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Post by mannmade on Sept 21, 2016 18:54:47 GMT -5
Would be nice...
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Post by mannmade on Sept 21, 2016 18:26:34 GMT -5
dbc, you may be right... all pure speculation as I mentioned earlier.
Money has to come from somewhere, sooner than later at this point... Doubt it will be from Al Mann's estate but just my opinion. So would likely have to come from open market or private party who gets access to info we don't have that gives them enough confidence to do a deal. Either way, as I see it, money is the big issue right now and it will need to be resolved first so that scripts have the time to take care of themselves as the resolution to the second big issue imho...
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Post by mannmade on Sept 21, 2016 17:57:56 GMT -5
With the end of September we see that scripts are climbing albeit much slower than one would have hoped, so the inevitable issue must be addressed... Dilution? When, How Many Shares, On what terms, and what effect will dilution have on the stock price and the future of MannKind...? Any answers are purely a guess or personal speculation at this point...
Imho, I continue to be a cautious optimist, although I do find myself revising and revisiting my MannKind investment plan regularly as opposed to my original Buy and Hold strategy. As a result, given the view of my current "snap shot" of MannKind I do not see dilution as a necessarily bad thing at this point.
However, I must give two caveats, first; scripts must continue to rise and eventually attain a weekly level that can help financially sustain the company in whole or in part (in combination with other products such as epi). Second, MannKind needs to raise enough money to gain enough time to get to the first caveat.
So while we are facing a tough time at the moment I have reasons for my cautious optimism as follows:
1. At .70 a share or so it looks like the pending dilution may have been baked in to some degree, although am not sure how much that might be, as s/p is also a reflection of weekly script totals. (However, s/p has held fairly steady the last few weeks since it declined to this level and weekly script counts remain mostly constant with slight upticks.)
2. If we get dilution and get enough money to have the time for scripts to ramp up and the epi launch or some other form of partnership, say 12 months, then once dilution occurs MannKind has effectively taken the financial issue off the table for a time. Ironically this may actually help keep the share price from going too low as money is one of the two big issues right now.
3. Even with 150m or more new shares on the market I think having the time to get scripts to a sustainable level is worth it at this point. Then once the s/p climbs back to say $2.50 to $3.00 based on script numbers of weekly trends and growth with real revenue, MannKind can do a reverse split to downsize the number of outstanding shares.
At the end of the day this is not what most of us were looking for, and I am not a professional at this, but for what it's worth I believe there is still reason to be optimistic so I thought it might generate an interesting discussion while we wait to see what happens over the next 6 to 8 weeks.
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Post by mannmade on Sept 21, 2016 15:52:35 GMT -5
rravis I think your description is fairly spot on. I have actively been working to help pwd get on AFREZZA and also working with doctors to educate them when I can and it seems appropriate. I just received a call today from a friend back east who has a 15 yr old son who is a T1. I have been working with her since last November to find a doctor willing to prescribe off label.
She just told me today that she met with a doctor who does have patients on AFREZZA most of whom like it very much. However, the doctor was unwilling to prescribe AFREZZA for her son because of her concern about unknown long term health effects. The doctor told her that she would do so if her son were able to give his own consent but unfortunately he is not. So we are on to the next doctor...
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Post by mannmade on Sept 20, 2016 16:40:29 GMT -5
Sorry, Patients: We Won’t Fill Your Prescription Here What does this mean for every current patient, as well as all the rest of us potential patients? 09/19/2016 05:48 pm ET | Updated 33 minutes ago
Jonathan Wilcox Co-founder and Policy Director, Patients Rising In case you missed it, last month pharmacy giant CVS announced it would terminate access to more than 30 new medications in 2017, including groundbreaking cancer and diabetes drugs. Shortly after the CVS announcement, Express Scripts – the nation’s dominant pharmacy benefits manager – followed suit with its list of drugs to be dropped in 2017.
What does this mean for every current patient, as well as all the rest of us potential patients?
CVS Health maintains more than 68,000 pharmacies nationally including the CVS Pharmacy Stores. It fills or manages 1.9 billion prescriptions per year and touches tens of millions of lives. The conglomerate’s own second quarter earnings report claims a savings of “more than $9 billion for clients without disrupting member care.” I’m sure those who will lose access to their cancer or diabetes medications might disagree.
To make matters worse, CVS’s announcement on the need to cut medications occurred the same day it beat Wall Street forecasts with a robust second quarter operating profit of $2.4 billion. Rather than telling hedge fund managers how many patients it is cutting off, shouldn’t CVS suggest ways to get patients the medicines they need?
Express Scripts, while not nearly as well-known as CVS, recently announced a growth in second quarter profits by nearly 21 percent with a net income of $720.7 million. The broker also announced its own 2017 formulary exclusion list – 85 drugs in all. What does that mean if you’re one of the many patients who needs one or more of those 85 medicines?
On its 2017 preferred drug exclusion list, Express Scripts provides the following instructions to patients: “If you’re currently using one of the excluded medications, please ask your doctor to consider writing you a new prescription for one of the following preferred alternatives.”
Basically, regardless of what your doctor determines is best for you, the final decision is in the hands of the of the pharmacy benefit manager and not your medical provider.
