Pfizer and Exubera

[Howard]

Exubera is Ihhaleable Insulin for some type 2 Diabetics, it may mean that some can give up taking injections and inhale their medication.

Hank Mc Kinnell, CEO,of Pfzier mistakenly said that they have received FDA Approval, which they haven't, but maybe it is close.

Pfizer needs a kick in the butt, maybe this can do what Viagra did?

I own Pfizer.

 

[Martha]

I wonder how much it matters. The real "pain" for diabetics is the blood testing more than the insulin shots.

 

[Howard]

Martha, ever tried to board a Plane or go through Customs with a Syringe??

 

[Martha]

Martha, ever tried to board a Plane or go through Customs with a Syringe??

Good point, but will that really effect the market? Where is Steve? He might have some thoughts on this.

 

[brewer12345]

More importantly, will the payors cover what is sure to be a premium priced product?

 

[cute fuzzy bunny]

Based on my recent experience with Lunesta, no. I am required to try two cheaper, established products and document how they dont work as well before blue cross will start the process of considering paying for it.

Considering the two they want me to try cost 13c and 15c a pill vs three bucks for lunesta, I guess I see their point.

 

[SteveR]

What the CEO meant to say was that Exubera was approved in the EU by EMEA (the EU FDA).  This is very common since FDA tends to take longer to review, longer to comment and finds more hoops for manufacturers to jump through than EMEA.  Pfizer will most likely add the EU post market data to their data packets for FDA so FDA will have more real data on efficacy to look at before they say yes or no.  This usually takes 6-12 months after EMEA approval; maybe more depending on the current political climate at FDA and what else they screwed up recently.

Insulin is a HUGE protein molecule and the only two ways to get it into the blood stream successfully has been oral (low efficacy) and injection via shot or via pump.  The inhalation route is an interesting one but it has its own set of unique drug delivery issues.  Lung function is a key issue.  Smokers and anyone with any lung function issues cannot use this drug.  The drug will actually reduce lung function so the doctors are going to have to prescreen people for it and then monitor over time.  The long term effects of this kind of treatment are of concern.

As for blood sugar testing.  There are a variety of less painful instruments on the market that take a tiny bit of blood from the lower arm instead of the fingers.  This is far less painful and is just as accurate for most people.  

 

[SteveR]

Based on my recent experience with Lunesta, no.  I am required to try two cheaper, established products and document how they dont work as well before blue cross will start the process of considering paying for it.

Considering the two they want me to try cost 13c and 15c a pill vs three bucks for lunesta, I guess I see their point.

CFB,
I too am struggling with the Lunesta issue with insurance providers. I have already gone through every other sleep aid known to man and this is the only one that was consistently worked for me with out feeling a hangover all the next day or waking up in the middle of the night and not being able to go back to sleep.

 

[cute fuzzy bunny]

We'll see how it goes with me. My biggest problem is my doctors lazy staff who take weeks and months to do things that should take minutes. I was told the other day that the six weeks i've waited was for them to successfully make one phone call to ask blue cross if they'd cover it, and to be told about needing to try two other covered options. "Well, they kept putting me on hold and I have other stuff to do".

You'd think I'm the first person they tried to prescribe a non covered med to.

Service is dead.

To compound the matter, my wife personally knows the doctor, works with him, and his staff knows this.

Funny thing is, everything else is an automatic non-starter. Lunesta is the ONLY product that the manufacturer recommends for use over 7-10 days. I've had insomnia for 20 years. Do the math peoples!

 

[SteveR]

News Flash,

FDA has approved Exubera. They issued an official Approval letter to Pfizer today. That opens up both the EU and US markets for this drug.