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Post by ashiwi on Nov 22, 2014 17:47:32 GMT -5
This was announced a few months ago, but it is worth re-reading again in my opinion. Just have to read between the lines while thinking where Afrezza will fit in. Medtronic and Coviden are scheduled to complete their merger in 1st quarter 2015. newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&id=1939865Sanofi and Medtronic to Form Strategic Alliance in Diabetes to Improve Patient Experience and Outcomes Initial Focus on Insulin-Device Combinations and Care Management Services PARIS, FRANCE, AND MINNEAPOLIS, MN - June 14, 2014 - Sanofi (EURONEXT: SAN and NYSE: SNY) and Medtronic, Inc. (NYSE: MDT) today announced that they have signed a memorandum of understanding to enter into a global strategic alliance in diabetes, aimed at improving patient experience and outcomes for people with diabetes around the world. The alliance will initially focus on two key priorities: the development of drug-device combinations and delivery of care management services to improve adherence, simplify insulin treatment, and help people with diabetes better manage their condition. The alliance will be structured as an open-innovation model, leveraging the capabilities, as well as the human and financial resources, of both companies. Based on the success of the two initial priorities, the companies may explore other areas for potential collaboration. "We know that insulin and other medicines are only one element of treating the whole patient. There is no day off in managing diabetes, and lack of adherence is one of the major hurdles to optimal disease management. That is why Sanofi is committed to developing integrated care solutions that focus on making life easier for people with diabetes and improving clinical outcomes that may help reduce costs to the overall healthcare system," commented Pascale Witz, executive vice president of Global Divisions & Strategic Development, Sanofi. "Through this important collaboration, Sanofi will tap into technology advances that aim to create holistic treatment solutions which take into account the individual patient's needs." "Diabetes is unfortunately rising in prevalence around the world, driving up system costs and, most importantly, adversely impacting the lives of millions of people. Like Sanofi, we believe there is tremendous opportunity to better align care across the diabetes care continuum through new and varied technologies and patient care management strategies," said Omar Ishrak, chairman and chief executive officer of Medtronic. "Medtronic is committed to taking a broader approach, expanding beyond our core strength in Type 1 diabetes, to co-develop an array of technologies and patient services that will deliver superior clinical outcomes at an affordable price. We also know we can't do it alone - so we are particularly excited to join in this effort with Sanofi who, like us, is committed to exploring new avenues and approaches to solving the challenges associated with diabetes." The alliance will pair Sanofi's extensive insulin portfolio and drug development expertise with Medtronic's expertise in insulin pumps and continuous glucose monitoring. One of the priorities of the alliance will be to deliver novel drug-device combinations, including new form factors that are affordable, convenient and easy to-use to increase therapy adherence and deliver better outcomes. These efforts will focus on improving the management of Type 2 diabetes, especially for people who cannot achieve glucose control even with multiple daily injections of insulin. Care management services, another priority area for collaboration, will be delivered through a program designed to guide people with Type 2 diabetes who are failing to achieve disease control on oral therapies through the initiation phase of insulin treatment. Insulin initiation can be challenging as a high number of patients drop insulin treatment in this early phase. As world leaders in complementary segments of diabetes care, Sanofi and Medtronic already have an agreement in place serving specific Type 1 diabetes patients in Europe with an implantable insulin delivery system, and intend to add this project and additional innovative projects to the alliance. Implementation of the alliance is subject to the negotiation and execution of a definitive agreement between the companies.
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Post by bigmoneytex on Nov 22, 2014 18:19:33 GMT -5
I don't see how MDT and SNY can pass on the opportunity to buyout MNKD sooner rather than later. I watched testimony from ADCOM from patients and docs and the common theme was not only was it more convenient, but it had better pharmacokinetics to the point where they felt safer and more in control of their blood sugar levels. The biggest questions to me are: when will SNY and/or MDT make a move and what will it look like? If they don't make a decisive move, why aren't they?