If this becomes standard operating procedure, we have likely taken a step from which there is no return.
In this potentially brave new world of a CVS on practically every street corner, this is what America’s anti-patient future looks like. If CVS can do this to patients, anyone can. Fictional characters who fear the future often say tomorrow will be a time when we have no control over our health, our finances, what we do and where we go.
But this is no paranoid delusion. It’s at least partly true right now if a doctor can prescribe a treatment, a patient can agree and a pharmacy benefit manager can overrule them both.
What is CVS going to tell the first patient who walks into one of its pharmacies on January 2nd and can’t get their medication?
CVS Caremark has more than 75 million members and has cleared billions of dollars in the health care business. It didn’t happen by selling oscillating fans, ice cream or wall calendars. It made those billions serving patients, and with this comes an obligation to those people. What are CVS’s ideas to make the system work better? Throwing up their hands and cutting patients? Is there really not a Plan B?
Of course we should hear these entities out and provide a fair opportunity to explain these controversial stands. But if the rationing of medicines goes forward, then we are at cross purposes.
Entities like CVS and Express Scripts can play a vital role, but they owe patients more than to silently and anonymously do things once unimaginable, but now outlined in black and white as financial corporate policy.
No one should begrudge either of these companies a strong balance sheet in the black. But is it too much to ask they do it without turning their backs on the millions of patients that enabled their billion-dollar bottom lines?
Walgreens, call your office. A million patients might be on the other line.
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Post by mannmade on Sept 20, 2016 12:30:55 GMT -5
West Virginia has taken a huge shot at the maker of the EpiPen
Linette Lopez 2h 4,219 4 FACEBOOK LINKEDIN TWITTER Mylan CEO Heather Bresch Mylan CEO Heather Bresch. Flickr/Center for American Progress West Virginia is accusing Mylan, the maker of the EpiPen, a life-saving autoinjector used to treat severe allergic reactions, of Medicaid fraud.
Specifically, it's accusing the company of inflating the price of the EpiPen by 500%. The case was announced by the state's Attorney General, Patrick Morrisey.
The price of the EpiPen (now $608 for a two-pack) caused national outrage earlier this year. Mylan purchased the drug back in 2007 when it cost $100.
That price increase has angered Washington and sent the company's stock plummeting. Rep. Elijah Cummings of Maryland requested a hearing to be held Wednesday.
Mylan's CEO, Heather Bresch, is the daughter of Joe Manchin, the US senator from West Virginia. That hasn't saved her company from scrutiny, and shortly after the EpiPen pricing scandal began Manchin said what she did should be illegal and vowed to support legislation against dramatic price increases.
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Post by mannmade on Sept 20, 2016 12:26:38 GMT -5
Health Type 2 Diabetes - The Rising Silent Epidemic. Anjana Rajguru 11 hours ago Comments Sign in to like Reblog on Tumblr Share Tweet Email image According to the World Health Organization (WHO), the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014. The WHO estimates that 90 percent of people around the world who suffer from diabetes suffer from type 2 diabetes.
People with diabetes either have a total lack of insulin (type 1 diabetes) or they have too little insulin or cannot use insulin effectively (type 2 diabetes).
What Is Type 2 Diabetes?
The pancreas makes a hormone called insulin which lets your cells turn glucose from the food you eat into energy. People with type 2 diabetes do make insulin, but their cells are unable to use it effectively. This is called insulin resistance.The cells become resistant to the action of insulin. Initially the pancreas makes the extra insulin but over time it can’t make sufficient insulin to overcome this resistance. Sugar builds up in the bloodstream instead of helping the cells to use the sugar for energy.
In type 2 diabetes, the body struggles to convert the carbohydrates in food into energy whereas in a healthy person, insulin helps turn food into energy. There is risk of serious conditions like cardiovascular diseases, blindness and nerve and organ damage which may happen over a period of time.
Symptoms
Type 2 diabetes can strike people of any age though the odds are higher as one ages. One-third of the people do not know they have the condition as they have no symptoms of the same or the symptoms are very mild to be noticeable. Some symptoms which could signal the disease are:
Increased thirst Dry mouthFrequent urinationPresence of ketones in the urineFatigueIrritabilityHeadachesIncreased hungerBlurred visionSlow-healing soresFrequent infectionsFrequent yeast infections.Recurring urinary tract infectionsItchy skinUnusual weight lossImpotency
Who Is At Risk?
Sometimes it is difficult to say why some people have this condition though they have none of the typical risk factors. However, there are some medical conditions or lifestyle related habits which could be responsible and these include:
Smoking Being overweight, more so at the waistSedentary lifestyleEating excessive sugars/sweets,red meat and high-fat dairy productsUnhealthy cholesterol and triglyceride levels
The above factors are mostly within our control but there are some which are not, like our ethnicity. Native Americans,Asians,Hispanics and African-Americans are more prone.
If it is in your genes and have a parent or sibling with the disease, your odds are higher. Women who have polycystic ovary syndrome or delivered a big baby above 9 pounds and pregnant women with gestational diabetes and their babies have a higher risk of developing obesity and type 2 diabetes later in life. The risk of Type 2 diabetes increases with age.
How Is It Diagnosed?
