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lakers_w 286 posts  |  Last Activity: 2 hours 47 minutes ago Member since: Jun 13, 2000
  • Reply to

    WebMD asked diabetes experts about Afrezza

    by lakers_w Oct 9, 2014 7:56 PM
    lakers_w lakers_w Oct 9, 2014 8:04 PM Flag

    One popular fast-acting pen insulin costs about $270 a month, without insurance coverage, for a person who needs 30 units a day, a common amount.

  • Reply to

    WebMD asked diabetes experts about Afrezza

    by lakers_w Oct 9, 2014 7:56 PM
    lakers_w lakers_w Oct 9, 2014 8:03 PM Flag

    Both studies were presented at the American Diabetes Association meeting in June.

    The FDA approved Afrezza's safety and effectiveness based on about 3,000 people, including 1,000 with type 1 diabetes and about 2,000 with type 2.

    Is this a game-changer for people with diabetes?

    Some experts think so, but others are taking a wait-and-see approach.

    "I think it is," Campbell says. He says the inhaler for Afrezza is better designed and easier to use than a more cumbersome one used with another inhaled insulin, Exubera, he says.

    Exubera was approved by the FDA in 2006 but withdrawn from the market by its maker, Pfizer, in 2007, in part due to low sales.

    Health care providers had to spend a half hour or so just to explain how to use the Exubera inhaler, Campbell says. The Afrezza inhaler, he says, ''is really small, easy to use, and it takes less than a minute to train a patient how to use the insulin."

    Marie McDonnell, MD, director of the Brigham Diabetes Program at Brigham and Women's Hospital, says Afrezza has promise if "we can show there is no risk to the lung tissue and the mouth and esophagus."

    "It works faster than both of the injected insulins we have now, the regular and the rapid-acting," she says. "This might mean you will need less insulin [overall] to get the same effects." And that may lessen the weight gain that often occurs in new users, she says.

    She plans to prescribe it, but on a case-by-case basis.

    George King, MD, chief scientific officer at Joslin Diabetes Center, says it may be helpful for some. "I think inhaled insulin would be good for people who are really adverse to needles," he says. But he estimates only 10% or 15% of people on insulin fit that category.

    What will it cost?

    "Our expectation is it should be priced comparably to current fast-acting [injected] insulins delivered in pen form," says Matthew Pfeffer, a MannKind spokesman.

    Prices for the fast-acting insulin pens vary.

  • How is Afrezza different than other insulin?

    Because it's inhaled, it's absorbed more quickly and in a different way.

    "Afrezza is rapidly absorbed from the cells in the lungs [to the blood stream]," says R. Keith Campbell, RPh. He's a certified diabetes educator and distinguished professor emeritus in diabetes care and pharmacotherapy at Washington State University College of Pharmacy. He has studied the drug but has no ties to its developer.

    "From the time you inhale it to the time it actually peaks [in the blood] is 15 to 20 minutes," Campbell says. Injected insulin taken before a meal, he says, takes about an hour to peak.

    The body also clears Afrezza more quickly than insulin injected at mealtime, says Bruce Bode, MD. He's a diabetes specialist in Atlanta who did a clinical trial funded by MannKind Corporation, the drug’s developer.

    Besides its rapid peak, the drug is ''pretty much gone in 2 or 3 hours," Bode says. Rapid-acting injected insulins, he says, usually ''hang around for about 4 hours. Afrezza is fast in, fast out. It is emulating, in essence, what the pancreas does."

    How is it taken?

    Users place a dose of Afrezza, in powder form, into a small, whistle-sized inhaler. Doses come in a cartridge, and each cartridge contains a single dose.

    How does Afrezza work compared to rapid-acting injected insulins?

    In a 24-week study, Bode compared Afrezza with a rapid-acting, injected insulin in more than 500 patients with type 1 diabetes . Afrezza and injected insulin controlled blood sugar equally well, he says. But he found that those using Afrezza were less likely to get very low blood sugar, a complication of insulin use.

    With Afrezza, "there is also less weight gain," Bode says. He credits that to the shorter time Afrezza remains in the body.

