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lakers_w 217 posts  |  Last Activity: Feb 9, 2015 5:05 PM Member since: Jun 13, 2000
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  • How investors can play the war against ‘globesity’

    Republish Reprint
    John Shmuel | December 11, 2014 6:06 PM ET
    More from John Shmuel | @jshmuel
    “We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, Bank of America Merrill Lynch equity strategist and lead author of the report.
    AP Photo/Kirsty Wigglesworth, File“We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, Bank of America Merrill Lynch equity strategist and lead author of the report.
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    Efforts to fight the rising rate of global obesity are opening up new opportunities for investors, says a new report from Bank of America Merrill Lynch.

    There are currently 2.1 billion overweight people in the world, with 671 million of them classified as obese. The report notes most countries are trying to decrease that number for health reasons, but little progress is being made and health-care costs are rapidly expanding as a result.

    “We believe that the obesity epidemic may be the most pressing health challenge facing the world today,” said Sarbjit Nahal, equity strategist and lead author of the report. “The number of overweight or obese people has tripled since 1980 … by 2030, close to 50% of the world’s population is projected to be overweight or obese.”

    The report highlights four entry points for investors to play what it calls the fight against “globesity,” specifically stocks in pharmaceuticals and health care, food retail, weight-loss and nutrition, and sports apparel and equipment.

    Medical stocks are one of the hottest entry points, given the impact obesity has on health. In a report last month, Canaccord Genuity said that obesity is the “next big thing in medical devices.”

    Related
    The global economic cost of obesity has risen to US$2-trillion annually, study says
    Sugar accelerates aging process as much as smoking does, U.S. study says
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    Canaccord analyst William Plovanic identified EnteroMedics Inc., which develops neuro-blockers to treat obesity, as a promising company. He rates the stock, which closed Thursday at US$1.40 on the Nasdaq, as a buy with a US$4 price target.

    Mr. Nahal of BofAML, meanwhile, sees more than a dozen health-care and medical device companies as potential buys, including Arena Pharmaceuticals Inc., MannKind Corp. and Tandem, Inc.

    “Healthcare and medical device companies are playing an increasingly important role in dealing with the impact of obesity-related co-morbidities, including heart disease and failure, type 2 diabetes, kidney failure, respiratory complications, osteoarthritis and incontinence,” he said.

    Beyond health care, Mr. Nahal notes that food companies that fill the demand for organic and healthier foods should also benefit in the coming years as consumers shift toward a more health-conscious mindset to combat obesity. He identified stocks such as Sprouts Farmers Market Inc. and United Natural Foods Inc. as good bets.

    In the area of weight loss, diet and nutrition stocks, Mr. Nahal highlighted Glanbia PLC and GNC Holdings Inc. as two companies with high exposure to tackling global obesity.

    Finally, Mr. Nahal said companies that are part of the US$365-billion global athletic market, which includes sports apparel markets and gyms, will benefit as more people try to lose weight. He said PSG Ltd. and Under Armour Inc. are well positioned in that market.

  • Sanofi will only acquire Afrezza and GLP-1 but will continue to pay licensing for using Technosphere in their production plants... Hence the long partnership.

    Aftezza will be the first of many T-drugs that comes down the pipeline, which is why I think Afrezza will go for $16-$18 per share. The evil mnholdem would absolutely love it if shareholders were paid by a dividend and keep their shares in MNKD. This would demolish shorts, who would be required to pay the dividend to the borrower.

    That would be sweeter than restructuring and a stock split between two legal entities.

    By mnholdem

  • lakers_w lakers_w Dec 13, 2014 3:11 PM Flag

    Amen Duke of Danbury! This is what most experts and Trade Journal have been saying if you check. Hail to Kevin, the Suppreme Allies (NATO) Commander of the Grand Alliance! He has been right all along! Shorts, don't you dare reply until you provide me a written report of what you learn from the 62-of Speaker's Bureau Afrezza Lauch Material.

    In case you don't know what Speaker's Bureau is:

    Why do biopharmaceutical companies sponsor peer speaker programs for health care professionals?