My theory is that MDT and SNY will come up with the right offer and divide MNKD to best serve their alliance. I can only imagine what the minds at MDT could do with the Technosphere platform and inhaler technologies. Sanofi could not only remain the worldwide diabetes leader with the only inhaled ultra-fast acting insulin (this will be the label in the future in my opinion) and the ability to expand their portfolio of medications to include technosphere platform.
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Post by dreamboatcruise on Nov 22, 2014 20:06:44 GMT -5
Who says there is a realistic opportunity that anyone is passing up. Al and company have always stated that the plan was partnering not selling out. If Al isn't ready to sell that would be one uphill battle to takeover the company. As for MDT and technosphere, it seem like their expertise in devices really has little applicability to Technosphere which really is a drug not a device. You don't see Medtronic selling asthma inhalers just because it has something mechanical to deliver the drug. Mannkind is in as good of position as anyone to move technosphere forward for other molecules. Further... as far as minds go... remember Al Mann is the mind behind the Minimed insulin pump that captured 80% of the market before Medtronic bought them. No need for Al to sell anything to have it in the hands of a hugely successful diabetes device leader... that's him.
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Post by jpg on Nov 23, 2014 0:15:33 GMT -5
Who says there is a realistic opportunity that anyone is passing up. Al and company have always stated that the plan was partnering not selling out. If Al isn't ready to sell that would be one uphill battle to takeover the company. As for MDT and technosphere, it seem like their expertise in devices really has little applicability to Technosphere which really is a drug not a device. You don't see Medtronic selling asthma inhalers just because it has something mechanical to deliver the drug. Mannkind is in as good of position as anyone to move technosphere forward for other molecules. Further... as far as minds go... remember Al Mann is the mind behind the Minimed insulin pump that captured 80% of the market before Medtronic bought them. No need for Al to sell anything to have it in the hands of a hugely successful diabetes device leader... that's him. Very well said wise green one. Medtronic has little to do with Afrezza or Technosphere. JPG
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Post by nadathing on Nov 23, 2014 7:48:40 GMT -5
"You don't see Medtronic selling asthma inhalers just because it has something mechanical to deliver the drug".
They do sell insulin pumps don't they? They don't sell insulin do they? MDT buying MNKD Technologies might be a stretch, but it would be an interesting marriage.
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Post by bigmoneytex on Nov 23, 2014 9:02:06 GMT -5
I would ask that you look at "bluhale" on MNKD tech's website. I believe that MNKD tech is a device/tech company and I think that the technology can be built upon by someone like MDT. I strongly disagree that Technosphere is a drug. It is a carrier system for the drug. We don't know the limits of the technosphere technology and what future versions can be capable of. I think that ignoring the fact that MNKD tech is something revolutionary is really discounting what Al has done with Afrezza and all future meds based on this platform.
I think many people think that because the tech allows for meds to be inhaled that it is like a glorified asthma inhaler. But, take a look at exubera bong and really study an asthma inhaler. Exubera is a big clumsy device that was just terrible to use and with an asthma inhaler you had to learn to time everything perfectly otherwise delivery is inefficient. Watching the demo on youtube with afrezza it is as simple as breathing in to deliver a precise dose of medication. It is amazing what the company has done to make this delivery system as simple and efficient as possible.
Off the top of my head I could see MDT tweaking the dreamboat inhaler to be able to communicate with one of their insulin pumps to help titrate the most precise doses to keep blood glucose optimally controlled. Or maybe using an app that keeps track of dosing protocol using afrezza and pump with wireless communication between the three devices.
My bottom line is that I think there is a significant piece of technology here that can be further developed and I believe MDT adds value. I understand that people here may disagree with me and that is fine, but I just see what I see and I have a different take on things.
