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CGMs are quite expensive.  It appears Abbott’s FreeStyle Libre is less expensive and quite promising. In Europe, at just €59.90 (~$77 US) for the touchscreen reader and each 14-day sensor, FreeStyle Libre has a much lower cost relative to current CGM. For example, Dexcom charges ~$885 for the starter kit and ~$72 per seven-day sensor.

Matt B has been testing FreeStyle Libre and according to him, Glucose changes shown 9 minutes faster than Dexcom G4, and 6 minutes faster than the Dexcom G5. afrezzadownunder.com/freestyle-libre/



FreeStyle Libre Pro Submitted for FDA approval, Potentially Coming to the US in 2016

8/7/15 - new now next

Twitter Summary: @abbott submitted FreeStyle Libre Pro to @us_FDA, with high likelihood of approval in 2016. How a blinded 14-day sensor can help patients + healthcare team

What’s the latest scoop on Abbott’s FreeStyle Libre technology coming to the US? Abbott’s quarterly update call revealed that the company has submitted the professional version of FreeStyle Libre for regulatory approval in the United States. If all goes well, the product might be approved and launched in 2016.

FreeStyle Libre Pro is a bit different from the patient version of FreeStyle Libre (available in Europe) that we tested in diaTribe in January. Libre Pro allows physicians to get continuous glucose data from patients over a two-week period. It consists of a small sensor (a bit larger than a US quarter dollar coin) worn on the arm. After applying Libre Pro in the doctor’s office, it is worn for two weeks, and the sensor automatically records glucose values every 15 minutes. Patients then return to the doctor’s office, where the sensor is downloaded. Abbott has done a really good job of making the glucose data download easy to interpret, meaning healthcare providers and patients can quickly grasp what is going well and what may need improvement.

Unlike the FreeStyle Libre system currently available in Europe, the Pro version does not give patients a reader device to look at glucose values in real time. While that seems like an obvious drawback, it’s a key design choice for a few reasons:

Many patients don’t want to wear a sensor all the time; wearing this product occasionally (i.e., twice a year) could offer many of the benefits of more continuous glucose monitoring (i.e., more comprehensive glucose data to change therapy), but without having to wear a sensor all the time.

Professional glucose monitoring systems like FreeStyle Libre Pro are generally reimbursed well by insurance, including Medicare. Medicare does not currently reimburse real-time CGM.

Many patients change their behavior in response to seeing the real-time data. A blinded sensor like FreeStyle Libre Pro makes it more likely patients will stick to their normal routine – allowing providers to get a more realistic view of a patient’s day to day management.

The FDA approval process for FreeStyle Libre Pro should be easier than the real-time version, since patients can’t make insulin dosing decisions off the blinded system.

Of course, we are huge fans of arming patients with real-time knowledge about their glucose, and we’re very excited about a real-time unblinded, commercial version of FreeStyle Libre coming to the US. For now, it’s not clear when that might happen, though we assume it will come after Libre Pro launches. The good news is that an FDA approval of FreeStyle Libre Pro might make the approval path for FreeStyle Libre easier. Our fingers are crossed! This US submission follows the Libre Pro’s launch in India earlier this year. 

diatribe.org/freestyle-libre-pro-submitted-fda-approval-potentially-coming-us-2016#sthash.ToI4I4K2.dpuf



Abbott’s FreeStyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside!

1/9/15 - TEST DRIVE

diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks#sthash.thrfOWrW.dpuf

by Adam Brown and Kelly Close Twitter Summary:

Wearing Abbott’s #FreeStyleLibre, a 14-day sensor intended to replace glucose meters, but provide CGM-like info; now available in Europe In October, Abbott launched its highly awaited FreeStyle Libre Flash Glucose Monitoring system in Europe. The unique product is intended as a replacement for blood glucose meters, while giving patients many of the benefits of continuous glucose monitoring (CGM), including real-time glucose values, trend information and comprehensive reports. Though it is not yet approved in the US, we were able to test the product over the past month (the device can only be ordered online from websites in Europe). Given what we had heard from so many European bloggers, we had high expectations going into our test, and FreeStyle Libre absolutely met them at every step – the system was easy to setup and use (a major win for healthcare providers); discreet to wear on the upper arm; accurate enough from which to dose insulin, with performance similar to Dexcom’s G4 Platinum CGM (though no fingersticks were required); and it gave an excellent picture of glucose trends through real-time and on-device reports. In short, it is transformative compared to the limited information provided by traditional blood glucose meters, all in a package anyone can pick up and learn to use.