    Doctors and other healthcare professionals with real-world clinical experience in specific therapeutic areas are uniquely qualified to educate and inform their peers about the medicines they prescribe. While physicians consult many sources for information, it can be a challenge for them to juggle the demands of clinical practice with the need to stay up-to-date with the latest science and FDA-approved treatment options.

    Interactions between physicians, including those participating in speakers bureaus, benefit patient care by facilitating the exchange of the latest FDA-regulated information (see below). This information exchange goes both ways: physicians provide pharmaceutical companies valuable feedback on how medicines are working for patients.

    What value do speakers programs provide in improving patient care?

    Interactions between healthcare professionals benefit patient care through the exchange of the latest regulated information about the benefits, risks and appropriate uses of medicines. Physicians need to stay up-to-date on information about new medicines, new uses of medicines, the latest clinical data, appropriate dosing and emerging safety issues.

  • lakers_w lakers_w Dec 13, 2014 2:58 PM Flag

    Pg 59, Pg 61 also mention Afrezza. Pg 61 said:
    Current State of the Art
    • Each of these approaches looks promising based on PK and PD studies
    • Each has its own issues regarding safety and/or practicality
    • None have been shown to have enhanced clinical efficacy for open-loop therapy except for MannKind insulin
    • None have been tested in closed-loop systems

    The slides detail the whole Solution incl. insulin pump Al sold to Medtronic. Now you can see Kevin's Grand Alliance and the triumvirate's closed-loop systems Grand Vision in its finest, awesome display.

  • lakers_w lakers_w Dec 13, 2014 2:36 PM Flag

    Dr. Bode has been a consultant, Member of the powerful Speaker's Bureau, received Grant Research and Support from the triumvirate Mannkind, Medtronic, Sanofi. Do you see the Grand Alliance in the making? It will never become clearer than this. Do you have to wait for flop, turn, river before making a bet? Isn't it time to Up the Ante? I give credit to Kevin for spotting this first and getting lots of arrows, bullets for it. You tireless passion will be handsomely rewarded. Danbury check! Valencia check! NJ check! Paris check! Minneapolis check ! All Systems Go! 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, Take Off !!

  • lakers_w lakers_w Dec 13, 2014 2:14 PM Flag

    Attention Everyone !! Make sure you download it to share with others before it's taken offline.

  • Do We Really Need Ultra-Fast Acting Insulins?
    Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia

    Consultant: Novo Nordisk, MannKind, Medtronic, Sanofi
    • Speaker’s Bureau: Lilly, Novo Nordisk, Medtronic, Sanofi
    • Grant and Research Support: Biodil, Lilly, MannKind, Medtronic, Sanofi

    ucdenverDOTedu/academics/colleges/medicalschool/centers/BarbaraDavis/OnlineBooks/Documents/Keystone2011/Keystone%202011%20Bode%20Ultra%20Fast%20Acting.pdf

    Afrezza is mentioned 17 times on pages
    19,45,48,51,52,53,54,55,56,58 of 62

    You guys are too harsh on Mnkd and Sanofi mgmt. They're doing a phenomenal Afrezza launch job behind the scene. No wonder Pipper Jaffray Top 15 2015 Bio Pharma Suprises lists "Mnkd/Sny launch goes well" at #6. Since I am working my butt off too, Longs or Shorts, can you promise to read 62 pages in their entirety before replying? They deserve your undivided attention.

  • lakers_w lakers_w Dec 12, 2014 8:15 PM Flag

    8. PD1 antibodies start to look like a thing of the past
    9. AMGN blocks REGN/SNY's PCSK9 antibody
    10. A biosimilar Soliris enters Phase 3
    11. Gene therapy cures blindness
    12. Iran gets the nuke; military spending hikes force other budget cuts
    13. Two large-cap biotechs get acquired
    14. CBD hits the radar screen for autism
    15. ProQR transforms the CF landscape

    Could bluebird bio (BLUE) Cure Sickle Cell Anemia in 2015? Is Big Bio in Pharma Radars?
    December 12, 2014 11:58 AM EST
    streetinsiderDOTcom/Analyst+Comments/Could+bluebird+bio+(BLUE)+Cure+Sickle+Cell+Anemia+in+2015%3F+Is+Big+Bio+in+Pharma+Radars%3F/10093058.html

  • After bolting 93% higher already this week on a positive ASH update, bluebird bio (NASDAQ: BLUE) is continuing higher Friday (+2.3%) in part as Piper Jaffray's Joshua Schimmer said one of his Top 15 potential "Surprise" Biopharma Events For 2015 includes bluebird bio curing sickle cell anemia.