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Post by daduke38 on Nov 23, 2014 11:10:09 GMT -5
I would ask that you look at "bluhale" on MNKD tech's website. I believe that MNKD tech is a device/tech company and I think that the technology can be built upon by someone like MDT. I strongly disagree that Technosphere is a drug. It is a carrier system for the drug. We don't know the limits of the technosphere technology and what future versions can be capable of. I think that ignoring the fact that MNKD tech is something revolutionary is really discounting what Al has done with Afrezza and all future meds based on this platform. I think many people think that because the tech allows for meds to be inhaled that it is like a glorified asthma inhaler. But, take a look at exubera bong and really study an asthma inhaler. Exubera is a big clumsy device that was just terrible to use and with an asthma inhaler you had to learn to time everything perfectly otherwise delivery is inefficient. Watching the demo on youtube with afrezza it is as simple as breathing in to deliver a precise dose of medication. It is amazing what the company has done to make this delivery system as simple and efficient as possible. Off the top of my head I could see MDT tweaking the dreamboat inhaler to be able to communicate with one of their insulin pumps to help titrate the most precise doses to keep blood glucose optimally controlled. Or maybe using an app that keeps track of dosing protocol using afrezza and pump with wireless communication between the three devices. My bottom line is that I think there is a significant piece of technology here that can be further developed and I believe MDT adds value. I understand that people here may disagree with me and that is fine, but I just see what I see and I have a different take on things. For months I have gone back and forth on the MDT connection. In fact during a the Matese game on YMB I had picked SNY and MDT as the Partners. There are several more recent statements and events that lead me to believe it is still possible and maybe likely. It doesn't seem on the surface to be a fit, but business model change and expand all the time. I think you make a good arguement as to how it could fit. Plus I think Al is already moving on. MNKD will not (in my mind) be in the manufacturing business. Does anyone really see them running "production only" eventually world wide? I know I am getting off track, but in a way, I think MDT could do a better job of developing technosphere applications than MNKD ever could. Nothing will happen until the inversion deal is settled, hopefully by FEB. Interestingly that is when Matt refered to the 2nd Board meeting. My concern or question is if SNY and MDT were to take over, would the launch be held back? It seems that a lot of people keep thinking of 1st quarter as Jan., but it could be March. We have less than 6 weeks left in 2014 and still don't know anything more than we did 2 months ago. Am I the only one who finds that strange? I am not saying MDT is a given, but I certainly wouldnt rule them out.
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Post by bigmoneytex on Nov 23, 2014 12:18:51 GMT -5
I just don't understand how people are dismissing medtronic's involvement with all of this. I mean they did just partner up with sanofi with the specific purpose of managing diabetes. Mannkind makes a drug with a innovative delivery for diabetes. Medtronic and Al Mann have a history with the insulin pump, so why would they just toss technosphere aside? Improvements to existing technology is what drives companies like MDT and what gives us more effective tools to manage diabetes.
"Sanofi and Medtronic to Form Strategic Alliance in Diabetes to Improve Patient Experience and Outcomes" To me this signals that sanofi and medtronic are going to collaborate on how to take Mannkind corp/afrezza and push the envelop to see how far they can push the delivery system. Also, let me add that after watching the adcom testimony from the patients' perspective afrezza improves the patient experience and their outcomes (less hypo episodes, easier to control blood sugar, convenient, etc.).
In summary, while I think afrezza represents a huge breakthrough in medicine I think its true value will be unlocked with an integrated system that only sanofi and medtronic can provide.
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Post by ezrasfund on Nov 23, 2014 12:32:34 GMT -5
Remember Al's comment that he does not think the artificial pancreas will be practical because it fails to meet the " 3 C's" test; cost, complexity, convenience. This is in spite of the fact that Afrezza is an important part creating the prototype artificial pancreas because other prandial insulins cannot mimic the body's mealtime insulin response well enough.
A closer alliance with Medtronic may be in the future, but not in the near future. MNKD just completed a complex and far reaching deal with no sunset clauses. It is very unlikely that they would try to supersede this deal after a few months or even years. Al Mann will sell only after what he believes to be the value of Afrezza and Technosphere and the inhaler technology is fully recognized.