We give FreeStyle Libre an emphatic thumbs up and would recommend it to nearly anyone with diabetes, especially those on insulin who test their blood glucose frequently and want more actionable information than fingersticks alone can provide. One key point of difference from CGM is that FreeStyle Libre does not have high or low alarms, meaning it is not as ideal for those with lots of hypoglycemia or hypoglycemia unawareness.

This article discusses our experience wearing and using the device, its accuracy compared to the Dexcom G4 Platinum CGM, how European readers can get it, when we might see it in the US, and how it’s different from CGM.

How the FreeStyle Libre Works

FreeStyle Libre includes a very tiny glucose sensor (0.2 inches in length, about the thickness of a hair) worn under the skin and connected to a water resistant, plastic on-body patch the size of a one-dollar coin. The sensor remains inserted for 14 days and does not require fingerstick calibrations (it’s “factory calibrated”). After putting it on the upper arm and waiting one hour, it immediately begins reading glucose and trend information. FreeStyle Libre is approved for dosing insulin except in three cases when a fingerstick is recommended: when hypoglycemic, when glucose is changing rapidly, or when symptoms don’t match the system’s readings.

To use FreeStyle Libre, users take a touchscreen reader device, hold it near (within 1.5 inches) the sensor patch, and wait for it to beep. In less than a second, they can see their real-time glucose value (e.g., 102 mg/dl), a glucose trend arrow (e.g., rising), and a trend graph showing the last eight hours of data. The reader device displays reports on its screen that can be downloaded to Mac and PC-compatible software. The system is currently available in Europe (pricing information below) for people with both type 1 and type 2 diabetes. Abbott does plan to bring it to the US, though we estimate it won’t come stateside until at least mid-2016.

Cost and How to Get It in Europe

FreeStyle Libre is available at online web-shops in seven European countries: UK, France, Germany, Italy, the Netherlands, Spain, and Sweden. The touchscreen reader (one time cost) and each 14-day sensor cost €59.90 (~$77 US) – significantly cheaper than paying cash for traditional CGM although definitely more expensive than several strips a day (what is covered for many type 2 patients). Notably FreeStyle Libre does not require a prescription in the EU. Payment for the system is out-of-pocket right now, though Abbott is currently enrolling participants for two clinical trials that should help support reimbursement throughout Europe. Do you want one? If so, you need a friend with a credit card based in one of the countries that it’s available, plus their ability to access the Freestyle Libre website in that country – plus, the ability to pay for this fascinating technology.

When is FreeStyle Libre Coming to the US?

Abbott is currently conducting an accuracy study of FreeStyle Libre in the US – more information is here. The study is expected to be completed in March. Abbott would then need to secure FDA approval of FreeStyle Libre, which would likely take at least 12 months. We imagine that at the very soonest, FreeStyle Libre could come to the US in mid-2016.

Appendix: How Is FreeStyle Libre Different From Continuous Glucose Monitoring (CGM)?

FreeStyle Libre incorporates elements of continuous glucose monitoring, such as a sensor placed under the skin, glucose values taken every minute, trend arrows, and downloadable data. However, it is really a new category of glucose monitoring that is meaningfully different from CGMs offered by Medtronic and Dexcom:

FreeStyle Libre does not have alarms or alerts, since the glucose sensor data is not sent continuously to the reader device. Rather, a scan of the sensor patch using the reader obtains the glucose data and trend information. By contrast, traditional CGMs continuously send the glucose data to the receiver/pump, allowing low, high, and rate-of-change alerts. This makes CGM a more attractive choice for those with lots of hypoglycemia and hypoglycemia unawareness. However, those who are bothered by lots of alarms might prefer the design of FreeStyle Libre.

FreeStyle Libre is “factory calibrated,” meaning users don’t have to enter any blood glucose meter values into the system. After the sensor is started and worn for one hour, it can show glucose data points and trends. Conversely, Medtronic and Dexcom CGMs require startup calibration, as well as daily calibrations to maintain the sensor’s accuracy. Factory calibration represents a highly impressive R&D achievement.

FreeStyle Libre is approved for dosing insulin except in three cases: when hypoglycemic, when glucose is changing rapidly, or when symptoms don’t match the system’s readings. In these cases, Abbott recommends confirming the value with a fingerstick. By contrast, Medtronic and Dexcom users are currently supposed to confirm every CGM value with a fingerstick before dosing insulin.

