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lakers_w 359 posts  |  Last Activity: 3 hours ago Member since: Jun 13, 2000
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  • Dropped by Insurance: Will Your Diabetes Injectables Be Covered in 2014?

    by The GoodRx Pharmacist
    on November 14, 2013 at 2:36 pm

    Express Scripts and Caremark have removed certain medications from their formulary starting in January 2014. These companies handle prescription benefits for more than 200 million Americans, so your prescription coverage will likely be changing in the new year.

    We’re reviewing which prescriptions will no longer be covered and the suggested alternatives to give you a better picture of your options. There have been some big changes to the coverage on diabetes meds removed from each formulary, particularly when it comes to insulin:

    Caremark

    Removed medications: Humalog and Humulin insulins || Suggested Alternatives: Apidra, Novolog, or Novolin insulins

    The Caremark exclusions here include Humalog, Humalog 50/50, Humalog 75/25, Humulin N, Humulin R, and Humulin 70/30 (but not Humulin U-500). I see more patients on Humalog than Novolog, however, both work on the body the same way, either rapid acting or a combination of rapid/intermediate acting.

    The main concern patients may have is “will my dose be the same?” The answer to that question is YES—the conversion from Humalog to Novolog and Humulin to Novolin is a 1:1 conversion. Therefore, if you using 10 units of Humalog you will also use 10 units of Novolog and the same applies for Humulin and Novolin. Apidra conversion is also 1:1, so once again your insulin dose will not change. These links from Group Health Cooperative and The Pharmacist Letter (via Albany.edu) will be very helpful for any questions about conversion: Part 1 and Part 2

    Novolog and Apidra also have manufacturer discounts available—you can find the Novolog program here and the Apidra program here.

    Express Scripts

    Removed medications: Victoza || Suggested Alternatives: Byetta or Bydureon

    Victoza has been gaining a lot of popularity in the diabetic community and among the prescribing doctors, including endocrinologists. A majority of patients are using Victoza injections compared to the covered alternatives of Byetta or Bydureon. Victoza is unique because it is a once daily injection rather than twice daily like its suggested alternative Byetta. However one positive is that Bydureon, the other alternative, is once weekly. Byetta, Bydureon, and Victoza all have manufacturer discounts available—you can find the Byetta program here, the Bydureon program here, and the Victoza program here.

    Removed medications: Apidra, Novolog, or Novolin insulins || Suggested Alternatives: Humalog and Humulin insulins

    Express Scripts will be covering Humalog and Humulin insulins (the same ones Caremark is dropping), and instead removing coverage for Apidra, Novolog, Novolog 70/30, Novolin N, Novolin R, and Novolin 70/30. The same conversions listed above apply here.

    If you’re taking one of the removed drugs, what should your next steps be?

    • Find out which company handles your prescription coverage. You can often check online, or call the number on your insurance card for more information.

    • Double check the exclusion list to review the removed medications and alternatives: Express Scripts and Caremark.

    • If your prescription won’t be covered next year, contact your doctor or healthcare provider and explain that your pharmacy coverage has changed and that there is a suggested alternative for your current medication.

    • You and your doctor can then decide which alternative to try, or whether to explore other options for coverage.

    What if you can’t / don’t want to switch to the covered alternative?

    Particularly for specialty pharmacy prescriptions, there are assistance programs out there that may be able to help if your prescription is no longer covered by your insurance plan, and switching isn’t an option for you. Organizations like the Partnership for Patient Assistance and NeedyMeds can help you find which programs you’re eligible for.

    Check the official website for your medication. In addition to prescription savings cards, the manufacturer will often offer a patient assistance program. You must meet income requirements or be uninsured for some programs, but others can help if you don’t have coverage for a particular drug.

    If all else fails, it never hurts to ask to see if your prescription can still be covered. Have your doctor write a note, plead your case, make some noise—we’ve heard about coverage exceptions for some patients.

    One last option: if you’re able to change your insurance plan, many of the drugs excluded by Express Scripts are covered by Caremark and vice versa (like the insulins mentioned here). If you can find a plan that works for you with the prescription benefit offered by a different company, you may be able to keep your coverage.