    In another study, researchers found that people with type 2 diabetes who weren't getting enough control of blood sugar with oral medications did better when they added inhaled insulin before meals.

  • Is Sanofi hitting its competitors where it hurts with Afrezza?
    Sometimes the best defense is a good offense. And that appears to be Sanofi's strategy with Afrezza. While other Big Pharmas may have passed on Afrezza because of the risk involved, I think Sanofi saw an opportunity to hit its chief competitors, Lilly and Novo, in the pocketbook. Lilly and Novo currently dominate the fast-acting insulin market. Taken together, these two injectables and their delivery devices raked in over $7 billion in sales in 2013.

    Afrezza's label restrictions won't allow it to completely replace these two fast-acting insulins, but it should be a handy add-on product that could cut deeply into their sales. Based on the market size and growth potential for fast-acting insulins, I think Afrezza could see upwards of $3 billion in peak sales by 2020, with the proper marketing. Perhaps what's key to note is that these sales will ultimately come at Lilly and Novo's expense via lost market share.

    Sanofi's reasons for inking this deal are bountiful
    The industry has come to view inhaled insulin products as risky following the Exubera calamity. And instead, we have seen a bitter competition break out in the basal and fast-acting insulin markets via minimally invasive injectables.

    On the basal side, Sanofi pretty much owns the market with Lantus. However, Lantus is set to go off patent protection in February, and major pharmas have been ramping up to launch generic versions. And Lantus makes up roughly 20% of Sanofi's revenue, so it's a pretty big deal for shareholders there.

    Sanofi is hoping to replace Lantus with a longer-acting form called Toujeo, but again, Lilly and Novo are hard at work developing competing versions called insulin peglispro and Tresiba, respectively. In sum, Sanofi's 80% market share of the basal insulin market is under serious duress.

    By playing the intellectual-property game, Sanofi may be able to fend off competitors long enough to transition most, if not

  • luvmeplezz said
    "Marteens is divorced, according to the QDRO he has to sell vested shares to give to his exwife. What's wrong with that? for you don't know what qdro is it's qualifying domestic relation order, judgement from court, if there's no pre-nupt exist, everything split 50/50"

    MannKind (NASDAQ:MNKD) VP Juergen Martens sold 63,800 shares of the company’s stock in a transaction dated Friday, October 3rd. The stock was sold at an average price of $5.48, for a total value of $349,624.00. Following the completion of the transaction, the vice president now directly owns 220,883 shares of the company’s stock, valued at approximately $1,210,439. The sale was disclosed in a document filed with the SEC, which is available at this link.

    A number of research firms have recently commented on MNKD. Analysts at Jefferies Group initiated coverage on shares of MannKind in a research note on Wednesday, August 27th. They set a “buy” rating and a $10.00 price target on the stock. Separately, analysts at Zacks reiterated a “neutral” rating on shares of MannKind in a research note on Wednesday, August 13th. They now have a $7.75 price target on the stock. Finally, analysts at RBC Capital cut their price target on shares of MannKind from $16.00 to $13.00 in a research note on Tuesday, August 12th. They now have an “outperform” rating on the stock. Four analysts have rated the stock with a hold rating and three have assigned a buy rating to the company’s stock. MannKind currently has an average rating of “Hold” and an average target price of $9.91.

  • lakers_w lakers_w Oct 8, 2014 2:46 PM Flag

    I sent a letter to mpfeffer@mannkindcorpDOTcom requesting him to issue a press release clarifying the supply agreement, and profit/loss sharing agreement thereby removing any FUD.

  • lakers_w lakers_w Oct 8, 2014 12:06 PM Flag

    Mnkd may issue a press release clarifying the deal "Mnkd will be reimbursed for $1B Afrezza prior investment before profit split using GM after COGS". This would immediately trigger short covering. Another stmt detailing the milestone criteria for bonus payment would catapult the pps.

