Week 10 and lots to talk about. Within our group there were two doctors appointments. First, Ann, who just measured a personal lifetime best of a 6.2 in under 90 days on Afrezza! Before Afrezza her A1C was a 7.0 and she is extremely pleased with her new inhalable insulin and will never, ever go back to her “old” treatment. Congrats Ann! In addition, Laureen had a 60 day checkup and measured a 6.5 A1C. That is also for her a lifetime best as a diabetic. Before starting Afrezza she measured a 6.7 and didn’t expect any drop, but was very pleasantly surprised to see that in only 60 days it had already dropped to a 6.5! If you’re keeping track that makes 6 out of 6 Lifetime Best A1C’s in 90 days or less on Afrezza within our group – and we’re not expected to realistically achieve our final A1C measurements until 120-130 days after beginning a new insulin treatment per Dr. Bode. This seems to suggest that the best is yet to come. We are all feeling very optimistic about the future and we hope others will learn from our firsthand experience. One member of our group – Howard was just featured in a story by Amy Tenderich today–it’s a great read and I highly recommend it.
Personally, I want to thank everyone for their words of support and encouragement during one of the most difficult times of my life. Thankfully, I was able to be there by my sisters side during the last steps of her journey and visit with her beautiful family. Grieving is such a strange process where you love so deeply and miss and hurt so profoundly at the same time. I will forever miss “my little Sis” and treasure the moments we shared together. One grateful part was being able to be “fully present” in her company and not totally distracted and occupied from having to manage around my diabetes like I used to. Afrezza is truly priceless when you consider how “life-changing” it is for every family situation, even during the most challenging of days.
1. 3-year vesting period; 1/36th vesting every month, being fully vested 05/21/2016. Exercisable 6/21/15, 30-day black out period. Expire in 10 yrs, 5/20/2025. Option strike price $4.63.
They exercise and HOLD instead of same day exercise and sell. Some exercise RSU and hold. If they continue to hold after 6/21/15, they think pps will appreciate more. It means that they fronted their own money $4.63 per share. This is the first time they have their skin in the game.
Week 15-And I would like to wish everyone a very happy and healthy 4th of July! This week we welcome our newest member Julie from Florida! She has been a Type 1 diabetic for the last 19 years and began using Afrezza in April. In two short months her A1C has already dropped from a 7.3 to a 6.3. Previously, she has experience with many diabetic treatments including the insulin pen and the insulin pump-which for her seemed to cause a lot of errors and issues, so she was very anxious to try Afrezza. One thing that Julie mentioned is that her doctor considered her A1C of 7.3 acceptable, but she knew it was still doing damage to her body, and insisted on even better control for better long-term health in the future (plus she was tired of dealing with her insulin pump). The other thing is that both Julie and I enjoy amusement parks, and if you would like to read an analogy I did on a previous post about diabetes and amusement parks then click here. Life on Afrezza is as exciting as any rollercoaster-without all the ups and downs and feeling nauseous when you can’t get off the ride–yes, the life of a diabetic before Afrezza. I greatly thank Julie for sharing her results and also her story with us, and being a part of a group that will continue to spread the word about how Afrezza has changed life as we all know it!
Also, this week, I got a call from Dr. Bode’s office asking if I would like to submit a short article for the Atlanta Diabetes Center Newsletter. Was very honored to be asked, and with their permission, I am including my portion of their newsletter here for you so you know what all their patients will be seeing this month:
Existing treatments are effective enough to control diabetes in most patients, but drug makers spend huge sums to keep developing new products and improving old ones.
Indeed, Sanofi just rolled out 2 novel versions of the very oldest diabetes treatment, an insulin glargine formulation called Toujeo and an inhalable form of human insulin called Afrezza.
Sanofi officials say both products will benefit large numbers of insulin users with both type 1 and type 2 diabetes mel-litus (T1DM, T2DM). Outsiders express a wide range of opinions.