    The GoodRx Pharmacist

  • Exubera, the other inhaled insulin, was pulled from the market after 2 years because sales were so low. I never prescribed it. The Exubera device was difficult to use and large. There is reason to believe that it will be different this time. The Afrezza device is small and easy to use.

    6. Two other drug companies that were making an inhaled insulin pulled out after the failure of Exubera.

    7. Insurance companies may decide to cover Afrezza because the studies of Afrezza show a low risk of hypoglycemia (low blood sugars). Low sugars can lead to substantial cost to insurers so they may embrace Afrezza.

    8. Afrezza is a rapid-acting inhaled insulin used prior to meals or within 20 minutes of starting a meal. Remember it is not a substitute for long-acting insulin and must be used in combination with long-acting insulin in patients with type 1 diabetes.
    by Dr. Sharon Orrange

  • seekingalphaDOTcom/article/2717075-mannkind-the-newest-bear-talking-point-is-absurd

  • This quote from you totally proves you don't, won't or don't care to know the benefits of Afrezza.. "They care only about the price and risk-benefit of Afrezza relative to injectable meal-time insulin." Every take shots in a restaurant before meals?? Read The Reason Why It's Superior to RAA's out there today. You, Karp, Cramer, can keep trying to help your short pals, Your running out of time.

    1. AFREZZA's Ultra Rapid Action is nearly an exact mirror to the endogenous post prandial insulin spike in a healthy non diabetic body, and as such it enters the body quickly and is active during the correct time frame to handle the meal time spike in blood sugar

    2. As a physiologic meal time prandial insulin it is even more critical that it does its job and then rapidly exits the body without leaving behind a long insulin "tail" that leads to dangerous drops in blood sugar/hypoglycemic events, and insulin stacking problems. The currently available prandial insulin products, even the "rapid acting" insulins such as Humalog and Novolog are way too slow and linger for way too long after meal time digestion is over. This leads to these currently available insulins transitioning from prandial insulins to becoming "more basal" insulin. This effect does lower HbA1c levels making them appear more efficacious to the ignorant/uninitiated, but that IS NOT A GOOD THING (though the closed minded FDA staffers would have us believe otherwise)! HbA1c as a long term average is a very poor and incomplete statistical measure for quantifying how you are managing your diabetes. The trials for AFREZZA heavily relied on HbA1c endpoints whilst discounting more important measures such as fasting blood glucose levels, time spent in target range, leveling out blood sugar levels with higher lows and lower highs, reduced weight gain, less hypoglycemic events, etc...

    3. Defensive snacking is largely eliminated with AFREZZA leading to weight loss, there is no longer a need to "feed the insulin" or face the risk of immediate coma or death.

    4. Complex mealtime titration is not necessary due to the PK/PD of AFREZZA. This is huge for patient convenience and compliance

    5. Constant finger pricks for blood glucose monitor testing is greatly reduced due to the PK/PD of AFREZZA. THIS IS A HUGE BENEFIT that the FDA has completely ignored. This is yet another way that the real world use of AFREZZA helps the patient move away from being a human pin cushion!

    6. AFREZZA has absolutely zero side effects for the vast majority of patients, and very very minor side effects for a tiny minority of patients, such as a minor cough that quickly goes away as you adjust to inhaling the medicine. This drug is very safe, and very effective. In fact AFREZZA will be one of the safest and most effective drugs the FDA will ever approve.

    7. AFREZZA will be (by orders of magnitude) the best insulin product on the market for making between meal adjustments for all diabetics across the spectrum of the disease. Currently available prandial insulins are far too slow. AFREZZA allows us to live in real time for the first time. Even patients who choose not to use AFREZZA as their everyday bolus, will NEED to have this product at their disposal for just this reason.

    8. AFREZZA is the only prandial insulin with the Ultra Rapid Action needed to close the loop for the artificial pancreas. It's the missing piece that allows this project to move forward.

    9. The unique and novel PK/PD of AFREZZA allows the patient to know their blood sugar levels are safe when they go to bed and not fear dying in their sleep as occurs with currently available products.

    10. Patients on AFREZZA have far less blood sugar extreme highs and lows which lead to a myriad of health problems: blindness, organ failure, amputation, coma, death.

