to Millennium, Celgene, and Novartis. K.C.A. serves on advisory boards to Millennium, Onyx, and MannKind. The remaining authors declare no competing financial interests. Correspondence: Kenneth C. Anderson, Dana-Farber Cancer Institute, Mayer 557, 450 Brookline Ave, Boston, MA 02215; e-mail: ude.dravrah.icfd@nosredna_htennek. www.medicalnewstoday.com/articles/248215.phpHumira (adalimumab) and its uses Humira is a drug that can relieve pain and reduce inflammation in people with a number of autoimmune diseases. Its generic name is adalimumab. Doctors prescribe Humira to treat rheumatoid arthritis, chronic plaque psoriasis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-infectious uveitis. Humira is a biologic drug. Scientists normally make biologics using protein antibodies from a living organism, such as humans, animals, microorganisms or yeast. They produce the proteins using DNA technology. It is a kind of genetic engineering. People normally take Humira at home, using a syringe or a pen device that already contains the medication. They cannot take it by mouth, because the human digestive system would destroy the active ingredient. MC reiterated several times: seekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-global Compatibility with diverse API. So we do look at small molecules and peptides. I want to say we can go to 150,000 Da or pretty large molecules. We are starting to think about vaccines as well as other local drugs for local effects. mnkd.proboards.com/thread/10487/united-therapeutics-science-day-nyc?page=3Compatibility with diverse API Small molecules, peptides, biologics Systemic delivery for vaccines.
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Post by lakers on Sept 22, 2018 12:05:11 GMT -5
Dreamboat, Cricket Advantage in RA patients. Inhaled PAH (TreT, PDE5 inhibitor, Tacrolimus), Inhaled Humira, Inhaled Corticosteroids using Dreamboat. www.sciencedaily.com/releases/2018/02/180223111543.htmComplex inhalers could prevent some patients from taking medicine, study suggests Simple prescribing changes could benefit patients, researchers say Date: February 23, 2018 Source: University of Bath Summary: Respiratory disease patients with arthritis could struggle to manage their conditions because their inhalers are too fiddly for them to use, new research has found. Medical professionals should check that patients with respiratory diseases and rheumatoid arthritis can use their inhalers properly to reduce the risk of them being unable to take their medicines say the scientists from the University of Bath's Department of Pharmacy & Pharmacology. Respiratory diseases, including asthma or chronic obstructive pulmonary disease (COPD), are common in people with rheumatoid arthritis. It is estimated that more than 60,000 people in the UK have both rheumatoid arthritis and a lung disease.
Arthritis often affects the hands making complex or finely controlled actions difficult and painful.The team recruited 34 patients with rheumatoid arthritis and compared how well they could use four types of commonly prescribed inhalers to a healthy control group. They discovered that only 15% of the arthritis patients could complete all the steps to use one type of inhaler, called a HandiHaler, whereas 94% of the control group were able to. The HandiHaler requires seven steps to operate it properly, including removing a capsule of powered medicine from a foil blister pack, inserting it into the inhaler and piercing it for inhalation. In contrast 85% of the arthritis patients and 100% of the control group could correctly use an inhaler called a Turbohaler, which has three steps; unscrewing a cap, twisting a dial and replacing the cap.Two other commonly prescribed inhalers saw the arthritis group struggle to complete the operating steps compared to the control group (50% to 91%, and 77% to 97%). The study is published in the journal Respiratory Medicine. Dr Matthew Jones, from the department of Pharmacy & Pharmacology, said: "These results show how important it is that health professionals make sure people can use any inhaler they prescribe. If someone gets home from a pharmacy with a new inhaler and finds they can't use it, their lung disease will not be properly treated and the NHS loses money, as some inhalers cost more than £50 each. "This