  • lakers_w lakers_w Oct 8, 2014 11:08 AM Flag

    MannKind’s substantial prior costs & Sanofi’s near term future costs will affect how soon profits will start to accrue.
    The date of initial profitability is less important than what happens to the early income from sales.
    Despite the delay in the date of profitability, the implications of the plan to make MannKind whole before declaring profits has enormous benefits for MannKind’s valuation.
    Ultimately, what matters is not either party’s share of the profits, but rather the size and timing of future sales.
    MannKind has negotiated a favorable partnership arrangement, and done so with the best possible partner.
    The partnership between Sanofi (NYSE:SNY) and MannKind (NASDAQ:MNKD) calls for all of each company's relevant present and prior costs to be counted when calculating net profits. This does not mean, as at least one commenter has suggested, that Sanofi is paying MannKind for its prior costs. Rather it means that sales revenue will be used to reimburse both companies for their relevant present and prior costs before there are any profits to distribute.

    Apparently, MannKind has invested well over $1 billion in Afrezza. Sanofi, in addition to making upfront and milestone payments to MannKind, will incur sizeable expenses related to negotiating the agreement, running studies, working with the FDA, and commercializing Afrezza.

    These arrangements have two major implications for MannKind. First, it delays the date when profits are split. When this fact finally dawns upon some investors, their first emotional reaction is likely to be negative.

    But the second implication is that because both companies will be made whole prior to distributing profits, MannKind will have plenty of money to spend before profits show up, without taking the upfront $150 million and milestone payments into consideration. Although MannKind spent more than $1 billion, it doesn't have long term debts anywhere close to $1 billion. According to its March 2014 quarterly balance sheet, its long-term debt was under $150 million. Thus if MannKind used all of its upfront payment to eliminate it long term debt (I am not championing this course of action), it would still have over $1 billion in revenue to spend as it chooses.

    Profits are not everything. Those who are arguing that the partnership's financial arrangements are unfair to MannKind are ignoring the fact that they will be receiving substantial income long before Afrezza becomes profitable. Because MannKind will soon have a greatly improved balance sheet and a robust R&D program focused on the technosphere platform and its recently-neglected pipeline, MannKind shares are considerably undervalued.

    Only if Afrezza is incredibly profitable will the 35%/65% profit make a difference in the long run. If it does, then as others have observed, there will be plenty for everyone. The most important part of the financial agreement was making MannKind whole before reaching profitability.

    How can MannKind supporters or skeptics say that this is a bad deal if, including the bonus and milestone payments, MannKind receives around $2 billion before adding in that it will also get more than a third of eventual profits? Given the structure of this agreement, the key to valuing MannKind shares is not its share of future profits, but the size and timing of future sales.

    Finally, Seeking Alpha author Psycho Analyst got it right: No one can do that better than Sanofi. Not only is its sales force outstanding, but Sanofi also fully understands the need for educating and coaching physicians and nurses, and it is also committed to making Afrezza affordable in developing companies. I am proud to be a MannKind investor.

  • jekatt
    Aug 13 05:40 PM
    He's is saying that the following language from the deal means that Mannkind's $1b+ investment to date in Afrezza (as well as Sanofi's costs to date and in the future) will be covered by sales BEFORE the 65/35 profit split:
    "The partnership between Sanofi (NYSE:SNY) and MannKind (NASDAQ:MNKD) calls for all of each company's relevant present and prior costs to be counted when calculating net profits."

    Jeff Eiseman
    Aug 13 05:37 PM
    Author’s reply » Derek:

    I agree that the last component of the milestone payment will not come in the near term, but the other components and the upfront payment plus the over $1 billion of prior costs when added to the final milestone payment are around $2 billion. So I am saying that the COGS pass-through plus the up front and milestone payments are more important than the ultimate profit distribution percentages. This is a tribute to, among other things, Matt Pfeffer and whoever else participated in the negotiations.

    Please note that I am not suggesting that MannKind got a better deal than Sanofi. I'm saying that they both got a great deal. That, after all, is the desired outcome when two rational parties negotiate in good faith, each looking out not only for their own interests, but also for those of the other party.