    11. AFREZZA will be the first and only Ultra Rapid Acting insulin.

    12. AFREZZA is easy for anyone to use, even the elderly and young children. The device is a marvel of modern design, small, efficient, and effective. Simple to use, inexpensive and disposable, few moving parts, you don't even have to break it down and clean it! This is exactly the type of revolutionary product that the FDA needs to make available to the public

    13. Approval of AFREZZA opens up the Technosphere drug/device platform for pharma development for many other innovative products to come such as pain relief medicines and vaccines. This is the type of innovation that the United States needs to remain the world leader for, lest we by surpassed by companies in other countries, and we are forced to watch the United States take a back seat.

    14. AFREZZA breaks down every barrier that physicians and patients face in initiating insulin therapy: 1. Needles, 2, Weight Gain, 3. Fear of Hypoglycemic Events, 4. Complicated Educational Process, 5. Gaining Patient Compliance

    15. Research indicates that AFREZZA slows the progression of the disease. More studies are necessary for a final verdict, but wow--what a benefit!

  • At PJ Conf Tues Dec 2. Mgmt will shed light on A launch, additional milestones bonus, TS strategic progress, mfgr ramp, mktg status, prescription advisory, insurance formulary acceptance at ExpressScript, CVS CareMark. Pricing is the same as pen insulin. Shorts who couldn't borrow shares resorted to bear raid to steal shares from longs. Don't set stop loss for You aide shorts.

  • lakers_w lakers_w Nov 28, 2014 2:32 PM Flag

    Mgmt promised to submit TS strategic proposal to BoD by Nov '14 end. BoD will brainstorm with mgmt, then announce TS strategic decision by early Feb '15 or sooner. Colten, Oppie, you can verify by asking Mnkd people directly before passing your knee-jerk judgement. If you can't make time to call them, then stay mum for your rebuttal is not substantiated. What do you think pps will do? Do you think TS and oncology pipeline will fetch zero? Yes? Think Again. Think Different!

  • 29 million Americans have diabetes, but a quarter of them don't realize it

    (c) 2014, The Washington Post.

    William Herman has spent decades researching diabetes, treating patients grappling with complications from it and trying to educate people on how to prevent it. During those same years, he also has seen the prevalence of the disease grow virtually unabated.

    "It really is an epidemic, both in the U.S. and globally," said Herman, director of the University of Michigan's Center for Diabetes Translational Research and a consultant to the World Health Organization (WHO).

    (Story continued below...)
    The statistics are staggering. More than 29 million Americans, or 9.3 percent of the U.S. population, have diabetes — but a quarter of them don't yet realize it, according to the Centers for Disease Control and Prevention (CDC). An additional 86 million Americans have pre-diabetes, which is marked by higher-than-normal blood-sugar levels and puts them at an elevated risk of developing diabetes. The WHO estimates that nearly 350 million people worldwide have the condition.

    Year after year, diabetes exacts a massive human and economic toll. Those who have it are at a higher risk of heart disease, stroke, kidney failure and blindness, and of losing toes, feet and legs to amputation. The risk of death for adults with diabetes is 50 percent higher than it is for adults without the disease, according to the CDC.

    "The costs of diabetes are enormous, and they are growing," Herman said. "People with diabetes account for a substantial portion of the total cost of health care in the United States."

    Medical expenses tend to be twice as high, on average, for people with diabetes than for those without the disease. Collectively, it costs the U.S. health system an estimated $250 billion a year, including major amounts of lost work and productivity. That includes billions spent on inpatient care, doctor's visits, medication and supplies such as glucose monitoring strips. The American Diabetes Association estimates that treating patients with the disease accounts for more than $1 of every $5 spent on health care in the United States.

    "It has affected all segments of the population," said Edward Gregg, chief of the epidemiology and statistics branch of the CDC's diabetes division. "But it hasn't affected everyone equally."

    The risks generally increase with age, but a growing number of people younger than 20 are diagnosed with diabetes. Asian-Americans, African-Americans, Hispanics and Native Americans all have higher rates of the disease than whites, and those who live in areas of extreme poverty have been hit particularly hard.

    The CDC found that diabetes diagnoses increased between 1995 and 2010 in every U.S. state, including by 50 percent or more in 42 states. During that period, the number of cases in the country more than doubled.