Trial data indicate that Toujeo controls glycated hemoglobin (A1C) levels about as well as Lantus, an insulin glargine formulation approved in the year 2000 that has just lost patent protection after years of blockbuster sales. Toujeo lasts longer than Lantus, however.1 It also provides the body a steadier stream of insulin1 and is associated with a significantly lower risk of nocturnal hypoglycemia.1
Afrezza performed similarly in a phase 3 trial. It roughly matched an existing competitor, insulin aspart (Novolog), in A1C reduction, and slightly outperformed it in several secondary ways. Afrezza use was associated with less hypoglycemia, lower fasting blood glucose, and slight weight loss rather than slight weight gain. It also reached peak levels very quickly, in just 12 to 14 minutes on average.2
That said, Afrezza’s medical importance will likely hinge on something that no trial can measure: how the change from injection to inhalation affects patient behavior. If the delivery method inspires patients to medicate themselves more consistently, Afrezza could produce huge health benefits. If patients use Afrezza like they use insulin aspart (a fast-acting insulin analogue), the new product could prove to be an expensive convenience.
Financial analysts mostly predict solid but unspectacular sales for both drugs, in part because federal regulations for-bid Sanofi from touting the comparative advantages of either drug. (The FDA did not allow language about less hypoglycemia in the label it approved, and therefore Sanofi cannot mention it in language it uses to promote the drug.)
Consensus estimates reported by Bloomberg predict annual Toujeo sales will reach about $1.3 billion by 20203 far below the $7.1 billion that Lantus generated in 2014. As for Afrezza, annual projections range from a paltry $182 million up to $2 billion, with the median in the $600 million range. The treatment’s unexpectedly poor performance during its first month on the market led Goldman Sachs to cut its annual sales projections by $1 billion.4
In other respects, however, both medications have gotten a good reception.
“The response to Afrezza on social media has been tremendous,” Rachele Berria, MD, PhD, who heads the Diabetes Medical Unit for Sanofi US, told Evidence-Based Diabetes Management in an interview. “Healthcare providers don’t seem to anticipate that patients will see much of a need to move away from injections, but actual patients see this as a valuable feature.”
Berria says the company will study real-life Afrezza use to see if patient enthusiasm translates into patient compli-ance, and that it will follow real-world Toujeo users to measure the practical effect of its longer, steadier flow of medication. “The goal in treating diabetes is to avoid peaks and valleys in both insulin and sugar, and Toujeo does that to a degree that once seemed impossible,” she said. “There’s no insulin spike when each new injection gets absorbed, and there’s no loss of efficacy in the final few hours. It’s a big stride forward from Lantus.”
Physicians have been using insulin to treat diabetes since 1922, when Frederick Banting and Charles Best injected the hormone into a diabetic teenager at a hospital in Toronto. Eli Lilly began producing it commercially within the year, and diabetes was transformed, virtually overnight, from a speedy death sen-tence to a chronic condition.5
Intermediate acting Neutral Prot-amine Hagedorn (NPH) insulin arrived about a quarter century later, in 1950. Long-acting insulin, on the other hand, didn’t reach patients until 2000, when Lantus went on sale in the United States and Europe.
The new drug reduced A1C levels about as much as NPH insulin, but trials demonstrated that it produced a greater reduction in fasting plasma glucose and fasting blood glucose as well as a far lower risk of nocturnal hypoglycemia.6
The other big advantage of Lantus was the convenience of longer action. Patients who had spent years toting around basal insulin and setting alarms for midday injections suddenly had nothing to carry and nothing to remember except a single injection before bed. By then, of course, insulin was not the only effective treatment for T2DM. The FDA had approved metformin in 1994, and its huge success spurred drug companies to develop the other oral treatments that now crowd the market.
Many of these treatments are quite effective, especially when used in combination. Indeed, if used properly, their excellent disease control could greatly reduce diabetic complications and the need for new drugs.