    Excel Capital Ventures
    Aug 13 05:05 PM
    Finally we have the right perspective on how to view this partnership agreement in the short term with the profit sharing really a long term value.
    In the short term due to the criterion of "making the partners whole", MNKD will actually get a bulk of the GROSS MARGIN (after production costs). The deal actually front loads disbursement to MNKD vs back ending it as most seem to think.

    As a percentage this works out to substantially more than the typical 20% royalty. And I believe is a better long term bet than an outright sale which some have asked for as any immediate sale would significantly undervalue the Technosphere platform.

  • lakers_w lakers_w Oct 7, 2014 3:22 PM Flag

    I think part of it was you have to know diabetes and I think at that time Pfizer really didn’t and two, you know, devices have a massive impact on product use. I mean, you know, if I go back to my old days selling Seretide Advair I think you’d probably find that the original sale projections for Seretide Advair are nowhere near what that product has achieved largely because the diskus inhaler ended up being such a big factor.
    And here, you know, you’ve got a much different device whereas the Exubera device was a brick like object. Here you’ve got something that looks like a breath spray that you might have. So, from an ease of use point of view, you know, you take a quick puff before lunch or a meal time and, you know, there’s a very rapid onset and a very rapid offset.
    Now when you actually start looking at A1C, see the actually A1C reduction doesn’t look all that exciting which is why people are sort of saying, well, you know, hey in terms of am I going to replace this with, you know, the short acting insulin out there? Maybe or maybe not, I think there is a big chunk of population level that don’t go on those products because they don’t want to take the injection but who needs something.
    So, you know, could you add this onto an oral? Could you add this onto a GLP1? That becomes a very easy thing for someone to do in fact. And you know, as I say this actually when you talk to Al Mann, you know, who’s put quite a lot of his own personal money behind this program. His excitement has always been that this behaves almost identically in terms of PK/PD to human insulin.

  • lakers_w lakers_w Oct 7, 2014 2:54 PM Flag

    being efficacious and safe. I think, the way we want to position Toujeo is you’ve got the safety and efficacy of Lantus with a benefit on hypoglycemia which is pretty simple straightforward and attractive. And especially because you’ve got a benefit on one of the key things that, you know, is a concern.
    And when you look at, for example, unlike respiratory when you initiate patients on insulin, so having waited that lost decade and you finally get them on, one of the most frustrating parts is that 50 percent will drop off insulin treatment in the first six months. You see the concern around hypoglycemia being much greater with primary care physicians than you do with diabetologists as an example.
    So, I think you have an argument, I think, with payers that, you know, if you can keep people on insulin longer and actually get to the right dose because the other problem we see is that you’ve got an awful lot of under dosing. Because of concern around that if you’ve got this PK/PD profile you could potentially get to, you know, a much more of a therapeutic dose that leads to better outcomes.
    And so I think, you know, and of course obviously pricing will come into it and we’ll have a look at that as we get closer to market but I think what you’re going to see is that hey if I can have this and this benefit, I mean, why wouldn’t I use it. And, you know, clearly we want to price this so that market access isn’t an issue.
    So, you know, I think the selling proposition is pretty straight forward.

  • lakers_w lakers_w Oct 7, 2014 2:48 PM Flag

    You know, you’ll probably get some people who say thank God I don’t have to take my shot anymore and I can just inhale. But I don’t necessarily say that that’s the only population nor do I think it’s necessarily the biggest potential population.
    Chris Viehbacher: The other thing I might just add about Afrezza is, and these are the words of, you know, of Al Mann but you know, unless you don’t eat something the risk of hypoglycemia is extremely small, right. Because if you take this before a meal and eat something because of this rapid onset and offset, you know, you’re not really going to have to worry about it.
    And when you look at -- when you talk to physicians the number one concern about putting someone on insulin is hypoglycemia. And you know, this could be well seen as something that, you know, is in that sense less of a concern for them. And that’s why we think sort of this pre-insulin market might be interesting.
    Richard Vosser: This person does have second question on M&A but perhaps I could just add in as we’re talking about diabetes just about Toujeo and how you’re thinking about that franchise? Clearly you’ve mentioned the hypoglycemia benefit with Afrezza and Toujeo has a hypoglycemia benefit over Lantus.
    But we’ve seen one of -- what with GSK that the payers getting involved in this -- in situations of upgrade here with Breo versus Advair has sort of maybe changed the market. Do you think that’s something that we should think about in terms of the insulin franchise and the switch or the roll out of Toujeo going forward?
    Chris Viehbacher:Well I think there’s a, you know, a number of differences. I haven’t really, you know, my knowledge of Breo was way back in the development days. And so I really wouldn’t want to comment on that specific launch. I think there is differences between the respiratory and the diabetes market.
    I mean I think the first is that in the asthma market you’ve got quite a wide range of alternatives and largely they’re seen as being