    Schimmer said 2015 is poised to be a big year for gene therapy, and success in alleviating the sickle cell phenotype with BLUE's approach would represent another landmark for the field. Heart failure and CHF are other gene therapy opportunities coming into focus in 2015 he said. "Other events in the gene therapy field in 2015 will likely include additional data from ophthalmology programs including AAVL (wet AMD) and AGTC (XLRS and achromatopsia)," he added.

    Another interesting potential "Surprise" event in the sector, according to Schimmer, is that two large cap biotechs gets acquired. "The number of large-cap ( $10B) biotech companies which offer attractive long-term growth opportunities to meaningfully inflect EPS trajectories for large pharma companies continues to grow," the analyst commented. "The list now includes BIIB, CELG, BMRN, PCYC, VRTX, ALXN, REGN and INCY. All could be appealing M&A targets and fit needs of larger pharma partners. While many investors may agree that one would be a boon for an industry, two of these could lead to a broader sector revalidation."

    Yet another potential "Surprise", is that MannKind and Sanofi Afrezza launch goes well.

    Below is a list of Schimmer's Top 15 Potential "Surprise" Biopharma Events For 2015:

    1. Gene therapy establishes proof of concept in hemophilia
    2. Heart failure explodes on the biopharma scene with gene therapy success
    3. Biopharma does even better in 2015 than it did in 2014
    4. Failed trials get approved, starting with BMRN's drisapersen
    5. BLUE cures sickle cell anemia
    6. BIIB finishes the year with the best large-cap pipeline and freedom to operate on
    Tecfidera
    7. SNY/MNKD Afrezza launch goes well

  • lakers_w lakers_w Dec 12, 2014 7:47 PM Flag

    Capital Health Plan is an independent Licensee of the Blue Cross and Blue Shield Association.
    2015 COMMERCIAL FORMULARY
    JANUARY 2015

    PA/QL
    Insulin human inhaled
    Tier 3
    AFREZZA, 24

    Drugs represented in the 2015 Commercial Formulary may have varying cost to the plan member. Most generic medications are typically available at the lowest cost, brand-name medications listed as Tier 2 will generally cost more than generics, and medications listed as Tier 3 will generally cost more than Tier 2 drugs. All compounded medications and some Specialty drugs will require Tier 3 copay. Based on your Summary of Benefit and Coverage, a Tier 4 copay or coinsurance may apply to Specialty drugs. Specialty drugs are medications that generally have unique uses, require special dosing, handling or administration, are typically prescribed by a specialist provider or are significantly more expensive than alternative drugs or therapies

  • Inhaling a concentrated cloud of insulin through the nose twice a day appears to slow — and in some cases reverse — symptoms of memory loss in people with early signs of Alzheimer's disease, a new pilot study has found.

    The study involved only 104 people and is considered very preliminary. But it suggests that a safe, simple and cheap measure that boosts flagging metabolism in key areas of the brain could hold off or possibly derail the progression of the devastating neurological disorder in its early stages. The results were published online Monday by the journal Archives of Neurology.

    Insulin is a metabolic hormone best known for its role in treating diabetes, a condition in which the hormone is either insufficiently produced or poorly used by the body's organs. But in recent years, studies have found that people with diabetes and prediabetes are at heightened risk of developing Alzheimer's, and autopsies have shown that diabetics whose condition was tightly managed had fewer of the brain tangles and plaques that are the hallmark of disease. Studies involving animals have suggested that insulin deficiency in the brain may be a key factor in the progression of Alzheimer's.