Yet pharmaceutical companies continue developing treatments like Toujeo and Afrezza because a huge percentage of diabetics fail to control their condition with current options. A recent study that examined records from more than 43,000 patients found that less than 55% of all Americans who have been diagnosed with diabetes, and prescribed medication to control blood sugar, actually man-age to keep their A1C level under 7%.7
The main cause of this problem seems to be patient behavior. Studies have found that patient adherence to oral treatment protocols can range from more than 90% down to just over 50%. Strict adherence to guidelines concerning injectable medications and proper diet tends to be lower, while strict ad-herence to guidelines concerning mod-erate, regular exercise and blood sugar checks is downright rare.8 The chance that any patient will adhere perfectly to a complex regimen is low, and studies of people with all types of chronic disease have typically found that only about half of them will make a serious effort to manage their condition.8
The consequences of this behavior are dire.Diabetes is the nation’s seventh-lead-ing cause of death. It increases the risk of stroke (by 50%), heart attack (by 80%), and death from cardiovascular disease (by 70%). It is also the leading cause of kidney failure and non-traumatic lower limb amputation. The American Diabetes Association estimates that the di-rect medical cost of treating diabetes reached $176 billion in 2012, and indi-rect costs such as lost productivity add-ed another $69 billion to the tally.
Matt's reply (from Thursday)
Sent: Thursday, August 6, 2015 4:11 PM
Subject: RE: Shareholder Value
I am sorry you feel this way. (I don't suppose you are the guy who posted on stock twits that you just sent me an e-mail to tell me you hated me and the company?)
In any event, as a large shareholder myself, I naturally think about stockholder value every day. But we are limited in what we can do. I think we have all persevered through some very difficult times and have actually delivered quite a lot to the stockholders. I am not happy that the stock is where it is, but we continue to work very hard to deliver value, which makes it all the harder when our efforts are not reflected in the stock price. We did in fact deliver good clinical data, a positive adcom panel vote, an FDA approval and a partnership with a major player in insulin. We then successfully geared up for and helped launch the product. We also got an additional cartridge strength approved, tripled our manufacturing capacity, revamped all of our systems to support all of this, and, in our spare time, have devoted countless hours to new product opportunities. So I think it a bit unfair to say we have not delivered value. What we have not delivered is a higher stock price. But that is something we don't have direct control over. Logic would dictate that all the other things we have delivered ought to have resulted in a higher stock price, but that is not the case, at least at the moment. We are working very hard with Sanofi to correct impediments to more scripts, and have had some success, but it takes time for those efforts to be reported in script counts.
It is hard not to take offense at some of your comments about compensation and such. I believe I work very hard and sacrifice a lot for every penny of compensation I get. I can promise you there are many opportunities to get at least as much from other companies, but I continue to believe in the potential of Afrezza, to believe in Al Mann, and to believe that it is only a matter of time until we get where we ought to be.
Dry powders comprising microparticles suitable for pulmonary delivery are well known in the art including, for example, those disclosed in U.S. Pat. Nos. 6,428,771 and 6,071,497, the disclosures of which are incorporated herein by reference in their entirety for all they disclose regarding microparticles. In respective exemplary embodiments, the dry powders, the active ingredient can be a protein, a peptide, or a polypeptide and combinations thereof, for example, and endocrine hormone such as insulin, glucagon-like peptide-1 (GLP-1), parathyroid hormone or analogs thereof.
In certain embodiments, a dry powder formulation for delivery to the pulmonary circulation comprises an active ingredient or agent, including a peptide, a protein, a hormone, analogs thereof or combinations thereof, wherein the active ingredient is insulin, calcitonin, growth hormone, erythropoietin, granulocyte macrophage colony stimulating factor (GM-CSF), chorionic gonadotropin releasing factor, luteinizing releasing hormone, follicle stimulating hormone (FSH), vasoactive intestinal peptide, parathyroid hormone (including black bear PTH), parathyroid hormone related protein, glucagon-like peptide-1 (GLP-1), exendin, oxyntomodulin, peptide YY, triptans such as sumatriptan, interleukin 2-inducible tyrosine kinase, Bruton's tyrosine kinase (BTK), inositol-requiring kinase 1 (IRE1), or analogs, active fragments, PC-DAC-modified derivatives, or O-glycosylated forms thereof. In particular embodiments, the pharmaceutical composition or dry powder formulation comprises fumaryl diketopiperazine and the active ingredient is one or more selected from insulin, parathyroid hormone 1-34, GLP-1, oxyntomodulin, peptide YY, heparin, PTHrP, analogs thereof and combinations thereof.