    Despite the immense number of people who have diabetes, it has not triggered national alarm. Other illnesses, such as cancer and Alzheimer's disease, often garner more attention. One reason is that people with diabetes sometimes go years before experiencing any decline in their quality of life. When complications do surface, they often do so gradually and manifest in various ways. People don't always recognize diabetes as the source of severe health problems.

    In fact, the CDC says diabetes is underreported as a cause of death, even though it is the seventh-leading cause of death in the United States. For instance, the numbers of people listed as dying each year from heart disease and stroke are larger than they are for diabetes but many of those people had diabetes as an underlying condition.

    Before the nation can turn the tide of the epidemic, society must recognize diabetes as the pervasive killer it is, said Marjorie Cypress, a nurse practitioner for ABQ Health Partners in New Mexico and president of health care and education for the ADA.

    "We have to convince people this is a serious disease," she said. "It really needs to be a big push on every level."

    The overwhelming majority of diabetes cases — as many as 95 percent — involve the Type 2 form of the disease. It occurs when the pancreas can no longer make enough of a hormone called insulin, and the body cannot effectively use the insulin being produced — a condition known as insulin resistance. The result is a build-up of glucose levels in the blood, which over time can harm the kidneys, eyes, nerves and heart.

    Early symptoms can include frequent urination, excessive thirst, persistent fatigue and a tingling or numbness in the hands or feet. Or there may be no symptoms until long after someone has developed diabetes, which is one reason doctors have placed a growing emphasis on early screening.

  • The biggest worry for MannKind (NASDAQ: MNKD ) has been whether doctors would prescribe its inhaled insulin drug, Afrezza, which would take market share away from injected insulin currently prescribed by physicians. But there might be a bigger concern: whether marketing partner Sanofi (NYSE: SNY ) can get a high enough price for the drug from insurers.

    On its third-quarter conference call, then-Sanofi CEO Christopher Viehbacher noted that the company received greater than 90% unrestricted coverage from U.S. insurers and government programs for its flagship insulin Lantus. However, the company's earnings press release explained that "the level of rebates required to maintain these positions has increased significantly due to aggressive discounting by competitors."

    That competition is likely Novo Nordisk (NYSE: NVO ) which sells Lavamir, Lantus' biggest competitor. Shares of both Sanofi and Novo Nordisk fell on the news. Discounts aren't good for anyone.

    Having to discount Afrezza would be a mighty blow for MannKind, especially since the drug-device combination is more expensive to manufacture than injected insulin.

    Afrezza inhaler. Source: MannKind.
    Afrezza won't compete with Lantus, which is a basal insulin, designed to provide background insulin levels to control blood sugar throughout the day. Afrezza is a mealtime insulin that helps with the spike in blood sugar after diabetics eat.

    But the only thing stopping a price war in mealtime insulin drugs is the drugmakers. As Viehbacher noted on the call, "You cannot have pricing pressure unless you have a competitor willing to reduce pricing in another market in the channel."

    Who are Afrezza's competitors? Eli Lilly's (NYSE: LLY ) Humalog and Novo Nordisk's Novolog. If one of them tries to grab market share by discounting its product, the others, including Sanofi and MannKind, will have to follow suit.

    Even if one of the companies that make mealtime insulin isn't willing to play the price-war game, Sanofi and MannKind still might have problems obtaining the premium required to get a decent gross margin on Afrezza. Insurers are clearly revved up for a fight with drugmakers over prices. With other options available, insurers don't have to cover Afrezza if Sanofi is charging more than they think the drug is worth.

    Drugs as commodities
    It's bad news when drug companies must compete on price. Research and development of new drugs is expensive: The Tufts Center for the Study of Drug Development pegs the cost at $1.4 billion per approved compound, not including lost returns on capital while the drug is in development, which adds another $1.2 billion. And after a drug is approved, pharmaceutical companies spend an average of $312 million more doing post-approval clinical trials and other R&D on the compounds.

    The good news for investors is there can't be a price war if drugmakers won't play along. Insurers can choose not to cover drugs, but if all the insulin makers hold their ground it's not like an insurer could refuse to cover any insulin. Unfortunately, it's tempting for the company on the bottom of the market-share chart to try to grab additional patients by discounting its drug, making up for lost profits with more volume.