BTW I believe that SNY was really the only partner that MNKD was consulting with all these years, as they were always working with Lantus, "the best basal insulin." The problem for MNKD was to create a competitive bidding environment so they could negotiate a fair price, which meant enticing other suitors. That was Greenhill's real job.
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Post by dreamboatcruise on Nov 23, 2014 12:42:18 GMT -5
The successive generations of the device culminating in the dreamboat are important and undoubtedly the result of good engineering, but the real innovation is technosphere which isn't a device. It is technosphere that allows the jump from an Exubera like device to one much smaller. The device is now in an elegant form factor that likely won't go through much further development because the size is pretty being limited by the need to have a cartridge large enough to hold the drug and probably also by the fact that you really wouldn't want something so tiny people are likely to drop it. Moving forward the R&D effort is on marrying technosphere with new drugs... matching PK/PD profiles to what is optimal, assuring stability of the molecules, etc.
As for Bluhale, yes I'm familiar with it. I don't believe the company has ever indicated they view this as something that would be utilized in normal patient treatment. It is an R&D tool. The beauty of Afrezza is that it is so quick acting and mimicking the normal human prandial response that it makes it much less important to worry about the exact dose. Further, the device has been designed to deliver reliable doses of Afrezza with a very wide range of inhalation rates. If there were a clinical usefulness to using Bluhale in normal administration of Afrezza I think we would have seen some clinical trials on that. It would need to be FDA approved. The body's response to insulin isn't always the same. For precise control using an insulin pump and rapid acting insulin, real-time glucose monitoring is the way to go. Bluhale isn't going to replace the need for that.
Mannkind has a very promising future with commercializing Afrezza and with that funding a soon to be announced (by Q1) pipeline of Technosphere based drugs, and perhaps even rekindling Al's initial idea of turning Mannkind into a biotech power house with developments in areas such as cancer research. I have a feeling Mannkind is going to be a fitting legacy, along with several foundations bearing his name.
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Post by bigmoneytex on Nov 23, 2014 12:49:07 GMT -5
I know Bluhale is the R&D tool and not the consumer product. My point is that as you try and marry new drugs to technosphere I believe that a certain degree of engineering will need to take place to ensure optimal delivery. I doubt it will be a one size fits all approach for new drugs. I have contacted MNKD tech to see what their limitations are and it seems that they are limited to 20 mg dosing for technosphere as it stands now. I think that Al created a great foundation that MDT can build on as one of the best if not the best device company on the planet. I know you are going to disagree with this, but I hold firm in my beliefs.
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Post by ashiwi on Nov 23, 2014 13:38:20 GMT -5
Bigmoneytex, I couldn't agree with you more. First of all, Al Mann is not a big fan of the artificial pancreas. He's passed over that with his basal insulin patch which is currently in trials under another one of Al's companies. Secondly, Al Mann also believes that the cricket device for instant migraine pain relief will be bigger than Afrezza. Those were pretty much his words, not mine. MNKD is just too small at this time and too focused on Afrezza manufacturing to do what's necessary to get the cricket to where it deserves to be. This is where Medtronic steps in. Medtronic is a device company, (with a history with Al ) the cricket is a device... Al is almost 90 and has other projects that he's working on. He's knows there is no one better than Medtronic to get the cricket for pain to market. So ultimately Sanofi -Medtronic- Mannkind are all linked with the pps of MNKD to benefit the most.
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Post by dreamboatcruise on Nov 23, 2014 14:17:19 GMT -5
I'm an engineer so I tend to want to look at things in detail, so let me suggest a few things that would make me question the thesis that Medtronic would be such a value multiplier for Technosphere.
From the FDA's standpoint a combination of cricket/dreamboat + technosphere + active molecule is a drug not a device. Additionally, the business model of Afrezza and any follow on drug I know of in pipeline would also seem to be one of a traditional pharmacy sold drug rather than fitting into the business/distribution model of the medical devices made by Medtronic. Does Medtronic have any experience with getting drugs on formulary and distributed to pharmacies around the world?