BUFFALO, N.Y.(WIVB)- These days, all Eric Fenar needs to do to regulate his blood sugar, is breathe.
The type one diabetic is using a new treatment for diabetes called Afrezza. Since Feb. 4, he’s been inhaling his insulin instead of injecting it.
Fenar researched the drug for months before the FDA gave it the green light in 2013.
When it was finally on the market, he was at the front of the line.
“When Afrezza finally became available to the public, I had doctors appointments set up every single week for a month out, because the day it became available I wanted to be one of the first,” he told News 4.
In fact, he was the second person in the U.S. to try the drug.
Since he’s been on Afrezza, his average blood sugar has dropped from 190 to 143, which is near the pre-diabetic range; a place Fenar never thought he’d be.
“There were times when my blood sugar would be 200-300, and you’re sitting there, and you’re just like ugh. When you have a high blood sugar, you just, your vision gets blurry, you’re drinking, you’re urinating a lot, you just feel yucky,” he said.
But since February, he hasn’t had a blood sugar spike and told News 4 he’s never felt better.
Afrezza is still new to the market; it’s not recommended for kids or anyone with asthma.
And because it’s so new, it’s not cheap and isn’t covered under Medicaid.
So could it be the new way to manage diabetes? Many in the medical community are approaching with caution.
“It’s tough to say because it is not necessarily going to replace using insulin in general, it is just making it a much easier dosage–a much easier form for the patients to be able to use,” said pharmacist Anthony Alter.
For a lot of people, the big draw to Afrezza is ditching the needles, but for Fenar, it’s how much faster it works.
“The old insulin, like I said was 45-60 minutes. This starts to work in 12 to 15,” he said.
And Fenar hasn’t been shy
Exhibit Hall (Hall A)
Sanofi's Booths 605 & 801 - Both booths are at the entrance.
SATURDAY, JUNE 6 2015
10:15 a.m.-11:00 a.m.
Afrezza®: An Alternate Insulin Delivery
Sponsored by Sanofi
Afrezza® is a new inhalable rapid acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. The presentation is intended to familiarize clinicians with Afrezza® including efficacy and safety data from randomized clinical trials. Some additional topics to be covered include Afrezza® pharmacologic studies, dosing and titration guidance, and practical instructions on inhaler use will be also be reviewed.
Presenter: Timothy Gilbert, MD
Lake Charles, LA
Location: Product Theater 2 (Booth 865)
SUNDAY, JUNE 7
10:15 a.m.-11:00 a.m.
Afrezza®: An Alternate Insulin Delivery
Within our group everyone is measuring A1C Correlations in the 5’s this week–yes, it’s really no surprise any longer – tighter control and ongoing improvement have become the new normal!
This Afrezza journey has been remarkable. And every single one of us has completely had a turnaround for what is acceptable as a diabetic–and our “Time in Zone” and “Blood Glucose” numbers clearly reflect that. For most of us, our upper limits on our Dexcom CGM’s went from 220 or higher down to 120, which is truly remarkable.
What surprises you most about the Week 11 data?
To tell you the truth, I am not surprised at our ongoing data. We’re almost 3 months in, and we’ve all got Afrezza “dialed in”, which in contrast to Novolog, which many of us used to take, was never “dialed in”, even after 10 to 20 year
Approaching 34M Volume. Longs don't quick flip this time as Schwab, Fidel offer 30%, 29.25% income interest. Longs can hardly find a better Dividend stock than this in the entire Nasdaq and foreign exchanges. Schwab raised income rate to 30%. Fidel 29.25%. No Short Covering.
Triple Crown 13Gs Filing in 10 days will test $11.48 resistance. No major resistance until then.
BR already owns 4.7%, 19,137,425 shares on 5/8/15. They only needs to accumulate 1.27M more shares to file 13G. So, this is already in the bag, filed by June End.