A blood test reveals the sugar levels; there are tests to determine the average sugar levels in the last few months too.
How Does One Manage The Condition?
If you are overweight, the first goal is to knock off the excess weight through exercises and diet modifications. Monitor your fat, carbs and protein intake.
Exercise regularly and take long walks. Do not lead a sedentary lifestyle; it is suicidal.
Practice yoga and meditation and keep stress at bay.
Take medicines/injections on time, as prescribed.
Monitor sugar levels regularly. Nowadays there are many easy to use home kits available for the purpose.
Complications
Over time, if the condition is not controlled, there is a risk of major complications like:
Cardiovascular disease
Chronic kidney disease
Blindness
Nerve pain
Heart Attack
Injuries/ wounds on the foot which do not heal may in extreme cases require amputation of the foot.
Gum Disease and tooth problems due to excess plaque build up.
Prevention Better Than Cure.
Preventing Types 2 diabetes is all about healthy living. Unlike Type 1 diabetes, Type 2 can be prevented with lifestyle modifications. Do the following regularly to keep the condition at bay.
Exercise for minimum 30 minutes a day and engage in physical activity even if it is in small amounts, throughout the day. In short, avoid a sedentary lifestyle. According to WHO, The Diabetes Prevention Program found that weight loss and increased physical activity reduced the development of type 2 diabetes by 58 percent during a three-year study period. Amongst older subjects (60 years or older), the reduction was 71 percent.
Monitor your diet and weight. Eat healthy.
Quit smoking.
It is estimated that by 2035, there could be more than 600 million living with Type 2 diabetes; it is a rising silent epidemic. Silence in this case is surely not golden.
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Post by mannmade on Sept 20, 2016 12:23:14 GMT -5
Mylan CEO's mother used position with education group to boost EpiPen sales nationwide Jayne O'Donnell, USA TODAY 12:54 p.m. EDT September 20, 2016 AP MANCHIN 2012 A ELN USA WV (Photo: Dave Martin, AP) After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented effort that encouraged states to require schools to purchase medical devices that fight life-threatening allergic reactions.
The association’s move helped pave the way for Mylan Specialty, maker of EpiPens, to develop a near monopoly in school nurses’ offices. Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the "EpiPen Law" in 2013 gave funding preference to those that did.
The CEO of Mylan then, and now, was Heather Bresch. Gayle Manchin is Heather Bresch’s mother.
Mylan is the subject of congressional investigations related to huge price hikes the company announced last month. It also faces an antitrust probe by the New York attorney general stemming from its EpiPen sales contracts with schools.
Bresch is testifying before the House Oversight and Government Reform Committee Wednesday at a hearing called by Republican and Democratic members of the panel.
In October 2012, Mylan sponsored a morning of health presentations at the association’s annual conference. The presentations included a panel described as being on three of the biggest school health concerns, including food allergies.
The presenter at the panel, Chicago-based allergy doctor Ruchi Gupta, received more than $400,000 last year from Mylan for research on which she was the principal investigator, according to Centers for Medicare and Medicaid Services records. The center began releasing drug and device makers’ payments to doctors in 2013, when Gupta got more than $17,000 from Mylan for speaking, education, food and travel.
About this time, Mylan launched its "EpiPen4Schools” program, which has provided more than 700,000 free EpiPens to 65,000 schools, about half the nation's schools. The New York attorney general's investigation centers on this program, which required schools to buy EpiPens rather than its competitors if they got discounted versions, but Mylan has since changed the policy.
In December 2012, the association announced an "epinephrine policy initiative" designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto injector access and use," according to a press release that month. The resulting policy “discussion guide” listed key components school policy and state legislation should have, including protection from legal liability for the school.
It was the first time the group had addressed food allergies as policy despite its own admission that it had been a growing issue since about 2000.
Previously, the association carefully avoided corporate influence, especially when its influential policy guidance was involved, says Brenda Welburn, the former longtime executive director. Companies would sponsor conference meals at the most, she said.
USA TODAY EpiPen's steady price increases masked until deductibles rose
Manchin became president-elect of the education association in late 2010 and Welburn retired at the end of 2011. Welburn recalls Manchin stopping by her office saying her "daughter's company" could donate to the group. The following year, it did. "It just looked so bad to me," Welburn said. "She (Manchin) becomes president and all of a sudden NASBE is saying EpiPens are a good thing for schools."
In a statement, Mylan said its sponsorships "focused on initiatives to raise awareness and understanding of anaphylaxis and encouraged policies that supported greater access." (Anaphylaxis is a severe allergic that can be life-threatening and may include trouble breathing, vomiting and a rash.)
"There is no truth to the suggestion that the company's efforts were anything but straightforward or that we are aware of anyone advocating inappropriately for the right of schoolchildren to have access to potential life-saving medicine," the statement said.
Manchin did not respond to requests for comment.
A family affair
Manchin was appointed in 2007 to serve a nine-year term on the West Virginia board of education by her husband, then-Gov. and now Sen. Joe Manchin, D-W.Va. Gayle Manchin became the association president in January 2012, the same month her daughter became Mylan’s CEO.
Minutes of a NASBE board of directors meeting in March 2012 show Mylan funding was discussed. It continued this year with what executive director Kristen Amundson said was a $15,000 contribution from Mylan in April.
