Diabetesmine article about Dance Biopharm mentions afrezza
Nov 3, 2018 8:36:26 GMT -5
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Post by tomtabb on Nov 3, 2018 8:36:26 GMT -5
www.healthline.com/diabetesmine/dance-inhaled-insulin-new-CEO#2
A new generation of inhaled insulin is inching closer to market, as a little-known biopharmaceutical company is gearing up for late-stage clinical research and FDA filing, and has just hired a seasoned CEO to lead commercialization efforts.
You may remember Dance Biopharm, the San-Francisco area startup that came on the scene in roughly 2010, after Pfizer's failed "bong-style" Exubera inhaled insulin was pulled from market and when MannKind's Afrezza was still in development. This startup has been working to create a whole new type of inhaled insulin for almost a decade.
The company is now making headlines with its recent hiring of former Sanofi exec Anne Whitaker, who's quite familiar with the inhaled insulin universe and the business side of bringing new medicines to market. She's based in North Carolina, where Dance Biopharm is actually preparing to relocate its HQ in the coming months. They'll stay on the West Coast for research, but the execs will be on the East Coast while Dance also prepares to open offices in China and England before long.
“We have been off the radar, one might say working in stealth mode. But when you look at the progress made, it’s notable. All of those things coming together… now is the time to bring this forward," Whitaker says of their novel product currently dubbed Dance 501 (the internal working name).
In a recent phone chat, Whitaker gave us the low-down on why she joined the Dance team and what we can expect in the next couple of years. But first, let's take a look at this new inhaled insulin, and what advantages it offers to patients.
The FDA will review and approve any proposed product brand name for this new inhaled insulin, which some refer to as Generation 3.0. Here's a look at the properties of what's still known as Dance 501:
Soft Mist: Unlike Afrezza insulin by MannKind that is an inhalable white powder, Dance 501 is a mist formulation, i.e. an ultra-concentrated recombinant insulin that requires only a few drops that are vaporized into mist form as you breath it deep into the lungs through a small handheld device.
Pure: Unlike other insulins, this product is preservative-free, which is important for the 1-2% of PWDs who actually have allergies to insulin – creating issues ranging from insulin site rashes to anaphylactic shock. It comes in liquid form in a small bottle, which is used to fill the handheld device just prior to each dose.
Handheld Inhaler: Small and easy to use, it's about the size of an old-school beeper that can fit into a pants pocket. This is quite different than early prototypes we saw; in December 2017 the company teamed up with industrial designer Phillips-Medisize for a revamped version. The result is an electronic inhaler that uses patented vibrating mesh technology designed to produce consistently-sized particles of liquid insulin in the form of a soft mist. (Fun fact: there are 120,000 vibrations in one second!). The device is breath-activated and it only takes a few breaths to inhale the Dance 501 insulin mist, with a green light indicating you're breathing in the mist appropriately before a blue light on the device flashes to indicate you’ve finished. Whitaker says they've recently sent the FDA their design recommendations for the initial device and expect to hear regulatory feedback by early November.
Next-Gen Inhaler Device: While the first generation uses a pair of AA batteries, Whitaker says that will likely change as quickly as six months after launch with a second-gen rechargeable device. That will reduce the size and weight of the device by 50%, to look more like a Chanel Lipstick tube.
Faster Acting: Whitaker says Dance 501 is faster acting than traditional insulins (Humalog, specifically) and improves upon Afrezza inhaled insulin, because the insulin action peaks just as quickly but has a "longer tail" that more closely mimics the body's natural reaction without a need for follow-up doses. Phase II studies are showing few hypos and very little cough from those using this inhaled insulin mist, which goes more naturally into the lungs without irritating the throat.
Data Tracking & Connectivity: Since the inhaler device is basically a little computer, it records insulin use data such as dosage amounts, when taken, rate of inhalation, insulin dosage amounts, and how much mist actually goes into the lungs based on breathing depth. Dance also plans to launch a mobile app for the smartphone containing that same data, for patients to view along with healthcare providers, and eventually to connect with other D-devices like CGMs and data platforms. All of that is unique, since other inhaled insulin devices to date haven't offered tracking or device connectivity.
R&D Timing: As exciting as Dance 501 may be, patience will be a virtue here... we're talking at least a few years out, if not longer. Dance has published early clinical research over the past several years, and that continues with Phase II trials ongoing through what it expects to be mid-2019. From there, they expect to begin late-stage Phase III trials in 2020 and probably get to the regulatory filing point by the end of that year. Of course, funding is key to all of this, so timing may vary depending on that, as well as whatever the research shows and what regulators eventually say.
Pricing: Whitaker also says the are still studying price-point and cost. She doesn't believe Dance 501 will be "an outlier for existing insulins today," but by going global instead of just US, that will help offset prices for patients. Of course they also plan to work with payers before moving to market.
Liquid Formulation, Too: Just because Dance is developing this mist-form of inhaled insulin, that doesn’t mean they aren’t also looking at a liquid version for use in a vial/syringe, pen, or insulin pump, similar to the traditional brands on the market now, Whitaker tells us.