Vanguard Group, Inc owns 15,960,530 as of 3/31/15. Van needs to accumulate 4.49M more shares to meet 5%. Thus, this is likely in the bag. Furthermore,
Vanguard Small-Cap Index Fund owns 4,257,307
Vanguard Total Stock Market Index Fund owns 4,091,602
Vanguard Small-Cap Growth Index Fund owns 2,795,698
Vanguard Extended Market Index Fund owns 2,425,035
FMR, LLC owns 9,214,968
Fidelity Select Portfolios - Biotechnology owns 8,063,306
Together the owns 17.2M. They need to accumulate 3.25M more shares to meet 5%. Thus, this is likely in the bag.
Sanofi's Afrezza Sales Leader Schwarts "This is Just Too Important". They most likely accumulating 20.45M shares from $3.6 all the way up. After 5%, Sny would be out of closet to negotiate w/ Mnkd for more Buy-In.
Expect $16-$24/sh for Afrezza using 130M approved by 2015 ASM, 200M SNY shares left over from 2014 ASM. respectively. Mnkd needs this to full-fledgedly fund Mnkd Tech Corp Pipeline R&D.
Dr. Denis I. Becker was rated top endocrinologist in 2014 and many other years by his patients and colleagues. I am grateful to be his patient.
Today we discussed the superior results of my blood tests which showed an A1C of 6.5 (dropped from 7.6). Liver enzymes and kidney results were also near the middle of the spec.
The lipid profile was excellent as triglycerides dropped from 188 to 104. The last closest number to that was 1/9/2010 which registered 132.
My total cholesterol was 146 and I've never reached that number since I kept records beginning 1/21/05. At that time it was 178.
I asked the doctor how this could have happened. He said you are lowering your blood glucose to a point now where your body is healing itself.
As I mentioned previously, Dr. Becker has been very impressed with my glucometer readings since reviewing them after beginning Afrezza.
He said that he would review the positive results with his colleagues.
I asked him today if he would tell me how many patients the clinic has on Afrezza. He said greater than 20 and they are all reporting very good results.
I was Afrezza #2 patient at this practice.
Could you imagine how script numbers would read if all national endocrine clinics emulated Raleigh Endocrinology? Where are the other doctors?
NYLefty, my UHC insurance doesn't cover it yet. I am getting assistance with the Sanofi savings card. They pick up $150 per script. Hate to do it since it comes off their bottom line but better than paying $258 out of pocket. No, I wouldn't get so personal as asking what insurance other Afrezza patients have. Hippa would hang me!
Matt Pfeffer (@MattPfef)
6/6/15, 11:32 AM
Hard to argue #AFREZZA is not obvious at a ADA. 10x20 ft sign at entry! pic.twitterDOTcom/lhKgPrztUu
Inhaled insulin may eventually mean no more shots for some diabetics
Rebecca Killion gives herself several insulin shots a day, a regimen she has followed for 16 years, to help control her blood sugar. It’s been tough, and still her glucose fluctuates a lot. So she is thinking about beginning a new drug — an inhaled insulin that would mean fewer of the needles she loathes. She hopes it comes with the bonus of better managing her diabetes, reducing risk of damage to her kidneys, eyes and other organs.
The 57-year-old Bowie, Md., woman heard about Afrezza while it was in clinical trials. Intrigued, she became the patient representative on the Food and Drug Administration panel that provided the feedback leading to the drug’s approval and then its commercial release in February.
Killion and other panel members reviewed reports from the drug’s manufacturer, MannKind, studied clinical trials and read through the FDA’s own reports. They determined, she said, that Afrezza had potential as an effective way to control glucose with fewer injections.
Some diabetes doctors are cautiously optimistic that this type of insulin could make life easier for patients who are averse to needles and possibly yield better outcomes. Diabetics inhale a dose before each meal to avoid glucose spikes after eating.
People with Type 1 diabetes — the less prevalent form, in which the body does not produce insulin — still need a daily injection to provide long-lasting insulin.
Type 2 diabetics — whose bodies don’t make enough insulin or are resistant to it — can use the inhaled version along with pills, though doctors say some may need a daily injection.