Considering the association's $2.5 million annual budget, Amundson said the $25,000 in 2012 to pay for the epinephrine discussion guide wasn't enough for the group to "engage in behavior to cause our members to question why" the money was accepted.
USA TODAY White House, Clinton lash out at EpiPen price hikes
Part of the "boilerplate" language in the association’s Mylan agreement says the group "will not directly or indirectly promote Mylan Specialty’s products," Amundson said.
It didn't have to.
Then, as now, EpiPen was about the only auto-injector for the drug epinephrine, which has been around since about 1900. The Mylan-sponsored materials rarely mentioned EpiPens. Instead, references to treatment for anaphylaxis mentioned only epinephrine and auto injectors.
In the epinephrine discussion guide,” the association acknowledged Mylan's support, but noted "NASBE alone is responsible for the editorial content contained herein."
David Kysilko, who was the group's director of publications until his retirement in 2014, says that for the discussion guide, "we were provided one person who was our contact within Mylan." That person "provided us with both the background and research (but) not all of it,” as well as contacts for other research, he said. The association also "gave them a look at an early draft," which he said is "fairly common whether it's a company or a foundation."
Still, "we were always very careful in terms of who made final editorial decision," he said.
Rhode Island attorney Patrick Guida, who succeeded Manchin as NASBE president in 2013, says he doesn't "cynically see any of the sinister motives of these companies" that others do.
Who knew what
When asked about the Mylan sponsorship of two panels she moderated at the association's 2012 annual conference, Brenda Gullett, a former Arkansas state senator and school board member, said she wasn't aware of Mylan's funding for either panel or the numerous policy publications.
"Had I been aware, I would have been concerned,” she said, “and, given my proclivity to speak up, I would have addressed it."
Brenda Gullett, a former Arkansas state representation, Brenda Gullett, a former Arkansas state representation, senator and school board member, is shown in 2014. (Photo: Beth Hall) Gullett wasn't the only one unaware of the Mylan-Manchin connection. "It's probably true that (NASBE) didn’t highlight that outside of the board of directors meetings," Kysilko said.
NASBE board member Alan Taylor of Connecticut says he doesn't recall knowing there was a family connection between Mylan and Manchin, who succeeded him as president. Guida said he was unaware of the relationship, and "I know Gayle pretty well."
Since there were highly publicized allergy-related deaths, which included a seven-year-old Virginia girl in 2012, state legislatures including Taylor's own were worried about liability if schools handled medication wrong, he said.
"It seemed like a useful thing for NASBE to do for state boards," Taylor said of some state-specific, Mylan-sponsored policy guidance. There were concerns the "funding would control the policy but of course everyone gets skeptical about that."
But Gullett said she can't imagine the group allowing a drug company to sponsor official guidance on concussions — a top school health concern at the same time food allergies were. And Welburn recalls when HIV/AIDs became a concern in the 1990s and NASBE suggested gloves should be worn around blood, she never would have entertained the idea of a latex glove maker sponsoring the education efforts.
"Companies like that don’t know schools," Welburn said. "They want to use you to get into schools."
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Post by mannmade on Sept 19, 2016 23:02:05 GMT -5
or maybe just a vacation...
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Post by mannmade on Sept 19, 2016 18:17:46 GMT -5
At this point everything about finances is speculation and conjecture.
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Post by mannmade on Sept 19, 2016 16:42:51 GMT -5
Diabetes Patients Need Earlier Administration Insulin: Novo Nordisk And Oramed Take The Lead Sep. 19, 2016 5:34 PM ET| About: Oramed Pharmaceuticals Inc. (ORMP) Samuel Rae Samuel RaeFollow(272 followers) Currencies, gold, biotech, healthcare Send Message|Diary of a Currency Trader Summary
Oral insulin is one of the Holy Grails of diabetes care, but it has been historically difficult to achieve for bioavailability reasons.
Novo Nordisk and Oramed are the two companies that look the most promising fro a development stage perspective right now.
Novo's legacy platform may make it unattractive for the company to go full-force on oral insulin commercializatoin.
Oramed could capitalize from this, since it can only gain from an FDA nod on its product.
Type 2 diabetes (T2D) care and management has improved dramatically across the last two decades, both from an availability of treatment perspective and from a patient education perspective. There is still lots of room for improvement in a number of areas of diabetic healthcare, however - areas that for whatever reason - time, resources, capital etc. - healthcare institutions and companies in the space have to-date been unable to address.
One of these major issues is very early stage care. By this, we mean healthcare from the point at which a physician first diagnoses a patent with T2D. For a variety of reasons, physicians are reluctant to start patients on an injectable insulin regimen right after they diagnose the patient with the condition. Instead, they will generally recommend a combination of diet and exercise, in an attempt to gain control of the condition naturally, before shifting to a chemical treatment regimen if and when the condition worsens. (Spoiler alert: it practically always does worsen.)
The reasons for this vary, from physicians not fully understanding the implications of delaying insulin treatment, to the patient not liking needles, or even a patient not thinking he or she can stick to an injectable dosing regimen for the rest of his or her life.