At just €59.90 (~$77 US) for the touchscreen reader and each 14-day sensor, FreeStyle Libre has a much lower cost relative to current CGM. For example, Dexcom charges ~$885 for the starter kit and ~$72 per seven-day sensor. Most US patients have reimbursement for CGM, so they pay less than that price; however, most European patients don’t have reimbursement for CGM, making FreeStyle Libre’s affordable price that much more notable. Abbott is currently conducting two studies to support reimbursement.

FreeStyle Libre does not require a prescription and can be ordered online. Dexcom and Medtronic CGM both require a prescription and have a longer on-boarding process (training, insurance verification, phone calls, etc.).

Raymond W. Urbanski appears to be a very good speaker.  He will be able to help Matt a lot going forward.

AFREZZA: WAS SANOFI SANDBAGGING AFREZZA?

Note: please see the link below for the version with links to the original sources.

www.afrezzajustbreathe.com/afrezza-was-sanofi-sandbagging-afrezza/

But Marcus, the Laguna Hills endocrinologist, said Sanofi’s educational and marketing efforts fell short, especially in teaching doctors how to do the FDA-mandated lung tests.

Those are tests endocrinologists don’t typically perform. Marcus said Sanofi offered a class, but no hands-on training with either lung-testing equipment or with the Afrezza inhalers themselves.

“Sanofi didn’t have a wise plan for introducing this product,” he said.

What’s more, Marcus said many of the patients he prescribed Afrezza to ended up dropping it because it wasn’t covered by their insurance. [As reported by LA Times].

“A world-changing drug deserves better marketing. I’ve done more to market Afrezza myself than Sanofi ever did,” a TuDiabetes user wrote. [As reported by LA Times].

“There is no doubt that Sanofi has been a poor partner. One wonders if there was ever any commitment to the product at all,” wrote another TuDiabetes user. [As reported by LA Times].

Sanofi is looking to reinvigorate growth in its diabetes franchise through its marketed products Lantus and Toujeo, and Patton said this left the French Pharma Giant “conflicted” when it came to Afrezza. “Inhaled insulin can directly compete with Lantus and Toujeo in Type 2 patients, and with all of the prandial insulins in both Type 1 and 2 they were conflicted. No way Sanofi was going to go against its golden goose franchise.” [As reported by mobile.in-pharmatechnologist.com]

I also want to say. Please do not pull the plug on this insulin yet. I still have hope it will survive. Sanofi did not market this drug correctly. The PROVIDERS and INSURANCE COMPANIES needed to be educated first, then the roll out to the patients. From what I am hearing Sanofi did not educate the endos. Everyone is afraid of the lung spirometry test which is NO BIG DEAL. Endos need to have the lung spirometry equipment in office (Dr. Goddard in New York City does it in office before prescribing Afrezza). But the insurance companies are refusing to pay. One big HINT for Mannkind and/or Sanofi. When rolling out a new drug, in today’s insurance market, PRICE IT COMPETITIVELY. Comment on Tudiabetes.org.

Sanofi did not promote this drug; in fact, I will quote one shareholder “Sanofi walked Afrezza into bankruptcy.” Or tried to. Comment on Tudiabetes.org.

Both my primary care and endo were happy to prescribe it… It’s not like the majority of doctors weren’t willing to prescribe it once they had been educated by the drug reps on the product— the problem is, the sanofi reps seemingly made no effort to do that— or when they did they totally failed to illustrate it’s amazing benefits—- and the vast majority of the diabetes population doesn’t know it exists…. Comment on Tudiabetes.org.

I have had ZERO severe hypos since starting it in February of last year. Your post is on point as it relates to the target marketing and launch of the drug and I won’t comment on whether or not I believe the drug is more appropriate for T2’s. Sanofi was the wrong partner, period. Comment on Tudiabetes.org.

Fair enough and this is why Sanofi has done an awful job on the marketing and distribution front. According to many they haven’t even heard about Afrezza and in most cases neither has their doctors or endos. There has to be a start somewhere and the early adopters are that start. Comment on Tudiabetes.org.

Good— sanofi never had its interests in mind and made exactly zero attempt to commercialize it’s game changing drug. Comment on Tudiabetes.org.

We can speculate all day as to Sanofi’s motives.. My understanding is that the last couple years, sales of Lantus, their biggest market-winner, have been dropping, despite an increase in the number of PWD overall, so they wanted another very different diabetes drug to try and offset that. Those plans may have been internally derailed by the development and approval for Toujeo and now the new T2D combo insulin+GLP-1 drug they’ve applied for approval (Lixilan), while at the same time Lantus will have new competition from Lily’s biosimilar insulin. So Afrezza didn’t get the attention it needed… Comment on Tudiabetes.org.