    The solution for investors is to find drugs that treat diseases for which there is little competition, or new drugs that are so much better than the current options that insurers must pay whatever drugmakers want to charge. Unfortunately for MannKind and Sanofi, Afrezza doesn't fit that description.

  • forbesDOTcom/sites/rogerkay/2014/11/25/intel-and-amd-the-juggernaut-vs-the-squid/?partner=yahootix

    And, for its part, AMD has been saying for several years now that it no longer focuses primarily on Intel, aiming instead for new markets where it can win. And this statement isn’t entirely sour grapes. AMD’s growth potential really does lie beyond the PC market.

    AMD’s ability to pivot over to ARM represents a narrow niche into which it can squeeze to help it remain viable. In 2011, I wrote that Intel was more ideologically committed to x86 than was AMD, and this view has been borne out by subsequent events. While AMD has no immediate plans to offer pure ARM chips for phone applications, it will have the opportunity to tap into the ARM ecosystem for tablets and other small devices and participate in any gains ARM makes in the server space. Meanwhile, it is targeting its new x86 chips at gaming notebooks and some enterprise applications. AMD is doing its best to squeeze all computing functions onto a single piece of silicon (a system on a chip or SoC) and deliver a streamlined platform to its customers at a good price.

    And one of AMD’s best plays is its semi-custom niche, which in the recent past has yielded spectacular results among game console makers. It won all three — Sony , Microsoft, and Nintendo — unseating IBM’s Power architecture. And while no one knows how long the great run in consoles will last, AMD CEO Lisa Su told analysts on the earnings call that the company has two new semi-custom wins: a non-gaming customer and a 64-bit ARM design, thus demonstrating semi-custom strength beyond consoles.

    The niches into which the squid can slip are narrow and hard to find, but it has avoided being squashed by the juggernaut so far, and a focus on best-in-class SoCs, the ability to work with large customers to create custom solutions, and the perfection of the rapid pivot may yet lead the struggling cephalopod into calmer waters.

  • lakers_w lakers_w Nov 18, 2014 12:41 AM Flag

    The Food and Drug Administration (FDA) has for the second time approved an inhaled form of insulin to treat diabetes. Afrezza (insulin human), manufactured by MannKind Corporation, is a fast-acting inhaled insulin that can be used to treat type 1 or type 2 diabetes. When Afrezza is used to treat type 1 diabetes, it must be used in conjunction with a long-acting insulin; in preapproval studies of Afrezza in patients with type 2 diabetes, it was used in addition to oral antidiabetic therapy, such as metformin alone or two or more drugs in combination. Afrezza cannot be used in the treatment of diabetic ketoacidosis.

    In 2006 the FDA approved the first inhaled insulin, Pfizer's Exubera, but Pfizer voluntarily pulled the drug from the market in 2007 because of poor sales. Exubera's poor market performance has been attributed to several factors: a cost higher than that of injected insulin; its large, unwieldy inhaler (about the size of a tennis ball can); and difficulties in determining the proper dose, which varied from 1 to 6 mg based on the patient's weight. MannKind Corporation addressed these concerns in designing Afrezza: the inhaler is now the size of a whistle, and the drug is dosed in amounts resembling doses of other insulins (an easy-to-use conversion guide is also part of the prescribing information). Afrezza's more-rapid onset of action gives it another advantage over Exubera. The exact cost of Afrezza hadn't been revealed at the time of this writing. On June 27, the date the drug was approved by the FDA, MannKind Corporation was in negotiations with major pharmaceutical companies to find a partner that can provide a sales force; the company announced in August that it had signed an exclusive worldwide licensing agreement with Sanofi to develop and commercialize Afrezza.

    Afrezza has been found to increase the risk of acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD); the labeling carries a boxed warning to that effect. Asthma and COPD and other chronic lung diseases are therefore contraindications to the use of Afrezza. Before starting Afrezza patients should be carefully assessed for lung disease (assessment should include a detailed medical history, physical examination, and spirometric evaluation). Afrezza produces a decline in lung function, as measured by forced expiratory volume in one second (FEV1), although lung function stabilizes and doesn't continue to decline with long-term use. Despite that stabilization, the FDA recommends that the FEV1 be assessed at baseline, after six months of therapy, and then annually, even if the patient is without pulmonary symptoms.