Some clinicians are skeptical. They feel it’s too early to know if the drug has therapeutic benefits. Its long-term safety and efficacy are still under investigation. The package carries an FDA label warning of health risks for people with chronic lung disease. It advises that Afrezza is not recommended for people who smoke or recently stopped smoking or for children.
Afrezza comes in premeasured cartridges that patients insert into a small device. They close it and inhale on its tip.
Killion was 38 when she was diagnosed with Type 2 diabetes, and although that wasn’t the best health news, at least her doctor thought her illness could be managed with pills.
Three years later, she lapsed into a diabetic coma.
“I woke up after a few days and heard I had Type 1 diabetes and needed injections every day for the rest of my life,” she said.
She tried an earlier form of inhaled insulin, Exubera, which was taken off the market in 2007 after a year and a half because of inadequate sales. Killion found the device was awkwardly large and not user-friendly.
“It was like a bong,” said Killion, adding that dosing units were different from liquid insulin, so patients had to figure out conversions, unlike with the new drug.
About 29 million Americans, more than 8 million of them undiagnosed, have diabetes, according to the Centers for Disease Control and Prevention. Some may have no symptoms for years, says Robert Ratner, chief scientific and medical officer for the American Diabetes Association, based in Alexandria.
David Proeber/AP Photo
David Proeber/AP PhotoScientists say it may be possible to stop the auto-immune response in type 1 diabetes patients that causes the destruction of insulin-producing cells.
Some people inject themselves three or more times a day, sometimes for 50 or 60 years, tempting them to stop the grueling routine, and interrupting treatment can be dangerous.
“People take an insulin holiday because it’s hard to do that often and long,” Ratner said. “And there are negative social perceptions that deter insulin usage.”
Many diabetics, he said, are not comfortable taking out a syringe and injecting themselves in public — in the lavatory of a restaurant, for example, before having a meal.
“We don’t know if Afrezza will do better, but a lot of lessons were learned from Exubera,” Ratner said, “and this is a better product.”
Killion has gotten her share of suspicious looks when she takes out her insulin vial and needle case in public or at work. “I was in a conference,” she said, recalling one experience, “and a woman yelled from across the table, ‘What are you doing?’ ”
Studies report that Afrezza reaches peak levels in 12 to 15 minutes, vs. an hour with injected insulin. And the body returns to pre-meal insulin levels quicker.
“This means Afrezza matches [natural body] dynamics of food intake and absorption well,” said Janet McGill, an investigator on Afrezza trials at the Washington University School of Medicine in St. Louis.
The most common adverse reactions are cough, throat irritation and hypoglycemia (low blood sugar); people with chronic lung problems may experience wheezing and constriction of air passages in the lungs.
The FDA is requiring further study to evaluate safety and efficacy in children. And Afrezza will be evaluated for cardiovascular risk and its long-term effect on pulmonary function.
As a precaution, patients must be monitored for lung function, said Dan Lorber, a New York endocrinologist who was among the investigators involved in the drug studies.
Farhad Zangeneh, an endocrinologist in Sterling, Va., began his first patient on Afrezza in March. The patient had long-standing, poorly controlled Type 2 diabetes, despite a daily long-acting injection, multiple pills, a good diet and exercise. Even that one shot was hard, as he deeply feared needles. Rather than amp up the injections, Zangeneh prescribed Afrezza.
“His glucose profile improved immediately and he has not had hypoglycemia,” he said.
Zangeneh has his patients take classes to learn how to use the inhaler, how the drug works and what the alternatives are.
“I want to make sure they understand not only how to use Afrezza, but other options. Then, if they have no lung issues and do not smoke, if they prefer inhaled insulin, I have no reservations,” he said.
Natasa Janicic-Kahric, an endocrinologist at MedStar Georgetown University Hospital in Washington, just began her first patient on Afrezza. The patient was badly bruised from years of insulin injections, and consequently was not absorbing it well. Janicic-Kahric hopes the inhaled drug will be more readily used by her body. She is also discussing this option with several patients who say they’ve grown weary with multiple injections.
“The inhaled option is convenient,” she said. “But I would prefer to wait a little longer to conclude whether it is effective.”