Interestingly, up here in rural Alaska, there was a swarm of sanofi reps touting afrezza for a week or two and then nothing…. I did see exactly one magazine advertisement while sitting in the waiting room at the dentist office—- A world changing drug deserves better marketing. I’ve done more to market afrezza myself than sanofi ever did. Comment on Tudiabetes.org.

I think ultimately they need a robust marketing and negotiation program with insurers to ensure both widespread awareness of how well it works and affordable prices in combination with good insurance coverage to be successful… Both things that sanofi failed miserably at— or seemingly didn’t even try to do… Comment on Tudiabetes.org.

Many providers clearly haven’t received solid education on the product. I guess we can pin that on Sanofi, or perhaps disinterest. Comment on Tudiabetes.org.

While we agree that the marketing of Afrezza by Sanofi was essentially nil (this comment by Sanofi’s rep was laughable, “Sanofi spokeswoman Susan Brooks said the company didn’t scrimp on promoting Afrezza.”) I think an often not talked about or considered barrier to entry is the fact that diabetics tend to be stubborn to change when things are going well. Kind of the “if it ain’t broke, don’t fix it” attitude. Comment on Tudiabetes.org.

I believe Sanofi had no intention of promoting Afrezza. Sanofi basically sat on the drug until they were able to market their new injectable…. the name of it escapes me at the moment. Remember how excited everyone was when Merck bought SmartInsulin from Dr. Zion. It was ready for large animal studies. Merck shelved it. Why? They had no insulin of any kind to sell. But they did have Januvia. And certainly were not interested in a cure while they could milk the huge Type 2 market. They are working on SmartInsulin now (under another name) but only because there is another company working on a Smart Insulin of their own. It’s all about the money. And they have made their $50 thou a year off my daughter for the past ten years. Sanofi is being sued by another company for failing to keep up their part of the bargain re marketing and promotion. Slow roll out? It was a NO Roll out. Comment on Tudiabetes.org.

Sanofi has destroyed the Afrezza launch and Mannkind is running out of money. They should be sued. Comment on Tudiabetes.org.

I’m voting with my feet when it comes to sanofi— I am switching from lantus to tresiba. Sanofi will never again profit from my illness in one hand while attempting to screw the world out of afrezza with the other. Comment on Tudiabetes.org.

I will boycott Sanofi as soon as we can. If Afrezza goes out of business, we will use the new Novo fast acting when it comes to market. She is using Tresiba. We will never use Toujeho. Comment on Tudiabetes.org.

Some comments on potential partners of Mannkind way back in 2006.  Based on the fact that Sanofi late actually signed a partnership agreement with Mannkind, these comments may have been built on some concrete sources then (i.e., 2006).

www.siliconinvestor.com/readmsg.aspx?msgid=22098030

William Tanner of Leerink Swann recently told clients that Novo Nordisk "has significantly cut back development activities" on AERx, thus making the company "potentially interested" in MannKind's product called Technosphere Insulin. He says Sanofi-Aventis, as well as Japan's Sankyo or Takeda might be interested in making deal with MannKind, whose Technosphere appears "superior to other inhaled insulin formulations." Tanner has an outperform rating on MannKind.

Nate's comment to the article:

seekingalpha.com/user/18076342/comments

Thanks for the article, George. As one of the few people out there that can say "I know exactly where you're coming from" and really mean it, I appreciate you taking the time share your thoughts during these challenging times for MannKind longs.

Like you, I've spent a sizable chunk of time lately dissecting the story for my subscribers in an attempt to understand where things went wrong, what can be changed, and, perhaps most importantly, what we should be doing about it from an investment standpoint.

As you know, I share your belief that not only does the the drug work, it seems to work very, very well; unfortunately, as has been the case with every other "next generation" insulin over the past 50 years, it appears that it is going to take awhile for it to catch on (all the docs I talked to about it pre-launch warned me their colleagues would be slow to switch - and it turns out they were right!)... and it remains to be seen whether MannKind will still be involved with the story when that inflection point is finally reached.

Obviously, if it turns out that "rapid-acting" really is "good enough" for the rest of time, Afrezza (and therefore MannKind) is probably doomed; however, given the advances being made in the management of diabetes, I believe the odds are very high that, at some point, "ultra rapid acting" is going to become the new norm (in the same way that rapid-acting eventually replaced fast-acting)... and regardless of what the label currently says, we all know that, at least for now, ultra-rapid means Afrezza (and only Afrezza).