  • lakers_w lakers_w Oct 7, 2014 2:31 PM Flag

    And so -- and that’s why, you know, human insulin actually works in the way that it does is that it prevents the glucose levels from ever getting so high in the first place. And as rapid acting as some of the injectables are they’re not as rapid acting as this. This is basically an hour, I think, onset and an hour offset. And so I think, you know, we are busy in a prelaunch mode looking at that but I think -- I don’t think I would look at this as simply saying are we going to go try to take a piece of the rapid acting insulin market.
    I think because of the ease of use, the elegance of the device, the way it mimics human insulin I think one can think of this in a broader way and that is what is actually behind the forecast of the people who have invested in Mannkind. Now, you know, I think this is one where let’s get it to market personally I think if you can have an easy to use inhaled product there are plenty of people who don’t like needles we know that from the business that we’re in.
    Now once you’ve got them on a needle and you’ve got that efficacy maybe they continue and maybe at that point because they’re more advanced you really want that strong A1C reduction. But, you know, I think the interesting thing that we saw is that this is potentially a way that has escaped us for many years is potentially seeing earlier insulin use because people really push this off until the last minute and they probably have done themselves an awful lot of harm because they’re not really controlling their diabetes well enough through that pre-insulin time frame.
    So, that’s the thing that we’re looking at, you know, we -- we’ll give you some more as we go back through but as we did the deal we started looking at this as a potentially a little different concept then just kind of, you know, taking the market share as I say of the -- now there’ll probably be some of that.

  • We’ve got a very interesting product with Afrezza. You know, I think this is going to be an interesting product. This is a, you know, this isn’t one that just goes and tries to take an injectable market. You’re talking about a product in a very easy to use inhaler that actually behaves very close to normal insulin to your own insulin. And there’s going to be a whole story around looking at excursions on glucose levels.
    And probably a very interesting product that, you know, will help to bridge the lost decade, you know, essentially between the time your oral medicines stop working and you finally go on insulin there’s often 10 years gets lost. And within that 10 year period we see quite a significant opportunity for this.

    Richard Vosser: I do have an e-mail question with two questions in. So, we’ll go for that before taking the lines. The first question is really on Afrezza and the question is the market has completely ignored Afrezza and probably discounting it after the Exubera disaster.
    So, what have you seen in Afrezza that you think it’s going to be a success and not end up like Exubera? And perhaps I’d just add on to that you seem to talk, if I got it correctly about targeting a different part of the market than sort of normal insulin. I don’t know whether I got that correctly but that’s the question.

    Chris Viehbacher: So, I mean I would say the market for Sanofi shares is largely discounting Afrezza. If you look at the market cap of Mannkind is clearly another group of investors that
    clearly have valued this differently and I, you know, I guess we’ll have to wait and see when we start selling this what the answer is.
    This is clearly a different model and there’s no question that, you know, the memories are of Exubera are there. I think there’s a couple of differences. First, is you know, we’ve been -- and remember Sanofi is the company that sold Exubera for I think $1.2 billion to Pfizer at the time.