In the past, these have all seemed like valid reasons to delay. Why force a patient to inject themselves with insulin when there is a chance the disease can be controlled by eating less sugar and exercising more? Seems reasonable. Well, now we know it's not. There is a large body of evidence, a body which is growing every day, that demonstrates the negative impact that delaying insulin treatment can have on a T2D patients' long term progression.
Here's one such study.
And another.
And one more for good measure.
As the above linked studies show, all the data now points to a correlation between early insulin administration and an improved prognosis medium to long term. To put this another way, the quicker a patient starts to dose with insulin after diagnosis, the slower the progression of his or her T2D will be, and the less severe the T2D will be in the long run.
With this said, it's all well and good establishing this correlation, but it's very difficult to actually do anything about it - at least under current conditions. Patients that are scared of needles will still be reluctant to self-administer, and those who are prone to falling short of a dosing regimen will likely be so whether a physician educates them as to the benefits of strict adherence or not. Similarly, there will always be physicians who - despite the evidence - are reluctant to jump to injectable insulin as a go-to first line, when they've been prescribing diet and exercise for decades.
There's an unmet need here, and a number of companies are working to fill it: find a way to administer insulin fro the outset, without having to force a patient to self-inject, and without having to have physicians prescribe injectable devices.
There's a front runner alternative right now, and a couple of companies are leading the pack in this alternative's development. The candidate is oral insulin, and the company we think is ahead of the curve in bringing it to market is Oramed Pharmaceuticals, Inc.(NASDAQ:ORMP).
For those not familiar with Oramed, and by way of a brief introduction, the company is an Israel based junior biotech with a primary focus on oral insulin. Its lead candidate is called ORMD-0801 (we'll get to this in a little more detail shortly) and it's currently carrying this candidate through mid to late stage clinical trials.
The oral insulin market (if it materializes) is expected to be worth more than $15 billion by the end of 2024, and right now there are two companies that are basically neck and neck when it comes to be first to bringing a pill to market. These are Oramed and Novo Nordisk A/S (ADR)(NYSE:NVO). For reference, Novo completed a phase II at the end of last year and reported what it refers to as 'favorable' results, but there seems to be some question over the company's motive for bringing such a drug to market. If effective, it could decimate Novo's legacy injectable insulin platform, and while the company would recover some of the lost injectable revenues through the sale of its oral product (assuming it targets a replacement, as opposed to a complimentary, indication), the company would be open to generic competition within a decade. Unless it's very carefully managed, in other words, Novo's oral candidate could end up doing far more harm for the company than good.
The rest of the companies are way behind, with very few even having crossed from pre clinical to human studies.
What does this mean? Well, that Oramed is the only company on the market right now that has both a late stage oral insulin asset, and has nothing to lose by picking up a marketing authorization from the FDA for the product. There's an unmet need at the diagnosis end of the T2D spectrum, a $15 billion opportunity across the entire sector, and just two companies in the race - one of which might very well be limiting its own progress so as to reduce the near to medium term impact on its behemoth insulin portfolio.
So, what has Oramed developed?
The drug in question is the above mentioned ORMD-0801, and while we know it's an oral insulin pill, that's pretty much the extent of our insight into how the drug works. This isn't through lack of understanding on our part - Oramed has been tight lipped about its science from day one. We don't see this as a concern, so long as the company can offset the opacity of its science with solid trial data, and to date, it has done just that.
To quickly share what we do know, the company describes its pill as insulin mixed with an absorption enhancer, protease inhibitors and an enteric coating. The protease inhibitor (it's likely an IDE inhibitor if we are to speculate on specificity) is there to stop enzymes (NYSE:IDE) breaking down the insulin. The enteric coating is just as it sounds - a coating designed to stop the pill degrading in the stomach. The absorption enhancer is what you might call the secret ingredient. It's what promotes the uptake of the insulin, and it's the element of this type of treatment that has to-date proven elusive in effective application. We know that Novo is using something called sodium caprate, and that this has proven an effective enhancer to a certain degree in a number of trials to-date. We can speculate that Oramed is using something similar, but at this stage it would be just that - speculation.
To reiterate our point, however, right now, it doesn't matter what the company is using. Nor from an investment thesis perspective. All we are looking at is performance, and so far, it looks good.
Data from a phase II hit press back in May, and the company built on this data with a more in depth release at the end of July. The trial, called ORA-D-007, was set up as a double-blind, randomized, 28-day study designed to assess the safety and efficacy of the drug in T2D patients.
The initial data, reported in May, demonstrated a stat sig decrease in the pooled night-time glucose mean percentage change (the primary endpoint of the trial) of 6.47% from run-in, between placebo and active cohorts. The p value on the study was 0.0268, easily surpassing the 0.05 threshold required for significance. The follow up data highlighted a number of key secondary endpoint hits, including a stat sig reduction in mean 24-hour glucose, fasting glucose, and daytime glucose, and a stat sig difference in what's called HbA1c, or glycated hemoglobin, which is considered the holy grail of diabetes management.
As a side note, this HbA1c measurement is optimized for a three-month measurement. As such, the one-month measurement used in the above discussed trial isn't overly useful. However, as the company moves into a pivotal, chances are we will see an extension on the timeframe and the glycated hemoglobin measurement will play a key role in the topline, registration-supporting numbers.