As you mention, there are plenty of possible roads the company can take from here... and if it manages to pick one that leads to success, getting to buy into the Afrezza (and TS) story when MannKind has a market cap of under $300M will likely prove to be one of the best opportunities most investors will come across in their lifetimes (and, of course, there is the very real possibility that they may instead wind up on a road that does not lead to success).

This has been one of the craziest stories I've ever seen unfold in my 28 years following biotech... and it wouldn't surprise me at all if there are still a few "twists" left to come in the story (including finding out how the extra 50% of the float that has been dumped on the market ends up being unwound... is Afrezza really worth $0?).

Anyhow, thanks again for taking the time to put this article together... here's to hoping the tide's about to turn.

I agree with most of the things stated above, except that Al right now probably does not have a few hundred millions to be put in Mannkind. But I do agree that there are many ways that Mannkind can survive and recover from the current situation.  

1.    I also like Spiro's idea of concentrating on a few key markets. If sales climb, Mannkind's market value will also climb.

2.    And the Griffins' reports of license to regional distributors (Europe, Middle East and Japan) also works. I would believe we can get some upfront fees from each such regional distributors. If we get $25 million from each of them, for example, that will extend the runway for another year or so if we really keep our expenses low.  

3.    As for TS licenses, if we can basically give away such licenses (with a very low share of future profits, say 10-15%), but with some upfront fee, say $50 million for one or two applications, I would think there will be BPs be interested. That will also extend the runway much further.

4.    Additionally, while Al Mann probably does not have a few hundred millions to put in Mannkind, he probably will be able to add $30 million to the existing Mann Group facility if it is absolutely necessary. 

5.    While a buy-out by Dexcom may be too much to expect, Al Mann may be able to pursuade Dexcom (Kevin) to purchase a minority interest in Mannkind (say 5-10%) and therefore increase the market value of Mannkind.  Dexcom has a market cap of over $6 billion. An investment of around $20-30 million isn't much for it right now.

6.    Mannkind can aggressively reduce the price of Afrezza to use up its current inventory and drive sales volume. I agree with Spiro that a 50% or more price cut is doable. Again, if sales climb, Mannkind's market value will also climb.

7.    Mannkind still has the headquarter building on sale. I recall it was listed for $20 million. If we can get $10-15 million from that. It also helps.

8.    Mannkind can raise some additional cash if its market value is recovered to some degree (say back to $2 a share, with a market cap of around $800-900 million) based on any of the above scenarios. If they can raise another $50-100 million, that will help.             

It appears to me that Dexcom is also well aligned with Afrezza. Basically, CGMs are aiming at real time monitoring. Afrezza will be able to offer real time correction of high blood sugar. Real time monitoring + real time correction => happier users.
So CGMs and Afrezza will be mutually contributing to the sale of each other. mnkd.proboards.com/thread/4803/google-mannkind-perfect-match  

On the other hand, Al Mann has mentioned a couple of times that Afrezza will make insulin pumps less needed. 

Additionally, for your information, Al Mann basically is the mentor of Kevin Sayer, the current CEO at Dexcom.  He was one of the speakers that spoke at the Al Mann Gala last May. Kevin worked for Al for seven years and per his speech, his office was next door to Al Mann's at that time.

www.dexcom.com/dexcom-leadership/kevin-sayer

Kevin Sayer

CEO & President

Kevin Sayer was promoted to President and Chief Executive Officer of Dexcom in January 2015. Mr. Sayer previously served as DexCom's President starting in 2011, and has been a board member since 2007. As President and Chief Operating Officer, Mr. Sayer was responsible for the Company's research and development, manufacturing, clinical, regulatory, finance, sales and marketing functions. From 2007 to 2010, Mr. Sayer served as Chief Financial Officer of Biosensors International Group, Ltd. ("Biosensors"), a medical technology company developing, manufacturing and commercializing medical devices used in interventional cardiology and critical care procedures. Previously, Mr. Sayer served as Chief Financial Officer of MiniMed, Inc. from 1994 until its acquisition by Medtronic, Inc. in 2001. He also has served as Executive Vice President and Chief Financial Officer of Specialty Laboratories, Inc., and as an independent healthcare and medical technology industry consultant. Mr. Sayer received his Master's Degree in Accounting and Information Systems concurrently with a B.A., both from Brigham Young University.