Janicic-Kahric is not sure she will offer it to Type 1 patients, uncertain it can provide the precise glucose control they require, since it comes in prepackaged doses. With injections, patients can vary the amount of insulin they receive by tiny amounts.
“Type 1 diabetics are much more sensitive to insulin, and even one unit too high or low can have a significant impact,” she said. “I’m hoping with time we will have more dosing options. Then I would more readily prescribe for Type 1.”
Zangeneh said he, too, would rarely prescribe Afrezza for Type 1 diabetics. If they are averse to shots, he prefers that they use a pump, which delivers insulin through a catheter placed under the skin.
Some endocrinologists are pleased that patients who may benefit from the drug would no longer have to plan their doses of insulin in advance of meals. Nor would they have to refrigerate it.
“They can sit at a table anywhere, take their inhaled insulin, and begin to eat right away,” Janicic-Kahric said.
Afrezza’s wholesale cost is about double that of injected insulin. But it should not cost consumers more. The company commercializing it, Sanofi, caps co-pays at $30, said Stefan Schwarz, vice president and head of U.S. marketing for Afrezza at Sanofi.
Killion is hopeful that Afrezza will help with an ongoing balancing act.
“After I eat, my glucose can go from 120 to 280 in 45 minutes. When it starts to come down, my insulin kicks in, and sometimes I get sugar lows because I have inadvertently overcorrected. It lingers and affects the next dose. It seems you are always chasing highs,” she said.
“Based on the literature, this insulin tends to act more like how my body would if I didn’t have this illness.”
What makes Killion happiest is that insulin-dependent diabetics may have a choice besides sticking something into their bodies.
“This is for the rest of their lives, and it gets old, taking five, six shots a day. An option other than a needle is huge.”
Afrezza 2nd Launch late Sept. Note conversion 9/24. World Launch Plan presented at JAC 9/22, date confirmed by IR. Vegas A&T training in Sept. EMA MAA filing.
Is it a coincidence? Think Different!
Just spoke with Toujeo rep, starting Sept Afrezza being added to all Toujeo Rep's portfolio. Big conference in Vegas Sept to cover training for joint Toujeo/Afrezza treatment. This is certainly good news, what I found more interesting was her comment International Rep's from Europe will be attending.
Jefferies Reiterates Bullish View on MannKind (MNKD) Following Positive Physician Feedback From ADA
June 9, 2015 8:23 AM
Jefferies analyst Shaunak Deepak reiterated his Buy rating and $9 price target on MannKind (NASDAQ: MNKD) following positive physician feedback from the American Diabetes Association (ADA).
"At the ADA meeting we spoke to 20 U.S. physicians who were familiar with Afrezza and found that while only six had prescribed the drug to date, only one of physicians was fundamentally concerned about prescribing it," Deepak commented. "The one physician who expressed caution about prescribing Afrezza said that he remained worried about delivery of insulin, a hormone, into the lung. As a reminder, our survey last month suggested an eventual range of 8-12% of physicians unwilling to prescribe Afrezza (see 5/15 Note). Of the remaining 13 physicians, we spoke to two pediatric endocrinologists who said they were not going to prescribe the drug until the FDA approved Afrezza for use in children. However, both were positive about the eventual opportunity, with one claiming that he would take Afrezza himself if he were diabetic. Three physicians we spoke to worked for the VA/DOD and each expressed concerns with their ability get access to Afrezza, with one hoping for a broad government contract and another asserting it would never be put on formulary. Five physicians cited Afrezza’s cost or the need for prior authorization as a primary reason for not yet prescribing the drug to their patients. Three physicians were reluctant to try Afrezza until they had identified the ideal patient in need of insulin intensification. We see the physician openness to prescribe Afrezza as a positive that could be realized as MNKD and Sanofi’s increase efforts and discourse with payors and begin direct to consumer advertisement in early 3Q."