So let's stick with the subject of a pivotal - when are we expecting a phase III? Well, the company has now drawn a line under its phase II study, and is actively putting together a protocol for a pivotal investigation as we speak. While management hasn't given a specific timeframe to watch from an enrollment and dosing perspective, we'd be very surprised if the company didn't get things rolling before the close of first quarter 2017. It will probably be a three-month trial, meaning we will be looking for topline at some point during early third quarter next year.
Beyond that, we're looking for extended applications of the science as potential market boosters/upside catalysts, near term. The thing with this sort of science is, proving it and applying for the first time is the hard part. Once it's established as working, Oramed can replace the insulin in its pills with another drug, and repeat the process. The first in line will be GLP-1. GLP-1 is is a peptide that induces the pancreas to release insulin in response to rising glucose (blood sugar) levels in plasma. There are a number of these currently available as self administration injectables, with perhaps the most well known being Novo's Victoza, and conversion to oral administration is just behind insulin on the list of tomorrow's diabetes markets and revenue streams.
The bottom line here is this: studies have proven that the earlier a T2D patient starts an insulin course, the better their prognosis in the long term. Oral insulin overcomes many of the hurdles to early stage prescription, and a marketed product could quickly fill what is a large, and growing, unmet need. Two companies are spearheading the development process right now, one large (Novo) and one small (Oramed), but Oramed has far more to gain from being first to market and we believe this gives it the edge, despite the comparable size difference between the two players.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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Post by mannmade on Sept 19, 2016 14:53:31 GMT -5
It also said Sanofi spent a billion dollars on AFREZZA. Now that's what I would call fuzzy math... Must be including all of the milestone payments we never saw...
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Post by mannmade on Sept 19, 2016 11:52:04 GMT -5
This Diabetes Breakthrough Is Great News or Terrible News, Depending on Your Perspective Lexicon Pharmaceuticals' dual SGLT-inhibitor is making waves in the diabetes space, and numerous companies are feeling the ripple effects.
Sean Williams (TMFUltraLong) Sep 19, 2016 at 9:44AM Woman With Glucometer Diabetes Testing Blood Getty IMAGE SOURCE: GETTY IMAGES.
It may not be as deadly as cancer or heart disease, but diabetes was the seventh-leading cause of death in the United States as of 2014.
According to the American Diabetes Association 29.1 million people in the U.S. had diabetes as of 2012, some 8 million of whom were undiagnosed (more than 90% of all cases are type 2 diabetes, which develops over time). The combined direct and indirect costs of treating diabetes and the co-morbidities associated with it tallied $245 billion. While it may not be an immediate killer, it's a serious disease that has drugmakers to do everything they can to find a cure.
Choices aplenty for diabetics Currently, you'll find no shortage of Food and Drug Administration-approved therapies to treat diabetes. One of the most common is Januvia, Merck's (NYSE:MRK) DPP-4 inhibitor to treat type 2 diabetes. In long-term cardiovascular studies Januvia was shown to be comparable to the placebo it was tested against (i.e., it didn't change the number of cardiovascular events to a statistically significant degree), and it's also a weight-neutral drug, which is a good thing, as type 2 diabetics are often overweight, which can lead to added complications.
Jnj Invokana Pic IMAGE SOURCE: JOHNSON & JOHNSON.
But new type 2 diabetes challengers have emerged over the past three years. These new challengers -- Johnson & Johnson's (NYSE: JNJ) Invokana, AstraZeneca's (NYSE:AZN) Farxiga, and Eli Lilly (NYSE:LLY) and Boehringer Ingelheim's Jardiance -- are part of a new class of drugs known as SGLT-2 inhibitors. Instead of working through the pancreas and liver, as prior diabetes medications have, SGLT-2 inhibitors block the absorption of glucose in the kidneys, allowing patients to excrete excess glucose through their urine.
What's notably different about SGLT-2s is that they also demonstrated the intriguing side effects of weight loss and reduced systolic blood pressure. Again, with weight and hypertension being common issues among type 2 diabetics, this could give drugs such as Invokana, Jardiance, and Farxiga preference among physicians over the likes of Januvia.
Further setting the stage for the SGLT-2 drugs was the September 2015 data release from Eli Lilly and Boehringer Ingelheim detailing superior long-term cardiovascular outcome results for Jardiance in the EMPA-REG OUTCOME trial. Specifically, Jardiance led to a 32% relative reduction in all-cause risk of death. This was the first-ever long-term cardiovascular study in which a diabetes drug demonstrated superiority in reducing the risks of all-cause and cardiovascular-related death.
Could Lexicon's dual SGLT-inhibitor change the game? However, last week an experimental drug from Lexicon Pharmaceuticals (NASDAQ:LXRX) made waves after it met its primary endpoint in a late-stage study for type 1 diabetes. Depending on your perspective as either a diabetic or as an investor, this is great or terrible news.
Lab Researcher With Blood Sampe Diagnostic Getty IMAGE SOURCE: GETTY IMAGES.