    Patients who smoke or who recently stopped smoking (within the previous six months) should not use Afrezza because its safety and efficacy in this population haven't been confirmed. Two patients in clinical trials (covering a total of 2,750 patient-years of exposure) were diagnosed with lung cancer, and both had a history of heavy tobacco use. Two additional cases of lung cancer in nonsmokers were diagnosed after the clinical trials were completed. MannKind Corporation has been asked to complete a postmarketing trial to gather more information on a possible risk of lung cancer associated with use of the drug.

    Afrezza use may increase patients’ risk of diabetic ketoacidosis. Other adverse effects are similar to those experienced with other fast-acting insulins: hypoglycemia, hypersensitivity reactions, and hypokalemia. Common adverse effects unique to Afrezza include cough and productive cough, throat pain or irritation, headache, diarrhea, fatigue, and nausea.

    Afrezza is administered at the beginning of a meal. Inhalation cartridges are single use and carry either four or eight units. The Afrezza inhaler is activated by the patient's breathing. When the patient inhales through the device, the powder is aerosolized and delivered to the lungs. The insulin molecules are attached to carrier particles, which aren't metabolized but are eliminated unchanged in the urine after absorption of the drug in the lung. The maximum serum insulin concentration from Afrezza eight units was reached 12 to 15 minutes after inhalation. In clinical trials patients with type 1 diabetes who received Afrezza had a mean reduction in glycated hemoglobin (HbA1c) that met the prespecified noninferiority margin of 0.4%. Afrezza, however, provided statistically significantly less HbA1c reduction than insulin aspart. Clinical trials of patients with type 2 diabetes found that therapy with Afrezza plus oral antidiabetic medication created a mean reduction in HbA1c that was significantly greater than therapy with oral antidiabetic therapy plus a placebo.

    Nurses should teach patients prescribed Afrezza how to use the inhaler and the cartridges. The single-use cartridges are either blue, containing four units of Afrezza insulin, or green, containing eight units. If stored in the refrigerator, the cartridges are placed into the inhaler after being brought to room temperature for 10 minutes, although unopened blister strips can be kept at room temperature for 10 days. The inhaler can be used for as long as 15 days and must then be replaced. Additional specific instructions regarding the administration technique are included in the drug labeling and the patient medication guide. The nurse should review these with the patient prior to the first use of the drug.

    Before the beginning of Afrezza therapy nurses should confirm that patients do not have any chronic lung diseases, do not smoke, or did not stop smoking within the previous six months. Nurses should tell patients that a decline in lung function with Afrezza therapy is possible and that they should report any changes. Pulmonary function should be monitored using spirometry prior to the start of therapy and then at the recommended intervals, even in asymptomatic patients. Patients should understand the importance of reading the medication guide every time they have a prescription filled because it will contain the most current information regarding adverse effects. Nurses should emphasize that Afrezza doesn't eliminate one's need to follow prescribed recommendations regarding diet and physical activity.

  • Diane S. Aschenbrenner MS, RN
    Abstract
    * Afrezza (insulin human) is a newly approved fast-acting inhaled insulin. It can be used in treating type 1 diabetes when added to a long-acting insulin; in studies, patients with type 2 diabetes used it in combination with oral antidiabetic therapy. Afrezza will be available in 2015.
    * Afrezza is taken before meals using a small, specially designed inhaler.
    * Patients should be carefully assessed for lung disease prior to starting Afrezza therapy. Chronic obstructive pulmonary disease and asthma are contraindications to use. Lung function can deteriorate after therapy begins.