    Researchers from the Veterans Administration's Puget Sound Health Care System in Washington state decided to test insulin on people without diabetes who had been diagnosed with mild to moderate Alzheimer's or amnestic mild cognitive impairment, a disorder characterized by increased forgetfulness that often progresses to dementia. Study participants were divided into three groups: 36 of them inhaled 20 milligrams of insulin twice a day for four months, 38 got 40 mg twice a day, and 30 were given a saline solution.

    After two months of treatment, those treated with 20 mg of insulin had improved performance on a memory test. The gains persisted after four months of treatment and were still evident two months after the insulin treatment stopped.

    Patients who got the higher dose of insulin had no change in their memory abilities, while those who got the placebo saw a decline. The differences between those on insulin and those on the placebo were "small in absolute terms," the authors wrote. But they were robust enough that by generally accepted research standards, they are unlikely to have been the result of chance.

    Subjects taking either dose of insulin were rated by their caregivers as holding steady in their overall social, mental and everyday functioning, while those on the sham medication were rated as having declined. And on physician-administered tests of cognitive function, subjects taking insulin showed less decline than those on the placebo.

    In a subset of subjects who underwent additional measurements, researchers found that there were fewer amyloid plaque deposits, protein tangles and other physiological hallmarks of Alzheimer's in those whose memory improved most on the insulin treatment compared with those who had weak responses or were on the placebo.

    But the persistence of insulin's effect was a mixed picture. Two months after the insulin treatments stopped, caregivers of subjects in all three groups noted similar declines in their overall daily function.

    Dr. Jacobo Mintzer, an Alzheimer's expert at the Medical University of South Carolina in Charleston who was not involved in the study, hailed the research as "a new way of thinking" about treating dementia.

    "As a clinician, I would not tell my patients to get their hopes up," he said. "But as a scientist, I always get very encouraged when the paradigm shifts," as he said it has here.

    An estimated 5.4 million Americans are believed to have Alzheimer's, according to the Alzheimer's Assn. Scientists acknowledge that while they can diagnose the disease earlier and offer medications to temporarily slow the progression of symptoms, they have been stymied in their search for ways to prevent, halt or reverse it.

    It will take a larger study involving more patients over a longer time to figure out whether nasally administered insulin merely slows the march of Alzheimer's or thwarts it, said Laurie Ryan, a neuropsychologist who directs clinical trials involving dementia at the National Institute on Aging, which funded the pilot study.

    In the meantime, she said, intranasal insulin has two things going for it: Insulin is already in wide use at relatively low cost, and the nasal inhaler allows it to be delivered directly and safely to the brain. That minimizes the risk of the hormone affecting blood sugar levels elsewhere in the body, which could be dangerous to kidneys, eyes and blood vessels.

    "A safe, easy delivery system — those are things we'd love to see for any kind of treatment for Alzheimer's disease," she said.

  • US drugmaker MannKind Corp (Nasdaq: MNKD) has licensed agreement exclusive worldwide rights to privately-held Colby Pharmaceutical to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers.

    Under the terms of the accord, Colby will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, with upfront and potential milestone payments of about $140 million total. MannKind will also receive tiered royalties on sales of products.

    Intra-lymph node injections (ILNI, vaccine inoculation directly into the normal lymph node with ultrasound image guided standard syringes) of cancer vaccine antigens have been reproducibly shown to generate much more potent therapeutic T-cell responses, when compared to cancer vaccine antigen immunizations using traditional intra-muscular or sub-cutaneous injections of the same cancer vaccine antigens in animals. In a Phase I human melanoma study of MKC1106-MT, the most advanced ILNI regimen from this program, repeat intra-lymph nodal injection for administration of the therapeutic antigens was well-tolerated and generated strong immune responses, clearly meeting the primary endpoints.