Very exciting, but of course we impatient patients can't help wondering: What the heck has taken so long to get to this point, and why are we still years away from seeing this product from Dance?
A new generation of inhaled insulin is inching closer to market, as a little-known biopharmaceutical company is gearing up for late-stage clinical research and FDA filing, and has just hired a seasoned CEO to lead commercialization efforts.
You may remember Dance Biopharm, the San-Francisco area startup that came on the scene in roughly 2010, after Pfizer's failed "bong-style" Exubera inhaled insulin was pulled from market and when MannKind's Afrezza was still in development. This startup has been working to create a whole new type of inhaled insulin for almost a decade.
The company is now making headlines with its recent hiring of former Sanofi exec Anne Whitaker, who's quite familiar with the inhaled insulin universe and the business side of bringing new medicines to market. She's based in North Carolina, where Dance Biopharm is actually preparing to relocate its HQ in the coming months. They'll stay on the West Coast for research, but the execs will be on the East Coast while Dance also prepares to open offices in China and England before long.
“We have been off the radar, one might say working in stealth mode. But when you look at the progress made, it’s notable. All of those things coming together… now is the time to bring this forward," Whitaker says of their novel product currently dubbed Dance 501 (the internal working name).
In a recent phone chat, Whitaker gave us the low-down on why she joined the Dance team and what we can expect in the next couple of years. But first, let's take a look at this new inhaled insulin, and what advantages it offers to patients.
The FDA will review and approve any proposed product brand name for this new inhaled insulin, which some refer to as Generation 3.0. Here's a look at the properties of what's still known as Dance 501:
Soft Mist: Unlike Afrezza insulin by MannKind that is an inhalable white powder, Dance 501 is a mist formulation, i.e. an ultra-concentrated recombinant insulin that requires only a few drops that are vaporized into mist form as you breath it deep into the lungs through a small handheld device.
Pure: Unlike other insulins, this product is preservative-free, which is important for the 1-2% of PWDs who actually have allergies to insulin – creating issues ranging from insulin site rashes to anaphylactic shock. It comes in liquid form in a small bottle, which is used to fill the handheld device just prior to each dose.
Handheld Inhaler: Small and easy to use, it's about the size of an old-school beeper that can fit into a pants pocket. This is quite different than early prototypes we saw; in December 2017 the company teamed up with industrial designer Phillips-Medisize for a revamped version. The result is an electronic inhaler that uses patented vibrating mesh technology designed to produce consistently-sized particles of liquid insulin in the form of a soft mist. (Fun fact: there are 120,000 vibrations in one second!). The device is breath-activated and it only takes a few breaths to inhale the Dance 501 insulin mist, with a green light indicating you're breathing in the mist appropriately before a blue light on the device flashes to indicate you’ve finished. Whitaker says they've recently sent the FDA their design recommendations for the initial device and expect to hear regulatory feedback by early November.
Next-Gen Inhaler Device: While the first generation uses a pair of AA batteries, Whitaker says that will likely change as quickly as six months after launch with a second-gen rechargeable device. That will reduce the size and weight of the device by 50%, to look more like a Chanel Lipstick tube.
Faster Acting: Whitaker says Dance 501 is faster acting than traditional insulins (Humalog, specifically) and improves upon Afrezza inhaled insulin, because the insulin action peaks just as quickly but has a "longer tail" that more closely mimics the body's natural reaction without a need for follow-up doses. Phase II studies are showing few hypos and very little cough from those using this inhaled insulin mist, which goes more naturally into the lungs without irritating the throat.
Data Tracking & Connectivity: Since the inhaler device is basically a little computer, it records insulin use data such as dosage amounts, when taken, rate of inhalation, insulin dosage amounts, and how much mist actually goes into the lungs based on breathing depth. Dance also plans to launch a mobile app for the smartphone containing that same data, for patients to view along with healthcare providers, and eventually to connect with other D-devices like CGMs and data platforms. All of that is unique, since other inhaled insulin devices to date haven't offered tracking or device connectivity.
R&D Timing: As exciting as Dance 501 may be, patience will be a virtue here... we're talking at least a few years out, if not longer. Dance has published early clinical research over the past several years, and that continues with Phase II trials ongoing through what it expects to be mid-2019. From there, they expect to begin late-stage Phase III trials in 2020 and probably get to the regulatory filing point by the end of that year. Of course, funding is key to all of this, so timing may vary depending on that, as well as whatever the research shows and what regulators eventually say.
Pricing: Whitaker also says the are still studying price-point and cost. She doesn't believe Dance 501 will be "an outlier for existing insulins today," but by going global instead of just US, that will help offset prices for patients. Of course they also plan to work with payers before moving to market.
Liquid Formulation, Too: Just because Dance is developing this mist-form of inhaled insulin, that doesn’t mean they aren’t also looking at a liquid version for use in a vial/syringe, pen, or insulin pump, similar to the traditional brands on the market now, Whitaker tells us.
Very exciting, but of course we impatient patients can't help wondering: What the heck has taken so long to get to this point, and why are we still years away from seeing this product from Dance?