simple training makes a real difference to how these patients can manage their respiratory disease. The consequences of not being able to physically operate an inhaler can be severe for patients, as badly treated asthma can be fatal. "Pharmacists, doctors and nurses need to make these easy checks not only help patients achieve better outcomes but also reduce demand on the NHS, not to mention taking away the stress and irritation of a complex and difficult process for the patient. It's a no-brainer." In the year to November 2017, 4.5 million HandiHalers were dispensed in the NHS in England alone to approximately 375,000 people at a cost of £135 million. Undergraduate pharmacy student Yasmin Shirmanesh, who conducted the study with Dr Jones, said: "Some of these inhalers are prescribed by the millions around the UK, so I was shocked to see the difference in how difficult patients find some types to use. If an inhaler can't be used properly it's no good for the patient, and a waste of money for the NHS. "No-one wants to see patients struggle needlessly to take the medicines they need to manage serious conditions, so I hope that our study will lead to change in how inhalers are prescribed." The study was funded through the Bath Institute for Rheumatic Diseases. RA and Corticosteroids: What Do Steroids Do for Rheumatoid Arthritis? www.rheumatoidarthritis.org/treatment/medications/corticosteroids/
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Post by lakers on Sept 21, 2018 6:25:24 GMT -5
The highest price paid for a priority review is $350 million in August 2015, when United Therapeutics sold its voucher to AbbVie who can expedite Inhale Humira in less than two years to protect its $21B-a-year cash cow which is the most successful prescription drug for 13 indications including rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis, dermatology and gastroenterology markets. Read more: mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor?page=2#ixzz5RjaJmYvx
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Post by lakers on Sept 20, 2018 22:56:57 GMT -5
Dr. Castagna joins MannKind from Amgen, Inc., where he spent over three years as Vice President, Global Commercial Lead for a portfolio of nine biosimilar drugs, and Vice President, Global Lifecycle Management. Prior to Amgen, Dr. Castagna, was Executive Director of Bristol-Myers Squibb’s Immunology franchise, where he served as co-lead to relaunch Orencia IV and launch Orencia SC, both rheumatoid arthritis drugs. Before BMS, Dr. Castagna was with Sandoz (Novartis) as Vice President and Division Head for Biopharmaceuticals, North America, where he established the US Biologics Business Unit and relaunched its lead product, Omnitrope, a human growth hormone. Amgen, Novartis's generics wing Sandoz, both are MC’s former employers, have already won approval for Humira bio similar to be launched in the U.S in 2023.seekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-globalCompatibility with diverse API. So we do look at small molecules and peptides. I want to say we can go to 150,000 Da or pretty large molecules. We are starting to think about vaccines as well as other local drugs for local effects.
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Post by lakers on Sept 20, 2018 21:50:35 GMT -5
LONDON (Reuters) 9/20/18 - Europe has approved a fifth copy of AbbVie's $18-billion-a-year biologic drug Humira – the world's best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs. Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won a European Commission green light to market their version of the injectable medicine, known as Hulio. They intend to launch it in Europe on or after Oct. 16, when AbbVie's primary European patent on Humira expires. The large number of Humira copies reflects intense rivalry for a slice of a huge market as demand for so-called biosimilars takes off in Europe, where adoption of the cut-price products has been much faster than in the United States. Europe accounted for around $4.4 billion of Humira's global sales in the 12 months to June 30, 2018, according healthcare data consultancy IQVIA.
Amgen, Novartis's generics wing Sandoz, South Korea's Samsung Bioepis and Germany's Boehringer Ingelheim have already won approval for four other biosimilars to Humira.