  • Reply to

    Sanofi and Afrezza

    by speedbirdd Oct 6, 2014 1:57 PM
    lakers_w lakers_w Oct 6, 2014 8:52 PM Flag

    We’ve got a very interesting product with Afrezza. You know, I think this is going to be an interesting product. This is a, you know, this isn’t one that just goes and tries to take an injectable market. You’re talking about a product in a very easy to use inhaler that actually behaves very close to normal insulin to your own insulin. And there’s going to be a whole story around looking at excursions on glucose levels.
    And probably a very interesting product that, you know, will help to bridge the lost decade, you know, essentially between the time your oral medicines stop working and you finally go on insulin there’s often 10 years gets lost. And within that 10 year period we see quite a significant opportunity for this.

  • Reply to

    Sanofi and Afrezza

    by speedbirdd Oct 6, 2014 1:57 PM
    lakers_w lakers_w Oct 6, 2014 8:50 PM Flag

    one of the key things that, you know, is a concern.
    And when you look at, for example, unlike respiratory when you initiate patients on insulin, so having waited that lost decade and you finally get them on, one of the most frustrating parts is that 50 percent will drop off insulin treatment in the first six
    Page 14
    months. You see the concern around hypoglycemia being much greater with primary care physicians than you do with diabetologists as an example.
    So, I think you have an argument, I think, with payers that, you know, if you can keep people on insulin longer and actually get to the right dose because the other problem we see is that you’ve got an awful lot of under dosing. Because of concern around that if you’ve got this PK/PD profile you could potentially get to, you know, a much more of a therapeutic dose that leads to better outcomes.
    And so I think, you know, and of course obviously pricing will come into it and we’ll have a look at that as we get closer to market but I think what you’re going to see is that hey if I can have this and this benefit, I mean, why wouldn’t I use it. And, you know, clearly we want to price this so that market access isn’t an issue.

    So, you know, I think the selling proposition is pretty straight forward.

    You know, I think there’s 2015 will be a year where this is going to be trickier. I mean there’s going to be with six launches we’re going to have to fund those but equally, you know, I think there are opportunities first for some cost reduction. I think also we’ll probably end up scaling some of these launches.
    Some of them don’t actually necessarily cost more. I mean a Toujeo, for example, is largely going to I think be able to use the resource that we have for Lantus. Some of it, you know, for instance say the Afrezzas of this world actually help us to kind of boost some of the spending because our share of voice is becoming there. So I think, you know, we’ll try to use new revenues to do this.

  • Reply to

    Sanofi and Afrezza

    by speedbirdd Oct 6, 2014 1:57 PM
    lakers_w lakers_w Oct 6, 2014 8:45 PM Flag

    Chris Viehbacher: The other thing I might just add about Afrezza is, and these are the words of, you know, of Al Mann but you know, unless you don’t eat something the risk of hypoglycemia is extremely small, right. Because if you take this before a meal and eat something because of this rapid onset and offset, you know, you’re not really going to have to worry about it.
    And when you look at -- when you talk to physicians the number one concern about putting someone on insulin is hypoglycemia. And you know, this could be well seen as something that, you know, is in that sense less of a concern for them. And that’s why we think sort of this pre-insulin market might be interesting.
    Richard Vosser: This person does have second question on M&A but perhaps I could just add in as we’re talking about diabetes just about Toujeo and how you’re thinking about that franchise? Clearly you’ve mentioned the hypoglycemia benefit with Afrezza and Toujeo has a hypoglycemia benefit over Lantus.
    But we’ve seen one of -- what with GSK that the payers getting involved in this -- in situations of upgrade here with Breo versus Advair has sort of maybe changed the market. Do you think that’s something that we should think about in terms of the insulin franchise and the switch or the roll out of Toujeo going forward?
    Chris Viehbacher:Well I think there’s a, you know, a number of differences. I haven’t really, you know, my knowledge of Breo was way back in the development days. And so I really wouldn’t want to comment on that specific launch. I think there is differences between the respiratory and the diabetes market.
    I mean I think the first is that in the asthma market you’ve got quite a wide range of alternatives and largely they’re seen as being efficacious and safe. I think, the way we want to position Toujeo is you’ve got the safety and efficacy of Lantus with a benefit on hypoglycemia which is pretty simple straightforward and attractive. And especially because you’ve got a benefit on

  • Reply to

    Sanofi and Afrezza

    by speedbirdd Oct 6, 2014 1:57 PM
    lakers_w lakers_w Oct 6, 2014 8:36 PM Flag

    And so -- and that’s why, you know, human insulin actually works in the way that it does is that it prevents the glucose levels from ever getting so high in the first place. And as rapid acting as some of the injectables are they’re not as rapid acting as this. This is basically an hour, I think, onset and an hour offset. And so I think, you know, we are busy in a prelaunch mode looking at that but I think -- I don’t think I would look at this as simply saying are we going to go try to take a piece of the rapid acting insulin market.