The drug, known as sotagliflozin, is a brand-new SGLT-inhibitor. But instead of solely targeting SGLT-2 within the kidneys, it also targets SGLT-1 inhibitors located in the intestinal tract. Both inhibitors work to block glucose absorption, which should presumably lead to improved glycemic balance. Prior to late-stage studies, the question had been whether or not the addition of SGLT-1 to complement SGLT-2 would be worthwhile. The data suggests it is.
Top-line results from Lexicon's type 1 diabetes study showed an average A1C reduction of 0.43% from the baseline with a once-daily 200 mg dose and a 0.49% A1C reduction with a once-daily 400 mg dose. Comparatively, the placebo led to a 0.08% A1C reduction after 24 weeks of treatment. The statistically significant improvement met the study's primary endpoint and likely sets sotagliflozin up for an approval to treat type 1 diabetes.
The real intrigue, though, is how sotagliflozin will fare in late-stage studies to treat type 2 diabetes. One company that's especially intrigued is Sanofi (NYSE:SNY), which signed a licensing deal worth up to $1.7 billion with Lexicon last November for sotagliflozin in type 1 and 2 diabetes. Sanofi handed over $300 million up front to Lexicon, and it may have to pay up to $1.4 billion in development, regulatory, and sales-based milestones, as well as possible double-digit royalties, on sales of sotagliflozin if it's approved. Since type 2 diabetes would cover tens of millions of potential patients, Sanofi is counting on late-stage success to make its partnership worthwhile.
Self Portrait Personal Perspective Getty IMAGE SOURCE: GETTY IMAGES.
Everything depends on your perspective If you're a diabetic (type 1 or type 2), the success of sotagliflozin in its phase 3 trial for type 1 diabetes is encouraging. Sotagliflozin could provide differentiation from the SGLT-2 inhibitors, giving consumers a new option to fight diabetes. With an FDA approval in type 1 diabetes looking likely based on its phase 3 top-line data, all eyes can now turn to its late-stage type 2 diabetes trials.
Conversely, it's time for Merck and its shareholders to start sweating, as another new class of diabetes drugs could soon hit the market (assuming the type 2 diabetes success of sotagliflozin). With SGLT-inhibitors demonstrating favorable side effects relative to Januvia, they could begin putting pressure on Merck's volume, forcing the giant drugmaker to lift Januvia's price just to keep sales on par year-over-year.
Even Johnson & Johnson, Eli Lilly/Boehringer Ingelheim, and AstraZeneca have to be a bit worried about the early success of Lexicon's lead drug. It's possible that the aforementioned differentiation could eat into the sales of all three drugs.
Of course, SGLT-2 inhibitors have two key advantages that could keep their market share lead in type 2 diabetes secure. To begin with, they have the precedence of beating the dual-SGLT-inhibitor sotagliflozin to market (again, assuming FDA approval for type 2 diabetes). Physicians trust these medications, as do consumers, so we may not see much switching to sotagliflozin even if it makes it to pharmacy shelves. New diabetes patients, though, could be up for grabs.
More importantly, Jardiance's long-term cardiovascular outcomes study results are a feather in the cap for SGLT-2 inhibitors. Johnson & Johnson's Invokana is expected to release its long-term study data soon as well, and if it more or less mirrors the benefits produced by Jardiance, it's likely that SGLT-2s will retain substantial market share moving forward.
Everything comes down to perspective, but things are definitely heating up in the diabetes space.
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Post by mannmade on Sept 17, 2016 17:06:41 GMT -5
Mylan’s Sneaky EpiPen Maneuvers (MYL, IMMY) By Rebecca Lake | September 17, 2016 — 6:00 AM EDT EpiPen, the life-saving device that’s used to treat severe allergic reactions, is at the center of a firestorm of controversy surrounding its pricing as well as some questionable strategizing on the part of its maker, Mylan (MYL). So what are Mylan’s alleged sneaky EpiPen maneuvers? Sneaky EpiPen Maneuvers: Who Benefits? The wholesale price of EpiPens has increased by nearly 500% since 2009, according to Rx Savings Solutions Chief Executive Officer (CEO) Michael Rea. That escalation in pricing has been passed on to customers, who have seen their out-of-pocket costs for the device skyrocket. The average retail cost of a standard two-pack of EpiPens has now crossed the $600 mark. (For more, see Mylan Increases Access to EpiPen After 545% Price Hike (MYL). [That percent increase is based on the pen's 2007 price.]) As a result, Mylan has become the target of protests, and at least 500,000 petitions objecting to the increase have been delivered to the company’s offices in Canonsburg, Pa. Mylan CEO Heather Bresch is scheduled to appear before the U.S. House Committee on Oversight and Government Reform on Sept. 21 to discuss the reasoning behind the price hike. A New York Times report suggests that Mylan is doing some behind-the-scenes work to soothe angry consumers while still protecting its bottom line. According to the report, a proposal has been put forth to add the EpiPen to a federal list of medical preventive services. This would pass on the higher cost to the federal government, insurers and employers, while removing the burden from the everyday consumers who need affordable access to the device – and perhaps silencing the chorus of complaints about high costs. Although the move to grant EpiPen federal status is a positive for consumers, the motivation behind it has been called into question. While the Times report acknowledges that the campaign has drawn support from medical professionals as well as the chief executive of the Allergy and Asthma Network Mothers of Asthmatics (AANMA), Tonya Winders, it