    The Food and Drug Administration (FDA) has for the second time approved an inhaled form of insulin to treat diabetes. Afrezza (insulin human), manufactured by MannKind Corporation, is a fast-acting inhaled insulin that can be used to treat type 1 or type 2 diabetes. When Afrezza is used to treat type 1 diabetes, it must be used in conjunction with a long-acting insulin; in preapproval studies of Afrezza in patients with type 2 diabetes, it was used in addition to oral antidiabetic therapy, such as metformin alone or two or more drugs in combination. Afrezza cannot be used in the treatment of diabetic ketoacidosis.
    In 2006 the FDA approved the first inhaled insulin, Pfizer's Exubera, but Pfizer voluntarily pulled the drug from the market in 2007 because of poor sales. Exubera's poor market performance has been attributed to several factors: a cost higher than that of injected insulin; its large, unwieldy inhaler (about the size of a tennis ball can); and difficulties in determining the proper dose, which varied from 1 to 6 mg based on the patient's weight. MannKind Corporation addressed these concerns in designing Afrezza: the inhaler is now the size of a whistle, and the drug is dosed in amounts resembling doses of other insulins (an easy-to-use conversion guide is also part of the prescribing information).

  • lakers_w lakers_w Nov 16, 2014 11:03 PM Flag

    The second one is TS licensing for inhalable GLP-1 development. Mnkd doesn't own the secretin. Mnkd will have many TS licensees in the future. TS is the crown jewel. Aapl didn't have to announce every deal or licensing. Mnkd slipped their tongue or pen about the TS licensing, then covered it up by Redacting Cat 4 "development" to satisfy NDA w/ Sny (Non Disclosure Agreement, not New Drug Application). What's wrong with that? The high tech industry often does that for competitive reason.

  • lakers_w lakers_w Nov 16, 2014 10:22 PM Flag

    Did you learn how Aapl operate in secrecy? Mnkd can legally lump the inhalable GLP-1 together with Afrezza in one Licensing Agreement. Nothing prohibits them from doing that. Were you abused when you grow up? It's a vicious circle. You should have used "excel" instead of "accelerate". You haven't given me a logical answer. Why inhalable GLP-1 in 2Q14 10-Q went AWOL in 3Q14? It is actually there but redacted.

    Why is mgmt paranoid about it?

    Mgmt filed 3Q14 10-Q at the 11th hour, which indicated there was some intense debate about what they could and couldn't reveal. There must be a lot of back-and-firths between Mgmt and Sny regarding this.

    What is the redacted milestone #4 which is neither mfgr, regulatory, sales while the preceding paragraph cited the mysterious Cat 4 "development". Afrezza development has finsisted. The new process is mfgr related. Other mandatory follow-up studies are regulatory related.

    Why did mgmt even redact the Cat 4 name which is construed as development?

  • lakers_w lakers_w Nov 16, 2014 9:39 PM Flag

    2nd qtr 10-Q mentioned inhalable GLP-1 in the Licensing Agreement. 3rd qtr 10-Q doesn't. Where does it go? Mgmt can't falsify the 10-Q. How else do you explain the discrepancy? Think before you say something. Your challenge fails. Give me a more logical challenge instead of spitting venom. Don't let your short money cloud your judgement and get the better of you. You are a better person than that. Did you read all 266 pages of 3rd qtr 10-Q. I assume you are literate. Maybe my assumption of you is wrong, yes?

  • lakers_w lakers_w Nov 16, 2014 3:01 PM Flag

    They hid GLP-1 under 6.2 Milestone Payments means that mgmt already had a licensing deal for inhalable GLP-1 with Sny. It's no longer 1st right of negotiation but a done deal. This shows how much they believe in the TS. It's a matter of price before BPs swallow up Mnkd as a whole or in parts. IMHO, Pfizer the largest in the world, Novo, Lily, Roche, Merck, GLK would give up without a fight. Especially Pfizer spurned by $100B acq of AZ has more than enough ammo to take Mnkd. Pfizer would ask what does Sny know that we don't, especially Sny sold a lemon named Exubera to Pfizer for $1.5B. It's payback time y'all !!
    This time they'd better phony up $$$. "You get what you pay for" ring true.

  • lakers_w lakers_w Nov 16, 2014 2:19 PM Flag

    2nd qtr 10-Q has inhaleable GLP-1. 3rd qtr 10-Q hasn't. Thus, GLP-1 was redacted. By SEC rule, CEO, CFO when signing 10-Q are personally sworn and held liable. They are subject to jail sentence and large fine. Don't think Al, Matt would risk that. So, in what section was GLP-1 redacted? It must be in "development".

    Where else do you think GLP-1 could be listed in the redacted 3rd qtr 10-Q?