  • Reply to

    Sanofi and Afrezza

    by speedbirdd Oct 6, 2014 1:57 PM
    lakers_w lakers_w Oct 6, 2014 8:32 PM Flag

    I think part of it was you have to know diabetes and I think at that time Pfizer really didn’t and two, you know, devices have a massive impact on product use. I mean, you know, if I go back to my old days selling Seretide Advair I think you’d probably find that the original sale projections for Seretide Advair are nowhere near what that product has achieved largely because the diskus inhaler ended up being such a big factor.
    And here, you know, you’ve got a much different device whereas the Exubera device was a brick like object. Here you’ve got something that looks like a breath spray that you might have. So, from an ease of use point of view, you know, you take a quick puff before lunch or a meal time and, you know, there’s a very rapid onset and a very rapid offset.
    Now when you actually start looking at A1C, see the actually A1C reduction doesn’t look all that exciting which is why people are sort of saying, well, you know, hey in terms of am I going to replace this with, you know, the short acting insulin out there? Maybe or maybe not, I think there is a big chunk of population level that don’t go on those products because they don’t want to take the injection but who needs something.
    So, you know, could you add this onto an oral? Could you add this onto a GLP1? That becomes a very easy thing for someone to do in fact. And you know, as I say this actually when you talk to Al Mann, you know, who’s put quite a lot of his own personal money behind this program. His excitement has always been that this behaves almost identically in terms of PK/PD to human insulin.
    And what you really want to do is during that meal time is the microvascular
    problems are often felt to be as a result of some of the excursions from the norms of where glucose levels should go. And, you know, A1C will certainly manage this on a
    Page 12
    longer term basis but on a day to day basis if you are continuously exceeding those normal bounds you’re probably creating some damage.

  • lakers_w lakers_w Oct 6, 2014 6:56 PM Flag

    Unilife has granted Sanofi non-exclusive access to its wearable injector technology during the agreement. Unilife maintains the right to enter into supply agreements with other pharmaceutical companies for the use of its wearable injectors, so long as Sanofi's non-exclusive access is preserved. Sanofi also has the option to extend the agreement for additional periods. In addition to an upfront payment and device sales, Unilife anticipates it will receive approximately $50 million from customization programs relating to Sanofi molecules and indications. Additional revenue is also expected from customization programs conducted under joint collaborations with Sanofi partners. Unilife will begin to generate revenue from Sanofi this fiscal year from an upfront payment, customization programs and initial commercial sales of the devices to Sanofi. Unilife and Sanofi will also collaborate in the development of other new technologies that address additional unmet or emerging needs for the delivery of large dose volume biologics. Additional information will remain confidential at this time.

    Mr. Alan Shortall, Chairman and Chief Executive Officer of Unilife said: "Unilife continues to advance our lead position in the fast-growing market for wearable injectors, a market which is expected to generate $8 billion in sales at an average $25 per unit by 2025. Based upon public information and industry forecasts, Unilife estimates that Sanofi has between 5 to 10 molecules that will be delivered in wearable injectors. With many pharmaceutical companies having up to a dozen large dose volume biologics that will each require an average of five million units per drug per year, our wearable injectors are poised to generate substantial revenue and growth moving forward. Additionally, we anticipate substantial incremental revenue will be generated from customization programs conducted under joint collaborations with Sanofi partners that choose to participate," Mr. Shortall concluded.

SNPS
40.98+0.21(+0.52%)Oct 31 4:00 PMEDT

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