also points out that one of the proposal’s biggest beneficiaries and advocates just happens to be Mylan itself. Dr. Leonard Fromer, who published an article in the American Journal of Medicine backing the idea, is reportedly a paid consultant for Mylan. Mylan has engaged in outreach efforts with various advocacy groups, including the one headed by Winders, to generate further support for the measure. It’s evident that the push toward EpiPen’s inclusion on the federal list isn’t solely based on the company’s desire to promote good will among its customers. Potential Remedies for Mounting Drug Costs In response to the ongoing outcry, lawmakers have introduced a new bill that would require drug companies to disclose their costs before raising prices by more than 10%. The initiative, led by Republican Sen. John McCain of Arizona and Democrats Sen. Tammy Baldwin of Wisconsin and Rep. Jan Schakowsky of Illinois, is aimed at increasing transparency on the part of drug manufacturers, making sure that consumers aren’t blindsided by major price jumps. (For more, see Two Senators Investigate Pricing of Mylan’s EpiPen (MYL).) In the medical community there’s a growing amount of buzz surrounding alternatives to the EpiPen that could prove to be more financially friendly to consumers. A recent Fortune report profiled Douglas McMahon of the Allergy and Asthma Center of Minnesota, who says he’s developed a more convenient method of administering epinephrine that would cost roughly a tenth of what the EpiPen does. Other drug companies are getting in on the action as well. Imprimis Pharmaceuticals (IMMY) is reportedly working on an EpiPen product that would cost approximately $100. Mylan has even gone so far as to announce its own generic version, with a price tag of $300. (For more, see Mylan to Launch a Cheaper Generic EpiPen (MYL).) Read more: Mylan’s Sneaky EpiPen Maneuvers (MYL, IMMY) | Investopedia www.investopedia.com/articles/insights/091716/mylans-sneaky-epipen-maneuvers-myl-immy.asp#ixzz4KYNNrhbD Follow us: Investopedia on Facebook
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Post by mannmade on Sept 17, 2016 17:00:07 GMT -5
There's something odd about the way insulin prices change Lydia Ramsey Sep. 17, 2016, 3:00 PM 709 4 FACEBOOK LINKEDIN TWITTER insulin A Type 1 diabetes patient holds up bottles of insulin. Reuters/Lucy Nicholson Insulin prices are rising — increases that mean some people are spending as much on monthly diabetes-related expenses as their mortgage payment.
But what makes the rise in insulin prices different than many other old drugs that have drawn scrutiny over prices, is that there is competition for insulin.
In most industries, competition drives down prices. In this case, the competitors appear to increase prices side-by-side — something that's been referred to as "shadow pricing."
At least three companies — Eli Lilly & Co., Novo Nordisk, and Sanofi Aventis — make and sell insulin.
Despite this competition, prices have steadily climbed over the past decade, taking single or double-digit list price increases in a year. A 10 milliliter vial of Sanofi's long-acting insulin, Lantus, first hit the US market at $34.81 a vial in 2001, according to data from Truven Health Analytics.
Since 2014, the last time Sanofi raised the price, it has been $248.51.
During the period in which Lantus's price rose 600%, a rival product from Novo Nordisk appeared. In 2006, the new drug, called Levemir, hit the market at $66.96 (close to what Sanofi's drug cost at the time). These days Levemir costs about $269.
In other words, the competition seems to have done nothing to push prices down. In fact, when charted side by side, the price increases seem to be in synch.
insulin prices lantus levemir V2 Andy Kiersz/Business Insider
When you look at short-acting analog insulins (the types of insulin that are taken around the time diabetics eat, or what's used in an insulin pump), the prices are in such lockstep that you can't see two lines.
Lilly's Humalog cost $20.82 in 1996 and now goes for $255.40, an increase of 1,124% over 20 years. Novo Nordisks's Novolog first hit the market in August 2001 at $39.75, and as of July 2016, a vial comes with a list price of $255.40 — exactly the same as Humalog.
insulin prices humalog novolog V2 Andy Kiersz/Business Insider
When asked about this timing, a spokesman for Novo Nordisk told Business Insider via email that this has to do with how the companies keep tabs on one another.
"It is possible to see price changes through a variety of databases, and we have always monitored the market closely, just as other companies do," he said. Sanofi's& spokeswoman said that the company sets the prices of its medications independently, and a spokesman for Lilly noted that the companies are all dealing with the same parts of the healthcare system — the pharmacy-benefits managers, the health insurers, etc., that affect pricing decisions.
Even if it seems odd that prices would rise like this in a competitive market, it highlights the hold that drug brands have over doctors who prescribe medicines, and the patients who pay for them.
Bloomberg's Robert Langreth explored the issue last year and spoke to a pharmacist and economist who said that it is proof that branded prescription drugs “are basically not a competitive market,” when it comes to prices. This isn't unique to insulin: When there was a viable competitor for EpiPen something similar happened, as with multiple-sclerosis drugs.
As for why the price has gone up so much, regardless of the similarities? The companies offer a number of explanations — including that rebates and other offsets mean that the income to the company is actually declining, and or that they're spending billions to produce and package insulin — making improvements in how the drug is delivered and produced.
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