Turning to the development expertise of Medtronic, it seems to be in two areas... devices that go Inside the body, and complex electronic/software systems that require life safety specific development (I've spent a career in high tech and very much appreciate the added complexity and expertise that goes into developing for fields like medical and aerospace). I don't see where any of this Medtronic expertise in development applies to Technosphere+dreamboat/cricket. If one of you has a specific Medtronic product/technology that you feel gives them expertise relevant to Technosphere delivery development, I certainly would be interested. I'm sure I don't know of all of Medtronics products, but I can't think of any that seem the expertise would lend itself to bettering Technosphere/Dreamboat/Cricket.
Bigmoneytex... The dosing limitation is one that Mannkind has already addressed and it is basically through refining the process of creating Technophere carrier particulars that are larger and have more surface area.
Ashiwi... I get the impression that you are one with some past contact with Al and/or others at Mannkind. We all know Al's history with Medtronic, but is there anything you can point to that has come from anyone at Mannkind indicating a desire or a rational for a merger with Medtronic. It seems Al has clearly indicated a desire to have Mannkind stay independent, with any questions about acquisition garnering a response that I read as "I have fiduciary responsibilities to shareholders, so I have to be open to an offer at some price, but it's not something I'm seeking".
Ezra... I agree about SNY likely being the preferred partner all along. I think having the basal patch be done outside of Mannkind is actually an indication of this as something competitive to SNY's basal franchise would have complicated the deal greatly as they would have seen that as a threat to existing revenue stream.
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Post by bigmoneytex on Nov 23, 2014 18:22:37 GMT -5
I don't see how the FDA's standpoint matters to the topic at hand and even if we do accept it then by extension the syringe + normal saline + active molecule is a drug too. My point is that MDT can utilize afrezza and technosphere to their existing product line and make modifications to suit their needs. Take a look at their careline system, for example. They could integrate afrezza to help make the insulin pump therapy even more effective.
As far as this idea that they don't have the expertise to do anything for TS, cricket and dreamboat, what experience did they have with insulin pumps before mini-med? I tried to find what they had come up with on their own and I couldn't find anything. They seemed to do just fine developing out mini med after the acquisition. My point here is that just because they don't seem to have any experience in these type of devices doesn't necessarily mean that they can't find ways to improve the existing technology.
I will finish this off by saying that you obviously are going to stick to your guns and I will stick to mine and we will see how it all plays out. All the best to you.
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Post by babaoriley on Nov 23, 2014 18:54:38 GMT -5
Trying to figure who might be interested in MNKD is interesting, but, to me, largely unimportant. If SNY and MDT decide they want to buy MNKD, fine, but the price won't be anything that anyone here will like if the sale is made before our stock rises significantly via marketing success with Afrezza. If our stock were at $15, then I could see as high as a $30 price tag, or double the then stock price. I just don't see us at $15 for a while, at least till the third quarter of 2015, and more likely, sometime beyond that. Of course, some great early sales figures could accelerate that, as could some technosphere collaborations.
If, indeed, a buyout is in our future, then I don't really care who buys us out, but you can be pretty certain that the buyout price will be close to the best we could get at the time, so, again, who doesn't much matter to me, but how much does. As for when, I don't want it coming down the pike at a time when we're under $15. If we were to get bought out tomorrow, I doubt we'd get more than $14, which is why we won't be bought out tomorrow or any time soon.
The arguments above are, like I said, interesting, but whether it's MDT or SNY or even IBM or XOM or WMT or F or WFC who buys us out, makes not one bit of difference to me - just show me the money! And assuming it's MDT, I would assume that whatever expertise they lack, between the MNKD employees that they would keep, and other key folk they could hire, there wouldn't be too much of a problem.
Now, speculation about potential partnerships may be a bit more relevant, cuz we'd want a great partner (for technosphere or whatever else we can partner in without SNY getting in the way). I think most of us feel we got a great partner with SNY. By the way, I know a great percentage of American marriages end in divorce, not sure about the rate for the French...
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