  • lakers_w lakers_w Dec 12, 2014 2:38 AM Flag

    MKC204 is an IRE-1 alpha inhibitor with potential application in the treatment of multiple myeloma. IRE-1 alpha is a protein important in the regulation of the Unfolded Protein Response (UPR) cascade. Additional potential indications for UPR pathway inhibitors include autoimmune diseases, cardiovascular diseases and neurodegenerative disorders.
    m.seekingalphaDOTcom/article/330132

  • The company also develops MKC1106-MT, an investigational cancer immunotherapy product, which is in Phase II clinical trials for the treatment of adults with type 1 or type 2 diabetes, and MKC204, which is in preclinical development stage for the treatment of malignancies and inflammatory diseases.

    In addition, its products include MKC253 (GLP-1), a Phase I clinical trials product for the treatment of type 2 diabetes; MKC1106-PP, a Phase I clinical trials product for diverse tumor types, metastatic disease, and/or progressive and refractory disease; and MKC180, an obesity compound and MKC1106-NS, a cancer immunotherapy product that are in preclinical trials

    MKC253 is a Technosphere formulation of GLP-1 (glucagon-like peptide). In initial clinical studies, MKC253 showed a lack of the characteristic adverse events, like nausea and vomiting, that are frequently associated with long-acting GLP-1 analogs. Results from a phase 1 trial supported the hypothesis that inhalation of MKC253 may be able to simulate the incretin effect that is lost in patients with Type 2 diabetes. In other words, it is another potential diabetes treatment.

    MKC253 seems to be stuck between phase 1 and phase 2 clinical for a few years now. This case becomes more curious to me the more I dig into it.

    MKC1106 is MannKind's active immunotherapy platform, and there are three separate programs. MKC1106-PP, designed to target solid tumors, completed an open label phase 1 clinical trial and objective responses were observed in prostate cancer and renal cell carcinoma. MKC1106-MT is now being evaluated in a phase 2 clinical trial for patients with advanced melanoma. MKC1106-NS may be applicable to a range of solid and blood cancers.

    At least Mannkind has this drug in phase 2 clinical.

    MKC204 is an IRE-1 alpha inhibitor with potential application in the treatment of multiple myeloma. IRE-1 alpha is a protein important in the regulation of the Unfolded Protein Response (UPR) cascade. Additional potenti

  • By examining those patents that MannKind filed with the U.S. Patent Trade Office and other governing bodies worldwide, it seems MannKind and its potential partners have the option to advance pain medicines, Alzheimer disease, irritable bowel syndrome, upset stomach and vaccines, just to name a few.
    retailinvestor360DOTcom/biotech/681-what-you-should-get-out-of-mannkind-s-earnings-and-conference-call.html

    MANNKIND : Patent Application Titled "Catalysis of Diketopiperazine ... for AVP-923 in Treatment of Agitation in Patients with Alzheimer's Disease ...

  • Reply to

    Sny's Afrezza Launch Readiness 12/11/14

    by lakers_w Dec 11, 2014 9:33 PM
    lakers_w lakers_w Dec 11, 2014 10:54 PM Flag

    Speakers bureau is the trade's jargon. Thus, the comment is legit by a Sny rep. There was also an email prepping for imminent launch.

  • Speakers bureau are being formed, marketing materials already to go, manage care contracts being negotiated, sales forces selling Afrezza already determined and ready, budgets to be decided very soon, all open position on the lead launch team almost 100% filled.

    physicians need to stay abreast of information about emerging drugs and devices, but the time pressures of clinical practice may limit their ability to do so independently. The companies that manufacture and sell these products have the resources and the motivation to “educate” physicians but cannot be expected to distinguish their marketing goals from physicians’ educational needs.

    One current context of this long-standing struggle is the “speakers’ bureau” system, in which pharmaceutical, biotechnology, and medical device companies recruit and train physicians to deliver information about products to other physicians, in exchange for a fee or other considerations, such as professional development opportunities.2 Participants in the system argue that physicians are best situated to deliver accurate information about new drugs and devices to other physicians and that industry is best placed to fund such communication. Critics reply that the speakers’ bureau system raises significant concerns about ethics and professionalism and that it is part of a complex system of drug promotion3,4 and relationship-building with physicians5-7 that contributes to irrational prescribing,8 inflated health care costs,2 and even harm to patients or society more generally. Some steps have been taken toward limiting participation in speakers’ bureaus.

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