On feedback from the prescribing physicians, the analyst commented: "We spoke with 6 physicians who had prescribed Afrezza to 1-12 patients each. Physicians varied in their reasons for starting patients on Afrezza: from needle phobia and injection-site burden to improving control of snacking and post-prandial glucose. For most prescribers, their experience with Afrezza was too limited to offer much patient feedback, however, the prescriber who had written 12 patients scripts noted that 2 had discontinued, one for cough and one for compliance, but that the other feedback was positive. We note that two of the prescribers had purchased spirometers, due to the initial requirement for lung function testing, and that one did not perform initial lung function testing in the two patients he started. It is our understanding that MNKD and Sanofi are working on programs to ease the burden of spirometry and note there were pamphlets at ADA specifically dedicated to putting lung function testing into perspective. We look forward to further physician outreach and marketing efforts in the coming quarters."
Deepak said a 2-unit cartridge could broaden adoption. "We were somewhat surprised that five physicians independently expressed concern with their limited ability to adjust the Afrezza dose to suit their patients needs. As a reminder, Afrezza is currently available as 4- and 8-unit cartridges and a 12-unit cartridge was recently approved. One physician who had prescribed Afrezza identified the limited dose titration as a big issue, since Afrezza can be dosed at 4 or 8 units, but not 6. Another prescriber commented that Afrezza was a limited product due to the limited dosing precision. One physician who had not yet prescribed Afrezza commented that the available doses were probably okay for Type 2 diabetics, but that it would be a better drug for Type 1 diabetics when a 2-unit cartridge is available, as it would allow more precise dosing. Similarly, an endocrinologist noted that the drug is better suited for bigger people in whom titration would be less of an issue. We expect MNKD to develop a 2-unit cartridge in conjunction with their pediatric development plan for Afrezza. We believe that the availability of the 2-unit cartridge should resolve concerns around dose-titration and further expand the population of patients that physicians would consider treating with Afrezza."
He/she will lead the business development team of approximately 30 people and orchestrate the day-to-day business development operations and transaction management. This role, more than any other, lies at the intersection of all corporate functions to establish relations with both science and commercial leaders. This role will require intrinsic capabilities including vision, strategy and partnering driving product and client acquisition, expansion and enhancement of current relationships to drive rapid growth, and expansion of technology and products.
DTC Advertising To Begin Early July 2015
Magazines From left to right:
Diabetes Forecast Published by ADA 6 per year,
Diabetic Living® by Meredith Corp 4 per year
Diabetes Self-management by ZZinesLLC 6 per year
Afrezza COACH now online
Extensive MD seminar series begun
Increasing MD interest: 54K sample packs (1.6M cartridges) delivered
Increasing Production Capacity: Expected to Triple by June End 2015, 12u cartridges first off New Lines
While Early, Afrezza SHows Strong Growth in Flat to Negative Market. Prandial Nrx vs Prior Month:
Initially we start with our an early launch focused very much on the kind of thought leaders in the areas the endocrinologist with the idea that ultimately it would expand increasingly to the general practitioner market and with things like DTC advertising which I think is uniquely well suited to product like this which we will start very shortly. We said early next quarter. The potential addition of ex-U.S. markets and there is a lot of them out there, some would require additional trials, some not. But we’re in the active process of looking through those opportunities right now and ultimately to the extent that Sanofi's starts manufacturing our supply of the raw material of insulin that will help the margin.
In the long run Sanofi said publically that they will have ideas for label expansion studies. We're in active discussions about with them about what those should be and we hope to finally put some of the safety issues [indiscernible] on longer term prospect. The good news is we're getting increasing attention and buzz out there
So we view that as something of a leading indicator very much as, for example Sanofi has a discount card program, some of you may be aware of prescription pharmacy discount card. So to the extent which those requested and so far tend to be leading indicators of future sales for us as well. So, I guess this is hope. Other new news there is increasingly and this is not public information pre-say but sometime it’s hard to find, increasing programs that have been done by doctors around the country by Sanofi and this is doctor to talking to doctor. So it’s very helpful especially given reactions from the doctors we keep hearing about, having talked to their peers about their experiences.
COACH is something that Sanofi recently rolled out, it’s an assistant program for the patients, helps them get started and know what to do. I thought this was a big secrete but I found it on their website, so I guess it’s not anymore, so I can safely put