    Mgmt slipped their pen in 2d qtr. They must be cautioned by Sny who wants to keep it a secret. Appl often does that. Had mgmt announced the inhalable GLP-1 licensing, it would have gone against Sny's wish, and mgmt has to disclose upfront payment, milestone, royalty. At the same time shareholders *eventually* have the right to know. As a balancing act, they redacted the entire Cat 4 "development"

    4. [***]
    [***] [***] $[***]

    And hid the GLP-1 development there, it's $$$ is deferred. It's unusual they redacted the entire Cat including the Cat name. But they can't fool me. I am still waiting for a logical debunking of this analysis. Next challenger please, long or short. I need a well reasoned rebuttal. $$$ is at stake.

  • lakers_w lakers_w Nov 16, 2014 5:36 AM Flag

    The total royalty stream, mid 20% or 25%, for the life of Afrezza and inhaleable GLP-1 would far exceed the upfront and bonus payment. Imagine when Mnkd creates multiple royalty streams. Al just passed 89. He won't be in this game much longer. As any smart biz man, he would set up a company which can generate multiple royalty streams for a foreseeable future. Such biz has north of 85 ops margin, or 100% GM. It's time to ring the cash register, cha-Ching! That's why I 100% believe he will explore some strategic options shortly. You all think he is 40 yrs old and lives forever? Just wear his shoes for a day! Then Think again. Many longs think he would wait a few more yrs? That borders on being naive. He would no doubt think about an exit plan.

  • lakers_w lakers_w Nov 15, 2014 10:09 PM Flag

    Also interesting that milestone payments are split and can be shifted between three legal entities... Mannkind, Mannkind Netherlands and Technosphere International. Likely just for tax accounting. TS royalty will most likely be moved offshore for lower tax rate. Can someone send the inhaled GLP-1 revelation to To-Millon? It probably moves Pps in a meaningful way. If you thumb down this thread, could you detail your logical reasoning? I'd like to know whether this is an iron clad analysis. $$$ is at stake.

  • lakers_w lakers_w Nov 15, 2014 9:23 PM Flag

    Pg 27/262 3Q14,

    "On August 11, 2014, we and Sanofi executed the Sanofi License Agreement, which subsequently became effective on September 23, 2014. Pursuant to the Sanofi License Agreement, we received a $150.0 million up-front fee and may earn potential payments of up to an aggregate of $775.0 million upon the achievement of certain development, manufacturing, regulatory and sales milestones. Worldwide profits and losses will be shared 65% by Sanofi and 35% by us.

    4. [...***...]
    [...***...] $[...***...]"

    Note the 4th category "development".

    The last redacted milestone was totally opaque indicating a Skunk Work project blacked out for competitive reason. The only conclusion is Afrezza II barely mentioned by exec previously or inhaled GLP-1.
    If you search the 3Q14 for glucagon or peptide or agonist, there was no match. Those words were clearly mentioned in 2Q14. Obviously, the consortium wants to supprise competitors. The redacted most certainly includes a separate royalty for the life of inhaled GLP-1. Sny ER slide new pipeline appendix includes a secrete GLP-1 in Phase 1.

    I defy any serious long or short to constructively dispute my analysis. I am all ears as low by as you provide sound reasoning.

  • Big things I saw:

    Section 4.2: looks like sanofi is on the hook for all regulatory costs (does this means the clinical study costs?) doesn't appear to be a cost that is split 65/35

    Section 6: while milestones aren't listed there's some good outlining here.

    What's really interesting is that there's a milestone listed that is redacted and is neither manuf, approval or sales driven. So, this must be milestone bonus related to inhalable glp-1.

    Note that the 3Q14, 10-Q didn't mention about inhaled GLP-1.

    However, 2Q14, 10-Q, pg 43:
    "Under the terms of the Sanofi License Agreement, we granted to Sanofi a right of first negotiation in the event we propose to grant to any third party a license to develop or exploit an inhaled glucagon-like peptide-1 agonist. In addition, if our board of directors determines to pursue a change of control of MannKind, we will be required notify Sanofi of such determination within a certain period of time so that Sanofi may, at is discretion, negotiate with us for a potential acquisition of MannKind by Sanofi"

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