Humira is used to treat a range of conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis. Its commercial success and popularity among patients means it has become a major cost for health systems across Europe, and health administrators say they will waste no time in exploiting the arrival of cheaper biosimilars to drive down bills. Because injectable biologic drugs such as Humira are made in living cells, they cannot be exact replicas of the original medicine, so regulators have come up with the notion of biosimilars - drugs that are similar enough to do the job. The conventional wisdom has been that biosimilar uptake would be slow and price discounts modest, since these products are expensive to develop and doctors may be wary about using a medicine that isn't identical to the original. But Europe's recent experience with the first wave of biosimilar antibody drugs - the biggest section of the biologic market - has upended expectations, suggesting AbbVie will face fierce competition. Still, analysts don't expect global Humira sales to fall off a cliff just yet, since there are delays in the arrival of biosimilars in the all-important U.S. market. While expiry of the Humira patent opens the door to biosimilars in Europe, such copies are not expected to launch in the United States until 2023. www.google.com/amp/s/mobile.reuters.com/article/amp/idUSKCN1M011N
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Post by lakers on Sept 20, 2018 20:53:23 GMT -5
You thought UTHR PAH Deal was big. The Following will numb you - Inhaled Humira for Rheumatoid Arthritis, instant relief. It was bandied about when Al was alive. www.google.com/amp/s/www.yahoo.com/amphtml/finance/news/abbvie-faces-california-insurance-department-150403837.htmlHumira is key driver of AbbVie’s revenues, accounting for more than 60% of its total sales. Currently approved for 13 indications, Humira sales have increased consistently, backed by robust demand trends. Humira recorded sales of almost $10 billion in the first half of 2018.Several companies including Amgen AMGN/Allergan AGN, Mylan MYL, Coherus, Novartis’ Sandoz, Pfizer and Samsung Bioepis are working on biosimilar versions of Humira. The entry of biosimilars will have a huge impact on AbbVie’s financials. Amgen, Mylan and Samsung Bioepis/Biogen’s Humira biosimilars are expected to be launched in the United States in 2023 while in the EU, Amgen and Biogen’s biosimilars are expected to be launched in October this year.The latest lawsuit adds to AbbVie’s Humira related woes. July 18, 2018 AbbVie, Inc. (ABBV - Free Report) has signed a non-exclusive licensing deal with Mylan (MYL - Free Report) regarding the latter’s proposed biosimilar version of AbbVie’s blockbuster arthritis drug, Humira, in the United States. Per the agreement, Mylan will have a license to launch its biosimilar Humira in the United States and in various other countries, excluding Europe, on Jul 31, 2023.Per the terms of the settlement, Mylan will pay royalties to AbbVie once its cheaper version is launched. AbbVie will make no payments to Mylan.AbbVie has similar licensing deals with Amgen, Inc. (AMGN - Free Report) and Samsung Bioepis. While Amgen can launch Amjevita, its biosimilar version of Humira in the United States on Jan 31, 2023, Samsung Bioepiscan launch Imraldi, its biosimilar version on Jun 30, 2023. While Amgen and Samsung Bioepis’biosimilar versions are already approved by the FDA, that of Mylan is yet to gain FDA approval.AbbVie made it clear that Mylan's U.S. license will not be accelerated by Amgen's or Samsung Bioepis' biosimilar launch. In most countries of Europe, Samsung Bioepis’ partner Biogen (BIIB - Free Report) and Amgen have license to launch their biosimilar versions from Oct 16 this year.Humira is the key driver of AbbVie’s revenues, accounting for around 65% of its total sales. Currently approved for 13 indications, Humira sales have increased consistently — 11.7% in 2015, 16.1% in 2016 and 14.6% in 2017 — backed by robust demand trends. The product continues to see strong growth in the dermatology and gastroenterology markets. The company expects Humira sales to approach $21 billion in 2020.Other than, Amgen, Mylan and Samsung Bioepis, Coherus BioSciences, Boehringer Ingelheim, Novartis’ Sandoz and Pfizerare also looking to get approval for a biosimilar version of Humira. In May, June and July, the Patent Trial and Appeal Board (PTAB) ruled against AbbVie on five inter parties review (IPR) challenge filed by Coherus and Boehringer Ingelheim, invalidating three AbbVie patents for Humira. AbbVie has appealed the decision. The entry of biosimilars will have a huge impact on AbbVie’s financials.However, AbbVie has successfully struck licensing deals with three companies to protect its revenues from Humira. Per settlements with Amgen, Mylan and Samsung Bioepis, biosimilar entry into the United States has been delayed until2023, which gives AbbVie more time to strengthen its pipeline with products that are capable of making up for the expected sales decline when Humira biosimilars are launched.www.google.com/amp/s/www.zacks.com/amp/stock/news/312029/abbvie-settles-with-mylan-to-delay-humira-biosimilar-in-us
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Post by lakers on Sept 20, 2018 2:42:07 GMT -5
I would expect Mike to talk about Technosphere and the potential it has to become disruptive in many areas of medicine. If he hints at specific drugs (other than Insulin and Treprostinil) that would be a pleasant and welcomed surprise. I believe that will be the case.
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